1. Oppositions made simple How to start: Leena Menghaney, MSF Access Campaign

2. 2000

3. 1987: first ARV AZT 1996: TRIPLE HAART THERAPY 2000: Glaxo Blocks Access To Lamivudine/Zidovudine in Ghana In letters to a drug distributor in Ghana and an Indian generic-drug maker, Glaxo said sales of generic versions of its drug, Combivir, in Ghana would be illegal because they would be violating company patents. As a result, the Indian company, Cipla Ltd. of Bombay, has stopped selling its low-cost version in Ghana, a small country in West Africa.

4. New Use patent on zidovudine Source: Lawyers Collective HIV/AIDS Unit

5. 20022002 – THAILAND – THE FIRST CHALLENGE

6. How we started in India

7. Globalisation of Patent Rules 1995 WTO Trade related aspects of intellectual property rights agreement (TRIPS) “minimum” standards of protection of intellectual property rights 20 year patents on pharmaceutical products No differentiation between lifesaving medicines and trivial goods 2005 Indian amended its patents act to be compliant with TRIPS and starts to grant product patents (transition period ends).

8. In 2001 Novartis introduced Glivec (Imatanib Mesylate) in India The Glivec story 1 month1 year Glivec US$ 2,500US$ 30,000 Generic equivalent US$ 200US$ 2,500 Comparative prices

9. INDIA SIGNED AN AGREEMENT WITH WTO TO MOVE FROM PROCESS PATENT 2005: PROCESS & PRODUCT PATENTS FOR MEDICINES In 1995… The Glivec story

10. 1998 Novartis applied for patent in India on for a crystalline form or polymorphic form of its anticancer drug imatinib mesylate (Glivec) Jan 2003 Based on this application Novartis applied for 5 yr EMR in India (no examination required or opposition allowed) Nov 2003 Novartis granted EMR 6/9 pharmaceutical companies told by court to stop marketing affordable generic versions of imatinib The Glivec story

11. 2004: Result of Glivec’s EMR CPAA could no longer supply the drug at subsidized rates. Meets with Lawyers Collective for Legal Aid

12. CIVIL SOCIETY OPPOSITION AGAINST INDIA CHANGING ITS PATENT LAW TOOK PLACE…

13. ACROSS INDIA…

14. AND THE WORLD…PROTESTS AGAINST INDIA BECOMING TRIPS COMPLIANT WERE HELD IN… SOUTH AFRICA GERMANY FRANCE GENEVA BURKINA FASO MOROCCO UNITED STATES OF AMERICA KENYA

15. Innovation in decline? patent protection has increased over the last 20 years, but the mean innovation rate has fallen Only 153 out of 1,035 new-drugs approved by the FDA during a 12 year period from 1989-2000 were for highly innovative drugs – medicines that contained new active ingredients and also provide significant clinical improvement. (NIHCM Foundation, 2002) 68% of 3,096 new products approved in France between 1981 and 2004 brought ‘nothing new’ over previously available preparations. (Prescrire International, 2005) Only 68 (5.9%) out of 1,147 newly patented drugs appraised by the Canadian Patented Medicine Prices Review Board between 1990 and 2003, met the regulatory criterion of being a breakthrough drug – the first drug to treat effectively a particular illness or which provides a substantial improvement over existing drug products. (Morgan et al, BMJ 2005)

16. Prevention is better than cure 3 steps Law/guidelines setting the patentability criteria Local examination – law provides for examination of every application Pre - Grant Oppositions

17. Examination system weeds out patent applications that should not be granted

18. Efforts to stop evergreening: India: Section 3(d) stipulates that the following shall not be treated as an invention within the meaning of the Act: “ the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance 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.—For the purposes of this clause, 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

19. Any other personGeneric CompaniesPatient Groups Pre Grant Opposition Post Grant Opposition Challenging Decisions of Patent Office Challenging decisions of Appellate Board Patent Office Appellate Board Court Patent Invalidation Appellate Board High Court Patent Revocation India Allows Pre-grant and Post-grant Opposition Oppositions and Appeals

21. Novartis patent application on life saving cancer drug – CPAA files opposition in 2005 Glivec’s base compound, Imatinib mesylate, was patented in 1993 and was not eligible for an Indian Patent because India joined the WTO only in 1995.

