AGAINST THE : EXEMPTION OF PHARMACEUTICAL PATENT RIGHTS AS A STRATEGY

Taiwo A. Oriola*

I. INTRODUCTION Acts of involve threats to use or use of weapons of mass destruction to kill, maim, or destroy property by individuals, groups, or states1 mainly on political grounds, and for maximum political effects.2 Terror attacks are characterized by stealth, indiscriminate violence, and destruction meant to heighten people’s fears and concerns for their lives and property.3 As terrorism has increased, so have the number of counterterrorism strategies by governments around the world.4 However, terrorism is as old as mankind.5

* Cardiff Law School, and the ESRC Centre for Business Relationships, Accountability, Sustainability, & Society, University of Cardiff, United Kingdom. 1. An early example of a state-sponsored terrorist was the Roman emperor Nero, who ruled by fear, slaughtered many members of the nobility, and has been blamed for the burning of Rome. CINDY C. COMBS & MARTIN SLANN, ENCYCLOPEDIA OF TERRORISM 201 (2002). Dysfunctional or anarchistic individuals or groups acting alone or in concert can perpetrate terrorist attacks. See Jonathan Glover, State Terrorism, in VIOLENCE, TERRORISM, AND JUSTICE 256, 257-60 (Raymond G. Frey & Christopher W. Morris eds., 1991) (contrasting historical state and independent terrorists, highlighting essential features of state-sponsored terrorism, and explaining why states commit acts of terrorism). 2. Political motivation has been described as “a necessary component to a definition of terrorism.” COMBS & SLANN, supra note 1, at 211. For examples of statutory definitions of terrorism, see Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA ) Act of 2001, Pub. L. No. 107-56, § 802, 115 Stat. 272, 376; Security Legislation Amendment (Terrorism) Bill, 2002, c. 5, § 100.1, sched. 1 (Austl.); Anti-Terrorism Act, 2001 S.C., ch. 41, § 83.01 (Can.); Herbert K. Tillema, A Brief Theory of Terrorism and Technology, in SCIENCE AND TECHNOLOGY OF TERRORISM AND COUNTERTERRORISM 13, 14-16 (Tushar K. Ghosh et al. eds., 2002). 3. See Avraham Bleich, Marc Gelkopf, & Zahava Solomon, Exposure to Terrorism, Stress-Related Mental Health Symptoms, and Coping Behaviors Among a Nationally Representative Sample in Israel, 290 JAMA 612, 612 (2003) (concluding that although “the survey participants showed distress and lowered sense of safety, they did not develop high levels of psychiatric distress, which may be related to a habituation process and to coping mechanism”); Press Release, Harvard Sch. of Pub. Health, Survey Shows Incidents Have Impact on People’s Worries and Behaviors in Three Cities Where Reported (Dec. 17, 2001), available at http://www.hsph.harvard.edu/news/press-releases/2001-releases/press12172001.html (revealing that the in the had an impact on the behavior of individuals living in the three affected cities); Frontline: Plague War (PBS televeion broadcast Oct. 13, 1998) [hereinafter Frontline] (“Infectious agents are and will continue to be that mysterious source of great panic . . . [a]nd while bombs clearly can create panic, infectious diseases almost spread it.”). 4. See generally NEIL C. LIVINGSTONE, THE CULT OF COUNTERTERRORISM: THE “WEIRD WORLD” OF SPOOKS, COUNTERTERRORISTS, AND NOT-QUITE PROFESSIONALS 293-315 (1989) (discussing the

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Terrorism is often excused, for right or for wrong, as a reaction to perceived or actual religious, proprietary, or political subjugation, the desire to be rid of an army of occupation, or a quest for a sovereign state.6 Ultimately, all acts of terror have political, ideological, economic or religious connotations.7 However, the borderline between acts of legitimate resistance and terrorism is vulnerable to semantic crisis when considering aspirations for self- determination and socioeconomic justice.8 Still, terrorism is inexcusable no matter the political, economic, or religious motivations of its perpetrators, and is rightly deplored and criminalized, especially in light of the innumerable non- violent means available for settling grievances and disputes domestically and internationally in contemporary times.9 It is moot that no state condones terrorism. In the wake of the September 11, 2001 terrorist attacks on the United States, many countries, including , the United Kingdom, Canada, and the United States, either enacted new anti-terrorism laws, or strengthened existing counterterrorism measures and legislation.10 For instance, in 2005, the United Kingdom Parliament enacted a new anti-terror measure over strong opposition both from within Parliament and the civil society entitled “The Prevention of Terrorism Bill.”11

counterterrorism tactics used by various countries). 5. See WENDY BARNABY, THE PLAGUE MAKERS: THE SECRET WORLD OF 20-22 (2000) (tracing biological attacks to the ancient world when Persians, Greeks and Romans poisoned their enemies); VICTORIA SUTTON, LAW AND BIOTERRORISM 3-10 (2003) (tracing the history of biological attacks to Hammurabi’s code of “an eye for an eye,” and pointing out that the Tartars were the first to use biological weaponry when they allegedly catapulted plague-infected corpses over city walls); George W. Christopher et al., Biological Warfare; A Historical Perspective, in BIOLOGICAL WEAPONS 17, 17 (Joshua Lederberg, ed., 1999) (arguing that the deliberate use of microorganisms and to harm others has been practiced for centuries, and will likely continue into the future). 6. See Charles W. Maynes, All Political Violence is Not Terrorism, in TERRORISM: OPPOSING VIEWPOINTS 22, 23 (Bonnie Szumski ed., 1986) (arguing that the United States definition of terrorism may be too broad); Martin Oppenheimer, Terrorism is Sometimes Justified, in TERRORISM: OPPOSING VIEWPOINTS, supra, at 87-88 (arguing that some terrorism is born from injustice and oppression, and that if governments acted in a just and humane manner, terrorism would not exist); Jordan J. Paust, Terrorism as an International Crime, in INTERNATIONAL COOPERATION IN COUNTER-TERRORISM: THE UNITED NATIONS AND REGIONAL ORGANIZATIONS IN THE FIGHT AGAINST TERRORISM 25, 31 (Giuseppe Nesi, ed., 2006) (addressing whether certain forms of terrorism are permissible under international law and concluding that the use of terrorism in war against enemy combatants could be permissible, but that terrorist attacks against detainees and non- combatants are unlawful). 7. Cf. Maynes, supra note 6, at 22-25 (pointing out that not all violence motivated by these issues is necessarily terrorism). 8. See generally Shannon E. French, Murderers, Not Warriors: The Moral Distinction Between Terrorists and Legitimate Fighters in Asymmetric Conflicts, in TERRORISM AND INTERNATIONAL JUSTICE 31, 31-46 (James P. Sterba ed., 2003) (discussing examples of armed insurrections in search of political freedoms, and economic or social justice). 9. See William McGurn, Terrorism Is Never Justified, in TERRORISM: OPPOSING VIEWPOINTS, supra note 6, at 90-95 (arguing that while violence can be justified in war, terrorism cannot because it deliberately targets innocent civilians, and operates outside of the rules of just warfare). 10. E.g., United States Public Health and Bioterrorism Preparedness and Response Act of 2002, Pub. L. 107-188, 116 Stat. 594; USA PATRIOT ACT, Pub. L. No. 107-56, § 802, 115 Stat. 272, 376 (2001); Security Legislation Amendment (Terrorism) Bill, 2002, c. 5, § 100.1, sched. 1 (Austl.); The Official Secrets Act, 2001 S.C., c. 41 (Can.); An Act to Amend the Foreign Missions and International Organizational Act, 2001 S.C., c. 35 (Can.); U.K. Anti-Terrorism, Crime and Security Bill, 2001, Bill [49]. 11. See Blair Defends Anti-Terror Plans, BBC NEWS, Feb. 24, 2005, http://news.bbc.co.uk/1/hi/ uk_politics/4293067.stm (discussing criticism and passage by the House of Commons of Tony Blair’s anti-

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The proposed legislation would have allowed the British government to place suspected terrorists under house arrest without trial.12 To justify what he called “difficult issues for any government,”13 Prime Minister Tony Blair contended that “[t]here is no greater civil liberty than to live free from terrorist attack.”14 It has been observed that technology shapes terrorist attacks.15 While terrorists have traditionally relied on guns and bombs, there is a real possibility that in the future biological pathogens could become the weapons of choice for terrorists looking to inflict maximum civilian casualties.16 According to Interpol Chief Ronald Noble, the bioterrorism alarm is “real and it is continuing to ring.”17 The United States believes that Al Qaeda is seeking bioweapons.18 Documents recovered in Afghanistan in 2001 revealed that Al Qaeda had conducted extensive research into the use of biological weapons, along with other weapons of mass destruction.19 Experts have frequently warned of the high likelihood of a bioterrorism attack.20 The theoretical inevitability of bioterrorism is further underscored by the relative ubiquity of modern, cutting-edge biotechnology, necessitated partly by a recent spike in scientific pursuits of cures for infectious diseases.21 For instance, revolutionary techniques have facilitated the creation of terror plan). 12. See id. (noting that there was serious opposition to the plan). 13. See id. (noting that the plans were subjected to additional government criticism). 14. See id. (quoting a politician who accused Blair of “using national security for political point scoring”). 15. BARNABY, supra note 5, at 22-23. 16. See Ronald A. Greenfield et al., Pathogens as Biological Weapons and Agents of Bioterrorism, 323 AM. J. MED. SCI. 299 (2002) (noting that terrorists could use bacterial pathogens in bioterrorist attacks and that such pathogens are relatively easily to obtain); Katharine R. Meacham & Jo Ann T. Croom, Tricksters, The Plague, and Mirrors: Biotechnology, Bioterrorism, and Justice, in CROSS- CULTURAL BIOTECHNOLOGY 177, 179 (Michael C. Brannigan ed., 2004) (noting that terrorists may use genetic engineering techniques); Barry Kellman, Biological Terrorism: Legal Measures for Preventing Catastrophe, 24 HARV. J. L. & PUB. POL’Y 417, 427-429 (2001) (discussing the relative ease with which terrorists could perpetrate bioterrorism and the potential risk to civilian populations). This view is underscored by the relative ease with which the 2001 anthrax attacks in the United States were carried out via the postal service. Richard Hollingham, FBI Draws Blank in Anthrax Probe, BBC NEWS, Aug. 5, 2003, http://news.bbc.co.uk/1/hi/ world/americas/3125885.stm. 17. Interpol Sounds Bio-Terror Alarm, BBC NEWS, Feb. 23, 2005 http://news.bbc.co.uk/1/hi/world/ europe/4289485.stm. 18. See Michael R. Gordon, U.S.: Al Qaeda Was Building Lab for Bioweapons, CHI. TRIB., Mar. 24, 2002, at A6 (noting that documents recovered from Al Qaeda facilities indicated that Osama Bin Laden was pursuing a biological research program). 19. Robert Cottrell & Richard Wolffe, Safe Houses Yielding Documents on Weapons of Mass Destruction, FIN. TIMES, Nov. 23, 2001, at A10. 20. See Frontline, supra note 3 (warning in 1998 that all of the conditions necessary for bioterrorism already existed, including terrorists determined to employ biological pathogens on civilian populations, and that the materials necessary to construct biological pathogens were both readily available and relatively affordable). 21. See Stanley N. Cohen et al., Construction of Biologically Functional Bacterial Plasmids In Vitro, 70 PROC. NAT. ACAD. SCIS. U.S. 3240, 3240-44 (1973) (explaining that the genetic engineering revolution was triggered in 1973, when Stanley N. Cohen, Herbert W. Boyer, and others successfully transferred foreign genes into the E. coli bacterium, which enhanced E. coli’s ability to resist certain antibiotics). See generally Steven M. Block, The Growing Threat of Biological Weapons, 89 AM. SCIENTIST 28, (2001), available at http://www.americanscientist.org (discussing the increasing threat of biological weapons).

290 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 superbugs, raising anew the “dual-use” research dilemma22 and the specter of “black biology” tailored to terror goals.23 The dual-use research dilemma inherent in cutting-edge genetic engineering techniques was amply illustrated in 2005, when U.S. scientists at the Center for Disease Control (“CDC”) in , Georgia recreated the 1918 influenza from its published full genome sequence.24 Furthermore, in 2003, United States scientists genetically engineered an extremely potent form of mousepox, a family of virus.25 Moreover, in 2001, Australian scientists, using bioengineering techniques, inadvertently created a superpox that killed mice by crippling their immune system.26 In the wake of recent coordinated global terror attacks, there is a real fear that these pathogenic recipes could fall into terrorists’ hands, thus potentially facilitating the concoction of a broad range of “designer diseases” ranging from a monstrous superpox to an engineered influenza virus species that may be impervious to all known vaccines and drugs.27 The possibility that potent recombinant viral agents or deadly life forms could be created by accident and even from scratch28 has heightened the specter of abuse by rogue scientists, who might sell such technology to unscrupulous clients or terrorists.29 In 2003, a South African scientist, who had worked at a secret bioweapon facility in apartheid-era South Africa, attempted to sell a cluster of genetically engineered, deadly pathogens to the United States government.30 According to

22. See NAT’L RESEARCH COUNCIL, BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM: CONFRONTING THE DUAL USE DILEMMA 15 (2004) (noting that although molecular biology and genetics have many positives, there is a real “possibility that the technologies could also be used to create the next generation of biological weapons. Biotechnology represents a ‘dual-use’ dilemma in which the same technologies can be used legitimately for human betterment and misused for bioterrorism.”). 23. See INT’L COMM. OF THE RED CROSS, REPORT ON “BIOTECHNOLOGY, WEAPONS AND HUMANITY” (2003), available at http://www.icrc.org/Web/Eng/siteeng0.nsf/iwpList515/962391D638B22A29C1256E5 50053DEC0 (noting that many have grave concerns about biological weapon proliferation); Peter Aldhous & Michael Reilly, Bioterror Special: Friend Or Foe?, NEW SCIENTIST, Oct. 14, 2006, at 20, 21 (noting that U.S. academic labs are allegedly engaging in a variety of experiments that may incidentally produce bioweapons); Block, supra note 21 (explaining that “Black Biology” is a shadowy science in which microorganisms are genetically modified for the sole purpose of creating novel weapons of terror or “designer diseases” such as “penicillin-resistant anthrax” or “stealth ” that can not be countered by known vaccines and antibiotics). 24. Terrence M. Tumpey et al., Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus, 310 SCIENCE 77, 77-80 (2005); Andreas Von Bubnoff, The 1918 Flu Virus is Reconstructed, 437 NATURE 794, 794-95 (2005). 25. Deborah Mackenzie, U.S. Develops Lethal New Viruses, NEW SCIENTIST, Oct. 30, 2003, available at http://www.newscientist.com/news/news.jsp?id=ns99994318. 26. Paul Tait, Calls for Safeguards After Chance Killer Virus Find, REUTERS, Jan. 11, 2001, available at http://archives.foodsafety.ksu.edu/animalnet/2001/1-2001/an-01-11-01-01.txt. 27. Block, supra note 21; see also CENT. INTELLIGENCE AGENCY, THE DARKER BIOWEAPONS FUTURE 1 (2003), available at http://www.fas.org/irp/cia/product/bw1103.pdf. 28. E.g., David Whitehouse, First Synthetic Virus Created, BBC NEWS, July 11, 2002, http://news.bbc.co.uk/1/hi/sci/tech/2122619.stm (reporting that in July 2002, researchers at the State University of New York at Stony Brook announced that they had created a polio virus from scratch, using the genome sequence for polio). 29. Block, supra note 21; Paul Elias, WHO Recommends Smallpox Virus Alteration, USA TODAY, Nov. 12, 2004, available at http://www.usatoday.com/news/health/2004-11-11-smallpox_x.htm. 30. Joby Warrick & John Mintz, Lethal Legacy: Bioweapons for Sale: U.S. Declined South African Scientist’s Offer of Man-Made Pathogens, WASH. POST, Apr. 20, 2003, at A1.

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Washington Post reports, the scientist and his team had promised the U.S. government “scores of additional vials containing the bacteria that cause anthrax, plague, salmonella and botulism, as well as antidotes for many of the diseases. Several strains . . . had been genetically altered, a technique used by weapons scientists to make diseases harder to detect and defeat.”31 Following the well-publicized U.S. refusal to purchase the engineered pathogens, the South African scientist reportedly told The Washington Post that private individuals had shown interests in acquiring his deadly wares.32 There is thus a justifiable and growing concern that technologies that could potentially compromise national and international security could be easily obtained by terrorists.33 Curbing hostile use of biology is very problematic because the same knowledge serves both legitimate and illegitimate purposes.34 Some scholars contend that any malign uses of biology could not be simply avoided by allowing the technology to self-regulate via elements of forces.35 These scholars were also skeptical of the neo-Luddite clamp-down solution that would stop the biological revolution in its tracks.36 They proposed national and international regulatory oversight of civil and military biological researches to curb possible abuses.37 Effective and transparent global regulatory oversight is no easy task and could prove elusive, due to its propensity to become entangled in policy quagmires and the web of mutual distrust that continues to define relations between cold warriors and their allies.38 In addition to setting up the National Science Advisory Board for Biosecurity, a bioterror watchdog agency tasked to monitor dual use of biology,39 the United States’ answer to the dual use and diffusion of biological technology centers on two strategies. First, safeguards and security measures must be established to ensure that research into pathogens is legitimate, as well as to prevent domestic and international terrorists from obtaining them.40

31. Id. 32. Id. 33. NAT’L RESEARCH COUNCIL, supra note 22, at 15-16. 34. Mark Wheelis & Malcom Dando, Neurobiology: A Case Study of the Imminent Militarization of Biology, 87 INT’L REV. RED CROSS 553, 553-71 (2005). 35. See id. at 556 (disagreeing with Robert Carlson’s proposition that a “free-market” solution could stem black biology and ensure that biology will be used for benign purposes). Contra Robert Carlson, The Pace and Proliferation of Biological Technologies, 1 BIOSECURITY & BIOTERRORISM: STRATEGY, PRAC., & SCI. 203, 203-14 (2003) (arguing that a free-market solution would be effective). 36. Wheelis & Dando, supra note 34, at 566. 37. Wheelis & Dando, supra note 34, at 567. 38. A Radioactive Subject, ECONOMIST, Feb. 3, 2007, at 60 (noting that Russia’s foreign minister characterized as a “provocation” a recent Georgian sting operation against illicit trafficking in radioactive materials by a Russian citizen and his Georgian accomplices, although it reportedly netted close to eighty grams of highly enriched weapons-grade uranium.); Thom Shanker, Russia Criticizes U.S. Plan for Missile Defense System, N.Y. TIMES, Feb. 10, 2007, at A7. 39. NAT’L SCI. ADVISORY BD. FOR BIOSECURITY, CHARTER (2006), available at http://www.biosecurityboard.gov/charter.asp. 40. See generally Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, § 201, 116 Stat. 594, 637-46 (codified at 42 U.S.C. § 262a) (providing for oversight of the research and transfer of certain biological agents and toxins).

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Second, information generated by federally-funded research in science, technology and engineering at colleges, universities and laboratories must be classified.41 Both strategies present huge logistical problems, and are of limited practicality. First, effective policing of all known U.S. biological laboratories is practically impossible. Second, classifying, monitoring, and controlling sensitive research that is either not federally funded or is conducted in private labs outside of the United States, is beyond the United States’ jurisdiction. Third, classified information is still vulnerable to espionage, a prospect that may have prompted the United States’ controversial visa restriction policy on foreign researchers in the wake of the September 11, 2001 terrorist attacks.42 Internationally, the increasing ubiquity of biological weapons know-how, especially on the Internet,43 has rekindled a call for viable biosecurity strategies44 and precipitated stringent measures on chemical and biological agents’ governance in labs across the United States and around the world.45 It has also engendered concerted international efforts to stem the proliferation and trafficking of weapons of mass destruction, particularly in the Middle East and in the Commonwealth of Independent States composed of former Soviet republics.46 This Article analyzes the likely large-scale public health crises resulting

41. National Security Decision Directives 189, National Policy on the Transfer of Scientific, Technical and Engineering Information (Sept. 21, 1985), http://www.fas.org/irp/offdocs/nsdd/nsdd-189.htm. 42. See Edward Alden & Stephanie Kirchgaessner, Foreign Researchers Face Tight Curbs in U.S., FIN. TIMES, Nov. 25, 2005, at 7 (noting that the United States recently proposed stringent rules and measures that could restrict Chinese and other foreign researchers from engaging in high-level research). 43. See Mark Shwartz, Biological Warfare Emerges as 21st Century Threat, STAN. REP., Jan. 11, 2001, available at http://news-service.stanford.edu/news/2001/january17/bioterror-117.html (concluding that even though recipes for creating deadly pathogens are public knowledge, and are already in the public domain, “[t]he idea that anybody can brew this stuff in their garage vastly overstates the case”). 44. See Mathew Meselson, Averting the Hostile Exploitation of Biotechnology, 48 CBW CONVENTIONS BULL. 16, 19 (2000) (describing practical preventative measures against chemical and biological weapons); James W. Parrett, Jr., A Proactive Solution to the Inherent Dangers of Biotechnology: Using the Invention Secrecy Act to Restrict Disclosure of Threatening Biotechnology Patents, 26 WM. & MARY ENVTL L. & POL’Y REV. 145, 145-146 (2001) (suggesting that as a biosecurity measure, the United States’ Invention Secrecy Act should be used to prevent the disclosure of dangerous biotechnology patents); Susan Wright, Taking Biodefense Too Far, BULL. ATOMIC SCIENTISTS, Nov. – Dec. 2004, at 58, 61-62 (noting that the Bush Administration, in 2002, initiated the $5.6 billion “Project Bioshield” to develop new vaccines and treatments to protect against bioterrorist attacks and setup the National Biodefense Analysis and Countermeasures Center to counter bioterrorism). 45. National health authorities, meeting at the U.N.’s World Assembly, recently approved new measures to control smallpox research, including a prohibition against building the virus from scratch and stricter scrutiny of lab safety and possible bioterrorism risks when reviewing proposals for new research on smallpox. Bioterror Fears Drive New U.N. Smallpox Research Rules, REUTERS, May 21, 2005, available at http://www.sspconline.org/news_details.asp?news_id=ns238; see also United States Public Health and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, § 201, 116 Stat. 594 (imposing restrictions on research of certain biological agents). 46. Joby Warrick, U.S. to Aid Ukraine in Countering Bioweapons, WASH. POST, Aug. 30, 2005, at A11; see also JEANNE GUILLEMIN, BIOLOGICAL WEAPONS: FROM THE INVENTION OF STATE-SPONSORED PROGRAMS TO CONTEMPORARY TERRORISM 148-68 (2005) (discussing attempts to keep track of the proliferation of bioweapons in the wake of the cold war); David P. Fidler, International Law and Weapons of Mass Destruction: End of the Arms Control Approach?, 14 DUKE J. COMP. & INT’L L. 39, 79 (2004) (noting that the United States and other nations have worked with Russian authorities to secure nuclear, biological, and chemical weapons of the former Soviet Union, and to prevent their proliferation).

