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Nanobiotechnology, Synthetic Biology, and RNAI: Patent Portfolios for Maximal Near-Term Commercialization and Commons for Maximal Long-Term Medical Gain Thomas M

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Nanobiotechnology, Synthetic Biology, and RNAI: Patent Portfolios for Maximal Near-Term Commercialization and Commons for Maximal Long-Term Medical Gain Thomas M Marquette Intellectual Property Law Review Volume 13 | Issue 1 Article 3 Nanobiotechnology, Synthetic Biology, and RNAI: Patent Portfolios for Maximal Near-Term Commercialization and Commons for Maximal Long-Term Medical Gain Thomas M. Mackey Follow this and additional works at: http://scholarship.law.marquette.edu/iplr Part of the Intellectual Property Commons Repository Citation Thomas M. Mackey, Nanobiotechnology, Synthetic Biology, and RNAI: Patent Portfolios for Maximal Near-Term Commercialization and Commons for Maximal Long-Term Medical Gain, 13 Intellectual Property L. Rev. 123 (2009). Available at: http://scholarship.law.marquette.edu/iplr/vol13/iss1/3 This Article is brought to you for free and open access by the Journals at Marquette Law Scholarly Commons. It has been accepted for inclusion in Marquette Intellectual Property Law Review by an authorized administrator of Marquette Law Scholarly Commons. For more information, please contact [email protected]. REVISED 3-13-09 MACKEY FINAL FORMATTED 3/16/2009 9:52 AM NANOBIOTECHNOLOGY, SYNTHETIC BIOLOGY, AND RNAI: PATENT PORTFOLIOS FOR MAXIMAL NEAR- TERM COMMERCIALIZATION AND COMMONS FOR MAXIMAL LONG-TERM MEDICAL GAIN THOMAS M. MACKEY∗ ABSTRACT .................................................................................................... 126 INTRODUCTION ........................................................................................... 126 I. PRESENT AND PROBABLE FUTURE SCIENTIFIC KNOWLEDGE AND TECHNOLOGICAL CAPACITIES ..................... 130 A. The Present and Near Future: Incremental Progress ............... 133 B. In 20-to-40 Years: Revolutionary Progress, Effecting Leaps Forward in Medicine ...................................................... 135 1. Interim Work Towards the Probable Revolutionary Advances: Identification and Removal, or Circumvention, of Scientific and Technological Obstacles............................................................................... 135 2. Medical Leaps in 20-to-40 Years: Vastly Improved Risk Identification, Prevention, Diagnosis, and Treatment for Common and Commonly Lethal Chronic Diseases ................................................................. 139 II. THE EFFECTIVE USE OF PATENT PORTFOLIOS TO NAVIGATE THROUGH COMPLICATED AND UNCERTAIN LEGAL, SCIENTIFIC, AND TECHNOLOGICAL TERRITORIES ....... 146 A. The Patent Portfolio: The Main Unit of IP Value in All Three Technologies .................................................................... 146 B. Patent Thickets and Low Quality Patents: Consequences ∗ JD, Georgetown University Law Center, 2004; PhD Candidate, Yale University, 1997-98; MPP, University of California-Berkeley, 1995; Licensed Attorney, New York State, United States Patent & Trademark Office. Thanks to Eric V. Slud, Professor, Statistics Program, Department of Mathematics, University of Maryland-College Park, for sharing his thoughts on my “probability of a probability” terminology (i.e., “p(p(x))”; see footnote 197), finding the terminology to “relate to” a Bayesian view of the specification of a probability. REVISED 3-13-09 MACKEY FINAL FORMATTED 3/16/2009 9:52 AM 124 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 13:1 of Patenting Too Early, Too Many, and Too Broadly in NB/BN, Synthetic Biology, and RNAi .................................... 153 C. Prosecuting to Maximize Patent Portfolio Value When the Pertinent Patent Law, Science, and Technology are All Uncertain and Quickly Changing ............................................. 157 1. KSR Int’l Co. v. Teleflex, Inc. and Pertinent Likely Provisions of the Patent Reform Act: Effects on Patent Prosecution .............................................................. 159 a. The Heightened Obviousness Bar for Post-KSR NB/BN, Synthetic Biology, and RNAi Claims to Combinations ................................................................. 159 b. Possible Forthcoming Statutory and PTO Rule Changes That Would Help Further Weed Out Patent Thickets and Increase Patent Validity: Creating a One-Year Post-Grant Opposition Period, Reducing the Litigation Estoppel Effect of Inter Partes Reexaminations, and Empowering the PTO to Make Rules That Limit Continuations .......... 168 2. Just-Now-Learning that Human Genetic Regulation is Not What We Thought: Specific Consequences for Prosecuting NB/BN, Synthetic Biology, and RNAi Patents .................................................................................. 170 3. General Strategies and Tactics in Patent Prosecution that Maximize Patent Portfolio Value in NB/BN, Synthetic Biology, and RNAi ............................................. 