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Public Health and Intellectual Property Management: the Challenges on Access to Medicines

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Public Health and Intellectual Property Management: the Challenges on Access to Medicines Public Health and Intellectual Property management: the challenges on access to medicines Dr. Inthira Yamabhai 1 | Public health, innovation and intellectual property Overview Intellectual property (IP) and implications on access to medicine – Trade Related Aspect of Intellectual Property Rights (TRIPS) – TRIPS+ through trade agreements Sources of information 2 | Different forms of IP Trademark: name under which product is marketed Patent: compound, crystalline forms, process, method of use, etc Protection of undisclosed data: clinical test data Copyright: package insert Design protection: packaging 3 | Patents There is nothing such as a worldwide patent! WIPO Patent Cooperation Treaty allows for worldwide filing, but applicant receives a bundle of national patents; same principle under European Patent Convention WTO TRIPS sets certain minimum standards: – Term: 20 years from filing data – Mandatory for all fields of technology – Criteria: novelty, inventive step, industrial applicability – Flexibilities: e.g. parallel importation and compulsory licensing 4 | One drug = one patent??? "…a key element of life cycle management strategies is to extent patent protection for as long as possible by filing secondary patents to keep generics off the market" (Burdon and Sloper 2003) Sofosbuvir: Expiry without patent term extension(s) • Broad compound patent (Markush) Market 2024 • WO2005003147A2 Authorization US: 2013/14 • Compound patent on prodrug • WO2008121634A2 2028 www.who.int/phi/impl ementation/ip_trade/ip • Crystalline forms _patent_landscapes/e n/ 2031 • WO2011123645A2 • Combination with ledipasvir 2032 • WO2013040492A • Composition & dosage 2032 • WO2013082003A1 Incremental innovation vs life cycle management Incremental advances for public health can include: ƒƒ Combinations & new dosage forms with improved efficacy: co-formulation of antiretroviral drugs ƒ Formulations with better product characteristics: vaccines stored in fridge rather than freezer New routes of delivery: tablets or nasal spray vs injections Paediatric formulations: dispersible flavored tablet of artemether-lumefantrine 7 | Granting patent in India: Imatinib case Novartis claims the drug is more easily absorbed into the blood that is enough of an improvement to warrant patent protection. India Patent Office disagreed that Novartis had shown significantly increased efficacy and refused to grant a patent on Glivec (imatinib mesylate) Novartis file a case and India’s Supreme Court refused to grant a patent for Glivec, as it’s known in some countries India’s trade and industry minister, Anand Sharma, has defended the decision, and was quoted by Agence France-Presse as saying it was “absolutely justified under the law” and that India’s patent law “does not accept evergreening.” 8 | Estimated impact of evergreening 84% of patent applications during 2000-2010 are evergreening patents For 59 patented medicines, Thailand could have saved around 1,177 million THB (35 million USD) from 2000-2010 Source: Sutapak U et al (2011), Evergreening patent applications of pharmaceuticals and access to medicines 9 | Differential pricing Sofosbuvir 12 weeks treatment course: US: US$84,000 (reductions since Abbvie came to market) UK: US$57,000 Egypt: US$900 (same price offered to public programme in Lao PDR; Mongolia) Pakistan: US$1,620 (private sector) 10 | Where to draw the line? Opposing trends: Argentina, India and Philippines follow new approaches in the pharmaceutical area to limit secondary patents Brazil and South Africa consider similar rules (only new chemical compounds are patentable unless new form is more efficacious) US through trade agreements endeavours to expand patentability, e.g. secondary uses, methods of use and to prevent limitation of secondary patents 11 | Policy options Price controls: ‘Value-based pricing’; price/volume agreements; pay for performance; risk-sharing agreement / patient access schemes; reference pricing schemes… Differential pricing/price negotiations Voluntary licensing agreements Local production/import TRIPS flexibilities, including compulsory licenses 12 | Public health, innovation and intellectual property Voluntary licenses HIV treatments (adults) INN Licensor Year Scope No countries Licsees EFV MSD 2007 South Africa 1 (allows export to Several SSA) d4T BMS 2001 SSA, India. country list 50 Several DDL BMS 2006 SSA; India; country list 50 Several RAL MSD 2011 LIC; SSA 56 2 SQV Roche 2006 LDC; SSA 65 Several DRV Tibotec (Janssen/J&J) 2012 Non-assert: LDC; SSA 65 1+non- License: India assert. ZDV; ZDV/3TC ViiV