No. 2] AGAINST THE PLAGUE 293 from a bioterrorism attack. Due to the overly destructive effects on large civilian population in a comparatively shorter time span, bioterrorism-induced diseases could precipitate public health crises that are relatively grander in scale, and with arguably more debilitating effects on public health infrastructure than naturally occurring infectious diseases such as HIV/AIDS, dengue fever, tuberculosis, or malaria.47 The parallel drawn in this paper, between known incurable, epidemic diseases like HIV/AIDS and bioterrorism-inflicted diseases, should not be construed as a of the enormous devastation wrought by HIV/AIDS, malaria, and other pandemic diseases. This devastation is evidenced by their great toll on human lives and resources—especially in sub- Saharan Africa48 —and the continuing challenge they present to modern medicine and the global public healthcare infrastructure.49 Rather, the comparison between these naturally-occurring pandemic diseases and bioterrorism-induced diseases is drawn both to underscore the dramatic and fundamental differences between the respective diseases in the context of disease onset, rate, disease progression and possible or inevitable death. These fundamental differences arguably justify different public health policy responses to the two categories of pandemic diseases. A critical countermeasure to bioterror attacks is a responsive and viable public health system, an integral element of which is an adequate and timely supply of essential vaccines and drugs. The 2001 anthrax attacks in the United States, which nearly precipitated a run on Bayer’s antibiotic ciprofloxacin,50 demonstrated that the public health care system could fall short of critical medicines to either the infected or stem the spread of infectious pathogens such as smallpox, anthrax and the plague. This is especially so since experts in the United States have said that pre-exposure medical countermeasures—that is, inoculation—for civilian populations is unlikely,51 despite dissenting views that immunizations should ideally be given prior to an attack.52

47. Smallpox is believed to have killed more people than all past and present wars and epidemics. Elias, supra note 29. 48. According to the World Health Organization, “HIV/AIDS is now the leading cause of death and lost years of productive life for adults aged 15-59.” WORLD HEALTH ORG., THE WORLD HEALTH REPORT 2004: CHANGING HISTORY xi (2004), available at http://www.who.int/whr/2004/en/report04_en.pdf [hereinafter WORLD HEALTH ORG., CHANGING HISTORY]. Furthermore, recent research by scientists at Oxford has shown that the number of cases of the deadliest form of malaria across the world could be twice the number previously predicted. Global Toll of Malaria “Doubled”, BBC NEWS, Mar. 10, 2005, http://news.bbc.co.uk/1/hi/health/4332921.stm. 49. A new “super strain” of HIV resistant to all known therapies, and with swifter progression from HIV to AIDS was recently discovered, prompting concerns among experts that the disease might become intractable. Jessica Berman, New AIDS Strain Discovered in US, VOA NEWS.COM, Mar. 12, 2005, http://www.voanews.com/english/2005-02-13-voa28.cfm. According to Jay Dobkin, the infectious disease specialist of the State University of New York, “Many of us up here remember the dark days before there was any effective treatment for HIV. And I think the case . . . should be a reminder that those days could come back.” Id. 50. See Keith Bradsher, A Nation Challenged: The Antibiotic; Bayer Insists the Cipro Supply Is Sufficient; Fights Generic, N.Y. TIMES, Oct. 21, 2001, at 1B (reporting that several pharmacies run out of ciprofloxacin despite Bayer’s insistance that the supply was sufficient). 51. BARNABY, supra note 5, at 146-48. 52. Compare JIM TURNER ET AL., A BIODEFENSE FAILURE: THE NATIONAL SMALLPOX VACCINATION

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Time is of the essence in getting crucial drugs to victims of bioterrorism attacks to save as many lives as possible, and authorities should be able to mass-produce crucial drugs with minimal delay. Drug stockpiling is of limited practical value since most drugs and vaccines have limited shelf-life,53 and no one knows for sure when terrorists would strike. Moreover, drug stockpiling is not a feasible bioterrorism policy option for resource-poor countries that, unlike the United States and other wealthy nations,54 are already overwhelmed by HIV/AIDS, and lack functional public health infrastructures and the resources to stockpile bioterrorism-specific drugs for their populations.55 Nevertheless, securing crucial drugs in the shortest time possible for those infected in a bioterrorism attack is no less important than other public health preparedness measures. It would undoubtedly minimize loss of life and effectively contain further spread of diseases and mass hysteria.56 However, the high propensity for rights wrangling—as exemplified by the skirmishes over Bayer’s ciprofloxacin in the wake of the September 11, 2001 anthrax attacks in the United States57 —could stymie authorities’ efforts to mass produce or parallel import crucial patented drugs within the shortest time possible, especially in resource-poor countries of Africa, , and Latin America. This makes an effective bioterrorism-specific pharmaceutical patent appropriation clause in international and national patent laws bereft of the bureaucratic trappings of the contemporary patent regime, and the TRIPS access to medicines paradigms. There is a plethora of literature on public health preparedness in

PROGRAM ONE YEAR LATER 3 (2004), available at http://biotech.law.lsu.edu/blaw/bt/smallpox/Congress/ 040129_ABiodefenseFailureOneYearLater.pdf, (indicating that without specific information about an attack, mass public vaccination prior to an attack would be unwise), and Martin Enserink, How Devastating Would a Smallpox Attack Really Be?, 296 SCIENCE 1592, 1592 (2002), available at http://www.sciencemag.org/cgi/reprint/296/5573/1592.pdf (“Because the vaccine can have serious and sometimes deadly side effects, CDC’s current plan is to use it only during an outbreak and give it just to those who have been close to a patient.”), with William Bicknell & Kenneth Bloem, Smallpox and Bioterrorism, WASH. TIMES, July 9, 2003, at A20 (noting that some scientists favor pre-exposure vaccination as a biodefense strategy), and Charles V. Peña, Give Americans the Choice to Take the Smallpox Vaccine, CATO INST., June 6, 2002, http://www.cato.org/dailys/06-06-02.html (arguing that the CDC’s statement on the risk of serious side effects from smallpox vaccination is overstated, and that potential side effects should not be used as a basis to delay pre-exposure vaccination). 53. The United States recently discovered that the bird flu vaccines it had stockpiled had lost their strength overtime and that one million fewer people could be innocuted than was originally estimated. Christian Nordqvist, Bird Flu Vaccines Lose Their Strength, MED. NEWS TODAY, Nov. 20, 2006, http://www.medicalnewstoday.com/articles157122.php. 54. In the wake of the 2001 anthrax attacks, the Bush Administration requested $1.2 billion for the production of vaccines and antibiotics and $643 million for expansion of the National Pharmaceutical Stockpile, to ensure pharmaceutical preparedness against bioterrorism attacks. Press Release, U.S. Dep’t of Health and Human Services, Secretary Thompson’s Testimony on HHS Readiness and Role of Vaccine Research and Development (Oct. 23, 2001), available at http://www.hhs.gov/news/press/2001pres/ 20011023.html. 55. WORLD HEALTH ORG., CHANGING HISTORY, supra note 48; Some public hospitals in Africa are without running water for months at a time. Susie Emmett, Uganda Battles Wave of Cancer, BBC NEWS Apr. 22, 2006, http://news.bbc.co.uk/1/hi/programmes/from_our_own_correspondent/4931506.stm. 56. Laura Spinney, Terror’s Hidden Ally: In a Climate of Fear, Mass Hysteria Can Lead to Symptoms as Troubling as Real Disease or Poisoning, NEW SCIENTIST, Oct. 2006, at 24, 24. 57. Andrew Pollack, Drug Makers Wrestle with World’s New Rules; A Delicate Balance: Patriotism vs. Business, N.Y. TIMES, Oct. 21, 2001, at A1.

No. 2] AGAINST THE PLAGUE 295 general,58 and public health legal preparedness in particular, fostering holistic discourses on counterterrorism and natural disaster countermeasures.59 Public health legal preparedness has been described as a subtext of public health preparedness.60 Its rising profile in legal scholarship since the late 1990s has been attributed to the recognition of the integral role of law in securing and enforcing public health preparedness strategies.61 While the scope of public health law is not clearly defined, it has been suggested that it could be “any law that has significant consequences for the health of a defined population,”62 and that “the term may encompass such nominally foreign domains as economic development laws, tax law, and law.”63 It is axiomatic that public health law encompasses intellectual property rights, especially patents and allied rights that directly regulate ownership of, and access to, critical medicines for public health needs,, particularly with regard to bioterrorism-induced diseases.64 Not the least of which because a lack of access to crucial drugs could have “significant consequences for the health of a defined population.”65 This is an ongoing, albeit unpleasant, reality for millions in resource-poor countries, arguably66

58. Public health preparedness has been defined as See Anthony D. Moulton et al., What is Public Health Legal Preparedness?, 31 J.L. MED. & ETHICS 672, 673 (2003) (defining “public health preparadness” as “ the readiness of a public health system (of a community, a state, the nation, the world community) to respond to specified health threats. It can also be phrased as a goal, i.e., as attainment by the public health system of a defined benchmark of response to conventional dangers and, specifically, to such emerging threats as Severe and Acute Respiratory Disease (SARS), terrorism, and the next major dangers to follow.”). 59. See id. at 674-76 (discussing initiatives to improve public health preparedness). 60. See id. at 673 (describing the term broadly to include “any law that has significant consequences for the health of a defined population). 61. Id.; see Edward C. Baker et al., Building the Legal Foundation for an Effective Public Health System, 30 J. L. MED. & ETHICS (SPECIAL SUPPLEMENT) 42, 48 (2002) (examining states’ approaches to public hea lth law and initiatives). 62. Moulton et al., supra note 58, at 673. 63. Id. 64. Since the inception of the TRIPS Agreement in 1994, the question of whether intellectual property righ ts fall with in the purview of public health law is now arguably beyond dispute, as TRIPS provides a direct link between intellectual property rights, especially pharmaceutical patents, and public health law. E.g., Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, art. 8.1, 33 I.L.M. 1125, 1201 (1994) [hereinafter TRIPS Agreement] (allowing members to adopt measures to protect public health and to promote the public interest). Intellectual property rights have been prominently linked to public health in recent institutional discourse, and the body of legal and economic scholarship on the relationship between intellectual property rights and public health continues to grow. See Joan-Ramon Borrell & Jayashree Watal, Impact of Patents on Access to HIV/AIDS Drugs in Developing Countries, (Ctr. For Int’l Dev. at Harvard Univ., Working Paper No. 92, 2002), available at http://www.cid.harvard.edu/cidwp/pdf/092.pdf (summarizing an empirical study of the impact of patents on access to new drug therapies in low and middle income countries); Carlos Maria Correa, Ownership of Knowledge – The Role of Patents in Pharmaceutical R&D, 82 BULL. WORLD HEALTH ORG. 784, 784-790 (2004), available at http://www.who.int/bulletin/volumes/82/10/en/784arabic.pdf (decrying “lax” patent rules which engender myriads of weak or otherwise invalid patents for “minor developments” in pharmaceuticals and arguing that such patents unnecessarily impede competition and raise the bar to access to medicines in resource-poor countries). But see Richard P. Rozek & Ruth Berkowitz, The Effects of Patent Protection on the Prices of Pharmaceutical Products, 1 J. WORLD INTELL. PROP. 181, 181-216 (1998) (finding that in the countries studied, intellectual property protection had little, if any, impact on drug pricing, including those drugs introduced after a change to the patent system). 65. See Moulton, supra note 58, at 673 (establishing criteria for “public health law”). 66. The effect of patents on the price of drugs is highly divisive and expert opinion is often sharply divi ded between industry and non-governmental organization or developing country perspectives. See Rozek

296 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 due, in part, to stronger pharmaceutical patents protection under the aegis of the World Trade Organization’s (“WTO”) TRIPS Agreement.67 The arrangement has effectively rooted international intellectual property rights governance in international trade rules.68 Despite the strong link between pharmaceutical patents and public health, most of the scholarship and regulatory regimes concerning public-health legal preparedness largely glosses over intellectual property law and access to medicines interface discourses, and instead focus mainly on the legal status of voluntary rescuers, public health employees, control of biological agents, civil liberties, and legal liability implications of compulsory quarantine and inoculation.69 While acknowledging the possible dearth of vaccines and drugs as a potentially critical logistic snag in the bioterror defense strategy, even the few articles that have explored potential patent obstacles sought solutions only within the traditional remit and the familiar ambit of the TRIPS Agreement, as well as national patent law and access to medicine paradigms, whose core is the compulsory licensing regime70 as circumscribed by the “consistency test.”71 This solution is arguably vulnerable to bureaucratic trappings and

& Berkowitz, supra note 64, at 181-216 (noting “industry” arguments that patents have little effect on drug prices). 67. Tying intellectual property rights governance to world trade rules has arguably commoditized inte llectual property rights. See Martin Khor, Rethinking Intellectual Property Rights and TRIPS, in GLOBAL INTELLECTUAL PROPERTY RIGHTS: KNOWLEDGE, ACCESS, AND DEVELOPMENT 201-13 (2002) (Peter Drahos & Ruth Mayne eds., 2002) (arguing that TRIPS is heavily slanted in favor of IP holders and against public interest). 68. Compliance related disputes under TRIPS are adjudicated under the multilateral procedures of the World Trade Organization Dispute Settlement Understanding. CARLOS M. CORREA, INTELLECTUAL PROPERTY RIGHTS, THE WTO AND DEVELOPING COUNTRIES: THE TRIPS AGREEMENT AND POLICY OPTIONS 3-6 (2000) [hereinafter CORREA, IP RIGHTS]. See generally TRIPS Agreement, supra note 64, arts. 63-64 (listing procedures for dispute resolution and settlement). 69. See, e.g., BIOLOGICAL WEAPONS DEFENSE: INFECTIOUS DISEASE AND COUNTERBIOTERRORISM xiii- xv (Luther E. Lindler et al. eds., 2004) (neglecting to mention intellectual property rights or access to medicines interface in discourse on counterterrorism strategies); SUTTON, supra, note 5; (focusing on civil rights and liberties issues relating to bioterrorism, quarantine law, tortious liabilities etc., with no discussion on the interface between intellectual property and bioterrorism); Moulton et al., supra note 58, at 674 (noting that public health legal preparedness should support voluntary participation in rescue efforts rather than using coercion which could be counterproductive, but not mentioning intellectual property rights). See generally United States Public Health and Bioterrorism Preparedness and Response Act of 2002, Pub. L. 107-188, 116 Stat. 594 (promulgating legal obligations, duties, rights and limitations on the rights of health workers, victims of terrors, etc.). 70. See generally Grace K. Avedissian, Global Implications of a Potential U.S. Policy Shift Toward Com pulsory Licensing of Medical Inventions in a “New Era of Super-Terrorism”, 18 AM. U. INT’L L. REV. 237, 286-88 (2003) (recommending that the United States implement compulsory licensing for prescription drugs as a counterterrorism measure to boost global access to generic drugs). The downside of the compulsory licensing solution is that it may be prone to beaurcratic delays and uncertainty in the value of the license, which renders it a last resort remedy, making it unsuitable for an extraordinary bioterrorism emergency. Id. 71. Article 8.1 of the TRIPS Agreement stipulates that “Members may, in formulating or amending their law s and regulations, adopt measures necessary to protect public health and nutrition, and to promote public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.” TRIPS Agreement, supra note 64, art. 8.1. Even measures aimed at curbing abuse of intellectual property rights by right holders must pass consistency muster. Id.

No. 2] AGAINST THE PLAGUE 297 wrangling over the adequacy of royalties payable to the patentees.72 At the very least, the process is both incongruous and anachronistic in the context of time-sensitive bioterrorism countermeasures.73 Time is clearly of the essence in bioterrorism attacks, and the need for swift action is the defining element of the thesis for pharmaceutical patent appropriation clause in the bioterrorism context as proposed in this Article. This Article argues that the access to medicines package, as provided by TRIPS74 is unsuited to the need for mass production of critical drugs in bioterrorism-induced public health crises. A case will be made for a legal framework that allows pharmaceutical patents to be overridden with adequate compensation in bioterrorism-induced public health crises. This argument is predicated on ethical grounds, overriding public interests, and the dictates of the fundamental right to health and life. Part II of this Article explains bioterrorism and its attendant extraordinary public health emergency crises. Part III discusses the dynamics of pharmaceutical research and development and the relevance of pharmaceutical patents to drugs access. Part IV analyzes the inherent limitations of the TRIPS Article 30 limited exception to patent exclusivity, the TRIPS Article 31 on compulsory licensing, and the TRIPS-Doha Declaration on public health. Part V spells out the grounds for a bioterrorism-specific exception to pharmaceutical patent exclusivity. Part VI sums up the discourse and concludes the article.

II. UNDERSTANDING BIOLOGICAL AGENTS AND BIOTERRORISM: THE SCALE OF THE PROBLEM Biological weapons involve the use of disease-causing micro-organisms and other replicative entities, including viruses, infectious nucleic acids, and prions.75 Bioterrorism is the deliberate use of biological weapons by terrorists to inflict death and destruction in pursuit of political, religious or ideological objectives.76 Biological weapons are unique in terms of affordability, ability to reach intended targets, ability to cause limited collateral damage, and ability to achieve the desired outcome.77 A United States government analyst once said

72. See generally Adi Gillat, Compulsory Licensing to Regulated Licensing: Effects on Conflicts Between and Access in the , 58 FOOD & DRUG L.J. 711 (advocating a lice nsing regime that would allow patentees to have a say about the amount of royalties they receive so that the adverse effects of a compulsory licensing regime will be lessened and innovation encouraged). 73. See discussion infra Part IV. 74. All TRIPS signatories are obliged to comply with the minimum standard of protection set out in the Agr eement. TRIPS Agreement, supra note 64, art. 1.1. Developed countries had one year from January 1, 1995 to c omply with TRIPS, developing countries five years, and the least developed countries eleven years. Id. arts. 65-66. 75. WORLD HEALTH ORG., HEALTH ASPECTS OF BIOLOGICAL AND CHEMICAL WEAPONS: REPORT OF WHO GROUP OF CONSULTANTS 60-78 (1970), available at http://www.who.int/csr/delibepidemics/ biochem1stenglish/en/print.html. 76. Tillema, supra note 2, at 17-19; Christopher et al., supra, note 5, at 19-28. 77. MICHAEL T. OSTERHOLM & JOHN SCHWARTZ, LIVING TERRORS: WHAT AMERICA NEEDS TO KNOW TO SURVIVE THE COMING BIOTERRORIST CATASTROPHE 7 (2000).

298 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 that “$1500 of nuclear killing power would set an anthrax assailant back by only a penny.78 In other words, biological weapons are at once cheap and fatally effective. Biological weapons are aptly described as weapons of mass destruction, whose potential for causing mass death can only be surpassed “. . .by the most powerful nuclear weapons, i.e. H-bombs.”79 This view is reinforced by a 1993 U.S. Congressional Office of Technology Assessment (“OTA”) study, which posited that a nuclear weapon comparative in size to the Hiroshima bomb has an explosive power equivalent to 12.5 kilotons of TNT, 300 kilograms of sarin nerve gas or 30 kilograms of anthrax spores.80 The bomb could kill between 23,000 and 80,000 people, the sarin could kill 60 to 200 people, and the anthrax could kill 30,000 to 100,000 people.81 Anthrax’s potential fatality figures outstrip and are potentially double that of a bomb of comparable explosive power. Moreover, anthrax (a ) outclasses sarin (a chemical agent) in terms of probable causalities.82 The real danger, however, is that anthrax, smallpox, and the plague are much cheaper and relatively easier to acquire than a hydrogen bomb, and could be deployed with greater stealth and swiftness to maximize civilian casualties.83 In the context of simulated worse-case scenarios, the following paragraphs will briefly review three potent and weaponizeable biological agents: the plague, anthrax, and smallpox.84 The possible public health crises scenarios occasioned by bioterrorism are juxtaposed with those resulting from naturally occurring epidemic diseases such as HIV/AIDS, tuberculosis, and malaria. This Article will then adduce reasons why the TRIPS access to medicine package and the exceptions in contemporary patent regimes are unsuitable for bioterrorism-induced diseases and are inadequate as a biodefense strategy. While there are more biological agents than those discussed here,85 discussions will be limited to the plague, anthrax, and smallpox for the following reasons: (1) space constraints preclude an extensive analysis of all known pathogens; (2) this discourse is not so much about epidemiological analysis, clinical prognosis of biological pathogens, or clinical management of exposed patients,86 as it is on the pathogens’ inherent virulence

78. Id. 79. BARNABY, supra note 5 at 31. 80. Id. (citing U.S. CONG., OFFICE OF TECH. ASSESSMENT, PROLIFERATION OF WEAPONS OF MASS DESTRUCTION: ASSESSING THE RISKS 53 (1993)). 81. Id. 82. Jonathan B. Tucker, The Future of Biological Warfare, in THE PROLIFERATION OF ADVANCED WEAPONRY 57 (W. Thomas Wander & Eric H. Arnett, eds., 1992). 83. The post September 11th, 2001 anthrax attacks in the United States demonstrated the ease with which terrorists can deploy bioagents. See Victoria V. Sutton, A Precarious “Hot Zone” – The President’s Pla n to Combat Bioterrorism, 164 MIL L. REV. 135, 135-36 (2000) (noting inter alia that biological weapons are more flexible than conventional weapons). 84. David R. Franz, et al., Clinical Recognition and Management of Patients Exposed to Biological Warfare Agents, 278 JAMA 399, 399-411 (1997). 85. Others include, for example, , , botulinum, viral encephalitides, and viral hemorrhagic fevers. Id. 86. A scientific analysis of biological pathogens is not only beyond the scope of this article, but also requires technical knowledge and expertise which the author does not posses.

No. 2] AGAINST THE PLAGUE 299 in bioterrorism context, and a case for developing alegal framework for accessing critical drugs and vaccines in the advent of their willful and negative deployment; and (3) the choice of the three pathogens in the foregoing discourse is informed by their relative availability, accessibility, weaponizability, and pliability to terrorist use.87

A. The Plague

The plague is an infectious, zoonotic disease caused by the Yersinia pestis bacterium, commonly carried by rodents and fleas.88 People usually become infected with the plague by being bitten by fleas that live on rats hosting Yersinia pestis.89 A swollen and very tender lymph gland on the neck, the bubo gland, is the typical sign of infection that gives the plague the alternate name of “.”90 Other symptoms of bubonic infection include fever, chills, headaches and extreme exhaustion.91 If bubonic plague is left untreated, the bacterium can invade the bloodstream, spreading fatal infection, with a case fatality of 30–60%.92 Bubonic plague is otherwise known as “the black death.”93 Bubonic plague is transmissible through the bite of an infected flea or exposure of skin wounds to an infected material.94 However, when the Yersina pestis bacterium invades the lungs, rather than the bloodstream, it causes severe respiratory problems, specifically pneumonic plague.95 Its symptoms include “high fever, cough, bloody sputum and difficulty in breathing.”96 Thus, the Yersina pestis bacterium causes two diseases: pneumonic plague and bubonic plague.97 Pneumonic plague could be spread through an aerosol attack; it is infectious and can manifest within one to six days after an attack.98 Pneumonic plague is a Category A critical biological agent that can easily be disseminated.99 The plague can be treated

87. See Tucker, supra note 82, at 57 (stating the weight for weight potency of microbial pathogens makes them an ideal terrorist weapon). 88. Centers for Disease Control and Prevention, Frequently Asked Questions About Plague (Apr. 4, 2005), http://www.bt.cdc.gov/agent/plague/pdf/plaguefaq.pdf [hereinafter CDC Plague FAQ]. 89. Medical Notes, Plague, BBC NEWS, Feb. 8, 2003, http://news.bbc.co.uk/1/hi/health/medical_notes/ n-p/1834332.stm. 90. Id. 91. Id. 92. World Health Organization, Plague, http://www.who.int/mediacentre/factsheets/fs267/en/ (last visited Oct. 27, 2007) [hereinafter WHO, Plague]. 93. Bubonic plague was given the name “the black death” due to the dark spots it causes on the skin. Peter Lavelle, On the Trail of the Black Death, AUSTL. BROADCASTING CORP., Jan. 22, 2004, http ://www.abc.net.au/science/features/blackdeath/default.htm. See generally ROBERT STEVEN GOTTFRIED, THE BLACK DEATH: NATURAL AND HUMAN DISASTER IN MEDIEVAL EUROPE 1-10 (1983) (providing a contextual history of the plague). 94. Centers for Disease Control and Prevention, Facts About Pneumonic Plague (Oct. 14, 2001), http://www.bt.cdc.gov/agent/plague/factsheet.pdf. 95. Id. 96. Id. 97. Id. 98. CDC Plague FAQ, supra note 88, at 1-2. 99. David T. Dennis, Tularemia and Plague: Assessing Our Understanding of the Threat, in BIOLOGICAL THREATS AND TERRORISM 55, 55 (2002).