22. Result of CPAA’s opposition Patent for Glivec rejected Generic versions of Glivec were once again available in the Indian market at affordable prices Jan 2006

23. MSF worried But since January 2005, India is obliged to grant patents on medicines  the source of HIV medicines may dry

24. MSF pharmacist: Generic pipeline Needed for (according to WHO) TDF1 st and 2 nd line TDF based FDC1 st line LPV/r tabs2 nd line Ritonavir2 nd line EC ddI2 nd line ATV2 nd line ABC1 st and 2 nd line All these needed ARVs will be at risk of production if patents are granted

25. Prognôsis A granted patent in India for an essential drug (including Antiretrovirals) will block generic production by Indian companies and make drugs either unavailable or unaffordable (or both) across the developing world Partnerships: PLHIV networks, legal AID groups and MSF need to work together on opposing HIV medicine patent applications

26. Patent Applications in India US received 288K patent applications in 1999

27. Source: Annual Reports of the IPO Major Increase in the number of patent applications filed at the Indian Patent Office (IPO) PCT is the favorite filing route – ~60% applications filed with the IPO were national phase filings under PCT Majority of filers are foreign residents (Bayer, Gilead) Major Increase in the number of patent applications filed at the Indian Patent Office (IPO) PCT is the favorite filing route – ~60% applications filed with the IPO were national phase filings under PCT Majority of filers are foreign residents (Bayer, Gilead) Patent Filing Trends in India Patent Filings at the IPO

28. Searching Indian Patents – A BIG Challenge -Opposition dependent on information available. But how does patent office manage publication in India: -no searchable database to identify applications (reduced to manual searching through thousands of patent applications) -Publication of only abstract. requirement of publication of patent specification deleted making it difficult to oppose effectively. - Information only available after visiting four patent offices in Mumbai, Delhi, Kolkata and Chennai (no centralised system) -Refusal to provide examination report Access to examination report available under USPTO & EPO -Refusal to provide copies of patent decisions/case law (trademark decisions are available in journals) under sec 153, rule 134 f). How we did it : Manual procurement of patent copies from the Indian Patent Office Need to submit request and fees at one of the four patent office branches where the application was filed (involves travel time & cost) Regular follow-up required to obtain the copy of the patent application May take three to four weeks for one application

31. Ex. of AZT+3TC patent application « a pharmaceutical composition and a method of inhibiting human immunodeficiency virus (HIV) is disclosed which comprises administering to an HIV infected patient a homogenous composition of lamivudine, zidovudine and a pharmaceutical glidant in an amount which achieves antiviral efficacy »

32. PatentWIPOIndiaStatus Lopinavir Crystalline WO 01/74787 IN/PCT/2002/12 43/MUM Rejected Divisional of (1243) WO 01/74787 894/MUMNP/20 07 Abandoned Lopinavir Crystalline - process and intermediates WO/2002/01834 9 259/MUMNP/20 03Pending Divisional of (259) WO/2002/01834 9 1732/MUMNP/2 009Pending Ritonavir PolymorphsWO00/04016 PCT/2001/00018 /MUM Abandoned Divisional of (00018)WO00/04016 676/MUMNP/20 07 Abandoned Divisional of (00018)WO00/04016 677/MUMNP/20 07 Abandoned Divisional of (00018)WO00/04016 1638/MUMNP/2 007 Pending Ritonavir - dosage formulation WO2006/09152 9 6733/DELNP/20 07 Pending Lopinavir/Ritonavir - Heat stable tablet WO2005/03955 1 339/MUMNP/20 06 Rejected Divisional of 339 WO2005/03955 1 726/MUMNP/20 09 Abandoned Divisional of 339 WO2005/03955 1 2474/DELNP/20 09 Withdrawn Lopinavir/Ritonavir - Soft Gel formulationWO 00/74677 IN/PCT/2001/01 312/MUM Abandoned LPV/r Patent Status

