Global pharma giants say they might go slow on research and development investments in India, post the Supreme Court?s denial of patent protection to Novartis? anti-cancer drug Glivec for not being innovative enough and failing to meet the therapeutic efficacy improvement criteria. Industry watchers, however, said pharma MNCs could ill-afford to ignore the Indian medicines market with a size of R75,000 crore and growing at 14% annually.
According to global pharma industry body Pharmaceutical Research and Manufacturers of America (PhRMA), the SC?s decision marks ?yet another example of the deteriorating innovation environment in India.?
?In order to solve the real health challenges of India?s patients, it is critically important that India promotes a policy environment that supports continued R&D of new medicines for the health of patients in India and worldwide,? said John Castellani, president and CEO of PhRMA.
Castellani said protecting intellectual property is fundamental to the discovery of new medicines and that the pharma industry needs to work closely with the Indian government and other stakeholders to find appropriate solutions to this challenge.
Western governments have also become a bit cautious about granting patent protection for slightly improved versions of medicines whose patents are about to expire, although they continue to be comparatively more liberal in according patents to these incremental inventions.
About 76% of the patented drugs in western countries are new versions of older drugs with minor modifications. That enables drug makers to get many patients to upgrade to their new, generally more expensive versions rather than the cheaper, generic knockoffs even though some doctors and patients argue that the improvements do not justify the high cost.
However, emerging countries like India have been bucking that trend and have been experimenting with licensing local pharmaceutical companies to make cheap generic versions of medicines with royalty payment to the innovator.
India recently overturned patents for several cancer drugs, including Bayer?s Nexavar, AstraZeneca?s Iressa, Pfizer?s Sutent and Bristol-Myers Squibb?s Sprycel.
The multinational drug companies may now find it tougher to win back patent protection.
Reacting to the SC order on Glivec, Novartis India vice-chairman and managing director Ranjit Shahani said the company will not invest on R&D in India.
He, however, added that the company will continue to introduce products in the country, file patent applications for innovative products and continue to invest in India ?but cautiously?. The company is not looking at further legal recourse at this point in time, he said.
A Pfizer India spokesperson said, ?We are focused on bringing clinically important, innovative products to the market and finding new ways to serve patients we are not reaching today. Pfizer will continue to support efforts that further strengthen the clinical and R&D environment, as long as it continues to facilitate innovations for new products that address unmet medical needs of India.?
The spokesperson added that the company would take ?every legal step to vigorously protect? its patents. Last month Pfizer?s chief intellectual property lawyer, Roy F Waldron, testified before a House trade subcommittee hearing on US-India trade relations that India?s stance makes it extremely difficult to get and keep a medicine patent in the world?s fourth largest drug market by volume.
?We have seen several countries adopt policies similar to India’s, which are leading to a worldwide deteriorating trend that weakens the competitiveness of US drugmakers and threatens US economic growth and future medical advances,? Waldron had said.
Industry body of MNC pharma companies, the Organization of Pharmaceutical Producers of India (OPPI), too, feels that the country should develop an environment to encourage incremental innovation.
?Innovation, including incremental innovation, is the life line for pharmaceutical industry. The Indian pharma industry and Indian patients will be greatly benefitted if appropriate rewarding climate is created for investment in innovation and incremental innovation,? said Tapan J Ray, director general, OPPI.
Industry players said launch of new drugs in India might also take a hit as MNCs would likely want their patents to be recognised in India before launch of a patented product.
However, pharma expert at Angel Broking Sarabjit Kour Nangra said, ?India is too big a market for MNCs to overlook. The positive is that with the clarity in law, foreign companies will now have to amend their strategy of operating in India.?