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Treatment + research activism in India Challenges and opportunities

Treatment + research activism in India Challenges and opportunities. UAEM conference John Hopkins University 30 th October 2011. Brief history. What is a patent?. Patent. No patent. One producer. Multiple producers. No competition. Competition. High prices of imported medicines.

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Treatment + research activism in India Challenges and opportunities

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  1. Treatment + research activism in IndiaChallenges and opportunities UAEM conference John Hopkins University 30th October 2011

  2. Brief history

  3. What is a patent? Patent No patent One producer Multiple producers No competition Competition High prices of imported medicines Low prices of locally produced medicine

  4. “MY IDEA OF A BETTER ORDERED WORLD IS ONE IN WHICH MEDICAL DISCOVERIES WOULD BE FREE OF PATENTS AND THERE WOULD BE NO PROFITEERING FROM LIFE OR DEATH.” - Indira Gandhi, Prime Minister of India at the World Health Assembly, Geneva, 1984

  5. 1970: Legal reform aimed at Local production

  6. AIDS Treatment costs come down with Indian supplies of low cost, quality medicines Source: ‘Untangling the Web of Antiretroviral Price Reductions’ Campaign for Access to Essential Medicines (MSF), 12th edition, 2009, http://utw.msfaccess.org/

  7. INDIA BECOMES PHARMACY OF THE DEVELOPING WORLD The absence of patent barriers allowed generic Companies to innovate simpler treatment - fixed dose combinations

  8. Cancer Medicines Imatinib Mesylate – used in Chronic Myeloid Leukemia Novartis price: US$ 2500 per patient per month Generic companies: US$ 200 per patient per month Cancer Patients Aid Association: US$ 20 per patient per month

  9. 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).

  10. 2005 – Product patent regime

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

  12. ACROSS INDIA…

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

  14. 2005 Indian Patents Act • Public health safeguards: • Automatic licensing for drugs already in production • Pre-grant opposition • Section 3d – Narrows the scope of patentability & limits patenting to real innovations • Compulsory licensing for drugs patented in India but not yet produced by generic manufacturers • Indian law sets international precedent for TRIPS implementation for developing countries

  15. 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. Key Indian law safeguard: Evergreening

  16. Efforts to stop evergreening: Patentability criteria –new, must have inventive step, industrial application. 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

  17. Glivec patent history • 1993 Novartis filed patent applications for the cancer drug imatinib in most countries in 1993. • At the time India did not grant product patents at that time. • 1998, Novartis applied for a patent on the beta-crystalline polymorph of a mesylate salt of imatinib i.e. imatinib mesylate, in India. • 2005 India to examine the 1998 application

  18. Blockbuster Orphan Drug • FDA approval in 2001 • Gleevec received orphan drug designation in US and EU • US tax credits • grants for clinical research cost during development • waiver of FDA prescription drug user fees. • Additional incentives EC includes the possibility of EMEA fee waivers. Some EU members states provide additional incentives: free scientific advice, exemptions from fees and taxes • Gleevec’s sales have been 7.5 billion US$ in less than 5 years.

  19. Result – Prevent Evergreening • CPAA files first pre-grant opposition • In January 2006, the patent on imatinib mesylate, (Gleevec) was rejected in India on the grounds that it only represented a new form of a known substance and therefore was not an innovation and not patentable under Indian law. • the selection of a salt of the active ingredient with the purpose to improve bioavailability is known in pharmaceutical art. It is common knowledge in the pharmaceutical field that salts result in different solubility and, therefore, in different bioavailability. • Novartis case!

  20. 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: • 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 • 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

  21. 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: • 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 • 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 application - Rejected II. Any person can oppose the grant of a patent application

  22. Treatment for: cytomegalovirus retinitis (CMV) in people with AIDS can lead to Blindness (CMV can be effectively treated with oral doses of valganciclovir consisting usually of 264 tablets given over four months). Alternative treatment: using intravenous ganciclovir requires infusions twice a day for 2 or 3 weeks, and then daily Infusions for another 2 or 3 Months with intraocular injections of ganciclovir - doctors have to repeatedly jab patients in one or both eyes In most countries Roche price US$ 10,000 A patent on valganciclovir was granted in India in June 2007. This prevented patients/govt from procuring the generic valganciclovir, leaving Roche as the sole source for the drug. Roche Pricein India – Rs. 1040/450mg tablet or total cost approximately Rs. 2,74,560 per patient 2010 – In the post grant opposition grant order on valganciclovir revoked recognising that it is a old drug in a new form) Oral Valganciclovir (four month therapy)

  23. Patented drugs expensive

  24. Patented Hepatitis treatment in India Pegylated interferon alfa 2a Rs. 14,700 per injection (180 mcg)

  25. Patented cancer drug sorafenib • Rs. 2,80,000 per month/per patient

  26. 2010 Free Trade Agreements and access to medicines

  27. EU INCLUDES DATA EXCLUSIVITY in DRAFT TEXT COLCHICINE • Extracted from plants of the genus Colchicum (autumn crocus, Colchicum autumnale, also known as "meadow saffron") • Use particularly as a therapeutic agent in the treatment of gout has a history of 3000 years; cannot be patented • Tablet formulation was widely available as a generic prescription drug in the United States since the 19th century. • It costs almost nothing to produce but was granted marketing exclusivity after US FDA accepted a 1 week trial of the drug done by a company & was then bound to grant DE. • The company enforced its exclusivity rights forcing other manufacturers off the market & the drug price rose 50 times from $0.09 to $4.85.

  28. Police Arrest during protest May-2010

  29. Police beat People living with HIV with lathis during 2ndUdyogBhavan protest Oct 2010 Comment posted "I have never seen so many police people with batons and guns.“ http://www.bbc.co.uk/news/health-11488711

  30. Global Fund ambassador visits India (wife of French President) How to get our concerns on FTAs to her? Activists donate 5 ml blood to get FTA message to Carla Bruni

  31. Thousands came to protest in March 2011

  32. Public Announcement India will not provide data exclusivity: Anand Sharma Business Standard Reporter / New Delhi March 30, 2011, 0:10 IST The government on Tuesday took a firm stand on protection of intellectual property rights (IPR) and the aspect of data exclusivity for drug manufacturers saying that the country would not extend data exclusivity that would hamper the domestic pharma industry. This was asserted during a meeting of consultative committee of the Parliament on challenges in Intellectual Property Rights-international and domestic, which was chaired by minister of commerce and industry Anand Sharma. "India does not provide data exclusivity for pharmaceuticals and agro-chemicals which is in the paramount interest of our generic pharmaceutical industry as grant of data exclusivity would have considerable impact in delaying the entry into the market of cheaper generic drugs," Sharma said in the meeting. Data exclusivity provides protection to the technical data generated by innovator companies to prove the merit of usefulness of their products. In the case of pharmaceuticals, it means the data generated by drug companies through expensive global clinical trials to prove the efficacy.

  33. R&D

  34. TB Old Drugs - Old diagnostics leave half of all patients undiagnosed!

  35. Challenges and opportunities • Complex issues • Ministry of Science & Technology • Resources and treatment activists • Research exemption clauses in patent law • Mapping the policies and money • Technical work • Getting research institutions to adopt pro-access licensing • International movement on R&D treaty • Norms for clinical trials • Very different context from the US and other developed countries • Hierarchy/bureaucracy • Civil society • Research institutions open to talk • Media • Student movement waiting to happen • MSF and DNDi • Rejection of the Indian Bayh • Dole Bill (UAEM + Indian civil society) • India is where the research is starting to happen • Generic industry

  36. Any Questions?

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