33. Efforts to stop evergreening Not all patent applications are valid. Many patent applications are for a new use of an old drug, or simply for derivatives of old drugs or combinations of old drugs. (TRIPS requires patent protection for ‘inventions’) E.g. AIDS drug patent applications: 1.a fixed dose combination of lamivudine/zidovudine used in the treatment of HIV/AIDS: not a new invention but simply the combination of two existing drugs. Status of application - Withdrawn 2.tenofovir disoproxil fumarate (TDF), a key AIDS drug: forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is common practice within the pharmaceutical industry, and should not be considered a new invention. Status of applications - Opposed II. Any person can oppose the grant of a patent application

34. Combivir patent opposition – Indian and Thai groups hold protests on the same day, issue joint press release… … GSK announces withdrawal of Combivir patent application 7 August 2006: PLHIV protest outside GSK offices in Bangkok, Thailand. 7 August 2006: Indian groups demonstrate outside GSK offices in Bangalore, India.

35. Loon Gangte, President of DNP+ being interviewed on the tenofovir opposition, 10 May 2006

36. Rejections due to local examination and application of strict patentability criteria Source: Lawyers Collective HIV/AIDS Unit

37. Legal safeguards: Prohibition of Evergreening & right to file oppositions The basic patents on Nevirapine (NVP) were applied for by Boehringer Ingelheim in November 1990, and are due to expire in November 2010. BI also applied for a patent on the hemihydrate form of NVP, used in the suspension in 1998, which is due to expire 2018. Additionally, BI applied for a patent on the extended release formulation of nevirapine in 2008, which is due to expire in 2028. India has a specific provision in its patent law that does not grant patents on minor changes to existing medicines. It allows any person to file a technical opposition

38. STAGES OF EXAMINATION PUBLICATION OF APPLICATION REQUEST FOR EXAMINATION REJECT/GRANT OF PATENT 3rd Party Representation Revocation/Amendment OPPOSITION PROMPTLY AFTER 18 MONTHS WITHIN 48 MONTHS FROM F.D. ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS WITHIN 12 MONTHS FILING OF APPLICATION PROVNL. / COMPLETE Decision of Controller EXAMINATION-ISSUE OF FER Appeal Appellate Board

39. Shortlist drugs Use organisations like MSF, Pharmacists, other treatment providers like CPAA Strategy for India : Identifying Barriers Study US/EP/PCT patent families of short-listed drugs As almost 80% patent filers are foreigners, there are good chances that the patent would have patent applications in US/EP/PCT Since full texts of all granted patents are not available online, and manual procurement of patents takes time, PCT, US, EP documents help in quick assessment As almost 80% patent filers are foreigners, there are good chances that the patent would have patent applications in US/EP/PCT Since full texts of all granted patents are not available online, and manual procurement of patents takes time, PCT, US, EP documents help in quick assessment Order full text of patents from relevant branch of the IPO Note the branch of the IPO in the application number, and order the full text from that branch only Presence of local vendor helps in regular follow up with the IPO and quicker delivery of patents Note the branch of the IPO in the application number, and order the full text from that branch only Presence of local vendor helps in regular follow up with the IPO and quicker delivery of patents Order full text of patent applications/patents from patent office You can ask a patent agent to find You can directly ask patent office for equivalent patent application Protests, Right To Information laws, prominent leaders can help You can ask a patent agent to find You can directly ask patent office for equivalent patent application Protests, Right To Information laws, prominent leaders can help

40. Patents Not Absolute Patent applications can be opposed during examination process (pre-grant oppositions) Patents can be challenged after grant (post grant opposition) Patents considered valid until challenged (ex: Thai patent on ddI

41. Message: Why are pre-grant oppositions important? Pressure on patent offices to do thorough analysis of patent applications TRIPS does not define: – inventions – patentability criteria Great majority of patent applications are on new forms / improvements of known compounds Rejection means access to generic medicines which are affordable

42. Check legislation Does your country examine application locally and then Some countries have no pre-grant opposition procedure but have post grant Some countries have pre-grant but no post grant (Thailand) Some countries have both (India) Some countries have neither (South Africa) Some countries grant opponents right to be heard (India) but others do not (Brazil)

43. Growing movement – SA, Thailand, Argentina, Philippines - Examination system weeds out patent applications that should not be granted. Direct benefit with earlier expiry of patents on ARVs. Compulsory licensing China - key announcement of procedures India – applications by generic competitors South Africa – reforms needed