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.
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-drug-bayer-case-appeal
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-licence-on-its-cancer-drug/?utm_source=daily&utm_medium=email&utm_campaign=alerts
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-drug-bayer-case-appeal
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