Updated on 26 October 2012
Who will win the compulsory licensing war – 'Alien' bigpharma or generic 'Predators'
When Indian patent office granted compulsory license to Hyderabad-based Natco Pharma to market a generic version of a patented cancer treatment Nexavar in March this year, eyebrows were raised around the world. Another case that is being closely followed by national and international media is Novartis' Glivec case where the multinational pharmaceutical giant is fighting for a patent based on increased safety of the drug due to modification of the naked chemical molecule. In another development, the Delhi patent office revoked a patent to Pfizer for its kidney cancer drug Sutent (sunitinib) following post-grant opposition by major generics players Cipla and Natco Pharma.
The debate is still on whether the Indian patent scenario is favorable for research and development of new drugs given the recent developments, but experts agree that compulsory licensing needs prudent use.
Mr Kirit S Javali, partner, Jafa & Javali, Advocates, New Delhi, elaborates that the grant of a patent confers limited monopoly on the patentee to the exclusion of others. "Though the law permits this, it also takes into account the fact that the monopoly granted through a patent may be abused and, hence, provides for certain restrictions to its enjoyment. The grant of compulsory license is one such restriction imposed on the absolute exploitation of a patent," he says.
Mr Y H Gharpure, Gharpure Consulting Engineers, Pune, says, "There is a provision in the patent act for government to evoke compulsory licensing under clause 100 as has been done by Brazil, thereby forcing the multinationals either to reduce the exorbitant prices of the patented drugs or the government take recourse to compulsory licensing and give the same to several companies so that essential drugs are available at reasonable prices."
India is not the first nation to have granted compulsory license to a drug company for a patent product. In last 10 years, governments of developing nations such as Zimbabwe (2003), Malaysia (2003), Zambia (2004), Indonesia (2004 and 2007), Thailand (2006 and 2007) and Brazil (2007) have evoked compulsory licensing to increase patients' access to medicines. But even after six months after the verdict on compulsory license to Natco Pharma for Nexavar, the debate is still raging on whether it was the right move.