300 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 with modern antibiotics such as streptomycin and gentamicin, although there are concerns about the increasing level of the disease’s resistance to drugs.100 Scientists in the United Kingdom have also experimented with the plague vaccine for their military, using genetic engineering techniques.101 However, the World Health Organization (“WHO”) recommends that vaccines should not be used for immediate protection in outbreak cases, but only “as a prophylactic measure for high-risk groups (e.g. laboratory personnel who are constantly exposed to the risk of contamination).”102 The plague is still very common in some parts of Africa, Asia, and Central America.103 According to the WHO, nine countries reported 2118 plague cases and 182 deaths in 2003.104 On the average, there are 1000 to 3000 cases of the plague each year.105 In 1997, a WHO modeling scenario predicted that the release of fifty kilograms of Yersinia pestis over a city of 5 million people could cause about 150,000 cases of the plague and result in 36,000 deaths.106 Neither HIV/AIDS nor malaria could wreak as much havoc as the plague in the same period of time. The plague is weaponizable as an aerosol, the expected mode of delivery in any biowarfare or terrorist attacks.107

B. Anthrax

Anthrax is a bacterium derived from B. anthracis, which resides naturally in soil.108 The organism enjoys a dual existence. In the infected host, it is a vegetative bacillus.109 In the environment, it is a spore.110 Anthrax spores would only form in the infected host if the body tissues are exposed to air.111 The spores are resilient, and can survive adverse environmental conditions, having the potential to last for decades.112 Although it exists naturally in soil, anthrax can be grown in any microbiology laboratory. Anthrax spores were weaponized by the United States in the 1950s and 1960s before its biological

100. CDC Plague FAQ, supra note 88. 101. Human Tests for Plague Vaccine, BBC NEWS, Aug. 26, 1999, http://news.bbc.co.uk/1/hi/uk/ 430502.stm. 102. WHO, Plague, supra note 92. 103. E.g., Craig Timberg, Deadly Plague Outbreak Feared in Congo, WASH. POST, Feb. 18, 2005, http://www.washingtonpost.com/wp-dyn/articles/A35329-2005Feb18.html (reporting than in February 2005, sixty-one miners died in Eastern Congo from pneumonic plague). 104. WHO, Plague, supra note 92. 105. CDC Plague FAQ, supra note 88, at 2. 106. Thomas V. Inglesby, Plague as a Biological Weapon, 283 JAMA 2281, 2282 (2000). 107. See CDC Plague FAQ, note 88, at 1 (arguing that the aerosol form of Yersinia pestis should be considered a biological weapon). 108. Franz et al., supra note 84, at 401. 109. Id. 110. Id. As a spore-forming microbe, the bacillus, when exposed to the proper conditions, curls “itself up in a tiny ball and buil[ds] around its outer surface a capsule that amount[s] to a hard hide. Such spores [are] known to be remarkably stable and resistant to the destructive influences of light and heat, and they could remain that way, with no loss of virulence, for a period of many years.” ED REGIS, THE BIOLOGY OF DOOM 11 (1999). 111. Franz et al., supra note 84, at 401. 112. Id.

No. 2] AGAINST THE PLAGUE 301 weapon program was terminated.113 The former Soviet Union and Iraq have also experimented with the offensive use of anthrax.114 Anthrax spores infect animals such as cattle, sheep, goats, and horses, usually while grazing.115 Humans get infected by skin-to-skin contact with infected animals.116 This is known as cutaneous anthrax, and it is rampant among workers who process raw goat hair into garment interlining.117 For instance, a forty-four-year-old New York man contracted respiratory anthrax from untreated animal hides in February 2006.118 Human infection is also possible by ingestion and by inhalation.119 If anthrax spores are dried and milled, they turn into a lethal, powdery white substance that is “ounce per ounce, more deadly than any explosive—and ‘smarter’ than the most expertly programmed smart bomb.”120 The aforementioned 1993 OTA study estimated that a hypothetical dispersal of 100 kg of anthrax by a small plane could kill one to three million people in a three-hundred-square mile area around Washington D.C.121 The hydrogen bomb, by comparison, could only kill 570 thousand to 1.9 million people.122 The only drug approved by the United States Food and Drug Administration (“FDA”) that is specifically labeled for the treatment of inhaled anthrax is Bayer’s antibiotic ciprofloxacin.123 However, in 1997, the United States Military began inoculating National Guardsmen in the Armed Forces and certain Ministry of Defense civilian contractors with anthrax vaccine absorbed (“AVA”).124 The program was temporarily halted on October 27, 2004, when the United States District Court for the District of Columbia ruled that the involuntary inoculation of National Guardsmen and civilian contract employees of the Department of Defense was illegal because the anthrax vaccine being used was an investigational drug prohibited by Congress.125 The court found further that in the absence of a presidential waiver, the

113. Id.; Jonathan B. Tucker, A Farewell to Germs: The U.S. Renunciation of Biological and Warfare, 1967-1970, 27 INT’L SECURITY 107, 107 (2002). 114. Franz et al., supra note 84, at 401. 115. Id. 116. Id. 117. See Doe #1 v. Rumsfeld, 297 F. Supp. 2d 119, 125 n.2, 126 (D.D.C. 2003) (citing Brachman study). 118. Sewell Chan, New York Anthrax Case Believed to Be Accidental, N.Y. TIMES, Feb. 22, 2006, http://www.nytimes.com/2006/02/22/nyregion/22cnd-anthrax.html?ei=5094=129966c. 119. BARNABY, supra note 5, at 34-35. 120. OSTERHOLM & SCHWARTZ, supra note 77, at 2. 121. OSTERHOLM & SCHWARTZ, supra note 77, at 9; U.S. CONG., OFFICE OF TECH. ASSESSMENT, supra note 80, at 54. 122. OSTERHOLM & SCHWARTZ, supra note 77 at 9. 123. See Kathleen Pender, Cipro Had Big Boost From U.S.; U.S. Tests Led to OK for Anthrax Use, S.F. CHRON., Oct. 25, 2001, at D1 (noting that the FDA and the CDC in 1998 selected ciprofloxacin, under a presidential directive, to treat exposure to advanced biological weapons, including anthrax). 124. Doe v. Rumsfeld, 341 F. Supp. 2d 1, 3 (D.D.C. 2004). 125. Id. at 19. An earlier Preliminary Order had been granted on December 22, 2003 in favor of the plaintiffs. Id. at 16. The Preliminary Order was based on Plaintiffs’ Motion for a Preliminary Injunction enjoining the defendants from inoculating them without their consent, in the absence of a Presidential waiver. Doe #1 v. Rumsfeld, 297 F. Supp. 2d 125 (D.D.C. 2003).

302 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 plaintiffs could not be inoculated without their consent.126 This ruling ostensibly prompted the December 10, 2004 determination by the Department of Defense that there was a heightened risk of anthrax attacks against United States military personnel.127 The Department of Defense’s determination led to the U.S. Secretary of Health and Human Services’ January 14, 2005 declaration of emergency, justifying the authorization of emergency use of AVA,128 and clearing the way for the FDA’s January 27, 2005 authorization of emergency use of anthrax vaccine.129 In October 2006, the U.S. Department of Defense announced that it would “resume mandatory anthrax vaccinations for more than 200,000 troops and defense contractors within 60 days.”130 It should be noted, however, that in 2002, the FDA had approved resumption of anthrax vaccine production.131 This implies that a reliable alternative to ciprofloxacin could soon be available to protect against anthrax outbreaks in civilian population.

C. Smallpox

Smallpox is a naturally occurring disease that often starts with a low fever.132 Its scientific name is Variola, a Spanish word for “blotchy pimples.”133 The virus only infects humans, and has two subspecies: Variola minor and Variola major.134 The former is a weaker strain and rarely kills its victims.135 However, the latter kills up to 45 percent of infected people who are not immune to it.136 Variola major has no cure, and usually bestows its pockmark-scars on lucky survivors.137 A smallpox outbreak occurred in the United States over fifty years ago138 and another in former Yugoslavia in 1972.139 It showed up again in Somalia in 1977140 and claimed

126. Doe, 341 F. Supp. 2d at 12. 127. Tommy G. Thompson, Sec’y, Dep’t of Health & Human Servs., Declaration of Emergency Pursuant to 21 U.S.C. § 360bbb-3(b) (Jan. 14, 2005), available at http://www.fda.gov/OHRMS/DOCKETS/98fr/dhhs- oc0523-let0001.pdf. 128. Id. 129. Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Availability, 70 Fed. Reg. 5452, 5452 (Feb. 2, 2005). The Emergency Declaration was further extended in July 2005. Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Extension; Availability, 70 Fed. Reg. 44657, 44657 (Aug. 3, 2005). 130. Christopher Lee, Mandatory Anthrax Shots to Return, WASH. POST, Oct. 17, 2006, at A3. 131. Louis W. Sullivan, A Safe Anthrax Vaccine, N.Y. TIMES, Feb. 6, 2002, at C14; Press Release, U.S. Food & Drug Admin., FDA Approves License Supplements for Anthrax Vaccine (Jan. 31, 2002), available at http://fda.gov/bbs/topics/NEWS/2002/NEW00792.html. 132. OSTERHOLM & SCHWARTZ, supra note 77, at 15-19. 133. Smallpox was given the name “variola” by Bishop Marius of Avenches in 580 A.D. Abbas M. Behbehani, The Smallpox Story: Life and Death of an Old Disease, 47 MICROBIOLOGICAL REV. 455, 456 (1983), available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=6319980. 134. Id. at 482. 135. Id. 136. Id. 137. OSTERHOLM & SCHWARTZ, supra note 77, at 17. 138. Id. 139. Id. at 18.

No. 2] AGAINST THE PLAGUE 303 its last known victim in England in the summer of 1978.141 Smallpox was declared eradicated by the WHO in 1980.142 In the last century, approximately five-hundred million people reputedly died of smallpox worldwide.143 The number of deaths caused by smallpox dwarfs the estimated 320 million combined deaths from the 1918 swine flu pandemic, HIV/AIDS, and all military and civilian casualties of twentieth century warfare.144 The WHO has expressed concern that smallpox “can easily be produced in large quantities in the laboratory and freeze-dried and its virulence thus preserved for months or years.”145 Officially, the U.S. CDC in Atlanta and the Russian State Research Center for Virology and Biotechnology are the only two WHO-approved repositories for smallpox in the world.146 However, there are reputed, clandestine stockpiles in obscure laboratories around the world, raising the fears that samples could get into the hands of terrorists.147 In 2001, there were official simulated smallpox terror attacks in the United States.148 Christened “Dark Winter,” the scenario featured three large smallpox laden aerosol clouds infecting one thousand shoppers each in Oklahoma City, Atlanta, and Philadelphia.149 The initial simulated attacks occurred during December 1st, and by the 22nd, about 16,000 residents had been infected across twenty-five states, while one thousand people had already died.150 Under this simulation, by early February, three million U.S. residents would have been infected and about one million would have died.151 The nation’s smallpox vaccine was inadequate, leaving panicking citizens no choice but to scramble across shuttered Canadian and Mexican borders.152 Additionally, the possible fatalities of smallpox attacks on civilian populations were reinforced in a chilling 2002 BBC docudrama.153 In the docudrama, a “suicide patient” in New York City triggered a global smallpox infection.154 Some commentators have attacked the two scenarios cited above as being overboard and exaggerated.155 Nevertheless, a comparison of the 2005 38.6 million global HIV , (which dated back to the 1980s), with the possible casualties in the simulated smallpox attack scenarios shows

140. , THE DEMON IN THE FREEZER 77. 141. Id. 142. Franz et al., supra note 84, at 404. 143. OSTERHOLM & SCHWARTZ, supra note 77, at 17. 144. Id. 145. Franz et al., supra note 84, at 404. 146. Id. 147. Id. 148. JOHNS HOPKINS CTR. FOR CIVILIAN DEF. ET AL., DARK WINTER 2 (2001), available at http://www.upmc-biosecurity.org/website/events/2001_darkwinter/dark_winter.pdf [hereinafter DARK WINTER]. 149. Id. at 20. 150. Id. at 16, 41. 151. Id. at 43. 152. Id. 153. See Smallpox 2002, BBC NEWS, http://www.bbc.co.uk/drama/smallpox2002 (last visited Oct. 24, 2007) (discussing the film Smallpox 2002). 154. Id. 155. Enserink, supra note 52, at 1592-93.

304 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 dramatically higher disease progression, infection rates, and casualty figures in the comparatively shorter time span of bioterrorism-induced diseases.156 Moreover, the global figure for AIDS deaths in 2005 alone was an estimated 2.8 million.157 This figure is dwarfed by the 3 million total smallpox infections and 1 million smallpox deaths in the United States within two months of the “Dark Winter” simulated smallpox attacks.158 The difference in death figures is further underscored by the obvious fact that those 2.8 million, who died of AIDS in 2005, were not infected with the HIV virus in 2005.159 The stark difference in disease onset, disease progression, disease timeline, and infection rates between bioterrorism-specific smallpox attacks and HIV/AIDS is put in a clearer perspective by Richard Preston in the following passage: It has taken the world twenty years to reach roughly fifty million cases of AIDS. Variola (smallpox) could reach that point in ten or twenty weeks. The outbreak grows not in a straight line but in an exponential rise, expanding at a faster and faster rate. It begins as a flicker of something in the straw in a barn full of hay, easy to put out with a glass of water if it’s noticed right then. But it quickly gives way to branching chains of explosive transmission of a lethal virus in a virgin population of nonimmune hosts. It is a biological chain reaction.160 A re-enactment of “Dark Winter” in a resource-poor country would arguably result in greater casualties in large measure due to a lack of critical drugs and vaccines.161 This is exemplified by a recent study on the estimated potential global deaths from an influenza pandemic.162 Of the fifty-one to eighty-one million estimated potential influenza deaths, 96% were from poorer countries in the developing world.163 This figure is due in part to the endemically parlous public health system, exemplified by the chronic drug shortages, dearth of competent health care professionals, and blighted public- health infrastructure.164 It is evident that, while wealthy nations like the

156. JOINT UNITED NATIONS PROGRAMME ON HIV/AIDS, GLOBAL FACTS AND FIGURES (2006), http://data.unaids.org/pub/globalReport/2006/200605-FS_globalfactsfigures_en.pdf. 157. Id. 158. DARK WINTER, supra note 148. 159. See Nat’l Inst. of Allergy and Infectious Diseases, The Evidence That HIV Causes AIDS (Feb. 27, 2003), http://www.niaid.nih.gov/factsheets/evidhiv.htm (noting that the HIV virus infection is believed to lead to AIDS over a period of time, depending on access to antiretroviral treatment). HIV’s progression from infection to full-blown AIDS to death is arguably slower than anthrax or smallpox. Id. 160. PRESTON, supra note 140, at 48. 161. See JOINT UNITED NATIONS PROGRAMME ON HIV/AIDS & WORLD HEALTH ORG., AIDS EPIDEMIC UPDATE 5 (2005), available at http://www.unaids.org/epi/2005/doc/EPIupdate2005_pdf_en/epi- update2005_en.pdf. 162. C hristopher J.L. Murray et al., Estimation of Potential Global Pandemic Influenza Mortality on the Basis of Vital Registry Data from 1918-20 Pandemic: A Quantitative Analysis, 368 LANCET 2211, 2213-15 (2006). 163. Id. at 2215. Endemic poverty was in part responsible for the huge discrepancy between potential influenza deaths in developed and developing countries. Id. 164. See Colin D. Mathers & Dejan Loncar, Projections of Global Mortality and Burden of Disease from 2002 to 2030, 3 PLOS MED. 2011, 2021-22 (2006), available at dx.doi.org/10.1371/journal.pmed.0030442 (discussing a recent WHO-sponsored study that showed that poorer countries have the highest rate mortality and bear the greatest burden from diseases).

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United States are restructuring their public health care systems165 and experimenting with and stockpiling anthrax and smallpox vaccines as part of a comprehensive biodefense strategy,166 resource-poor nations who are equally vulnerable to bioterror attacks are materially challenged to cope with bioterrorism-induced public health crises.167 Securing adequate supplies of critical vaccines and drugs in the wake of bioterror attacks is imperative for all nations, rich and poor. This need was amply demonstrated by the 2001 “Dark Winter” simulated smallpox attacks, where inadequate smallpox vaccines aggravated the spread of the virus in the United States.168 In light of the foregoing analysis, it is clear that access to critical medicines could be compromised if patented drugs or vaccines cannot be mass-produced or parallel-imported within a short period to combat bioterrorism-induced diseases.169 The danger of inadequate supplies of vaccine or shortages of critical drugs in the wake of a bioterrorism attack, as noted earlier, was exemplified by the well-publicized skirmishes over Bayer’s antibiotic ciprofloxacin (Cipro) in Canada and the United States in the wake of the 2001 anthrax attacks.170 If the anthrax attacks had persisted and become widespread in the United States, then U.S. Health Secretary Tommy Thompson could have undoubtedly made good on his threat to override Bayer’s patent and mass-produce ciprofloxacin.171

165. Although there is still much to be done, major progress has been made in bioterrorism public health preparedness under “Project Bioshield,” which includes: coverage of 89% of the U.S. population by the Ce nters for Disease Control and Prevention emergency communications networks; bioterrorism plans in varying degrees of progress in all fifty states; and preliminary laboratory equipment, facilities, and staffing upgrades. SHELLEY A. HEARNE ET AL., READY OR NOT? PROTECTING THE PUBLIC’S HEALTH IN THE AGE OF BIOTERRORISM EXECUTIVE SUMMARY 2 (2003), available at http://healthyamericans.org/state/bioterror/ Bioterror-execsum.pdf. In addition, the U.S government set up a Bio Watch program to protect major U.S. cities by monitoring the air for biological agents that could be released by terrorists. Sean Spicer, A Few Facts About Homeland Security and Economic Security, INSIGHT MAGAZINE, June 15, 2004, available at http://www.insightmag.com (archives available to subscribers only). 166. See generally United States Public Health and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, § 121, 116 Stat. 594, 612 (establishing a strategic stockpile of various drugs, vaccines, an d biological products). Following the 2001 anthrax attacks in the United States, the Bush Administration asked Congress for $1.5 billion in biodefense funding which Congress increased to $2.5 billion. Wright, supra note 44, at 58-61. With Congressional approval of $7.45 billion in biodefense funding in 2005, bioterrorism defense funding has increased 1,500% since 2001. Id. 167. See Frederick M. Abbott, The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. INT’L ECON. L., 469, 474 (2002) [hereinafter Abbott, Doha De claration] (noting that the state of public health care in developing world is “a continuing catastrophe”). 168. DARK WINTER, supra note 148. 169. The impact of patents on developing countries’ access to crucial drugs has been well documented. E.g., Padmashree Gehl Sampath, India’s Product Patent Protection Regime: Less or More of “Pills for the Po or”?, 9 J. WORLD INTELL. PROP. 694, 694 (2006). 170. Anthony York, Is It Time to Bust the Cipro Patent?, SALON.COM, Oct. 18, 2001, http://archive.salon.com/tech/feature/2001/10/18/cipro_patent/index.html (describing how New York Democratic Senator Charles Schumer and the Canadian government suggested Bayer’s patent could be overridden to allow the production of generic Cipro in the wake of the 2001 Anthrax attacks). Canada actually ordered 1 million tablets of a generic version of Cipro from a Canadian pharmaceutical company. Keith Bradsher & Edmund L. Andrews, A Nation Challenged: CIPRO; U.S. Says Bayer Will Cut Cost of Its Anthrax Drug, N.Y. TIMES, Oct. 24, 2001, at B7. Bayer later granted a significant price concession to the United States to avoid the production of a generic version of Cipro. Id. 171. Bradsher & Andrews, supra note 170. The U.S. government could have overridden Bayer’s patent in ciprofloxacin under 28 U.S.C. § 1498 (2000) on patent and cases. Section 1498 empowers the

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When asked about the prospects of the United States government applying compulsory licensure to facilitate generic production of ciprofloxacin, the Health Secretary at the time replied “[we] are looking at the patent issue very closely.”172 Similarly, Canadian authorities announced that they had overridden Bayer’s patent on ciprofloxacin, without prior consultations with Bayer or permission from the Canadian Commissioner for Patents as required by section 19(1) of the Canadian Patent Act.173 Although Canada later reversed its decision to override the ciprofloxacin patent,174 the haste with which the decision was made without due compliance with the procedures in the Canadian Patent Act,175 underscores the extraordinary urgency that characterizes bioterrorism-induced public health crisis. In justifying the measure, a Canadian health official was quoted as saying that “Canadians expect and demand that their government will take all steps necessary to protect their health and safety.”176 Had the spread of anthrax assumed epidemic proportions, a decision overriding Bayer’s patent in ciprofloxacin by U.S. and Canadian authorities would, in retrospect, be considered an ethical and necessary public-health policy measure, important enough to trump pharmaceutical proprietary rights.177 Recently, a repeat of Bayer’s ciprofloxacin patent imbroglio loomed large amidst global avian flu pandemic fears. There were great global apprehensions that the bird flu virus could jump the species barrier and mutate into a transmissible human flu virus, akin to the 1918 global influenza pandemic that claimed at least 20 million lives.178 With barely enough Tamiflu (oseltamivir

U.S. government to use, manufacture, or contract another party to manufacture any invention described by a U.S. patent without obtaining a license from the owner, but in return must reasonably compensate the patent holder. Id. Section 1498 could be used to authorize the manufacture of generic ciprofloxacin. Id. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 clarified the Health Secretary’s responsibility for securing drugs and vaccines for bioterrorism emergencies. Public Health and Bioterrorism Preparedness and Response Act § 101(b)(3), 116 Stat. at 597. Section 101(b)(3) of the Act makes “[d]eveloping and maintaining medical countermeasures (such as drugs, vaccines and other biological products, medical devices, and other supplies) . . .” a key bioterrorism preparedness strategy. Id. If the Health Secretary were faced with a situation similar to the ciprofloxacin crisis, he could validly override the affected patent under 28 U.S.C. § 1498 based on his authority to do so in Section 101(b)(3) of the Public Health Security and Bioterrorism Preparedness Act of 2002. 28 U.S.C. § 1498; Publich Health and Bioterrorism Preparedness Response Act § 101(b)(3), 116 Stat. at 597. 172. Robert Kuttner, Anthrax May Change U.S. Drug Policy, S.D. UNION-TRIB., Oct. 21, 2001, at 1B; Donald McNeil, A Nation Challenged: The Drug; A Rush for Cipro, and the Global Ripples, N.Y. TIMES, Oct. 17, 2001, at A1. 173. Patent Act, R.S.C., ch. P-4, s. 19 (1985) (Can.). 174. See Amy Harmon & Robert Pear, A Nation Challenged: The Treatment; Canada Overrides Patent for Cipro to Treat Anthrax, N.Y. TIMES, Oct. 19 2001, at A1 (noting that Health Canada granted a compulsory license to a local pharmaceutical company to produce one million generic ciprofloxacin for anthrax treatment). 175. Richard Gold, My Body, Your Patent, GLOBE & MAIL, Oct. 29, 2001, at A13. 176. Harmon & Pear, supra note 174. 177. David B. Resnik & Kenneth A. De Ville, Bioterrorism and Patent Rights: “Compulsory Licensure” and the Case of Cipro, 2 AM. J. BIOETHICS 29, 29 (2002) (arguing that compulsory licensing of Cipro under circumstances similar to the 2001 anthrax attacks would be morally wrong). 178. Von Bubnoff, supra note 24, at 794-795.

