The Indian Patent Appeals Board (IPAB) in a ruling upheld the compulsory license granted in March 2012. The IPAB ruling came in response to a petition filed by the German drug-maker Bayer on May 4, 2012 seeking to reverse the compulsory license issued by the Controller General of Patents, Designs and Trademarks to NatcoPharma Ltd., a company based in Hyderabad.
“We strongly disagree with the conclusions of the IPAB,” Bayer said in a statement and further added, “Bayer is committed to protecting its patents for Nexavar and will rigorously continue to defend its intellectual property rights within the Indian legal system.
The landmark decision brought the price of Nexavar down to 97%, from over $5,500 per month to $175, and set a new precedent for allowing the sale of generic versions of new medicines that are still under patent protection. This, however, will amplify the access to medicine to the people who need it most.
In its appeal, Bayer argued that a generic version of Nexavar is already available in Indian market, which is also a concurrent low-cost alternative and, therefore, the compulsory license should be removed. Bayer further argued that the ruling "weakens the international patent system and endangers pharmaceutical research". Bayer however did not deny that the compulsory license has led to a dramatic drop in the price of Nexavar, bringing it within the reach of millions of people in India.
Humanitarian agency Médecins Sans Frontières (MSF), welcomed the decision. It stated, “The way has been paved for compulsory licences to be issued on other drugs now patented in India. We hope that, in the near future, compulsory licences will be issued for the newest drugs to treat HIV and affordable generic versions will be available not only in India, but in the rest of the developing world".
Nexavar is a generic version of patented drug, used to treat kidney and liver cancer owned by Bayer AG of Germany. Initially, Bayer refused NatcoPharma’s plea for a license for commercially manufacture Nexavar, which subsequently prompted NatcoPharma apply for a compulsory license in order to allow them copy and sell the Drug in the Indian market.
The story was first published in INTELLECT Issue no.3, dated November 2013.