Novartis has been denied patent protection for its Glivec cancer drug in India, raising doubts about the country’s commitment to upholding intellectual property.
This is the first major decision on a patent application in India since the country signed up to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement just over a year ago, a move made possible by the passage of the Patent Protection Act on January 1, 2005.
India trumpeted the legislation, saying that its enactment should lead to an upsurge in investment by overseas companies in the country’s pharmaceutical sector, and do away with the practice of local companies reverse engineering and manufacturing drugs for sale in the domestic market and other countries with lax patent protection laws.
The ruling covers a patent filed by Novartis in 1998, which resulted in the company being granted an exclusive marketing right for Glivec (imatinib) in 2003, by which time a number of domestic companies had already started selling the drug.
Opposition from local manufacturers, including Cipla and Ranbaxy, kicked off on the grounds that Novartis first filed for its product before 1995 – under the TRIPs agreement only products filed after January 1, 1995, can claim patent protection. The Indian Drug Manufacturers’ Association also claimed that the government should grant compulsory licenses for generic copies on the grounds of public interest.
Now, a court has thrown out Novartis’ 1998 patent on the grounds that it was obvious, mainly because the information contained in it was already in the public domain, suggesting that loopholes remain in the new patent regime, or at least confusion over what is actually patentable.
The ruling will add to a perception, highlighted in a report from Ernst & Young, which said recently that two thirds of pharmaceutical executives still considered that the intellectual property regime still constituted a business risk in India.
Commenting on the case, Manisha Singh Nair of Lex Orbis Intellectual Property Practice said: “It was widely speculated that the product patent regime would destroy almost 15% of the existing Indian pharma market.”
But, in fact, only around 135 new chemical entities were discovered between 1995 and 2005, and many of the applications for new “salts, isomers, metabolites, polymers, solvents or such modification of an already patented entity” made during this period would not qualify for protection.