No. 2] AGAINST THE PLAGUE 307 phosphate) for 2% of the world’s population being supplied by Roche,179 Taiwan reportedly vowed to make a generic version of Roche’s Tamiflu without Roche’s consent and in breach of Roche’s patent.180 Similarly, United States Senator Charles E. Schumer called on Roche to reach an agreement that would allow at least five U.S. companies to manufacture Tamiflu within a month or face legislation that would strip the company of its patent.181 However, Senator Schumer’s ultimatum to Roche appears moot because U.S. patent law’s compulsory licensure provision has specific, narrow and limited applications and is rarely used for patented pharmaceuticals.182 Additionally, the United States is reluctant to derogate from pharmaceutical patents rights in large part because its pharmaceutical industry reputedly derives about forty percent of its income from exports.183 In 2003, the U.S. pharmaceutical industry was reportedly responsible for $63.9 billion in real output, for a total of $172.7 billion, including economic ripple effects.184 Furthermore, the U.S. pharmaceutical industry reputedly has an average annual turnover of nearly US$200 billion; much of it derived from patents.185 Consequently, overriding Roche’s patent in Tamiflu would weaken and undermine the U.S. global drive for stronger pharmaceutical patents rights and protection.186 It was most certain that the United States would not invoke the TRIPS compulsory licensure provision187 to mass produce Tamiflu, notwithstanding Senator Schumer’s ultimatum to Roche. Nevertheless, Senator Schumer’s threat was not without significance. While it did not represent the official position of the U.S. government, Senator Schumer’s ultimatum arguably mirrored the general sentiments of a nation enthralled by the avian flu pandemic prospects, and the imperative of stopping the pandemic by any means.188 It was also reminiscent of the United States’

179. Declan Butler, Wartime Tactic Doubles Power of Scarce Bird-Flu Drug: Use of Common Drug Could Stretch World Stocks of Tamiflu, 438 NATURE 6, 6 (2005). 180. Taiwan to Ignore Flu Drug Patent, BBC NEWS, Oct. 22, 2005, http://news.bbc.co.uk/2/hi/asia- pacific/4366514.stm. 181. Marc Kaufman, Swiss Firm May Cede Bird Flu Drug Rights, WASH. POST, Oct. 19, 2005, at A13. 182. Under 35 U.S.C. §§ 203(a)(1)-(2) (2000) compulsory licensing is limited to federally funded pharmaceuticals. 35 U.S.C. § 296(a) (2000) excludes states from immunity in patent infringement lawsuits filed pursuant to 35 U.S.C. §§ 203(a)(1)-(3), (b). 183. John A. Harrelson, TRIPS, Pharmaceutical Patents, and the HIV/AIDS Crisis: Finding the Proper Ba lance Between Intellectual Property Rights and Compassion, 7 WIDENER L. SYMP. J. 175, 183 (2001). 184. Id. at 6. 185. MICHAEL BAILEY & RUTH MAYNE, PRICED OUT OF REACH: HOW WTO PATENT POLICIES WILL REDUCE ACCESS TO MEDICINES IN THE DEVELOPING WORLD 1, 11 (2001), http://www.oxfam.org.uk/ what_we_do/issues/health/downloads/priced.rtf. 186. Daniel R. Cahoy, Treating the Legal Side Effects of Cipro: A Reevaluation of Compensation Rules for Gover nment Takings of Patent Rights, 40 AM. BUS. L.J. 125, 135 (2002) [hereinafter Cahoy, Legal Side Effects] (arguing that the use of compulsory licenses by the United States for pharmaceuticals would undermine its drive for stronger worldwide intellectual property protection). 187. Kaufman, supra note 181. This decision, made under the auspices of the compulsory licensing regime in Articles 30 and 31 of TRIPS, was necessary to give members who lack manufacturing capacity, an opportunity to import pharmaceutical products. TRIPS Agreement, supra note 64, arts. 30-31; see also General Council for Trade-Related Aspects of International Property Rights, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health Decision, WT/L/540 (Aug. 30, 2003) (clarifying obligations under a compulsory license pursuant to TRIPS). 188. The public’s support for Senator Schumer’s threat to strip Roche of its patent was reminiscent of

308 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 and Canada’s 2001 battles for Bayer’s ciprofloxacin, and Brazil’s 2001 compulsory licensure threat to Roche’s Nelfinavir, all of which ended in negotiated price reductions and promises of adequate supplies.189 Given the antecedence of successful open threats and ultimatums in the face of looming public health pandemics, Roche’s ostensible capitulation to the Taiwanese and the U.S. Senator’s threats was inevitable, as evidenced by the company’s subsequent announcement that it was ready to license its Tamiflu patent under negotiated terms.190 It has thus become a standard practice to coerce drug companies into allowing generics of critical drugs by threatening a breach of their patents.191 While there is arguably the luxury of time for licensing negotiations in a looming pandemic scenario, there is precious little time for coaxing, cajoling, or haggling over mutually agreeable terms of license and royalty in a bioterrorism-induced public health crisis scenario. This is amply demonstrated by the haste with which the Canadian government initially overrode Bayer’s patent before eventually backpedaling.192 This makes having a definitive legal framework for automatically overriding pharmaceutical patents imperative in the face of highly probable bioterrorism crises. The absence of such a law presently renders patents overridden as an effective, self-help, emergency public health policy measure; however, as a response it is largely ad hoc, perfunctory, and vulnerable to patent-grab criticisms.193 This Article calls for the enactment of a definitive legal framework for pharmaceutical patent rights derogation, and its operational paradigm in bioterrorism situations. Against this background, the following section will critically examine the dynamics of the pharmaceuticals and patents interface in general. Special focus will be on the propriety of the TRIPS compulsory licensure and access to their support for possible government override of Bayer’s patent in Cipro during the 2001 anthrax crisis. See Cahoy, Legal Side Effects, supra note 186, at 128 (describing public opposition to Bayer’s monopoly over Cipro, the only drug that was then effective for the treatment of anthrax). 189. Following the breakdown of negotiations between the Brazilian government and Roche over price reductions for Nelfinavir, the Brazilian government threatened to invoke compulsory licensing to mass produce the drug. Bradly J. Condon, The Twin Security Challenges of AIDS and Terrorism: Implications for Flows of Trade, Capital, People, and Knowledge, in THE WTO AND THE DOHA ROUND: THE CHANGING FACE OF THE WORLD TRADE 251, 268 (Ross P. Buckley ed., 2003). The Brazilian government’s threat forced Roche to reduce the price of Nelfinavir, making it 70% cheaper in Brazil than it is in the United States. Id. 190. James Kanter, Licensing for Drug Awaits Talk, INT’L HERALD TRIB., Oct. 18, 2005, available at http://www.iht.com/articles/2005/10/18/news/roche.php. 191. See Sebastian Mallaby, A Double Dose of Failure, WASH. POST, Nov. 7, 2005, at A21 (examining the United States’ dilemma of supporting pharmaceutical patents in principle, yet supporting compulsory licensing during public health crises). 192. Harmon & Pear, supra note 174, at A1. 193. See Abbott, Doha Declaration, supra note 167, at 471 (discussing criticism of the double standards and inconsistencies in the United States’ simultaneous advocacy of strong pharmaceutical patent protection measures while initially opposing South Africa’s use of compulsory licensing for the production of antiretroviral drugs to treat HIV/AIDS sufferers); Sarah Boseley, Drug Dealing, GUARDIAN, Oct. 24, 2001, at 2. (noting the dilemma the United States faced over Bayer’s patent on ciprofloxacin, and predicting that developing countries may exploit United States’ stance on Cirpofloxacin at the WTO meeting); William Drozdiak & Paul Blustein, Serious Conflicts Threaten Trade Talks; Battle of Rich, Poor Nations Could Kill Planning for New WTO Discussions, WASH. POST, Nov. 6, 2001, at A1 (criticizing U.S. threats to override Bayer’s patent on ciprofloxacin in the face of anthrax, given the nation’s opposition to a similar measure by South Africa for HIV/AIDS).

No. 2] AGAINST THE PLAGUE 309 essential medicines regime for bioterrorism induced-public health crises, and the prospects for a special, bureaucracy-free, bioterrorism appropriation clause in patent laws.

III. STRONG MEDICINE: THE PATENTS AND PHARMACEUTICALS ENIGMA The debate about pharmaceutical patents and access to medicine is an enduring subject of legal,194 economic,195 and political discourse.196 Although there were minor skirmishes over drugs pricing between the pharmaceutical industry and AIDS activists in the United States in the mid 1980s,197 the pharmaceutical patents and access discourse was effectively ushered into the public domain, and imprinted in the public’s psyche by the well-publicized spat between the pharmaceutical industry and the South African government.198 The latter sought to invoke the compulsory licensure provision of its patent law, via the 1997 Medicine Act,199 to facilitate cheap imports of anti-retroviral drugs for the nation’s 4.2 million HIV/AIDS sufferers. The 1997 Medicine Act empowers the South African health minister to revoke any pharmaceutical patents if he perceives any associated medicines to be too expensive.200 The 2002 Act also permits parallel importation of medicines and empowers the health minister to overrule regulatory decisions on the registration and safety of medicines.201 The ensuing patent squabble was

194. E.g., KEN BLUESTONE ET AL., BEYOND PHILANTHROPY: THE PHARMACEUTICAL INDUSTRY, CORPORATE SOCIAL RESPONSIBILITY AND DEVELOPING WORLD 14-16 (2002), available at http://www.oxfam.org.uk/what_we_do/issues/health/downloads/beyondphilanthropy.pdf; COMM’N ON INTELLECTUAL PROP. RIGHTS, INTEGRATING INTELLECTUAL PROPERTY RIGHTS AND DEVELOPMENT 34 (2002), available at http://www.iprcommission.org/papers/pdfs/final_rep ort/Ch2final.pdf; WORLD TRADE ORG. & WORLD HEALTH ORG., WTO AGREEMENTS AND PUBLIC HEALTH 23-24 (2002), available at http://www.wto.org/English/res_e/booksp_e/who_wto_e.pdf; Naomi A. Bass, Implications of the TRIPS Agreement for Developing Countries: Pharmaceutical Patent Laws in Brazil and South Africa in the 21st Century, 34 GEO. WASH. INT’L L. REV., 191, 222 (2002); Suresh Koshy, The Effects of TRIPS on Indian Patent Law: A Pharmaceutical Industry Perspective, 1 B.U. J. SCI. & TECH. L. 4, 4 (1995). 195. See KEITH E. MASKUS, INTELLECTUAL PROPERTY RIGHTS IN THE GLOBAL ECONOMY 27-169 (2000) (assessing the effects of strong international intellectual property rights). 196. See, e.g., Markus Nolff, Compulsory Patent Licensing in View of the WTO Ministerial Conference De claration on the TRIPS Agreement and Public Health, 84 J. PAT. & TRADEMARK OFF. SOC’Y 133, 133-35 (2002) (discussing the effect of the WTO Ministerial Declaration on compulsory licensing). 197. Martin Delaney, AIDS Activism and the Pharmaceutical Industry, in ETHICS AND THE PHARMACEUTICAL INDUSTRY 300, 300-25 (Michael A. Santoro & Thomas M. Gorrie eds., 2005). 198. See Patrick Bond, Globalization, Pharmaceutical Pricing and South African Health Policy: Managing Confrontation with U.S Firms and Politicians, 29 INT’L J. HEALTH SERVS. 765-67 (1999) (discussing how the profit motive acts as an incentive in the development of pharmaceuticals); cf. Anthony Faiola, Brazil to Ignore Patent on AIDS Drug, WASH. POST, Aug. 23, 2001, at A20 (discussing Brazil’s intent to declare AIDS a national emergency, thus triggering a law that would allow the generic production of AIDS drugs). 199. The Medicines and Related Substances Control Act of 1997 s. 10, 12 (S. Afr.), available at http://www.doh.gov.za/docs/legislation/acts/1997/act90.pdf (amending certain sections of the Principal Act 101 of 1965). 200. The Medicines and Related Substances Control Act s. 13 (S. Afr.). 201. The Medicines and Related Substances Act 59 of 2002 (S. Afr.), available at http://www.info.gov.za/gazette/acts/2002/a59-02.pdf (providing “for the delay of coming into operation of provisions requiring a license before a person can compound and dispense or manufacture medicines, or act as a wholesaler or distributor; to provide for appeals against the decisions of the Director-General and the council; to provide for regulations relating to marketing of medicines; and to provide for matters connected

310 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 arguably responsible for forcing a rethinking of the interface between patent and public health issues by the WTO, and striking a political bargain aimed at addressing the public health crisis in resource-poor countries in the November 2001 WTO/TRIPS Doha Ministerial Declaration.202 The ensuing legal fracas unleashed torrents of broadsides from non-governmental organizations and civil societies across the globe.203 It also helped swell an army of anti- corporatization and globalization activists from the streets of Seattle to Genoa,204 culminating in a disastrous blackening of the pharmaceutical industry’s image. The incident also became a standard reference point in noisy discourse on the north/south knowledge divide, and the acceptable modalities for fair trading rules, knowledge access, and technology transfer.205 It was, undoubtedly, a public relation disaster for the pharmaceutical industry, which quickly abandoned the South African lawsuit, while some of its members retreated quickly into damage-control strategies, including the selling of antiretroviral drugs to resource-poor countries at discounted prices in order to soothe tensions.206 While it may appear that the pharmaceutical industry went too far in challenging South African law, the economics of pharmaceutical research and development justified industry opposition to the South African cheap drugs initiative. The pharmaceutical industry is one of the most research-intensive industries,207 and, empirically, the most patent-dependent of all capital-

therewith”). 202. World Trade Organization, Ministerial Declaration of 14 November, 2001, WT/MIN(01)/DEC/1 41 I.L.M 746 (2002). 203. Nathan Ford, Public Health and Company Wealth, 326 BRIT. MED. J. 1296, 1296 (2003) (advocating for the development of an international convention “to ensure the new medicines are developed according to global health needs, and equitable drug pricing . . . through a mandatory framework”); Consumer Project on Technology, About the Consumer Project on Technology, http://www.cptech.org/about.html (last visited Oct. 24, 2007) (campaigning for access to essential medicine); Press Release, Medecins Sans Frontieres, People Not Getting the Treatment They Need to Stay Alive (Nov. 29, 2006), available at http://www.msf.org/msfinternational/invoke.cfm?objectid=32EF6B3A-5056-AA77-6C437DDBAD509BC6& component=toolkit.pressrelease&method=full_html (arguing that health problems in developing countries are not adequately addressed under current law). 204. ALEXANDER COCKBURN & JEFFREY ST. CLAIR, THE FIVE DAYS THAT SHOOK THE WORLD: THE BATTLE FOR SEATTLE AND BEYOND 13 (2000); JANET THOMAS, THE BATTLE IN SEATTLE: THE STORY BEHIND AND BEYOND THE WTO DEMONSTRATIONS, 64-75 (2000); Stephen Skinner, Death in Genoa: The G8 Summit Shooting and the Right to Life, EUR. J. CRIME CRIM. L. CRIM. JUST. 232, 235 (2003). 205. VANDANA SHIVA, PROTECT OR PLUNDER: UNDERSTANDING INTELLECTUAL PROPERTY RIGHTS 69-85 (2001); Condon, supra note 189, at 251; Martin Khor, Seattle Debacle: Revolt of the Developing Nations, in GLOBALIZE THIS! THE BATTLE AGAINST THE WORLD TRADE ORGANIZATION AND THE CORPORATE RULE 48-52 (Kevin Danaher and Roger Burbach, eds., 2000); Werner Scholtz, The Transfer of Technology Between the North and South: Killed by the TRIPS Agreement?, 12 TILBURG FOREIGN L.R., 208, 208 (2005); Vandana Shiva, TRIPS, Human Rights and the Public Domain, 7 J. WORLD INTELL. PROP. 665, 665 (2004). 206. See ROBERT L. OSTERGARD, JR., THE DEVELOPMENT DILEMMA: THE POLITICAL ECONOMY OF INTELLECTUAL PROPERTY RIGHTS IN THE INTERNATIONAL SYSTEM 97 (2003) (noting the pharmaceutical industry’s attempts to repair its image by distributing free drugs to developing countries); Steve Sternberg, AIDS Drug Costs Hurt Africa: New Discounts Mean Little in Poor Nations, USA TODAY, Mar. 15, 2001, at 7A (noting that Bristol-Myers Squibb and Merck & Co. were the first drug companies to announce discount sales of antiretroviral drugs to poor African countries). See Drozdiak & Blustein, supra note 193 for a critical view of the pharmaceutical industry’s ad hoc approach for access to low cost drugs in developing countries. 207. RIK VAN REEKUM, INTELLECTUAL PROPERTY AND PHARMACEUTICAL INNOVATION: A MODEL FOR MANAGING THE CREATION OF KNOWLEDGE UNDER PROPRIETARY CONDITIONS 1 (1999); PHARM. RESEARCH &

No. 2] AGAINST THE PLAGUE 311 intensive, high-technology industries.208 The odds of a new prescription drug entering the market are one in five thousand.209 Even then, only 30% of the drugs in the marketplace produce revenue that exceeds their cost of development.210 Moreover, it is axiomatic that millions of dollars of private research and development funding are sunk into the industry in pursuit of innovative and blockbuster drugs.211 In the United States, advancement of a potential new medicine from “a research idea to treatment” averages ten to fifteen years, and costs $800 million.212 Similarly, a controversial 2003 report by Bain & Company put the costs of developing a single new drug at $1.7 billion.213 Although the actual cost of pharmaceutical research and development is a highly controversial topic—especially with the pharmaceutical industry’s estimated research and development cost estimates constantly attacked as being exaggerated214—there is no denying the significance of patents to the pharmaceutical industry.215 The patent system ensures that the pharmaceutical industry can recoup its huge financial investments, by keeping out competitors during patent pendency.216

MFRS. OF AM., PHARMACEUTICAL INDUSTRY PROFILE 2006, 1-4 (2006), http://www.phrma.org/ files/2006%20Industry%20Profile.pdf. 208. Richard Frank & David Salkever, Pricing, Patent Loss and the Market for Pharmaceuticals, 59 S. ECON. J. 165, 165-79 (1995); Edwin Mansfield, Unauthorized Use of Intellectual Property: Effects on Investment, Technology Transfer, and Innovation, in GLOBAL DIMENSIONS OF INTELLECTUAL PROPERTY RIGHTS IN SCIENCE AND TECHNOLOGY 107, 111-19 (Mitchel B. Wallerstein, et al., eds., 1993) (indicating that of the six U.S. industries polled, the chemical industry, which includes pharmaceuticals, had the highest percentage of firms that said they would not directly invest in certain countries due to weak intellectual property protection). 209. NRLC Position on Drug Price Controls in Medicare (Jan. 2007), http://www.nrlc.org/HealthCare/ PriceControlsQA.html. 210. Id. 211. CARSTEN FINK, INTELLECTUAL PROPERTY RIGHTS, MARKET STRUCTURE, AND TRANSNATIONAL CORPORATIONS IN DEVELOPING COUNTRIES 123 (2000); see Shanker A. Singham, Competition Policy and the Stimulation of Innovation: TRIPS and the Interface Between Competition and Patent Protection in the Pharmaceutical Industry, 26 BROOK. J. INT’L L. 363, 373 (2000) (highlighting the high cost of pharmaceutical research and development). 212. PHARM. RESEARCH & MFRS. OF AM., supra note 207, at 2; Joseph A. DiMasi et al., The Price of Innovation; New Estimates of Drug Development Costs, 22 J. HEALTH ECON. 151, 151 (2003). 213. Drug Development Costs Rise to $1.7 Billion, Study Finds, DRUG INDUSTRY DAILY, Dec. 9, 2003, at s. 239. 214. Opponents contend that the pharmaceutical industry’s reaserch and development figures were exaggerated and did not take into account the amount that the U.S. government spends on the National Institute of Health and other health related agencies such as the FDA, CDC, DOE, etc. Most recently, Representative Sherrod Brown called on the Bush Administration to investigate the actual cost of pharmaceutical reasearch & development. Rep. Brown Asks White House for Study of Drugs R&D Costs, DRUG INDUSTRY DAILY, Apr. 26, 2005, available at http://www.fdanews.com/newsletter/ article?issueId=7484&articleId=71492; Letter from James Love, Dir., Consumer Project Tech., to the Dep’t of Commer ce, Int’l Trade Admin. (Jul. 1, 2004), available at http://www.cptech.org/ip/health/rndtf/ drugpricestudy.html; see also MARCIA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT, 37-51 (2005) (debunking the pharmaceutical industry’s estimate of $802 million in research and development costs per drug, and accusing the industry of concealing the real costs of about $100 million after taxes). 215. See Andrew Beckerman-Rodau, Patent Law – Balancing Profit Maximization and Public Access to Technology, 4 COLUM. SCI. & TECH. L. REV. 1, 15-18 (2002), available at http://www.stlr.org/cite.cgi? volume=4&article=1 (illustrating that there are also downsides to obtaining a patent). 216. GRAHAM DUTFIELD, INTELLECTUAL PROPERTY RIGHTS AND THE LIFE SCIENCE INDUSTRIES: A TWENTIETH CENTURY HISTORY 98, 107 (2003); MASKUS, supra note 195, at 109-42; Harvey E. Bale Jr.,

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This is otherwise known as patent exclusivity, and is conferred on all patentable inventions by Article 28 of the TRIPS Agreement.217 In the Canada-Patent Protection of Pharmaceutical Products (“Canada-Patent Protection”) case, the WTO Panel Report highlighted the significance of TRIPS’ Article 28 as follows: The normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of market exclusivity. . . . Patent laws establish a carefully defined period of market exclusivity as an inducement to innovation, and the policy of those laws cannot be achieved unless patent owners are permitted to take effective advantage of that inducement once it has been defined.218 The above quote affirms the twin functional values of patents embodied in the reward and prospects doctrines.219 Primarily, the societal quid pro quo for patent exclusivity is the expected concomitant rise in research and development investments, and public disclosure of the patented invention220 which, in turn, assures conditions for competitive, innovative and beneficial products.221 The pharmaceutical industry is, however, highly vulnerable to cheap imitations and piracy because chemicals are easily replicable.222 It is estimated that about 6% of world global trade in medicines is lost due to .223

Patents and Developing Countries: Access, Innovation and the Political Dimnesions of Trade Technology, in THE ECONOMICS OF ESSENTIAL MEDICINES 100 (Brigette Granville ed., 2003); Richard C. Levin et al., Appropriating the Returns from Industrial Research and Development, in THE ECONOMICS OF TECHNICAL CHANGE 243 (Edwin Mansfield & Elizabeth Mansfield, eds., 1993). 217. TRIPS Agreement, supra note 64, art. 28. 218. Panel Report, Canada-Patent Protection for Pharmaceutical Products, WT/DS114/R (Mar. 17, 2000) [hereinafter Canada-Patent Protection]. 219. The reward doctrine posits that patents are rewards given to inventors who contribute to economic and technological progress of a nation that give them incentive to keep working. NUNO PIRES DE CARVALHO, THE TRIPS REGIME OF PATENT RIGHTS 1-8 (2005) The prospect doctrine posits that patents are certificates that grant inventors the power to prospect the market for commercial opportunities. Id. The prospect doctrine thrives on the apparent weakness of the reward theory that most patents are never worked and that it is impossible to know the full potential of a patent when it is granted. MICHAEL PERELMAN, STEAL THIS IDEA: INTELLECTUAL PROPERTY RIGHTS AND THE CORPORATE CONFISCATION OF CREATIVITY 59-63 (2002) (giving specific examples specific examples of patents that were never worked or developed). However, Nuno Pires de Carvalho argues that both the Reward and Prospect doctrines are flawed because they do not offer a complete systematic explanation of the patent system as a whole. PIRES DE CARVALHO, supra, at 1-8. Nevertheless, the two theories do highlight some of the practical functions of the patent system. Edmund W. Kitch, The Nature and Function of the Patent System, 20 J.L. & ECON. 265, 266 (1977). 220. Beckerman-Rodau, supra note 215, at 17-18; Stanley M. Besen & Leo J. Raskind, An Introduction to the Law and Economics of Intellectual Property, 5 J. ECON. PERSP. 3, 5 (1991). But see PERELMAN, supra note 219, at 45-73 (citing instances where patents stifled innovation rather than promoted it). 221. Abbott, Doha Declaration, supra note 167, at 472-73 (noting the pharmaceutical industry’s argument that patents are indispensable to continual funding of research and development of innovative pharmaceuticals). 222. See PAUL R. PARADISE, TRADEMARK COUNTERFEITING, PRODUCT PIRACY, AND THE BILLION DOLLAR THREAT TO THE U.S. ECONOMY 175 (1999) (citing a tragic example of the effects of drugs wh ere 2,500 people died after being administered a counterfeited meningitis vaccine in the Niger Republic in April 1995). 223. Association of the British Pharmaceutical Industry, The Trade in Counterfeit Medicines (July 2003),

