1. TRIPS FlexibilitiesPreventive Measures Johanna von Braun, PhD University of Cape Town, South Africa Kiev, 21/22nd June, 2010

2. Outline • Overview preventive measures • Patentability Criteria • EPO Guidelines • Indian Patent Act • Exclusion from Patentability • Patent Opposition • Thailand • India • Brazil

3. Preventive Measures • Policy options to prevent patents / regulatory barriers to being granted in the first place • “Prevention is better than cure” • Cheaper • Faster • Less politically sensitive • One of most famous – 2016 extension for patent protection on pharmaceuticals but only for LDCs

4. Patentability Criteria

5. Patentability Criteria Art. 27.1 TRIPS : (…) 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. Free to define: ‘new’, ‘inventive step’ and ‘industrial applicability’ One of the most important criteria:  what is an invention for the purpose of protection?

6. Importance for Access to Medicines European Commission Report (2008): • From 2000 – 2007 total decline of new medicines • But pharmaceutical patent applications doubled • 87% of which “secondary” patents – i.e., non on active substance itself, but various ancillary features, such as formulations, salt forms, methods of treatment. • evergreening: artificial extension of market exclusivity through protection of secondary features • Strict patentability criteria can limit ‘evergreening’

7. How to go about it From public health angle: Broad definition for novelty • What constitutes prior art? • Oral, written, use, anywhere in the world? High standards on inventive step • can anybody skilled in the art come up with this invention? • Does it have a surprising effect? Strict concept of industrial applicability • Is it a technical solution to a certain problem? • Can it be manufactured / marketed? Could be in form of guidelines / legislative amendments.

8. Guidelines for examination EPO industrial application Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods. BUT Guidelines of no use if legislation specifically allows for patentability

9. Legislative: Sec. 3(d) - Indian Patent ActExceptions from patentability …the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy (…) or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation to Section 3 (d): Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

10. Section 3(d) in action – Novartis Case 1970 India abandons pharmaceutical product patents 1993 Novartis granted patent for active compound imatinib/Glivec(not in India) 1997 Novartis filed patent application in Madras for a crystalline salt of Imatinib EMR in 2003 (±2500USD/mth vs ±250USD/mth) 2005 India introduced patent protection for pharma products Patent examination of Imatinib salt

11. Novartis (2) 2005 Indian generics / patient groups filed pre- grant opposition: new form of known substance – not patentable under S.3(d) 2006 Madras patent office refused grant: obvious, lacked novelty and not patentable under 3d – appealed by Novartis • Novartis challenges section 3 (d) at Madras High Court for not being TRIPS compatible. Court points towards WTO DSB 2009 IP Appellate Board rejects appeal 2009 Novartis moves appeal to Indian Supreme Court

12. Other relevant exclusions in TRIPS

13. Other Relevant Exclusions in TRIPS Art. 27: Members may exclude from patentability inventions, (…) to protect ordre public or morality, including to protect human, animal or plant life or health (…) (…) diagnostic, therapeutic and surgical methods for the treatment of humans or animals

14. Patent Opposition

15. Patent opposition TRIPS does not regulate patent opposition • Even in well staffed patent offices mistakes are made • USFTC: 30% of patent infringement cases that are fully litigated patent issued was invalid • Litigation expensive and lengthy – chilling effect • Need for observation mechanisms to oppose patent • Before granting when application is published • Shortly after patent is granted (or both) • Reduced transaction costs and allows for public to examine patents before they have to go to court • Given budget restraints – of particular relevance in developing countries

16. Thailand: Pre-grant Opposition Patents applications may be challenged by any person within 90 days of publication • Lack of patentability • Lack of entitlement to file application / inappropriate filing 2001 patient groups / NGOs challenged BMS patent application of didanosine invalid because a dose restriction in the original patent was unlawfully altered Won case and opened up for domestic production 2006 Health and Development Foundation challenged GSK for patent on Zivudine/lamivudine fixed dose combination for lack of novelty Won case and prevented patent price (USD 2436/year vs. USD276/year).

17. India: Pre & post grant opposition • pre-grant: as patent application filed and published • Post grant: one year after patent grant published 2006 Challenge GSK jointly with Thai activist groups GSK also withdraws patent application in India and all other countries Continuing use of opposition procedures by civil society

18. Brazil’s pre-grant opposition Amendment of patent act in 2001: Pharmaceutical product/process patent application need consent from National Sanitary Agency • Same examination criteria but from health perspective • ±10% of patents have been rejected by ANVISA • Others only granted after claims redrafted Roche filed a federal lawsuit arguing that the ANVISA had no legitimacy to interfere in patent applications  Case ongoing

19. Conclusion • Preventive measures extremely important TRIPS flexibilities • Avoid lengthy, costly and political sensitive patent challenges • Ensure high quality of patents / patent files • Need for guidelines and/or legislative amendments to allow such options • Important to avoid TRIPS plus provisions that may undermine preventive measures

20. Thank you! Johanna.vonbraun@uct.ac.za