This row concerns the Indian Patent Office not honouring Novartis' wish to extend its patent on the drug for another twenty years by introducing incremental innovations. As is the case with many so-called blockbuster drugs, pharmaceutical firms often try to forestall dramatic drops in sales when patents expire and generics or low-priced copies enter the market. A common ploy is to make incremental changes to try and extend the life of these patents. Further, they claim this practice is acceptable under WTO TRIPS. The point of contention in Indian courts is that the efficacy of newer formulations of Glivec may not necessarily be substantial enough to warrant patent extension. Nevertheless, Novartis has been pressing India hard on this particular case for obvious reasons: aside from being a huge potential market, India is also one of the world's largest producers of generics.
Hence the battle rages on. The latest news is that Novartis' appeal against Indian patent law will be ruled on shortly. Just as before, Medicin Sans Frontieres (Doctors Without Borders) is particularly wary since its global supply of generic versions of the leukemia drug would be under threat if Novartis succeeds. From Agence-France Presse:
Supply of cheap copycat drugs for the developing world could be blocked if Swiss pharmaceutical giant Novartis wins a challenge to India’s patent law, medical charity MSF said on Monday. The warning came as India’s Supreme Court was due Tuesday to hear more arguments in an appeal by Novartis seeking patent protection for its leukaemia drug Glivec in a case watched closely by the global pharmaceutical industry.I have outlined above why this case is one Novartis wishes to pursue because of the importance of India to the future of the pharmaceutical trade. I also think that Novartis perceives the negative publicity from this case as being outweighed by the "litmus test" nature of its outcome. Do not forget that in ongoing negotiations for the EU-India FTA, one of the main sticking points is access to affordable medicines. Hopefully the latter won't be so eager to complete a deal that it caves in on this issue for there will be substantial implications for other LDCs' supplies because of India's status as a major source of generics. All the same, I think that these attempts to circumvent compulsory licensing LDCs can rightfully avail of and jam up various countries' legal systems reflect badly on Big Pharma.
“If the patent law challenge is successful, it would have a devastating impact on access to affordable medicines across the developing world,” said Leena Menghaney, India representative of Medecins Sans Frontieres (MSF). Novartis is “trying to shut down the pharmacy of the developing world,” she said.
The Supreme Court case is the final act in a legal battle between Novartis and patient groups which has stretched over six years in India, where local firms produce generic versions of branded drugs for a fraction of their price. Pharmaceutical companies argue that protecting patents are crucial to stimulating the research and development of new drugs.
Novartis’ challenge goes to the heart of India’s patent act, which says a new patent cannot be granted for an old drug unless changes make it significantly more effective. Novartis said it could not make any immediate comment. But in the past the drug maker has insisted so-called “incremental innovations” should be patentable and India’s refusal breaches World Trade Organization (WTO) obligations [i.e., Trade-Related Intellectual Property Rights or TRIPS].
MSF buys 80 percent of its generic AIDS drugs from India, and the humanitarian organisation said it is currently keeping 170,000 people in 19 countries alive through the treatment. “We couldn’t afford to treat them all without these generic drugs,” said Joanna Keenan, spokesman for the Geneva-based charity.
If the nature of this case is heard by a wider audience, I am sure the public outcry would make the likes of Novartis give in once and for all. With so much at stake and less-than-stellar media coverage, though, I think these firms have decided to take their chances.
Also see the "NGO Open letter over Novartis’ persistent legal actions in India" for a better understanding of the civil society standpoint.