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Empirical study has established that cheap imitations of original products could adversely affect incentives for further innovation.224 This is one of the reasons the pharmaceutical industry is ever keen on promoting stronger patent protection for pharmaceuticals and fending off production of cheaper generics prior to expiration of patents.225 Companies have employed tactics like collusive agreements with competitors in clear breach of anti-competition rules.226 They have also used infringement lawsuits as barriers, and they have crafted perennial patent monopoly rights via new patents on slightly modified process or product pharmaceutical patent claims.227 This is exemplified by ongoing patent disputes between Novartis and Indian pharmaceutical companies in a Chennai court.228 The former sought patent protection for Glivec, a modified form of its leukemia drug, under the Indian 2005 Patent Act, while the latter contended that the modified cancer drug constituted mere “incremental ,” and suffered from prior publication, lack of inventive step, and insufficient description, and did not represent a significant improvement on the original off-patent leukemia drug, therefore making it ineligible for protection under the Indian Patent Act.229 Significantly, the Indian generic version of Glivec retailed only “for about a tenth of the $2,600 that Novartis charge[d] for a month’s course of treatment.”230 Novartis’ challenge to Indian Patent law was premised on its alleged non-compliance htt p://www.abpi.org.uk/press/media_briefings_03/2003/Counterfeit_030705.pdf. 224. See Edwin Mansfield, Mark Schwartz & Samuel Wagner, Imitation Costs and Patents: An Em pirical Study, 91 ECON. J. 907, 907, 915 (1981) (surveying firms, including pharmaceutical companies, and determining that about half of their patented innovations would not have been introduced if patent protection were not available). 225. The pharmaceutical industry was reputedly a key member of the multinational consortium that pressed for stronger international patent protection in the context of international trade agreements, culminating in the 1994 WTO-Marrakech Agreement. M.B. RAO & MANJULA GURU, UNDERSTANDING TRIPS: MANAGING KNOWLEDGE IN DEVELOPING COUNTRIES 20-22 (2003); Robert Weissman, A Long Strange TRIPS: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries, 17 U. PA. J. INT’L ECON. L. 1069, 1077, 1084-85 (1996). 226. The U.S. pharmaceutical industry has been accused of illegally extending pharmaceutical patent mo nopolies by abusing a loophole in the Hatch-Waxman Act relating to the early approval process for generics. Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace: Hearing Before the S. Comm. On the Judiciary, 108th Cong. 250 (2003), available at http://www.ftc.gov/os/2003/06/030617pharmtestimony.htm (prepared statement of Timothy J. Muris, Comm’r, Fed. Trade Comm’n). Monopolistic abuses include anti-competitive agreements between names and generic drug companies to prevent early market entry of generic drugs. See e.g., In re Ciprofloxacin Hydrochloride Antitrust Litig., 363 F. Supp. 2d 514, 519 (E.D.N.Y. 2005) (finding that Bayer paid $ 49.1 million to Barr, in return for delaying the market entry of a generic drug against Bayer’s ciprofloxacin); In re Terazosin Hydrochloride Antitrust Litig., 164 F. Supp.2d 1340, 1346 (S.D. Fla. 2000) (reporting that a generic manufacturer received a pay-off of $4.5 million a month); In re Cardizem CD Antitrust Litig., 105 F. Supp. 2d 682, 701 (E.D. Mich. 2000) (finding that a generic company agreed to delay early market entry for $10 million per quarter). 227. Lara J. Glasgow, Stretching the Limits of Intellectual Property Rights: Has the Pharmaceutical Industry Gone Too Far?, 41 INTELL. PROP. L. REV. 227, 235-37 (2001). 228. Amelia Gentleman, Battle Pits Patent Rights Against Low-Cost Generic Drugs, N.Y. TIMES, Jan. 30, 2007, at C5. 229. Id.; BISWAJIT DHAR & K.M. GOPAKUMAR, POST-2005 TRIPS SCENARIO IN PATENT PROTECTION IN THE PHARMACEUTICAL SECTOR: THE CASE OF THE GENERIC PHARMACEUTICAL INDUSTRY IN INDIA 18 (2006), http://www.iprsonline.org/unctadictsd/docs/ Dhar%201Indian%20Pharma%20November06.pdf. 230. Gentleman, supra note 228, at C5.

314 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 with TRIPS.231 Pharmaceutical patents are so crucial to the pharmaceutical industry’s survival that many nations have drafted special legislation to extend the term of pharmaceutical patents beyond the standard twenty years.232 For instance, in the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”)233 permits limited extensions for pharmaceutical patents to make up for time lost during the marketing approval process conducted by the FDA. Similarly, the and Australia have conditional pharmaceutical patent term extension provisions in their patent laws.234 Apart from patents, the pharmaceutical industry often resorts to trademarks235 and trade secrets or know-how236 to protect their from generic competition. Such plus-patent protection is especially crucial for off- patent drugs. This is more so for trademark, which is as effective as patent in blocking parallel importation of generics even when brand names are off- patent.237 The know-how component of pharmaceutical production is protected by laws guaranteeing exclusive rights on clinical drug test data, which are indispensable for securing marketing rights in most countries.238

231. The Chennai court subsequently dismissed the writ petition. Novartis, India Glivec Patent Case, http://www.novartis.com/about-novartis/corporate-citizenship/india-glivec-patent-case/index.shtml (last visited Oct. 24, 2007). 232. Wendy H. Schacht & John R. Thomas, PHARMACEUTICAL PATENT TERM EXTENSIONS: A BRIEF EXPLANATION 2 (2002), available at http://www.boozman.house.gov/UploadedFiles/HEALTH%20- %20Pharmaceutical%20Patent%20Term%20Extensions%20A%20Brief%20Explanation.pdf. If a patent is not granted within three years from the filing date, then the patent holder may receive a day-for-day extension of the patent term. American Inventors Protection Act of 1999, Pub. L. No. 106-113, § 4402, 113 Stat. 1501A- 552, 1501A-557. In the United States, as in most countries, the grant of pharmaceutical patents and marketing approval are two distinct events. See In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995) (pointing out the differing requirements for obtaining a patent and obtaining government approval to market a drug for human consumption). To make up for the time loss between patent grant and marketing approval, the United States enacted the Drug Price Competition and Patent Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585. 233. Drug Price Competition and Patent Term Restoration Act § 156. 234. Council Regulation 1768/92, Concerning the Creation of a Supplementary Protection Certificate for Medicinal Products, 1992 O.J. (L 182) 1. For a judicial interpretation of the supplementary protection ce rtificat e rationale, see the European Court of Justice’s decision in Case C-350/92, Kingdom of Spain v. Co uncil of European Union, 1995 E.C.R. I-1985, at 15. Patent Act, 1990, c.6, §. 70 (Austl.), available at http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/s70.html. 235. S. CALLENS ET AL., CHAPTERS ON PHARMACEUTICAL LAW 100 (2000). It is theoretically possible to use trademark or to protect expired patents provided the mark or dress is not claimed in the expired patent and has no functional value. See, e.g., TrafFix Devices, Inc. v. Mktg. Displays, Inc., 532 U.S. 23, 29 (2001) (using the to scuttle an alleged product design trade dress infringement suit). 236. See Ian Dodds-Smith, Data Protection and Abridged Applications for Marketing Authorizations in the Pharmaceutical Industry, in PHARMACEUTICAL MEDICINE, BIOTECHNOLOGY AND EUROPEAN LAW 93, 93 (Richard Goldberg & Julian Lonbay eds., 2000). 237. Glasgow, supra note 227, at 252-54. 238. Notwithstanding the grant of a patent, clinical testing data is required before drugs are allowed to be marketed in most countries. In the United States, the FDA monitors clinical trials of new drugs in order to ensure public health safety. Information for Clinical Investigators, http://www.fda.gov/cder/about/ smallbiz/clinical_investigator.htm (last visited Oct. 27, 2007). In Europe, medicines for humans must be approved before they can be sold, which involves submission of clinical test data for the drug for which approval is sought. Council Directive 65/65, art. 4, 1965 O.J. 369 (EEC). Approval of the Medicine Evaluation Agency for market authorization is validated by certificates issued to that effect. Aaron Xavier Fellmeth, Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of

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For instance, Article 39.3 of the TRIPS Agreement enjoins WTO members to preserve the confidentiality of clinical drug test data submitted for marketing approval, except in cases of overriding public interest.239 Similarly, in the United States,240 Canada,241 and European Union,242 generic-drug manufacturers may not rely on clinical drug test data submitted by brand manufacturers for marketing approval, until five to ten years after initial marketing approval.243 However, there are exceptions to the panoply of legal protection for pharmaceuticals. In the context of intellectual property rights in general, these exceptions are generally hinged on the imperatives of balancing the conflicts among intellectual property rights, unbridled technology diffusion, and competition or antitrust policy.244 In the context of the TRIPS Agreement, the significance of the interplay between intellectual property and competition policy was underscored by the constitution of the WTO Working Group on the Interaction between Trade and Competition Policy at the December 1996 Singapore Ministerial Conference.245 With regard to pharmaceutical patents in

Marketing Approval Data Under the TRIPS Agreement, 45 HARVARD INT’L L.J. 443, 445 n.12 (2004); European Medicines Agency, About EMEA – Contact Points, http://www.emea.europa.eu/htms/aboutus/ emeainfopoint.htm#certificates (last visited Sept. 30, 2007). 239. TRIPS Article 39.3 provides: Members, when requiring, as a condition of approving the marketing of a pharmaceutical or of agricultural or chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except when necessary to protect the public, or unless steps are taken to ensure the data are protected against unfair commercial use. TRIPS Agreement, supra note 64, art. 39.3. 240. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585. The FDA as a matter of law, will not entertain a generic manufacturer’s application for marketing approval without the prior approval of the initial registrant (brand manufacturer). 21 U.S.C. § 355(c)(3)(E)(ii) (2000). 241. Food and Drugs Act, C.R.C., ch. 870 (1985), amended by § C. 08.004.1, 129 C. Gaz. 2494 (Can.). 242. Council Directive 2001/83/EC, art. 10, 2001 O.J. (L 311) 75. 243. In Europe, clinical test data is usually protected for six to ten years. See Dodds-Smith, supra note 236, at 113. 244. Although the TRIPS Agreement does not expressly address competition law, its Article 40(1) notes tha t “some licensing practices or conditions pertaining to intellectual property rights which restrain competition may have adverse effects on trade.” TRIPS Agreement, supra note 64, art. 40(1). Article 40(2) stat es that nothing in TRIPS prevents members from specifying “licensing practices or conditions that may in particular case constitute abuse of intellectual property rights having an adverse effect on competition in the relevant market.” TRIPS Agreement, supra note 64, art. 40(2). Article 31 is an important provision in the context of pharmaceuticals as it allows non-exclusive compulsory licensing. TRIPS Agreement, supra note 64, art. 31; see infra Part IV. 245. World Trade Organization, Singapore Ministerial Declaration, WT/MIN(96)/DEC, ¶ 20 (1996), available at http://www.wto.org/english/thewto_e/minist_e/min96_e/singapore_declaration96_e.pdf. The Working Group has since discussed topics including the objectives of intellectual property and their rel ationship to competition policy, the optimal treatment of intellectual property licensing agreements and the implications of the territorial segmentation of intellectual property protection in the context of competition policy. See, e.g., WTO, Working Group Set Up by Singapore Ministerial http://www.wto.org/english/ thewto_e/minist_e/min99_e/english/about_e/16comp_e.htm (last visited Oct. 24, 2007). For discussion on the adequacy of the TRIPS competition policy, see Fredrick M. Abbott, Are the Competition Rules in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights Adequate, in REFORMING THE WORLD TRADING SYSTEM: LEGITIMACY, EFFICIENCY, AND DEMOCRATIC GOVERNANCE 317, 317-34 (Ernst-Ulrich Petersmann & James Harrison, eds., 2005) (concluding that there are no compelling grounds for change, but

316 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 particular, derogations from patent exclusivity are often anchored on public policy underpinnings for public health protection. A good example of such derogation from patent exclusivity is the “Bolar” exception rule in the United States that allows the use or sale of a patented invention, if such dealings are reasonably related to the development and submission of information under a federal law governing the manufacture, use, or sale of drugs or veterinary biological products.246 A comparable Canadian provision247 was held compatible with Article 30 of the TRIPS Agreement by the WTO Dispute Settlement Understanding (“DSU”) Panel on March 17, 2000 in the Canada- Patent Protection case.248 Similarly, the European patent regime recognizes particular249 and general250 exceptions to bio-pharmaceutical patent exclusivity. William Cornish and David Llewellyn noted that general exceptions cover both private and experimental use.251 While private use covers private and non-commercial acts,252 experimental use covers all non-commercial experimental activities in relation to the subject matter of the invention.253 The experimental use exception is especially controversial in the context of successful blockbuster drugs.254 However, recent trends in the European Patent Convention countries show increasing acceptance of the commercial experimental use exception.255 For instance, while accepting the Bolar-type exception rule, the German

that developed nations could do more to encourage their businesses to abandon restrictive business practices abroad). 246. 35 U.S.C. § 271(e)(1) (2000). Section 271(e)(1) was enacted following a Federal Circuit decision in Ro che Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 863-64 (Fed. Cir. 1984), which held that clinical data testing was not within the purview of the common law experimental use doctrine. 247. Patent Act, R.S.C., ch. P-4, § 55.2(1) (2001) (Can.) (“It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.”). 248. Canada-Patent Protection for Pharmaceutical Products, supra note 218, ¶ 7.45. 249. Particular exceptions include “extemporaneous” preparations by pharmacists from prescriptions provided by the Council Agreement Relating to Community Patents 89/695, art. 27(c), 1989 O.J. (L 401) 1, 14 (EEC), and the “farming” use exception in conformity with the Council Directive 98/44, art. 11, 1998 O.J. (L 213) 13, 19 (EC). For discussion, see WILLIAM CORNISH & DAVID LLEWELYN, INTELLECTUAL PROPERTY: PATENTS, COPYRIGHT, TRADE MARKS AND ALLIED RIGHTS 245-47 (5th ed., 2003). 250. CORNISH & LLEWELYN, supra note 249. 251. Id. at 245. 252. Acts by governmental, educational, or charitable organizations might not be commercial, but would not likely be regarded as private use. Id. 253. Id. Note that the non-commercial experimental use exception is permitted only when it relates to the subject matter of the patented invention. The commitment to this very limited interpretation is evidenced by the laws of WTO members. E.g., Council for Trade-Related Aspects of Intellectual Property Rights, Review of Legislation in the Field of Patents, Layout-Designs (Topographies) of Integrated Circuits, Protection of Undisclosed Information and Control of Anti-Competitive Practices in Contractual Licenses, IP/Q3/DEU/1 (Oct. 27, 1998); Council for Trade-Related Aspects of Intellectual Property Rights, Review of Legislation in the Field of Patents, Layout-Designs (Topographies) of Integrated Circuits, Protection of Undisclosed Information and Control of Anti-Competitive Practices in Contractual Licenses, IP/Q3/BEL/1 (Mar. 16, 1998); Council for Trade-Related Aspects of Intellectual Property Rights, Review of Legislation in the Field of Patents, Layout-Designs (Topographies) of Integrated Circuits, Protection of Undisclosed Information and Control of Anti-Competitive Practices in Contractual Licenses, IP/Q3/IRL/1 (Oct. 22, 1997). 254. CORNISH & LLEWELYN, supra note 249, at 249. 255. Id.

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Federal Supreme Court held in the 1995 case of Boehringer Ingelhiem Int. GmbH vs. Dr. Rentschler Arzneimittel GmbH and others256 that “it is not contrary to the permissibility of clinical tests that the Defendants are carrying out or supporting these with the further aim of licensing the laws relating to pharmaceuticals.”257 Moreover, the European Parliament gave a fillip to the Bolar-type exception in a resolution dated April 16, 1996 supporting the measure.258 Other possible exceptions to pharmaceutical patent exclusivity include: international exhaustion of intellectual property rights (on which Article 6 of TRIPS is mute), the limited exceptions under Article 30 of TRIPS, the compulsory licensing provisions of Article 31 of TRIPS, and the TRIPS-Doha Declaration on Public Health for leveraging access to critical medicines in resource-poor countries. The following paragraphs will critically review the propriety and efficacy of these exceptions for securing crucial drugs for bioterrorism-induced diseases in the context of attendant extraordinary public health crises.

IV. THE PROPRIETY OF TRIPS PROVISIONS AND OTHER EXCEPTIONS TO PATENT EXCLUSIVITY FOR BIOTERRORISM-INDUCED DISEASES The following examines TRIPS Article 6 on the exhaustion of intellectual property rights, TRIPS Article 30 on limited exception to patentees’ rights, TRIPS Article 31 on compulsory licensing provisions, the TRIPS-Doha Declarations on Public Health, and other general exceptions to patents exclusivity as they affect pharmaceutical patents rights in relative detail. The discourse will primarily draw on these patent-limiting provisions of TRIPS and the patent laws of the United States, the European Union, Canada, and other Anglo-American jurisdictions for comparison. This Part will argue that the existing exceptions are inadequate for bioterrorism-induced public health crises.

A. TRIPS Provision on Exhaustion of Rights and Implications for Parallel Importation of Pharmaceuticals for Bioterrorism-Induced Diseases

In principle, especially within the territory covered, intellectual property rights are exhausted after first sales by the right owners or with the right owners’ consent.259 However, the law concerning international exhaustion of

256. CORREA, IP RIGHTS, supra note 68, at 79-80. 257. Id. at 79. 258. Paragraph 17 of the European Parliament 1996 Resolution provides as follows: Measures should be introduced which enable pharmaceutical companies to begin, in advance of patent or supplementary protection certificate (SPC) expiry, such laboratory experiments and regulatory preparations as may be required only for the registration of generic pharmaceuticals developed in the EU, to be available on the market immediately, but only after the expiry of a patent or SPC for a proprietary product. Id. at 80. 259. CORNISH & LLEWELLYN, supra note 249, at 42; PAUL TORREMANS, INTELLECTUAL PROPERTY LAW 440-46 (2005) (discussing exhaustion agreements in the EU). Exhaustion is known as the “first-sale doctrine”

318 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 intellectual property rights is not as settled, since intellectual property rights are inherently territorial, and national intellectual property rights can still be used to bar the importation of goods sold abroad by national rights owners, or sold abroad with their consent.260 The significance of international exhaustion of pharmaceutical rights policy lies in its dual use to allow or forbid cross- border importation of cheap medicines.261 In the European Union, for example, cross-border parallel importation of medicines is an established practice, rooted in the common-market principle and validated by the European Court of Justice in numerous cases.262 Article 6, the key provision of the TRIPS Agreement on exhaustion, states, “For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”263 In principle, patentees can use their national rights264 to bar cross-border importation of goods originally sold abroad by them or with their consent. In the context of the TRIPS Agreement however, patentees’ right to bar cross- border importation of goods is ostensibly constrained by Article 6 of the TRIPS Agreement,265 which excludes exhaustion of intellectual property rights from within its ambit in dispute settlement situations.266 In other words, there can be no justiceable complaint against parallel importation of patented products under Article 6 of TRIPS. This position is reinforced by paragraph 5(d) of the November 2001 Doha Declaration on the TRIPS Agreement and Public Health, which states, “The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge subject to the MFN and national treatment provisions of in the United States. Abdulqawi Yusuf & Andres Moncayo von Hase, Intellectual Property Protection and International Trade: Exhaustion of Rights Revisited, 16 WORLD COMPETITION 115, 119-124 (1992). 260. CORNISH & LLEWELYN, supra note 249, at 42. 261. For further discussion of parallel trade in medicines, see Bess-Carolina Dolmo, Examining Global Access to Essential Pharmaceuticals in the Face of Patent Protection Rights: The South African Example, 7 BUFF. HUM. RTS. L. REV. 137, 137-39 (2001); Nick Gallus, Parallel Policies on Pharmaceutical Parallel Trade, 11 INT’L TRADE L. & REG. 77, 77-83 (2005). 262. See Case 104/75, Offieve van Justice v. de Peijer, 1976 E.C.R 613 (holding that a Dutch law prohibiting parallel importation was incompatible with Article 36 of the European Economic Community Treaty). 263. TRIPS Agreement, supra note 64, art. 6. 264. Article 28 of TRIPS vests ownership in patentees as follows: (1) A patent shall confer on its owner the following exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product; (b) where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process. TRIPS Agreement, supra note 64, art. 28. 265. The footnote to Article 28 provides as follows: “This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6 above.” TRIPS Agreement, supra note 64, art. 28 n.6. 266. TRIPS Agreement, supra note 64, art. 6. It has been suggested that Article 6 only excludes dispute settlements and does not exclude intellectual property rights exhaustion entirely from TRIPS. DANIEL GERVAIS, THE TRIPS AGREEMENT: DRAFTING HISTORY AND ANALYSIS 112 (2d ed. 2003).

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Articles 3 and 4.”267 Significantly, paragraph 5(d) of the Doha Declaration neither adds anything substantial to Article 6 of TRIPS, nor radically changes its scope. The main provision of TRIPS that pertains to exhaustion is Article 6, and, arguably, it already tacitly allows Members to decide their exhaustion regime. Therefore, paragraph 5(d) of the Doha Declaration is no more than a reassuring restatement of the law as provided under Article 6 of TRIPS. According to Carlos M. Correa, although paragraph 5(d) “does not add substantively to the TRIPS Agreement, it certainly reassures Members wishing to apply an international exhaustion principle that it would be legitimate and fully consistent with the Agreement to do so.”268 Theoretically, this is bound to detract from TRIPS’ ability to rein in parallel importation of patented, cheap pharmaceuticals. It is axiomatic that TRIPS’ reticence on exhaustion of intellectual property rights is not a proactive endorsement of anti-parallel importation policy, but rather some passive neutrality designed to gloss over a highly controversial subject that divided negotiators269 and scholars270 into pro- and anti-international intellectual property rights exhaustion camps. It is noteworthy however that, while TRIPS is reticent on exhaustion of intellectual property rights, it does not forbid member countries from embracing a national intellectual property rights exhaustion policy. In fact, as noted earlier, paragraph 5(d) of the Doha Declaration expressly endorses such a right. For instance, the United States, like the European Union and ,271 operates a national patents rights exhaustion policy.272 To ensure the viability of its patent law in this regard, the United States consistently seeks cooperation with its trade partners in shoring up supports for national intellectual property rights exhaustion policy, especially for pharmaceuticals. This arguably explains the ubiquitous anti-international intellectual property rights exhaustion clause in the intellectual property chapters of the United States’

267. World Trade Organization, Declaration on the TRIPS Agreement and Public Health of 14 November 2001, WT/MIN(01)/DEC/2, available at http://www.wto.org/english/thewto_e/minist_e/min01_e/ mindecl_trips_e.pdf [hereinafter Declaration on the TRIPS Agreement and Public Health]. 268. CARLOS M. CORREA, IMPLICATIONS OF THE DOHA DECLARATION ON TRIPS AGREEMENT AND PUBLIC HEALTH 18 (2002). 269. Some negotiating parties, led by Australia, Brazil, , India and , favored the inclusion of international exhaustion of intellectual property rights. GERVAIS, supra note 266, at 112-113. Other negotiating parties, including the United States, Canada and the European Union preferred national exhaustion. Id. Under international exhaustion, once a product has entered the market with the right holder’s consent anywhere in the world, all intellectual property rights in that product are exhausted. Id. Under national exhaustion, intellectual property rights are marked by territoriality. Id. Right holder’s authorization would be required prior to exploitation of rights outside of the territory where the product first entered the market. Id. 270. E.g., Marco C.E.J. Bronckers, Where Should WTO Law Go on the Exhaustion of Intellectual Property Rights, in INTELLECTUAL PROPERTY: TRADE COMPETITION, AND SUSTAINABLE DEVELOPMENT 231, 231-34 (Thomas Cottier & Petros C. Mavrodis, 2003). 271. See Daniel Erlikhman, Jazz Photo and the Doctrine of Patent Exhaustion: Implications to TRIPS and International Harmonization of Patent Protection, 25 HASTINGS COMM. & ENT. L.J. 307, 323-31 (2003) (explaining that the U.S., European Union, and Japan use national exhaustion policy). 272. 5 DONALD S. CHISUM, CHISUM ON PATENTS § 16.03[2][a] (2007) .

