Actions in India
“Millions in the developing world depend on India for generic medicines at affordable costs. Restriction of generic drug production in India will have a devastating public health impact around the world and adversely affect the right to health of millions of patients."
-- Anand Grover, UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of health
India is the leading source of affordable HIV/AIDS medicine for the world today, including lopinavir + ritonavir.
Following oppositions by people living with HIV networks and others in India, Abbott abandoned some of its patent applications relating to lopinavir and ritonavir. A recent patent opposition by the Initiative for Medicines, Access and Knowledge defeated an Abbott patent application for heat-stable lopinavir + ritonavir that could have restricted the world’s ability to access affordable generics.
Now, concerns surround new Abbott patent applications claimed to relate to lopinavir + ritonavir.
Committee on Energy and Commerce's Hearing: A Tangle of Trade Barriers. June 27, 2013.
See Public Citizen's Documents:
- Public Citizen Comments to the United States International Trade Commission Re: Investigation No. 332-543, Trade, Investment, and Industrial Policies in India: Effects on the U.S. Economy
New! India Patent Office Rejects Bayer Against Generic Version
On March 9th, 2012, the India Patent Controller issued its first compulsory license for the local manufacture of “Sorafenib”, a drug used to treat advanced liver and kidney cancer. The medicine is commercialized in India by German pharmaceutical Bayer Corporation, under the name “Nexavar”. The Indian patent for this drug was obtained by the company in 2008. Last year, Natco Pharma Limited, an Indian generics company, requested that Bayer issue a voluntary license on Nexavar. When they refused, Natco applied for a compulsory license through the India Patent Office. In September 2012, Bayer filed an appeal to India’s Intellectual Property Apellate Board (IPAB). On March 4th 2013, the IPAB upheld the compulsory license citing affordability issues and a lack of access to the drug. This license allows Natco to produce and distribute the drug in India, as long as it does not charge more than $175 per month (about 3% of the price charged by Bayer, which was 280,000 rupees or $5,500US per month).1 Natco must pay Bayer a 7% royalty for all sales of the drug.2
According to Section 84 of the Patent Act, there exist three requirements for a compulsory license to be issued. These are: -“that the reasonable requirements of the public [in India] with respect to the patented invention have not been satisfied”; -“that the patented invention is not available to the public [in India] at a reasonably affordable price”; or -“that the patented invention is not worked in the territory of India”. The Controller of Patents can issue a compulsory license if any of these requirements is satisfied.3
The IPAB found that the drug was not sufficiently affordable. According to several indicators, including Bayer’s own admission, slightly above 2% of Indians requiring the treatment had access to it.4
1 “India upholds compulsory licence on cancer drug in Bayer case appeal”, Médecins Sans Frontières, March 4, 2013. Available online at: http://www.msfaccess.org/content/india-upholds-compulsory-licence-cancer...
2 Intellectual Property Watch, “Bayer Will Appeal India Compulsory Licence On Its Cancer Drug”, IP Watch, March 5, 2013. Available online at: http://www.ip-watch.org/2013/03/05/bayer-will-appeal-india-compulsory-li...
3 Section 84 of the India Patents Act 1970 (as amended by 2005)
4 “India upholds compulsory licence on cancer drug in Bayer case appeal”, Médecins Sans Frontières, March 4, 2013. Available online at: http://www.msfaccess.org/content/india-upholds-compulsory-licence-cancer...
- Patent opposition to lopinavir/ritonavir (links to I-MAK.org)
- February 21, 2013-Report of the Committee on Price Negotiation for Patented Drugs (links to pharmaceuticals.gov.in)
- September 14, 2012-Intellectual Property Appellate Board, Chennai decision regarding Bayer case
- March 12, 2012-First ever compulsory license granted in India for the cancer drug sorafenib tosylate
- September 30, 2010-Public Citizen letter to Indian Department of Industrial Policy and Promotion (DIPP) on compulsory licensing
- July 15, 2014 - Livemint: Bombay HC upholds Nexavar compulsory licensing decision (links to livemint.com)
- April 15, 2014: Business Standard: Indian laws should not be considered discriminatory: Group (links to business-standard.com)
- February 24, 2014: BBC: US-India relations suffer in trade spat over cheap drugs (links to bbc.com)
- August 14, 2013: The Hill: India honors--not dishonors--patent laws (links to thehill.com)
- August 6, 2013: Kractivism: Press Release- Campaign for Affordable Trastuzumab (links to kractivist.org)
- April 5, 2013- Info Justice: Debunking Pharma's Cant Against the Novartis Judgement: Myth and Fact (links to infojustice.org)
- April 3, 2013- Knowledge Ecology International: R&D costs for Gleevec (links to keionline.org)
- April 2, 2013- Lawyers Collective: Strictest patent laws will foster genuine innovation (lawyerscollective.org)
- April 2, 2013- Bilaterals: Manmohan Singh must learn from the Novartis judgement (links to bilaterals.org)
- April 2, 2013- Live Mint: Glivec ruling: Putting patients before profits (links to livemint.com)
- April 1, 2013 Analysis: India’s Supreme Court Upholds Strict Patent Standards and Patients’ Right to Access to Affordable Medicines; Court dismisses unmeritorious court challenge by drug giant
- April 1, 2013 Patent's defeat in India is Key Victory for Generic Drugs
- April 1, 2013- Knowledge Ecology Interntional: KEI comments on Novartis decision (links to keionline.org)
- April 1, 2013 Novartis Cancer-Drug Patent Denied by India Supreme Court
- March 12, 2013 Indian court ruling might boost cost of vital drugs
- March 5, 2013-IP Watch: Bayer Will Appeal India Compulsory Licence On Its Cancer Drug (links to ip-watch.org)
- March 4, 2013-IP Watch: India's First Compulsory Licence Upheld, But Legal Fights Likely to Continue (links to ip-watch.org)
- March 4, 2013- Pharmalot: India Rejects Bayer Appeal on Compulsary License (links to pharmalot.com)
- March 4, 2013-The Wall Street Journal: India Appeals Body Rejects Bayer's Plea on Nexavar (links to online.wsj.com)
- March 4, 2013-India upholds compulsory licence on cancer drug in bayer case appeal (links to msfaccess.org)
- February 21, 2013-KEI's February 17, 2013 Statement in Nexavar India compulsory licensing case (links to keionline.org)
- September 17, 2012- Intellectual Property Appellate Board (Chennai) dismisses Bayer's request for a stay on compulsory license for sorafenib (links to keionline.org)
- August 17, 2012-The Hindu Business Line: Cipla bats for automatic compulsory licensing (link to thehindubusinessline.com)
- March 12, 2012-Comments from James Love of Knowledge Ecology International (KEI) on the granting of compulsory license on patents for the cancer drug sorafenib tosylate by India and news articles on the license (links to keionline.org)