Patents in Medicines

• An expert committee on compulsory licensing has recommended that the department of industrial policy and promotion (DIPP) issue a compulsory licence for the manufacture of Bristol-Myers Squibb Co.’s anti-cancer drug Dasatinib to two companies


• It will be India’s second compulsory licence and a significant blow to the New York-based drug maker. A compulsory licence would allow the government to produce a generic version of the patented medicine and sell it at a cheaper price.


• In March 2012, India issued its first compulsory licence to Natco Pharma Ltd for the manufacture of Bayer AG’s Nexavar, another anti-cancer drug.


• Under the Indian patents Act, a compulsory licence for manufacture of a patented pharmaceutical product can be issued if the drug is considered unaffordable by the government.


• The World Trade Organization’s (WTO’s) TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement allows a country to issue a compulsory licence without the consent of the innovator if it is in public interest.


• In January 2013, the health ministry approached DIPP for issuance of compulsory licences for three anti-cancer drugs —Roche Holding AG’s breast cancer treatment Herceptin (Trastuzumab); and Bristol-Myers Squibb’s leukaemia medicine Sprycel (Dasatinib) and chemotherapy drug Ixempra (Ixabepilone). India’s patent office comes under the purview of DIPP.


• DIPP forwarded this request to the committee on compulsory licensing, which has reached a decision on all three drugs. A single 50ml vial of 40mg Trastuzumab costs Rs.1.24 lakh, a 45mg vial of Ixempra costs Rs.66,430.60 and 60 tablets of 20mg each of Dasatinib are priced at Rs.1.17 lakh.

Patents in India : Under protection or over protection

• The Indian Supreme Court, in a landmark judgment in April, turned down a request by the pharmaceutical company Novartis to retain the patent on a cancer drug because it judged the drug to be an extension of existing medications, not a groundbreaking advancement.


• In fact, a U.S. court invalidated a Pfizer patent covering a blood pressure medication (Norvasc) on grounds very similar to the Novartis decision, i.e. mere physical advantages cited for the salt form such as increased stability and solubility were not good enough to merit patent protection.


• Between 2005 and 2011, more than 4,000 patents for pharmaceutical inventions were issued by the Patent Office. Of these, more than 85 per cent were awarded to multinational drug companies.