320 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 post-TRIPS bilateral free trade agreements.273 The pertinent question is whether TRIPS’ reticence on intellectual property rights exhaustion could avail a member to parallel import critical pharmaceuticals in a bioterrorism related public health crisis? Theoretically, members could employ Article 6 of TRIPS to parallel import crucial drugs for bioterrorism-induced ailments. While such an action may not constitute a justiceable complaint by an aggrieved member under the TRIPS DSU, legal remedies outside of TRIPS’ DSU regime, (such as alleged breach of intellectual property components of bilateral trade agreements) are not entirely foreclosed.274 TRIPS’ ambivalence on international exhaustion of intellectual property rights provides no legal basis for cross-border parallel importation of drugs, and may not avail a member who seeks to do so. Moreover, political pressures and threats of economic sanctions from aggrieved members with the requisite clout may render any decision to parallel-import crucial drugs for bioterrorism-related diseases under paragraph 5(d) of the Doha Declaration and the ostensible indifference of Article 6 of TRIPS, obtuse or even imprudent.275 Furthermore, a WTO member may not avail itself of Article 6 of TRIPS to parallel import crucial drugs to meet a bioterrorism crisis if it is obliged by a bilateral free trade agreement to the contrary.276 Singapore’s position best illustrates this point. Prior to signing a bilateral free trade agreement with the United States in August 2003,277

273. The United States is championing bilateral Free Trade Agreements that incorporate stronger intellectual prop erty protection standards than TRIPS requires. E.g., PEDRO ROFFE, BILATERAL AGREEMENTS AND A TRIPS-PLUS WORLD 5 (2004). Commenters have referred to these agreements as “TRIPS-plus” agreements. Id. The United States has signed bilateral free trade agreements with Bahrain, Chile, Jordan and Singapore. Carlos M. Correa, Investment Protection in Bilateral and Free Trade Agreements: Implications for the Granting of Compulsory Licenses, 26 MICH. J. INT’L L. 331, 334-35 tbl.I (2004) [hereinafter Correa, Investment Protection]; Peter Drahos, Bits and Bips: Bilateralism in Intellectual Property, 4 J. WORLD INTELL. PROP. 791, 793-97 (2001); Peter Drahos, Expanding Intellectual Property’s Empire: The Role of FTAs, GRAIN, Nov. 2003, 8, http://www.grain.org/rights_files/drahos-fta-2003-en.pdf. 274. Note, however, that parties may not unilaterally impose sanctions for non-compliance with bilateral trade agreements without WTO authorization. Panel Report, United States – Section 301-310 of the Trade Act of 1974, WT/DS152/R 851 (Dec. 22, 1999). 275. Countries where pharmaceutical manufacturing contributes significantly to the GDP, such as the Un ited S t ates and the European Union, are keen to ensure enforcement of international intellectual property protection for pharmaceutical and chemical products. E.g., Trade Act of 1974, 19 U.S.C. § 2242(b)(1) (2000) [hereinafter Special 301] (authorizing the use of trade sanctions under by the Office of the United States Trade Representative (“USTR”). Special 301 empowers the USTR to categorize a country as a “priority foreign country” if (i) the country’s acts, practices and policies are the most onerous to U.S. industry; and (ii) the country is not in good faith multilateral or bilateral negotiations to provide adequate and effective intellectual property protection. Id. Special 301 has been used, with a relative degree of success, to persuade countries to protect the intellectual property rights of U.S. businesses in pre- and post- TRIPS dispensations. E.g., Judith H. Bello & Alan F. Holmer, “Special 301”: Its Requirements, Implementation, and Significance, 13 FORDHAM INT’L L.J. 259, 261 (1989-1990); Stefan Kirchanski, Comment, Protection of U.S. Patent Rights in Developing Countries: U.S. Efforts to Enforce Pharmaceutical Patents in , 16 LOY. L.A. INT’L & COMP. L.J. 569, 587-90 (1994); Arthur Wineburg, U.S. Trade Threats Spur Asian Laws on Intellectual Property, NAT’L L. J., July 13, 1992, at 29. 276. It is not clear whether such a member could resort to the public health provisions of the TRIPS agreement, without first declaring a public health emergency, and seeking a compulsory license to manufacture or import such drugs. See Declaration on the TRIPS Agreement and Public Health, supra note 267, ¶ 5 (providing grounds for compulsory licenses and the determination of national emergencies). 277. United States-Singapore Free Trade Agreement Implementation Act, Pub. L. No. 108-78, 117 Stat.

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Section 66(2)(g) of the Singapore Patent Act 1994 allowed for international exhaustion of patents rights in all patented processes and products.278 However, the 2003 United States-Singapore Free Trade Agreement excluded pharmaceuticals from the scope of Section 66(2)(g), by specifically foreclosing parallel importation of patented pharmaceutical products without the authorization of the patent owner.279 A fortiori, the provisions of paragraph 5(d) of the Doha Declaration and Article 6 of the TRIPS Agreement’s reticence on exhaustion of intellectual property rights are of little practical use for parallel importation of crucial drugs in bioterrorism-induced public health crises situations, or any public health emergency for that matter.

B. The Propriety of Article 30 of the TRIPS Agreement for Bioterrorism- Induced Diseases Article 30 of the TRIPS Agreement allows for derogation from patent exclusivity on grounds of “exceptional use” by imposing three distinctive, but cumulative, exceptions on Article 28(1) of the TRIPS’ patents exclusivity: (1) the exceptional use must be limited; (2) the exceptional use may not unreasonably conflict with the normal exploitation of the patent; (3) the exceptional use may not unreasonably prejudice the legitimate interests of the patentee, taking into account the legitimate interests of third parties.280 The pertinent question is whether Article 30 of TRIPS could be used in sourcing crucial drugs and vaccines in bioterrorism-induced public health crises. The negotiating history of Article 30 and the Canada-Patent Protection case281 offer some insights into the scope and usefulness of Article 30 in this

948 (2003), available at http://waysandmeans.house.gov/media/pdf/singapore/hr2739SingaporeSAA7-15- 03.pdf. 278. Section 66 (2)(g) of Singapore’s 1994 Patent Act provides that an act is not infringing if: [I]t consists of the import, use or disposal of, or the offer to dispose of, any patented product or any product obtained by means of a patented process or to which a patented process has been applied, which is produced by or with the consent (conditional or otherwise) of the proprietor of the patent or any person licensed by him, and for this purpose “patent” includes a patent granted in any country outside Singapore in respect of the same or substantially the same invention as that for which a patent is granted under this Act and “patented product,” “patented process” and “licensed” shall be construed accordingly . . . . Patent Act, 1994, §66(2)(g) (Sing.), available at http://statutes.agc.gov.sg/non_version/cgi- bin/cgi_retrieve.pl?actno=reved-221&doctitle=patents%20act%oa&date=latest&method=part. See Ng-Loy Wee Loon, The IP Chapter in the U.S-Singapore Free Trade Agreement, 16 SING. ACAD. L.J., 42, 60-68 (2004) (discussing the United States-Singapore Free Trade Agreement). 279. Article 16.7.2 of the United States-Singapore Free Trade Agreement provides: [A] cause of action to prevent or redress the procurement of a patented pharmaceutical product, without the authorization of the patent owner, by a party who knows or has reason to know that such product is or has been distributed in breach of a contract between the right holder and a licensee, regardless of whether such breach occurs in or outside its territory. Each Party shall provide that in such a cause of action, notice shall constitute constructive knowledge. Free Trade Agreement art. 16.7.2, U.S.-Sing., May 6, 2003, available at http://www.ustr.gov/assets/ Trade_Agreements/Bilateral/Singapore_FTA/Final_Texts/asset_upload_file708_4036.pdf. 280. Article 30 of TRIPS provides that “[m]embers may provide limited exceptions to the exclusive rights conferred by a patent provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.” TRIPS Agreement, supra note 64, art. 30. 281. See Canada-Patent Protection, supra note 218 (noting the historical antecedence of Article 30 in

322 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 respect. The Canada patent case will be analyzed in detail due to the significant light it sheds on the prospect of Article 30 being used as a tool for the procurement of critical drugs in a public health pandemic or bioterrorism crisis. The negotiating history of Article 30 of TRIPS indicates that it was originally designed to accommodate a wide range of specific, authorized exceptions. This included prior users’ rights; private and non-commercial acts; experimental acts; manual preparation by pharmacists and medical doctors in accordance with a prescription, or acts performed with a medicine so prepared; acts done in reliance upon such acts not being prohibited by a valid claim as initially granted in a patent, but subsequently prohibited by a valid claim of that patent as amended; and governmental acts performed for government uses.282 Apparently, these specific exceptions never made it to the final provisions of Article 30 as it is presently construed.283 In the Canada-Patent Protection case, the European Community challenged the consistency of Sections 55.2(1) and 55.2(2) of the Canadian Patent Act with Articles 27.1, 28, 30, and 33 of TRIPS.284 Section 55.2(1) of Canada’s Patent Act provided that a patent shall not be infringed if the patented invention is used or sold for uses that reasonably relate to the development and submission of information required under any Canadian law.285 This is otherwise known as the “regulatory review exception,”286 which is akin to the United States’ Bolar exception in the Hatch-Waxman Act.287 However, Canada’s patent law went beyond the Bolar exception in Section 55.2(2), by authorizing third parties to manufacture and stockpile patented pharmaceuticals during regulatory review processes, six months prior to the expiration of the patent term.288 The WTO panel report examined the validity of the twin exceptions in Sections 55.2(1) & (2) of Canada’s Patent Act vis-à-vis Article 30 of TRIPS. The panel found that Section 55.2(1), which embodied the regulatory review Bolar-type exception, was consistent with Articles 27.1 and 28.1 of TRIPS because it was authorized by Article 30 of TRIPS.289 In effect, the WTO panel sanctioned acts of manufacturers and suppliers of active pharmaceutical components, as well as producers of generic pharmaceuticals, provided such acts were reasonably related to marketing approval of a generic pharmaceutical product.290 The WTO panel. however,

paragraph 7.70 of its reports). 282. Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Co unterfeit Goods, Chairman’s Report to the GNG, MTN.GNG/NG11/W/76 (July 23, 1990). 283. PIRES DE CARVALHO, supra note 219, at 304. 284. Canada-Patent Protection, supra note 218. 285. Patent Act, R.S.C., ch. P-4, s. 55.2(1) (1985) (Can.), available at http://laws.justice.gc.ca/en/P- 4/9 1964.html#rid-91992. 286. See PIRES DE CARVALHO, supra note 219, at 304 (discussing application of the TRIPS agreement). 287. 35 U.S.C. § 271(e)(1) (2000). 288. Canada-Patent Protection, supra note 218, ¶¶ 7.2, 7.7. 289. Id. ¶¶ 7.84, 7.105, 7.38, 8.1. 290. Id.

No. 2] AGAINST THE PLAGUE 323 found that the stockpiling exception under section 55.2(2) of the Canadian Patent Act ran afoul of Article 28.1 of TRIPS because it was outside of the ambit of allowable exceptions under Article 30 of TRIPS.291 Therefore, Article 30 was narrowly construed.292 The WTO panel’s ruling, severing the stockpiling exception from the regulatory review exception of Canada’s patent law, demonstrates the narrow ambit of the limited exceptions allowable under Article 30 for the production of generic pharmaceuticals. It also unequivocally demonstrates that Article 30 of TRIPS is improper for the challenges of bioterrorism emergency situations; drug stockpiling, though of limited practical use,293 is arguably an integral logistical measure of bioterrorism preparedness. Although the “limited exceptions” provision was narrowly construed, the precise parameters were left undefined by the WTO panel ruling, rendering it vague and vulnerable to semantic arguments.294 While any number of patent- limiting provisions could theoretically fit into its narrow confines, in practice, only those that are less threatening to patented inventions, like the experimental use exception as opined by the WTO panel in the Canada-Patent Protection case, would pass muster.295 The inappropriateness of Article 30 for bioterrorism emergencies is further underscored by the cumulative nature of its three conditions.296 Non- compliance with any of the three provisions contravenes Article 30 as a whole.297 The following paragraphs will examine conditions two and three in an attempt to shed more light on their usefulness for securing crucial medicines in any bioterrorism context.

1. Conflict with Normal Exploitation of a Patent

The second condition of Article 30 of TRIPS requires that exceptions to the rights conferred should not unreasonably conflict with a normal exploitation of the patent.298 While TRIPS does not define “normal exploitation,” the WTO panel in the Canada-Patent Protection case defined “normal” as “a normative standard of entitlement” and “what is common within a relevant community.”299 The Panel went on to define “exploitation” as the “commercial activity by which patent owners employ their exclusive patent rights to extract economic value from their patent.”300 The panel

291. Id. 292. Id. ¶ 7.30 (“The term ‘limited exceptions’ must therefore be read to connote a narrow exception— one which makes only a small diminution of the rights in question.”). 293. See Nordqvist, supra note 53 (noting that the U.S. government recently had to restock its flu vaccine stockpiles due to the vaccines’ loss of strength). 294. See generally Canada-Patent Protection, supra note 218 (declining to precisly define “limited exceptions”). 295. See id. ¶ 4.30 (discussing the limited character of the experimental use exception). 296. See infra Part IV.B.1. 297. Id. 298. TRIPS Agreement, supra note 64. 299. Canada-Patent Protection, supra note 218, ¶ 7.54. 300. Id.

324 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 summed up what it perceived as the essence of the second leg of Article 30 of TRIPS by stating that “[t]he normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of market exclusivity.”301 The panel’s construction of the second prong of Article 30 was arguably too restrictive. Without a doubt, patent owners would love to exclude all forms of competition and breach stringent anti-competitive rules if they could do so. However, the TRIPS Agreement does not envisage an unbridled patent monopoly as evident in Article 31(k), which enjoins against anti-competitive practice and would avail the grant of a compulsory license to loosen up any anti-competitive gridlock.302 If anything, the second condition of unreasonable conflict with normal patent exploitation under Article 30 of TRIPS makes it nearly impossible to employ the Article to acquire needed drugs in bioterrorism emergencies.303 Such a use would no doubt be an extreme measure vis-à-vis the stockpiling provision of section 55.2(2) (now repealed) of the Canadian Patent Act which the panel found invalid under Article 30 of TRIPS.304 Furthermore, applying the second prong of Article 30 to the acquisition of crucial drugs for bioterrorism attacks could be complicated by a lack of a understanding of critical terms like limited exceptions, normal exploitation, or unreasonable conflict. The panel’s proposition in this respect is too descriptive and very pro-patent. For instance, it is very unlikely that a WTO member could successfully parallel import crucial drugs for bioterrorism attacks via the second prong of Article 30. If Canada could fail to retain its drug stockpiling exception during the generic pharmaceuticals regulatory review process, any urgent measure aimed at securing crucial medicines for victims of bioterrorism attacks outside of the TRIPS systemic-bound provisions would be doomed to invalidity under Article 30 for unreasonably conflicting with the normal exploitation of the pharmaceutical patent in question.

2. Legitimate Interests of Patents Owner and Third Parties The third part of TRIPS Article 30 requires that any exception to patent exclusivity should not unreasonably prejudice the legitimate interests of the patent owner.305 It ostensibly seeks to maintain a balance, however, by

301. Id. ¶ 7.55. 302. Article 31(k) of TRIPS provides: Mem bers are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti- competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur. TRIPS Agreemen t, supra note 64, art. 31(k). 303. TRIPS Agreement, supra note 64, art. 30. 304. Canada-Patent Protection, supra note 218, ¶ 8.1. 305. TRIPS Agreement, supra note 64.

No. 2] AGAINST THE PLAGUE 325 requiring that the legitimate interests of third parties be taken into account.306 It is pertinent at this juncture to analyze the implications of the requirement of “the legitimate interests of third parties” on the effectiveness of the third limb of Article 30 for critical drug procurement in bioterrorism emergencies. Article 30 of TRIPS coincides with Articles 13, 17, and 26(2) of TRIPS on general exceptions to the exclusive rights of copyright, trademark, and industrial designs.307 It is reminiscent of Article 9(2) of the on literary and artistic works, with its time-honored three-step tests.308 However, Articles 17, 26(2), and 30 of TRIPS on trademark, industrial designs, and patents, respectively, differ from the Berne Convention’s Article 9(2) and TRIPS Article 13 on Copyright by the additional requirement that legitimate interests of third parties should be considered.309 Daniel Gervais views this as a broadening of the scope of the exceptions to industrial property exclusive rights.310 Is it a coincidence that only the industrial property rights provisions of TRIPS contain the additional requirement for consideration of the legitimate interest of third parties? The answer is, arguably, “no.” This is underscored by the absence of such a requirement under Article 13 of TRIPS dealing with derogation from copyright exclusivity.311 The significance of this differential treatment between industrial property on the one hand ( in Article 17; industrial designs in Article 26(2); and patents in Article 30) and copyright on the other hand (Article 13) arguably lies in the former’s association with technical products and capital-intensive goods and services of comparatively greater economic value than products traditionally protected by copyright.312

306. Id. 307. Article 13 of TRIPS provides a general exception to copyright exclusivity, stating “[m]embers shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.” Id. art. 13. A rticle 17 of TRIPS provides a general exception to trademark exclusivity, stating “[m]embers ma y provide limited exceptions to the rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of the legitimate interests of the owner of the trade mark and of third parties.” Id. art. 17. Article 26(2) of TRIPS on industrial designs provides: Members may provide limited exceptions to the protection of industrial designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of the protected industrial designs and do not unreasonably prejudice the legitimate interests of the owner of the protected design, taking into account the legitimate interests of third parties. Id. art. 26. 308. See Berne Convention for the Protection of Literary and Artistic Works, Sept. 9, 1886, 828 U.N.T.S. 222 (amended Sept. 28, 1979) (“It shall be a matter for legislation in the countries of the Union to permit the reproduction of such works in certain special cases, provided that such reproduction does not conflict with a normal exploitation of the work and does not unreasonably prejudice the legitimate interests of the author.”). 309. Id. Article 30 of TRIPS was taken from Article 9(2) of the Berne Convention. JACQUES J. GORLIN, AN ANALYSIS OF THE PHARMACEUTICAL-RELATED PROVISIONS OF THE WTO TRIPS AGREEMENT 28 (1999). The addition of consideration for the legitimate interest of third parties was clearly deliberate, although no special reason was offered for its inclusion. Id. 310. GERVAIS, supra note 266, at 241. 311. TRIPS Agreement, supra note 64, art. 13. 312. This is the case notwithstanding that copyright law is now the basis for digital rights management in the burgeoning information society. PETER DRAHOS & JOHN BRAITHWAITE, INFORMATION FEUDALISM: WHO OWNS THE KNOWLEDGE ECONOMY? 169-186 (2003); Pamela Samuelson, Copyright and Freedom of Expression in Historical Perspective, 10 J. INTELL. PROP. L. 319, 326-27 (2003); Alan Story, Don’t Ignore

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Since we live in an increasingly technology-dependent era, societal stakes in industrial property rights-related inventions are undoubtedly very high. Third parties, comprising the society at large, naturally have legitimate interests in the methodology for patented pharmaceutical technology dissemination, diffusion, and access. While patent owners have legitimate interests in securing their ownership rights, society has equally legitimate interests in accessing the protected inventions. However, whether third parties could couch the need for access to crucial drugs in bioterrorism situations as “legitimate interests” under the third prong of Article 30 remains an open question, and arguably doubtful, due to the narrow and limited construction by the DSU Panel in the Canada-Patent Protection case.313 The term “legitimate interests” appears to be the operating force in the third prong of Article 30 of TRIPS. Again there are no clues from TRIPS on the exact meaning of “legitimate interests.” However, the panel on pharmaceuticals described “legitimate interests” as interests that “. . . are supported by relevant public policies or other social norms.”314 The panel then alluded to experimental use of patented products for scientific experimentations, throughout the duration of patents, as an example of legitimate interests.315 Both patent owners and society have legitimate interests in using the patent for the advancement of science and technology. Arguably, this is an integral element of patent policy fundamentals. The patentee trades his patent specifications and workings for a limited monopoly. The societal quid pro quo in this seemingly mutually beneficial arrangement is the knowledge revealed in the disclosed patent. Herein resides the critical mass for the parties’ respective legitimate interests, alluded to by the panel on pharmaceuticals.316 It is, however, doubtful whether the legitimate interests of pharmaceutical patent owners and the legitimate interests of third parties could be mutually consistent in the context of a need to mass-produce crucial drugs to aid victims of bioterrorism. Under this scenario, the pharmaceutical patent owner would claim to have legitimate interests in excluding the third party from mass- producing the required drugs, while the third party would claim to have legitimate interests in doing so. Article 30 is ill-suited to handle this conflict of rights due to its narrow construction by the WTO panel in the Canada-Patent Protection case. It is significant that, although the panel endorsed the scientific experimental use exception as properly within the ambit of any legal construct or analysis of the third leg of Article 30, the panel cautioned that it did not draw any conclusions about the correctness of any such exception in national

Copyright, the ‘Sleeping Giant’ on the TRIPS and International Educational Agenda, in GLOBAL INTELLECTUAL PROPERTY RIGHTS, supra note 67, at 125, 129. 313. Canada-Patent Protection, supra note 218, ¶ 7.69. 314. Id. 315. Id. 316. Id.

No. 2] AGAINST THE PLAGUE 327 patent laws.317 The panel would not speak to the validity of experimental use exceptions to patent exclusivity under Article 30 of TRIPS. The panel’s reticence is understandable, lest national authorities seize onto it to validate definitive experimental use under Article 30 of TRIPS. It is significant, however, that the panel only cited the experimental use exception as an example of a third party’s legitimate interest. It was one of the original specific exceptions proposed during the negotiation of Article 30.318 It is arguably also the least patent-threatening activity relative to other original exceptions, such as government use,319 which could be more effective in parallel importing or mass producing drugs in the event of a pandemic or bioterrorism crisis. The European Community suggested a liberal interpretation of Article 30 in a 2002 paper submitted to the Council of TRIPS.320 This was to facilitate the implementation of Paragraph 6 of the 2001 TRIPS/Doha Declaration on Public Health,321 for exporting of pharmaceuticals to WTO members with or without limited manufacturing capacity.322 Despite support for the proposal by developing countries,323 the United States was resolutely opposed to using Article 30 in this way, on the grounds that it would be prejudicial to the rights of WTO members, under the TRIPS Agreement.324 A fortiori, the cumulative limited exceptions of Article 30 are ill-suited to meeting the challenges of securing crucial patented drugs under the extreme emergency situations of a pandemic or bioterrorism crisis.

C. Compulsory Licensure Regime: Is Article 31 of the TRIPS Agreement Fit for Bioterrorism-Induced Public Health Crises? The provisions of Article 31 of the TRIPS Agreement incorporate conditions under which a WTO member could use patented technologies without the authorization of the right holders.325 This power is known as the “compulsory licensure regime.”326 This raises a couple pertinent questions.