172 III. DESIGNING AND EXECUTING ROADMAPS THAT MAXIMIZE COMMERCIAL VALUE: USE OF PATENT PORTFOLIOS, LICENSES, VENTURE CAPITAL, AND ACQUISITIONS .................. 174 A. Early Thorough Integrative Research Planning that Culminates in a Multi-Dimensional Modifiable Roadmap ... 174 B. Maintaining and Modifying the Roadmap to Maximize Commercial Value ..................................................................... 180 C. Using the Patent Portfolio to Facilitate Commercial Development .............................................................................. 180 D. Exclusive Licensing .................................................................... 181 E. Maximizing Patent Portfolio Value to Obtain and Maintain Venture Capital .......................................................... 182 F. Through the Minds of Prospective Buyers: How Pharmaceutical and Biotechnology Companies Acquire NB/BN, Synthetic Biology, and RNAi Technology ............... 185 IV. OVERCOMING NEAR-TERM OVER-OPTIMISM TO REALIZE REVISED 3-13-09 MACKEY FINAL FORMATTED 3/16/2009 9:52 AM 2009]NANOBIOTECHNOLOGY, SYNTHETIC BIOLOGY, AND RNAI 125 LONG-TERM REVOLUTIONARY GAINS: A SOBERING LOOK AT THE MODEST MEDICAL GAINS IN FIGHTING AMERICA’S TOP THREE KILLERS—HEART DISEASE, CANCER, AND CEREBROVASCULAR DISEASE ....................................................... 186 V. POLICY PRESCRIPTIONS: FURTHER WEED OUT THE PATENT THICKETS, INCREASE PATENT QUALITY, AND SHIFT THE MAIN FOCUS FROM MAXIMIZING NEAR-TERM COMMERCIALIZATION TO MAXIMIZING LONG-TERM MEDICAL PROGRESS ....................................................................... 188 A. Further Weed Out the Patent Thickets and Increase Patent Quality: Why KSR and the Patent Reform Act Probably Will Not Suffice and How We Could Do More ...................... 192 1. Additional Changes Recommended: Prosecution History Estoppel, Improved Injunctive Relief to Deter Holdups from Trolls, and Removal of the Prior Art Limit to Reexaminations ............................................. 192 2. Impractical Given the Extraordinary Cross-Industry Nature of the Technologies: Extensive Industry- Specific Patent System Reform .......................................... 193 B. Parallel Science and Technology Commons ............................ 194 1. Commons for Pertinent Upstream Basic Science and Technology: Which Commons Type for Valid and Reliable Building Block Standards in the Three Nascent Technologies? ....................................................... 194 2. Which Commons Type for Very High Risk and Very Long-Term Technological Developments That Could Truly Revolutionize Medicine? ......................................... 197 CONCLUSION ................................................................................................ 204 REVISED 3-13-09 MACKEY FINAL FORMATTED 3/16/2009 9:52 AM 126 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 13:1 ABSTRACT This Article has a dual focus: the use of patent portfolios for maximal near-term commercialization in nanobiotechnology, synthetic biology, and interference RNA, and the creation of commons for maximal long-term medical gain in these technologies. These three technologies show great promise for clinical medicine, but only in the long-term. At least twenty years of R&D will be required to overcome scientific and technological barriers to a revolutionary medical breakthrough. For near-term R&D, different routes to patent portfolio- enabled commercialization are described and prescribed. A patent portfolio theory is presented which views the portfolio as the principal unit of intellectual property value because many firms maximize scale and diversity of intellectual property protection through a careful drafting of many distinct, but related, patents. The theory is qualified by the extraordinarily valuable outlier patent that to some extent is “decontextualized,” i.e., its market value is partly independent from that of its portfolio. Patent thickets and low quality patents, as well as recent doctrinal and likely forthcoming statutory changes that should reduce these problems, are addressed. Multidimensional, modifiable roadmaps to commercialization are prescribed to meet near-term challenges. Research-based alliances (e.g., cross-university alliances), as well as exclusive licenses with start-ups, should often be considered. Plans for acquiring venture capital and developing patent portfolios that attract good acquisition offers from pharmaceutical or biotechnology companies often must also be made. Patent portfolio-enabled commercialization should be complemented by foundational commons that solidify the upstream basic science and technology building blocks for the technologies. Commons are also needed for high risk, but also potentially very high medical return, multidisciplinary and long-term R&D in these three technologies. INTRODUCTION This is an attempt to
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