JOIN USGlobal drugmakers, battered by recent intellectual property decisions in India, are girding for a landmark court ruling next week that could have broad consequences for their ability to sell lucrative patented medicines in the country.
The Supreme Court is due to decide on April 1 whether or not an amended form of Swiss giant Novartis AG's cancer treatment Glivec deserves a patent in the country.
"Big Pharma is nervous because nothing has gone in their favour in the recent past," said Ajay Kumar Sharma, associate director of the pharmaceutical and biotech practice at business consultancy Frost & Sullivan. "With this verdict, at least, things will get clearer about what is the definition of patented medicines."
Novartis has been fighting since 2006 to win a patent for an amended form of Glivec, which many oncologists view as a major advance in treating chronic myeloid leukaemia, which kills 80-90 percent of sufferers, and some gastrointestinal cancers.
India has refused protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound — a decision consistent with domestic patent law which sets tight restrictions on multiple patents for a drug.
By contrast, in the United States, amended versions can be patented. Novartis is seeking to overturn a clause in Indian Patents Law that restricts patent protection for newer forms of existing molecules, and next week's ruling could set a precedent for how other similar patent claims are treated.
"India is a formidable world power with international rights and obligations," Ranjit Shahani, vice-chairman and managing director of Novartis India Ltd, the firm's India unit, said in an email to Reuters. "Novartis understands and recognizes the contribution of generics once drug patents expire; our concern is with the non-recognition of intellectual property rights that ultimately help sustain and advance pharmaceutical research and development."
While Western firms see huge potential in India's rapidly growing $13-billion drugs market, 90 per cent of which is made up of generics, they worry that India is failing to recognise valuable medical innovation. Among Big Pharma's setbacks in the country, India last year allowed local drugmaker Natco Pharma to sell cheaper copies of Bayer AG's cancer drug Nexavar through the controversial mechanism of "compulsory licensing".
A global agreement, known as Trade-Related Aspects of Intellectual Property Rights or TRIPS, allows countries to issue compulsory licences for certain drugs that are deemed unaffordable to large sections of their populations.