317. Id. 318. Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, supra note 282, § 2.2.3. 319. See Canada-Patent Protection, supra note 218, ¶ 5.6 (discussing the purposes behind the government use exception). 320. Council for Trade-Related Aspects of Intellectual Property Rights, Concept Paper Relating to Pa ragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, ¶ 16, IP/C/W/339 (March 4, 2002) [hereinafter EC to WTO Communication] (relaying a communication from the European Comission to t he World Trade Organization). 321. Declaration on the TRIPS Agreement and Public Health, supra note 267, ¶ 6. 322. EC to WTO Communication, supra, note 320, ¶ 5. 323. A group of developing nations supported a similar interpretation of TRIPS Article 30 to the one ad vanced by the European Community. Council for Trade-Related Aspects of Intellectual Property Rights, Pa ragraph 6 of the Ministerial Declaration on the TRIPS Agreement and Public Health, ¶ 8, IP/C/W/355 (Ju ne 24, 2002). 324. Council for Trade-Related Aspects of Intellectual Property Rights,, Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/C/W/340 (Mar. 14, 2002). 325. TRIPS Agreement, supra note 64, art. 31. 326. Lena Sund, Will the WTO Deal on Compulsory Licenses for Medicines Improve Access to Treatment for Disease Stricken Populations?, ACP-EU COURIER, Nov.-Dec. 2003, at 28, 28.

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How might Article 31 of the TRIPS Agreement be used to facilitate access to crucial patented medicines in bioterrorism crises, and what are the prospects for such use in the context of Article 31’s concomitant conditions? The following paragraphs examine these questions in the context of recent literature, case law, and a comparative analysis of relevant national patent laws.

1. Article 31(a): Authorization of Use Shall Be Considered on its Individual Merits

Article 31(a) provides that the use by any government or authorized third party of a compulsory licensure shall be considered on its individual merit.327 Article 31(a) arguably implies that the grounds for invoking compulsory licensure are subject to oversight in order to determine their meritorious propriety. While not specifying or delimiting the grounds for compulsory licensure (with the exception of semi-conductor technology), Article 31(a) suggests that it may not be granted on frivolous grounds.328 The pertinent question is whether a compulsory licensure for the production of critical generic drugs in the event of a bioterrorism attack pass the merit muster. Ostensibly, it should, as an indisputable public health crisis incident generally cognizable under Article 7 and Article 8.1 of the TRIPS Agreement.329 However, Article 31(a) of the TRIPS Agreement has conceptual and definitional lacunas that could pose serious interpretational problems, and potentially undermine its use in bioterrorism scenarios. First, the TRIPS Agreement is reticent on the question of who should assess the grounds for compulsory licensure. This lacuna arguably accommodates a number of possible scenarios. Is the merit assessment role incumbent on the government that authorizes compulsory licensure for its own benefit? Is the role incumbent on the third-party beneficiary of such a governmental

327. TRIPS Agreement, supra note 64, art. 31. 328. Article 27.1 of TRIPS appears to prohibit compulsory licensing of patented products or services on grounds of a lack of local working or manufacturing: Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. Id. art. 27. 329. Article 7 of TRIPS provides: The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Id. art. 7. Article 8.1 provides: Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement. Id. art. 8.1.

No. 2] AGAINST THE PLAGUE 329 authorization? Or, is it the pharmaceutical patent right holder, the TRIPS Council, or the entirety of the stakeholders mentioned above? These questions harbor a practical problem which allows any number of stakeholders or interested parties to interfere with the use of a compulsory licensure by raising its meritorious propriety, even in cases of proven public health emergency crises such as a bioterrorism attack. The obvious downside to this scenario is the likelihood of flimsy objections questioning the merit of compulsory licensure grounds, and the inevitable delay that could result from wrangling over the merits of a compulsory licensure in procuring critical drugs for victims of bioterrorism. The authorities could ill-afford a delay in the context of bioterrorism crises. Moreover, the possible delay could be exacerbated by the absence of any guidance from Article 31(a)—or any other provisions of the TRIPS Agreement—on the timeframe for challenging the grounds adduced for a compulsory licensure invocation. In this circumstance, the meritorious propriety of the grounds for granting compulsory licensure could, as a justiceable ground, stall the compulsory licensure process in possible lawsuits or administrative challenges by the right holder or any interested party. However, a lawsuit or administrative challenge to compulsory licensure could still be pursued after the grant of a compulsory licensure,330 and should consequently not pose a genuine obstacle to the production or procurement of critical drugs for bioterrorism victims. Nevertheless, to the extent that challenging compulsory licensure prior to procuring critical medicines could not be entirely precluded under Article 31(a) of the TRIPS Agreement, its effectiveness in the bioterrorism context is questionable. Article 31(a) of the TRIPS Agreement provides fodder for disputes over grounds for compulsory licensure that could delay the critical timeline required for manufacture, importation, and distribution of crucial drugs to the victims of bioterrorism attacks. Time is of the essence in containing the spread of pathogenic agents such as anthrax, the plague, or smallpox.

2. Article 31(b) of the TRIPS Agreement: Evidence of Prior Authorization on Reasonable Commercial Terms Required Article 31(b) provides that prior to the invocation of compulsory licensure, the would-be licensee must seek a negotiated license from the patent right holder on reasonable commercial terms and conditions.331 Additionally,

330. Id. art. 31(i). 331. Article 31(b) provides: [S]uch use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditio ns and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly. . . .

330 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 efforts at a negotiated voluntary license on reasonable commercial terms must have failed within a “reasonable period of time.”332 These terms pose definitional and conceptual obstacles that could potentially hamstring the effectiveness of Article 31(b) in the context of bioterrorism. Significantly, the TRIPS Agreement provides no clues on the meaning of both “reasonable commercial terms and conditions” and “reasonable period of time.” This leaves these concepts open to any number of disparate interpretations, potentially fueling disputes and making litigation inevitable. The term “commercial,” however, connotes business and profits. The Longman Dictionary of Contemporary English defines “commercial” as “related to the ability of a product or business to make a profit.”333 The phrase “reasonable commercial term and conditions” presupposes that both parties are expected to negotiate and agree on a mutually acceptable reasonable royalty that is concomitant with the market value of the goods in question. In fact, Article 31(h) of TRIPS Agreement requires that “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization.”334 While both “reasonable commercial terms and conditions” and “adequate compensation” imply value recompense for compulsory licensure, the parameters for delineating their full compensatory imports remain unclear. The process is fraught with potential disputes as patentees could refuse to deal or resort to litigation if they thought a royalty unreasonable or inadequate.335 An incident from India in the late 1960s exemplifies this.336 The Indian government’s attempt to negotiate a compulsory license for a patented drug got mired in endless negotiations and ended in a stalemate when the patentee demanded a royalty of 25%.337 Four years after commencement of negotiations, the parties agreed to a 10% royalty.338 It is sacrosanct that compensational disputes are potential stumbling blocks to compulsory licensure in any bioterrorism scenario. The real obstacle, however, is not compensational disputes, but the delay such disputes could create in securing critical medicines within the shortest time possible for bioterrorism victims. Compensational disputes for patent takings are, in practice, deferred to national courts.339 National patent laws would have to be used to determine compensation for compulsory licensure.

Id. art. 31(b). 332. Id. 333. LONGMAN DICTIONARY OF CONTEMPORARY ENGLISH 305 (4th ed. 2005). 334. TRIPS Agreement, supra note 64, art. 31(h). 335. See Dianne Nicol, Cross-Cultural Issues in Balancing Patent Rights and Consumer Access to Bi otechnological and Pharmaceutical Inventions, in CROSS-CULTURAL BIOTECHNOLOGY 155, 162-64, (Michael C. Brannigan ed., 2004) (discussing practical problems in determining remuneration). A patentee could still refuse to deal if he was offered a royalty at reasonable commercial terms, on grounds it was inadequate. Case 238187, Volvo v. Veng, 4 C.M.L.R. 122, [1986-1988 Transfer Binder] Common Mkt. Rep. (CCH) ¶ 14,498, 18,697 (1988) (affirming the right of a patentee to refuse a license). 336. See DHAR & GOPAKUMAR, supra note 229 at 22 n.38 (discussing an incident in India where negotiation costs were excessive and forced the abandonment of an important project). 337. Id. 338. Id. 10% was still higher than the 5% the Indian government sought. Id. 339. E.g., TRIPS Agreement, supra note 64, art. 31(j).

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However, national judicial compensatory awards would have to conform to the tenets of the TRIPS Agreement.340 In the United States, the Fifth Amendment of the U.S. Constitution requires just compensation for any private property taken by the government for public use.341 Otherwise known as eminent domain, this concept is rarely employed by the United States for appropriating pharmaceuticals patents.342 In addition, the term “reasonable period of time” is inherently ambiguous, and any clarifications are absent in the TRIPS Agreement. Parties are expected to prove that they failed to agree on terms of voluntary license within a “reasonable period of time” before compulsory licensure could be invoked.343 Nuno Pires de Carvalho opines that WTO members regard a “reasonable period of time” as ranging from ninety days to six months.344 He suggests that “the ultimate criterion should be left to the market practices and to the assessment of the parties’ real intention.”345 However, the problem is, for the meaning of “reasonable period of time,” there are no standard or customary market practices. To expect a WTO member faced with a critical shortage of drugs in a bioterrorism crisis to wait for three to six months to agree to “reasonable commercial terms and conditions” before invoking compulsory licensure would be preposterous. Furthermore, either party—right holder or licensee—could seize on the inherent ambiguity in “reasonable period of time or conditions” to justify its reasons for blocking or seeking compulsory licensure through a lawsuit or an administrative challenge.346

3. Waiver of Patentees’ Prior Authorization Due to National Emergency or Other Circumstances of Extreme Urgency or Public Non-commercial Use The requirement for prior authorization from patent right holders before the grant of compulsory licensure may be waived by a WTO member in the event of a “national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.”347 Therefore, a WTO member faced with a bioterrorism crisis could seek refuge under the waiver provision by characterizing its problem as a national emergency or a situation of extreme urgency. Moreover, if the drugs in question would be given gratuitously to the

340. Id. art. 45 (authorizing award of adequate damages to the right holder to compensate for the injury oc casioned by infringement, as well as reimbursement of the right holder for incidental fees such as attorney’s fees). 341. U.S. CONST. amend. V (providing inter alia that no one shall be deprived of their private property for public use without just compensation). 342. See Daniel R. Cahoy, Patent Fences and Constitutional Fence Posts: Property Barriers to Ph armaceutical Importation, 15 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 623, 672-73 (2005) (discussing the viability of a suit against the government on eminent domain rather than patent infringement grounds); Cahoy, Legal Side Effects, supra note 186, at 139-146 (arguing that under the current statutory scheme, unauthorized government appropriations of private rights should be treated as eminent domain takings). 343. TRIPS Agreement, supra note 64, art. 31(b). 344. PIRES DE CARVALHO, supra note 219, at 234. 345. Id. 346. For instance the right holder might contend that compulsory licensing was premature because a “re asonable period of time” for the discussion of an adequate royalty or compensation had not elapsed. 347. TRIPS Agreement, supra note 64, art. 31(b).

332 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 public, a bioterrorism-afflicted WTO member might even be able to claim the “public non-commercial use” exception for dispensing with patentees’ prior consent or authorization.348 Furthermore, in a bioterrorism crisis, a besieged nation could derogate from pharmaceutical patents rights and patents exclusivity guaranteed respectively by Articles 27 and 28 of the TRIPS Agreement.349 This derogation is facilitated by the November 2001, WTO Ministerial Declaration on the TRIPS Agreement and Public Health.350 The Declaration affirms “that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ [sic] right to protect public health and, in particular, to promote access to medicines for all.”351 Additionally, paragraph 5(b) of the WTO Ministerial Declaration affirms the right of members to “grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.”352 A WTO General Council Decision of August 30, 2003 granted resource-poor nations who lack manufacturing capacity for pharmaceuticals the right to import essential medicines for public health needs, via the compulsory licensure regime.353 Given the TRIPS Agreement’s generous latitudes for pharmaceutical patent rights derogation—as exemplified by the national emergency, circumstances of extreme urgency, and the public health crises exceptions highlighted above—the case for a pharmaceutical patent appropriation clause in national and international patent regimes for bioterrorism crises situations would appear obtuse. However, the seemingly generous terms in which the “national emergency or circumstances of extreme urgency” exceptions are crafted arguably belie the concomitant conditionality and lurking political and economic externalities that are guaranteed to frustrate their usefulness in any bioterrorism scenario.

a. Key Grounds for Waiver of Prior Authorization are Susceptible to Definitional and Interpretational Problems A major impediment to the effective use of the consent waiver provisions characteristically centers on the susceptibility of key terms to semantic and interpretational problems. For instance, while it might seem obvious, it is not inconceivable that a reluctant pharmaceutical right holder could contend that a bioterrorism attack was no more than a normal or non-extreme urgency

348. This would be without prejudice to patentees’ right to adequate compensation as required by Article 31(h) of the TRIPS Agreement. Id. art. 31(h). 349. Id. arts. 27-28. 350. See Declaration on the TRIPS Agreement and Public Health, supra note 267. 351. Id. ¶ 4. 352. Id. ¶ 5. 353. The General Council’s decision was made pursuant to paragraph 6 of the WTO Doha Ministerial Declaration on the TRIPS Agreement and Public Health. Id. at ¶ 6. Paragraph 6 recognizes the difficulties that WTO members with insufficient or non-existant pharmaceutical manufacturing capacity face in making effective use of TRIPS’ compulsory licensing regime. Id.

No. 2] AGAINST THE PLAGUE 333 situation , and that invocation of compulsory licensure for procurement of critical medicines without prior consultation or authorization was premature. Furthermore, the usefulness of the “public non-commercial use”354 exception is equally dicey in the bioterrorism context, where it could only be availing if drugs were given gratis to victims. Even then, the possibility of elements of “commercial use” creeping into the transaction is very high indeed. This would be especially true if authorities used paid private contractors to distribute drugs to the populace, with a view to easing the burdens on public health officials and institutions or accelerating the distribution process in order to save as many lives as possible as quickly as possible. In such a scenario, the right holder could contend that it was not a “public non-commercial use” and that prior consent or negotiation was mandatory before the invocation of compulsory licensure, albeit in the bioterrorism context.355 Thus, the scenario allows “national emergency” or “circumstances of extreme urgency” and “public non-commercial use” exceptions to coalesce with tangled and complicated legal results.356 For example, authorities faced with a bioterrorism crisis, and intent on waiving prior authorization of pharmaceutical right holders, would have to decide whether to inform the right holders “as soon as reasonably practicable” (as required by the “national emergency” or “extreme urgency” exception) or “promptly”, (a la “public non-commercial use” grounds).357 These legal uncertainties could potentially hamstring the use of compulsory licensure for a bioterrorism-induced public health crisis.

b. Economic and Political Expediencies as Impediments to the Usefulness of the Consent-Waiver Provisions of Article 31(b) of the TRIPS Agreement Another significant impediment to the propriety of the compulsory licensure regime in a bioterrorism context is the complex politics underpinning the political economy of international intellectual property rights.358 The knowledge-based economy,359 which has ridden the back of a strong

354. See TRIPS Agreement, supra note 64, art. 31(b) (defining public non-commercial use as “where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government”). 355. See id. (requiring a potential user of a patented product to first attempt “to obtain authorization from the right holder”). 356. See id. Article 31(b) requires that when prior authorization is waived on grounds of a “national emergency or other circumstances of extreme urgency” the right holder shall be “notified as soon as rea sonably practicable.” Id. However, when prior consent is waived on grounds of “public non-commercial use,” then right holders “shall be informed promptly.” Id. This is further complicated by TRIPS’ failure to define “as soon as reasonably practicable” and “shall be informed promptly.” See id. (providing no definition of the terms). These are crucial timelines that a would-be compulsory licensee could have difficulty complying with. This would be so especially where the right holder or patentee is outside of the would-be licensee’s jurisdiction or where the patentee’s whereabouts are not immediately known. 357. Id. 358. Analysts believe that the idea of incorporating intellectual property rights in TRIPS was seeded by intense lobbying of corporate interests in the United States, Europe, and Japan. DUNCAN MATTHEWS, GLOBALIZING INTELLECTUAL PROPERTY RIGHTS: THE TRIPS AGREEMENT 7-45 (2002). 359. See generally DRAHOS & BRAITHWAITE, supra note 312, at 39-60 (explaining that knowledge is “the

334 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 intellectual property protection regime to a roaring success,360 seethes with interest groups, rent seekers, and free-riders, intensely battling for the soul of intellectual property.361 Interest groups with vested economic interests are adept at lobbying the political establishment, are better organized, and are able to dull authorities’ political will to appropriate intellectual property rights for public good.362 In the United States, the political climate makes influence-peddling extremely easy for the pharmaceutical industry. For instance, the Pharmaceutical Research and Manufacturers of America reputedly contributed $3,505,052 in campaign funds to politicians in the run up to the 2002 elections in the United States.363 Moreover, a 2005 report by the Center for Public Integrity claims that the pharmaceutical industry topped the list of lobbyists with a record $800 million in federal lobbying and campaign donations in the span of seven years.364 It is therefore unsurprising that the U.S. pharmaceutical industry is able to pressure the United States Trade Representative Office and Congress to resist a flexible interpretation of the TRIPS Agreement provisions on pharmaceutical patents by foreign governments.365 The industry has also become adept at co-opting the generics market, reputedly worth over $20 billion in the United States alone.366 Powerful right holders with vested interests and pro-intellectual property scholars tend to rationalize stronger intellectual property protection on utilitarian grounds,367 dismissing any suggestion at proportionality, balancing source of profits in modern global markets”). 360. See, e.g., MASKUS, supra note 195, at 169 (“[I]ndustrialized countries, which have strong systems of intellectual property protection remain the overwhelming sources of new invention and artistic creation.”). 361. The greatest challenge of intellectual property rights governance is striking the right balance between appropriation and diffusion. See generally, LAWRENCE LESSIG, FREE CULTURE: HOW BIG MEDIA USES TECHNOLOGY AND LAW TO LOCK DOWN CULTURE AND CONTROL CREATIVITY 17-18 (2004) (discussing a war against copyrighted media piracy); Peter Drahos, Negotiating Intellectual Property Rights: Between Coercion and Dialogue, in GLOBAL INTELLECTUAL PROPERTY RIGHTS supra note 67, at 161, 166-74 (discussing developed countries’ leverage in TRIPS negotiations). 362. Strong intellectual property protection has been partly attributed to the ability of interest groups to influence the legislature. Viktor Mayer-Schönberger, In Search of the Story: Narratives of Intellectual Property, 10 VA. J. L. & TECH. 11, ¶¶ 21-25 (2005), http://www.vjolt.net/vol10/issue4/v10i4_a11-Mayer- Schonberger.pdf. 363. Evelyn Pringle, Pharma To Republicans: Time To Pay Up Again, MEDIA MONITORS NETWORK, Nov. 24, 2005, http://usa.mediamonitors.net/content/view/full/23115. 364. M. Asif Ismail, Drug Lobby Second to None: How the Pharmaceutical Industry Gets Its Way in Washington, CENTER FOR PUB. INTEGRITY, July 7, 2005, http://www.publicintegrity.org/rx/ report.aspx?aid=723#. 365. Frederick M. Abbott, The Cycle of Action and Reaction: Developments and Trends in Intellectual Property and Health, in NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES 27, 31- 32 (Pedro Roffe, et al. eds., 2006) [hereinafter Abbott, Action and Reaction]. 366. Knock It Off: A Row Is Brewing in America over Generic Drugs, ECONOMIST, Feb. 24, 2007, at 76. The pharmaceutical industry invented a variant of generics known as “authorized generics” that are promoted by owners of the patents for the original branded drugs rather than by generic manufacturers. Id. The aim of “authorize d generics” is to compete against genuine generics and mitigate financial losses arising from drugs going off patent. Id. at 77. The U.S. C ongress has l aunched a legislative bid to crack down on authorized generics. Id. It remains to be seen if Congress will succeed given the pharmaceutical industry’s economic and political clout. 367. Utilitarianism is one of the dominant theories justifying intellectual property rights protection. Utilitarianism posits that creativity would decline in the absence of incentives in the form of monopoly rights.

No. 2] AGAINST THE PLAGUE 335 of rights, or rights derogation as a campaign against innovation368 or unsound public policy.369 This strand of scholarship or argument resonates well with the fundamentals of free market economies and underscores the apparent reluctance of the U.S. authorities to use compulsory licensing for Bayer’s ciprofloxacin,370 despite the presence of compulsory licensure provisions in the Orphan Drug Act of 1983.371 It is safe to say that authorities in the United States are more apt to use their eminent domain powers to appropriate land for real estate developers372 than pharmaceutical patents to secure affordable medicines for Americans.373 For instance, only eight out of more than two thousand new eminent domain cases filed in 2003-2004 involved intellectual property rights.374 Governments around the world have attempted to use compulsory licensure or have attempted to regulate pharmaceutical pricing.375 However, in the post-TRIPS era, such attempts are bound to be heavily criticized and met with stiff resistance from the pharmaceutical industry.376 For instance, in the pre-TRIPS era (1969-1987), Canada reined in drug prices and famously had some of the cheapest medicines in industrialized world for patented pharmaceuticals.377 The strategy purportedly saved the country an estimated

CORNISH & LLEWELYN, supra note 249, at 35-37; Mayer-Schönberger, supra note 362, ¶¶ 8-14. 368. Sidney Taurel, The Campaign Against Innovation, in ETHICS AND THE PHARMACEUTICAL INDUSTRY, supra note 197, at 326, 326-28. 369. Richard P. Rozek & Renee L. Rainey, Broad-Based Compulsory Licensing of Pharmaceutical Technologies: Unsound Public Policy, 4 J. WORLD INTELL. PROP. 463, 463 (2001). 370. See Shankar Vedantam & Terence Chea, Drug Firm Plays Defense in Anthrax Scare, WASH. POST, Oc t. 20, 2001, at A4 (noting that the U.S. government’s reluctance to override Bayer’s patent on Cipro, due in part to the signal such an action would send to the international community). 371. Orphan Drug Act, Pub. L. No. 97-414 §§ 525-27, 96 Stat. 2049, 2049-50 (1983). 372. See, e.g., Kelo v. City of New London, 545 U.S. 469, 478 (2005) (holding that the confiscation of private property, for use as part of a redevelopment plan that could be economically beneficial to the entire community was a permissible public use under the Takings Clause of the Fifth Amendment). See generally JOHN RYSKAMP, THE EMINENT DOMAIN REVOLT: CHANGING PERCEPTIONS IN A NEW CONSTITUTIONAL EPOCH (2006) (discussing public opinion about eminent domain and the Kelo decision); Charles E. Cohen, Eminent Domain After Kelo v. City of New London: An Argument for Banning Economic Development Takings, 29 HARV. J.L. & PUB. POL’Y 491 (2006) (discussing the Kelo decision). 373. See David Malakoff, NIH Declines to March in on Pricing AIDS drug, 305 SCI. 926 (2004) (discussing the National Institute of Health’s rejection of a plea to use its power to rein in the spiraling cost of an AIDS drug). 374. Aaron S. Kesselheim, Biomedical Patents and the Public’s Health: Is There a Role for Eminent Domain?, 295 JAMA 434, 435 (2006). 375. See Crater Corp. v. Lucent Tech., 255 F.3d 1361, 1368 (Fed. Cir. 2001) (reaffirming the power of the federal government to use compulsory licensing for technology acquisition and holding inter alia that 28 U.S.C. § 1498 grants the government the authority to use compulsory licensure for patented technologies); Ab bott, Action and Reaction, supra note 365, at 29-30 (noting that imposition of price controls was the most common regulatory response by governments). 376. Abbott, Action and Reaction, supra note 365, at 31-33. 377. Christopher Scott Harrison, Protection of Pharmaceuticals as Foreign Policy: The Canada-US Trade Agreement and Bill C-22 versus the North American Free Trade Agreement and Bill C-91, 26 N.C. J. INT’L L. & COM. REG. 457, 457 (2001); see also Michael Halewood, Regulating Patent Holders: Local Working Requirements and Compulsory Licenses at International Law, 35 OSGOODE HALL L.J. 243, 246 (1997) (discussing the benefits of compulsory licensing). See generally Christina Del Valle, Intellectual Property Provisions of NAFTA, 11 J. PROPRIETARY RTS. 4, 8 (1992) (discussing how the system allowed a manufacturer of generic drugs to produce patented drugs in Canada by notifying the patentee and paying a