Healthcare 2010 LDC; LIC; SSA 69 Several TPV Boehringer-Ingelheim 2004/07 LIC; LDC; Africa, India 78 Several NVP Boehringer-Ingelheim 2004/07 LIC; LDC; Africa; India 78 Several DTG; DTG/ABC MPP: ViiV Healthcare 2014 Country list 73 (+ no patent MPP count.) EVG; QUAD MPP: Gilead Sciences 2011 Country list 100 Several TDF+FTC+EVG EVG13; QUAD| Public health,Gilead innovationSciences and2011 intellectual Country property list 100 + 9 semi- 4 TDF+FTC+EVG exclusive licenses for MICs ATV MPP: BMS 2013 Country list 110 (+ 34 no patent MPP count.) RPV/TDF/3TC or Tibotec (Janssen/J&J) 2011 Country list 112 5 FTC; RPV TDF Gilead Sciences 2006/11 Country list 112 Several TDF; TAF; FTC MPP: Gilead Sciences 2011/14 Country list 112 Several Recent compulsory licenses & government use Country Medicine Indication Measure Period Royalties Remarks Ecuador Abacavir+la HIV/AIDS Gov use 2012 5% of US Local prod. mivudine price adjusted by diff. in GDP Indonesia Seven HIV/AIDS; Gov use 2012 0.5% Local prod. products hepatitis India Sorafenib Cancer CL 2012 6% Local prod. Ecuador Ritonavir HIV/AIDS Gov use 2010 0.42% of US Import; local price prod. Thailand erlotinib; Cancer; Gov use 2006-2008 3-5% Import letrozole; heart docetaxel; disease; clopidogrel; HIV/AIDS lopinavir/rito navir Brazil Efavirenz HIV/AIDS Gov use 2007 1.5% Import & local prod. Thailand14 | PublicEfavirenz health, innovation HIV/AIDS and intellectualGov use property 2006 0.5% Import Impact of CLs: Examples Brazil: – price reduction (from US$1.59 to US$0.43) – first import from India, followed by local production after two years (argument: lack of sufficient disclosure) Ecuador: – price reduction (from US$1000 to US$800 initially; 50% reduction anticipated) – import from India (2010 CL); local production (2012 CL) Thailand: – price reduction (3.4 to 6.4 fold for efavirenz and ritonavir) – GPO could initially not ensure local production of high quality products – import from India India: – price reduction from Rs.280000 to 8880, plus free supply to 600 patients annually Source: Kamp R, Doha Declaration on TRIPS & Public Health: Creating Legal Avenues for Access to Medicines, Trade and Public Health Workshop, 15 | 2016 New mega-RTAs Trans-Pacific Partnership (TPP) Transatlantic Trade and Investment Partnership (TTIP) (EU-US) Regional Comprehensive Economic Partnership (RCEP) (East Asia, 16 countries) Free Trade Area of the Asia-Pacific (FTAAP) (APEC, 21 countries) 16 | Size of new coming RTAs Source: http://www.bilaterals.org/?businesses-believe-apec-s-free 17 | IP protection requirements: TRIP-Plus Expand scope of patentability – new forms of existing entities – new uses – new formulations and combinations, etc. Data exclusivity (exclude use of registration data) 5+ years New indication, formulation, method of administration 3+ years Biological products8+ years Extend patent term for regulatory delays Patent linkage: Link drug registration and patent status Criminal enforcement mechanisms for patent infringement 18 | TRIP-Plus impedes the use of TRIP flexibilities IP Chapter Article 18.76: • Investment Chapter Annex 9 Special Requirements related (3B): expropriation to Border Measures – Philip Morris filed a case – German customs authorities against Australian government wrongfully seized a drug due to warnings on cigarette shipment of “Amoxicillin” on the packaging and removing suspicion that it infringed the branding from cigarette brand name “Amoxil” 4 weeks packaging its trademark and delay investment rights – Dutch customs authorities seized a shipment of abacavir sulfate while it was en route from India to Nigeria. Sources: WTO, European Union and a Member State – Source: Seizure Of Generic Drugs in Transit, May 19, 2010. https://au.news.yahoo.com/thewest/a/29064155/tob Zarocostas, J., Brazil and India file complaint against acco-giant-sues-australia/ EU19 over | seizure of generic drugs, BMJ 2010;340:c2672 Sources of Information WHO-WIPO-WTO Study on “Promoting Access to Medical Technologies and Innovation (2013): www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf All you need to know about IP and health: http://www.who.int/phi/publications/category/en/ Everything that is not happening in the WTO: www.bilaterals.org WTO RTA database: http://rtais.wto.org 20 | Public health, innovation and intellectual property 20 Sources of Information World Trade Report 2011: The WTO and Preferential Trade Agreements: http://www.wto.org/english/res_e/publications_e/wtr11_e. htm Texts of RTAs: www.ustr.gov www.efta.int http://ec.europa.eu/enterprise/policies/international/facili tating-trade/free-trade/index_en.htm 21 | Thank you Dr Peter Beyer Senior Advisor World Health Organization [email protected] Tel. +41-22-791 25 07 Dr Inthira Yamabhai Technical officer [email protected] 22 | .
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