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US$211 million per year.378 It is extremely doubtful that Canada could re- enact its pre-TRIPS, laissez faire, pharmaceutical patent policy in the current regime of patents fencing. The U.S. Congress recently encountered difficulty on May 3, 2001, when it introduced the Affordable Prescription Drugs and Medical Inventions Act, a bill that was quite audacious in its quest to make patented drugs more affordable.379 Of note was section 158(d) of the bill, whose six grounds on licensing and remunerative terms for compulsorily licensure would have, if passed into law, revolutionized the drug access paradigm.380 Not surprisingly, the bill did not make it past the House of Representatives and never became law.381 The House was undaunted, however, and the bill, rechristened the “Public Health Emergency Medicines Act”, was reintroduced in October 2005.382 Predictably, the new bill, like its predecessor, failed to become law.383 The pharmaceutical industry’s power transcends the United States, and has been exerted, directly or by proxy, in nations such as Brazil,384 South Africa,385 Canada,386 and the United Kingdom,387 to block unfavorable drug policy. In Britain, for instance, compulsory licensure and Crown Use could, in principle, be used to derogate from patent exclusivity.388 Great Britain was confronted with the imperatives of a restrictive drug pricing policy option

fixed 4% royalty fee); John F. Burns, Canada Split on Drug Patents, N.Y. TIMES, Aug. 24, 1987, at D1. 378. See David Crane, New Debate over Generic Drugs Looms, TORONTO STAR, June 9, 1987, at A18 (noting that University of Toronto economist, Harry Eastman, estimated savings through compulsory licenses). 379. Affordable Prescription Drugs and Medical Inventions Act, H.R. 1708, 107th Cong. (2001). 380. Id. § 158(d). 381. Bill Summary and Status, Affordable Prescription Drugs and Medical Inventions Act, H.R. 1708, 107th Cong. (2001), http://thomas.loc.gov/cgi-bin/bdquery/z?d107:h.r.01708:. 382. Public Health Emergency Medicines Act, H.R. 4131, 109th Cong. (2005). 383. Bill Summary and Status, Public Health Emergency Medicines Act, H.R. 4131, 109th Cong. (2005), http://thomas.loc.gov/cgi-bin/bdquery/z?d109:h.r.04131:. 384. Brazil’s threat to use compulsory licensing for AIDS drugs forced Roche to reduce the price of Nelfinavir, making the Brazilian price 30% of the price in the United States. Condon, supra note 189; see Jennifer R ich, Roche Reaches Accord on Drug with Brazil, N.Y. TIMES, Sept. 1, 2001, at C1 (detailing the pr ice reduction). Brazil also fought a proxy patent battle with the United States, when the United States commenced WTO proceedings against Brazil for its failure to protect pharmaceutical patents of U.S. companies. See Panel Report, Brazil – Measures Affecting Patent Protection, WT/DS199/3 (Jan. 9, 2001) (listing cl aims by the United States that Brazil’s “local working” requirement discriminated against United St ates owners of Brazillian patents). 385. See Tshimanga Kongolo, Public Interest Versus the Pharmaceutical Industry’s Monopoly in South Africa, 4 J. WORLD INTELL. PROP. 609, 609 (2001) (noting that the pharmaceutical patents wrangling between South Africa and the pharmaceutical industry are well documented). 386. Canada has used compulsory licensing extensively. See Harrison, supra note 377, at 412-13 (discussing compulsory licensing in Canada). 387. See Susie Mesure, Energetic OFT Head Turns His Guns on Big Pharma, INDEPENDENT, Feb. 21, 2007, http://news.independent.co.uk/business/analysis_and_features/article2290061.ece (noting that the U.K. pharmaceutical industry recently criticized an Office of Fair Trading report which charged that the industry was overbilling the National Health Service for prescription medicines); Pharma Industry Finds Fault in OF T’s Report on Drug Prices, PHARMATIMES.COM, Feb. 21, 2007, http://www.pharmatimes.com/WorldNews/ ViewArticle.aspx?id=10409&src= (describing the pharmaceutical industries response to an Office of Fair Trading report charging them with overbilling); see also OFFICE OF FAIR TRADING, PHARMACEUTICAL PRICE REGULATION SCHEME 1 (2007), http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885.pdf (recommending government reform of the Pharmaceutical Price Regulation Scheme). 388. WILLIAM CORNISH, INTELLECTUAL PROPERTY: OMNIPRESENT, DISTRACTING, IRRELEVANT? 24-28 (2004).

No. 2] AGAINST THE PLAGUE 337 when it introduced a national health insurance policy for the first time in 1911.389 By 1951, when free medical care was extended to the entire population, the number of prescriptions under the National Health Service had risen to 200 million, increasing government financial commitments, and precipitating an undue government preoccupation with price regulation, much to the chagrin of the pharmaceutical industry in post-World War II Great Britain.390 In the 1960s, the British government’s attempt to grant compulsory licenses to generic-drug manufacturers became mired in litigation and was unsuccessful.391 Out of fifty applications submitted by generic manufacturers, only four were successful, due to the difficult legal procedures with which applicants had to comply.392 A similar situation occurred in Italy, where a constitutional challenge, mounted by the pharmaceutical industry to 1978 Italian legislation overriding pharmaceutical patents, was successfully upheld by the Constitutional Court.393 Thus, while compulsory licensure may be legally and theoretically feasible in bioterrorism contexts, it runs against the grain of the free market and could be scuttled by economic and political expediencies that could potentially hamstring authorities’ political will. An unconditional and unambiguous pharmaceutical patent appropriation clause is clearly necessary not only in the bioterrorism context, but in all situations where public health is threatened.

V. CONFRONTING THE PLAGUE: RATIONALIZING THE CASE FOR THE INCLUSION OF A PHARMACEUTICAL PATENT APPROPRIATION CLAUSE IN THE PATENT REGIME This Part of the Article uses ethical justifications, overriding public interest, and human rights as bases for the inclusion of an pharmaceutical patent appropriation clause.

A. Ethical Justifications for a Pharmaceutical Patents Appropriation Clause in Bioterrorism Context: Utilitarianism as a Two-Edged Sword. It is ethically justifiable to have a bioterrorism-specific pharmaceutical patent appropriation clause, despite such philosophical concepts like utilitarianism. Utili ta ri anism pitches incentive imperatives in an intellectual

389. See JOHN ABRAHAM, THE POLITICAL ECONOMY OF MEDICINES REGULATION IN BRITAIN 230 (2002) (“The Liberal government introduced the 1911 National Health Insurance Act. The aim was to assist people below certain minimum income level to receive medical benefit through a national insurance for sickness funded by statutory contributions from the employer, the government and the employed.”). 390. Id. at 236. 391. CORNISH, supra note 388, at 24-26 (noting that under the compulsory licensing regime preceding the 1977 Patent Act, food and drug patents could be licensed under conditions set by the Patent Office); see also DUTFIELD, supra note 216, at 122-26 (noting that Pfizer sued the Department of Health for infringing its patent on tetracycline).

392. DUTFIELD, supra note 216, at 125-26. 393. Id. at 127.

338 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 property context, and is rooted in philosophical underpinnings exhorting support for rights in tangible and intangible private proprietary holdings.394 Utilitarianism holds that moral rules must be oriented towards maximizing human well-being.395 By extrapolation, intellectual property protection would incentivize innovative and beneficial inventions, which, in turn, improve the lot of the populace.396 Conversely, the absence of intellectual property protection would lead to a downward spiral in intellectual creativity and life- impacting innovation, with concomitant depreciation in societal well-being. The incentive element of utilitarianism resonates well with the general economic-right argument for intellectual property protection,397 and is often linked, rightly or wrongly, to John Locke’s labor theory.398 While espousing natural law justification for proprietary rights,399 Locke posited that objects produced by an individual through the mixing of labor with resources held in common are the property of that individual alone, provided enough is left in common for others,400 and that no person takes from the common more than he can use.401 However, Locke’s labor theory has been branded ambiguous in the intellectual property context.402 For example, Robert Nozick argued that Lockean justification for intellectual property would only be valid if other persons did not suffer net harm.403

394. The normative and theoretical bases for individual property rights are the subject of centuries old discourse between philosophers, theologians and economists. Terry L. Anderson & Fred S. McChesney, Introduction to Part I of PROPERTY RIGHTS: COOPERATION, CONFLICT, AND LAW 13-19 (Terry L. Anderson & Fred S. McChesney eds., 2003). However, Peter Drahos notes that a distinction is seldom made between real property and intellectual property. PETER DRAHOS, A PHILOSPHY OF INTELLECTUAL PROPERTY 1 (1996). Drahos wonders whether existing theories of property can accommodate intellectual property or whether a distinctive theory of intellectual property is necessary. Id. 395. See OSTERGARD JR., supra note 206, at 17-21 (faulting the utilitarian argument that juxtaposes long- term social development with the short-term drawbacks of exclusive intellectual property, and arguing that intellectual property protection slows the diffusion of technology and can possibly engender monopolistic behavior). 396. Id. 397. Jakob Cornides, Human Rights and Intellectual Property: Convergence or Conflict?, 7 J. WORLD. INTELL. PROP. 135, 149-50 (2004); Sigrid Sterckx, Patents and Access to Drugs in Developing Countries: An Ethical Analysis, 4 DEVELOPING WORLD BIOETHICS 58, 66-67 (2004). 398. Mayer-Schönberger, supra note 362, ¶¶ 8-14. 399. JOHN LOCKE, TWO TREATIES OF GOVERNMENT 101 (Peter Laslett ed., Cambridge University Press 1988) (1690). John Locke’s idea that a person who labors on resources unowned or held in common has a natural property right to the fruits of his labor which must be respected by the State, has been argued to have some correlations with intellectual property, where ideas and subjects of inventions could be part of the public do main. See Justin Huges, The Philosophy of Intellectual Property, in INTELLECTUAL PROPERTY: MORAL, LEGAL, AND INTERNATIONAL DILEMMAS 81, 107 (Adam D. Moore ed., 1997) (discussing the Lockean justification for intellectual property); Sigrid Sterckx, Can Drug Patents be Morally Justified?, 11 SCI. ENG’G. ETHICS 81, 81-82 (2005) (examining natural rights justification for drug patents). But see Edwin Hettinger, Justifying Intellectual Property, 18 PHIL. PUB. AFF. 31, 36-40 (1989) (disagreeing with John Locke’s natural property rights theory). 400. LOCKE, supra note 399, at 167; see also Carys J. Craig, Locke, Labour and Limiting the Author’s Right: A Warning Against a Lockean Approach to Copyright, 28 QUEEN’S L.J. 1, 11-12 (2002) (discussing the provisos in the context of critiquing the Lockean justification for copyright). 401. LOCKE, supra note 399, at 167. 402. William Fisher, Theories of Intellectual Property, in NEW ESSAYS IN THE LEGAL AND POLITICAL THEORY OF PROPERTY 168, 170 (Stephen R. Munzer ed., 2001). 403. ROBER NOZIC, ANARCHY, STATE, AND UTOPIA 178-82 (1974). Net harm in this context means that other people should not be left poorer than they were before the property was acquired. Id.

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Scholars such as Resnik and De Devile have used utilitarianism, sentimentality, and moral considerations to justify restrictive construction of the U.S. compulsory licensure provision for patented pharmaceuticals.404 According to Resnik and DeVille, broad and unrestricted use of compulsory licensure for patented pharmaceuticals would be unethical and antithetical to the overall social good.405 However, as a consequence-based theory,406 utilitarianism is two-faced, and could equally be used to justify pharmaceutical patent derogation if the majority of the population would be left worse off.407 Peter Drahos and John Braithwaite shared this perspective by arguing that a “patent system that does not recognize the utility preferences of much of the world’s population when it comes to disease can hardly look to utilitarianism for comfort.”408 Thus while intellectual property may be justified on utilitarian grounds, there is ample room in utilitarianism to accommodate pharmaceutical patent appropriation in bioterrorism context. To the extent that pharmaceutical patent appropriation policy could facilitate prompt access to critical medicines, it would produce the greatest happiness of the greatest number in the society, making its inclusion in national and international patents regimes morally justified and imperative.409

B. Overriding Public Interest The public interest is an integral element of governmental regulatory intervention policy.410 Carlos Correa opined that public interest could justify governmental actions to achieve public policy objectives of promoting health, education, and socio-economic developments.411 Mike Feintuck points two two examples in which a u thorities may intervene on the grounds of public economic interest: (1) market failure; or (2) the imperative of curbing abuse of monopolistic or oligopolistic power via anti-trust or competition rules.412 While acknowledging the legitimacy of private property rights in market- oriented economies, Feintuck posits that the “untrammeled exercise of private

404. David B. Resnik & Kenneth A. DeVille, Bioterrorism and Patent Rights: “Compulsory Licensure” and the Case of Cipro, 2 AM. J. BIOETHICS 29, 39 (2002). 405. Id. 406. TOM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 340-1 (5th ed., 2001) (defining consequentialism as a label used to describe moral theories that posit that actions are right or wrong according to the balance of their positive and negative consequences); see also, Philip Pettit, Co nsequentialism, in A COMPANION TO ETHICS 230, 230-32 (Peter Singer ed., 1971) (pointing out that utilitarianism is a type of consequentialism). 407. OSTERGARD, JR., supra note 206, at 17-21. 408. DRAHOS & BRAITHWAITE, supra note 312, at 15-17. 409. See generally WILL KYMLICKA, CONTEMPORARY POLITICAL PHILOSOPHY: AN INTRODUCTION 10-52 (2002) (discussing utilitarianism as a political morality). In the context of global pharmaceutical governance, Cohen and Illingworth use utilitarianism to justify morally the equitable pricing of pharmaceuticals. Jillian Clare Cohen & Patricia Illingworth, The Dilemma of Intellectual Property Rights for Pharmaceuticals: The Tension Between Ensuring Access of the Poor to Medicines and Committing to International Agreements, 3 DEVELOPING WORLD BIOETHICS 27, 27-48 (2003). 410. See generally MIKE FEINTUCK, ‘THE PUBLIC INTEREST’ IN REGULATION 13-41 (2004) (discussing governmental responsibility to serve a public interest). 411. Correa, Investment Protection, supra note 273, at 349. 412. FEINTUCK, supra note 410, at 13-14.

340 JOURNAL OF LAW, TECHNOLOGY & POLICY [Vol. 2007 property rights has the potential to cut across the legitimate democratic expectations of others in terms of parity of esteem and the ability to participate fully in society.”413 He argues further that “[i]f the activities of private entities in practice result in damage to the democratic fabric of society, by restricting the ability of others to act as citizens, they should expect such activities to be challenged or indeed curtailed and economic forces should not remain unconstrained.”414 In the context of intellectual property rights and public health, it has been suggested that public welfare considerations should trump private interests and determine the drug-access paradigm.415 There is no doubt that it is in the overall public interest that authorities should be able to get critical medicines to bioterrorism victims within the shortest possible time due to the extraordinariness of the ensuing emergency situation. However, as demonstrated earlier in this Article, such a prompt response is liable to become entangled in inherent bureaucratic gridlocks in the access paradigm of national and international patent regimes. Viewed from this perspective, a pharmaceutical patent appropriation clause in national and international patent regimes is justifiable due to overriding public interests.

C. Human Rights Perspectives Securing access to life-saving drugs has been described as an issue within the rubric of international human rights law.416 Since an intellectual property regime is an integral element of the drug-access paradigm, there has been a considerable renewed interest in the interface between intellectual property and human rights.417 It has been noted by the UN Sub-Commission on Human Rights that there are apparent conflicts between the fundamental tenets of international human rights and the principles of international intellectual property regime as embodied in the TRIPS Agreement.418 However, the stance of the UN Sub-Commission on Human Rights on

413. Id. at 15. 414. Id. 415. Sol Picciotto, Defending the Public Interest in TRIPS and the WTO, in GLOBAL INTELLECTUAL PROPERTY RIGHTS, supra note 67, at 224-25. 416. Zita Lazzarini, Making Access to Pharmaceuticals a Reality: Legal Options under TRIPS and the case of Brazil, 6 YALE HUM. RTS. & DEV. L.J. 103, 117 (2003) (“A careful reader will find no ‘right to access to pharmaceuticals’ in the International Bill of Human Rights or in any subsequent modern human rights instruments. However, such obligation—although not a defined human right itself—is firmly grounded in the implications of existing substantive provisions and in the special needs created by the current circumstances.”). 417. See Peter Prove & Miloon Kothari, Human Rights Bodies Gear Up on TRIPs, BRIDGES, July-Aug. 2000, 13, 13, available at http://www.ictsd.org/English/BRIDGES4-6.pdf (criticizing TRIPS for threatening key human rights, including “the right of everyone to enjoy the benefits of scientific progress and its applications, the right to health, the right to food and the right to self-determination”). 418. U.N. Econ. & Soc. Council [ECOSOC], Sub-Comm. on the Promotion and Prot. of Human Rights, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, Report of the High Commissioner, ¶¶ 21-28, U.N. Doc. E/CN.4/Sub.2/2001/13 (June 27, 2001); U.N. Econ. & Soc. Council [ECOSOC], Follow-up to the Day of General Discussion on Article 15.1(C), Monday, 26 November 2001: Human Rights and Intellectual Property, ¶¶ 1 n.1, 2-4, U.N. Doc. E/C.12/2001/15 (Nov. 26, 2001).

No. 2] AGAINST THE PLAGUE 341 international intellectual property regime is supremely ironic because as a type of property, the ostensible strengthening of intellectual property rights via the TRIPS Agreement should be in conformance with the tenets of international human rights law, reputed for its avowed support for property rights.419 For instance, Article 17(1) of the Universal Declaration of Human Rights (“UDHR”) provides that “Everyone has the right to own property alone as well as in association with others.”420 Most importantly, and in an apparent reference to intellectual property, Article 27(7) of UDHR provides that “Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.”421 At the regional level, the First Protocol to the European Convention on Human Rights, which is legally enforceable, alludes to intellectual property, in its exhortation of proprietary rights protection.422 In addition, and more specifically, Article 17(2) of the Charter of Fundamental Rights of the European Union on right to property, which is non-justiceable, provides that “Intellectual property shall be protected.”423 Furthermore, Article 15(1)(c) of International Covenant on Economic, Social, and Cultural Rights, requires signatory states to recognize the right of everyone “to benefit from protection of moral and cultural material interests resulting from any scientific, literary or artistic production of which he is the author.”424 If TRIPS is antithetical to the fundamental ideals of human rights law as suggested in the excerpts of the UN-Sub-Commission on Human Rights,425 how can international human rights law’s apparent support for property rights ,including intellectual property, be justified, which the TRIPS appears to promote? In other words, how could international human right law be interpreted to abhor what it promotes? The seeming contradiction is symptomatic of the complex interface between intellectual property and human rights, and is aptly put in context by Audrey Chapman as follows: The development of a global economy in which intellectual property plays a central role underscores the need for human rights community to claim the rights of the author, creator and inventor, whether individual, a group or a community, as a human right. It is equally important for human rights advocates to protect the moral interests and

419. Universal Declaration of Human Rights, available at http://www.unhchr.ch/udhr/lang/eng.pdf (last visited Oct. 31, 2007). 420. Id. 421. Id. 422. European Convention on Human Rights, art. 1, Nov. 4, 1950, 213 U.N.T.S. 222, available at htt p://www.hrcr.org/docs/Eur_Convention/euroconv8.html. The European Court of Human Rights’ definition of “possession ” would appear to cover intellectual property. Id. 423. Charter of Fundamental Rights of the European Union, art. 17(2), 2000 O.J. (C 364) 1, 12, available at http://www.europarl.europa.eu/charter/pdf/text_en.pdf. 424. International Covenant on Economic, Social and Cultural Rights art.15(1)(c), opened for signature De c. 16, 1 966, 993 U.N.T.S. 3 (1976), available at http://www.unhchr.ch/html/menu3/b/a_cescr.htm. 425. Ruth L. Okediji, The International Relations of Intellectual Property: Narratives of Developing Co untry Participation in the Global Intellectual Property System, 7 SING. J. INT’L & COMP. L. 315, 346 (2003) (suggesting that both the innovator’s right to protection and the public’s access to the innovation are both cognizable as human rights).

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rights of the community to securing access to this knowledge. A third human rights consideration is whether relevant laws identifying rights to creative works and scientific knowledge and determining the subject matter which can be claimed as intellectual property are consistent with respect for human dignity and the realization of other human rights.426 It seems then that the challenge of resolving the apparent conflict lies in finding a balance between intellectual property rights protection and human rights.427 Property rights, like other rights, are neither absolute nor sacrosanct.428 In the context of public health protection and preservation, intellectual property rights should give way to every human’s right to health and life. It has been argued that whenever terrorism threatens public health, personal and economic rights should give way to public health protection imperatives.429 Thus, in public health terms, the right to life and health trumps property rights.430 Viewed from this perspective, a pharmaceutical patents appropriation clause in the context of bioterrorism does not necessarily contravene property rights and is justified by the fundamental right to health and life.

VI. CONCLUSION This Article proposes the inclusion of a bioterrorism-specific pharmaceutical patents appropriation clause in national and international patent regimes. The thesis is predicated on the impropriety of the current bureaucracy-prone access to medicines paradigms in international and national patent regimes for bioterrorism-induced public health crises situations. Using highly plausible, worst-case scenarios of bioterrorism attacks, this Article argues that vast swathes of the population could become simultaneously vulnerable to deadly bioweapons, exposing millions of people to inevitable deaths, in a comparatively shorter time span than naturally-occurring diseases like HIV/AIDS or tuberculosis. In this circumstance, time is of utmost essence in saving as many lives as possible. This makes it imperative for authorities to override patents on crucial drugs or vaccines without the consent of patent

426. Audrey R. Chapman, Approaching Intellectual Property as a Human Right: Obligations Related to Article 15 (1) (c), COPYRIGHT BULL., July-Sept. 2001, at 4, 6-7, http://unesdoc.unesco.org/images/0012/ 001255/125505e.pdf#page=4. 427. See PERELMAN, supra note 219 at 2-3 (acquiescing to the creativity promotion rationale for intellectual property protection, but railing at the regime’s degeneration into a system which now “threatens to exhaust creative activity”). 428. Lawrence O. Gostin, When Terrorism Threatens Health: How Far Are Limitations on Human Rights Justified?, 55 FLA. L. REV. 1105, 1168 (2003) 429. LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 20 (2000). 430. George G. Djolov, Patents, Price Controls, and Pharmaceuticals: Considerations from Political Economy, 6 J. WORLD INTELL. PROP. 611, 611-31 (2003); James Thuo Gathii, Rights, Patents, Markets and the Global Aids Pandemic, 14 FLA. J. INT’L L. 261, 263-351 (2002); Faizel Ismail, The Doha Declaration on Trips and Public Health and the Negotiations in the WTO on Paragraph 6: Why PhRMA Needs to Join the Consensus!, 6 J. WORLD INTELL. PROP. 393, 393-401 (2003); Nadia Natasha Seeratan, The Negative Impact of Intellectual Property Patents Rights on Developing Countries: An Examination of the Indian Pharmaceutical Industry, 3 SCHOLAR 339, 339 (2001).

No. 2] AGAINST THE PLAGUE 343 holders, thus avoiding lengthy negotiations that might be destined for failure. Moreover, this Article deems a bioterrorism-specific appropriation clause in global patents regimes expedient, in light of the pervasive and dominant pro- patents forces intent on a stronger intellectual property regime. This regime rationalizes patent protection solely on utilitarianism, and would cast attempts at proportionality of rights as campaigns against innovation. A fortiori, absent a bioterrorism-specific pharmaceutical patent appropriation clause, authorities could be bogged down by political and economic expediencies of pharmaceutical patent appropriation, fostering indecision that would make securing critical medicines in bioterrorism pandemics situations nigh impossible. This Article justifies the case for bioterrorism-specific pharmaceutical patents appropriation on ethical grounds, overriding public interests, and fundamental rights to health and life.