The rejection of Novartis' claim is a boost to the patent law.
With the Madras High Court rejecting a challenge to the country's patent laws by Swiss pharmaceutical giant Novartis, the Indian patent law has received a much-appreciated shot in the arm.
Novartis had challenged India's patent laws, which disallowed a patent application for what it claimed was a new and more effective version of its leukemia drug Gleevec, known as Glivec. Novartis insists that its improved Gleevec drug is more easily absorbed by the body.
But this was contested by Indian drug companies that say it is merely a new form of an old drug invented before 1995. As this is being made generically in India for a fraction of the cost, it would be pointless, they said, to grant a patent which would make it unaffordable for the millions of poor.
India's patent laws only allow patents for products that represent new inventions after 1995 (when India joined the WTO) or for an updated drug that shows greater efficacy. It does not grant patent for incremental innovation alone.
The debunked Mashelkar committee report had in fact sought to take a fresh look at the patent law and see if it was TRIPS compliant in restricting patents to new chemical entities. It had gone on to suggest that incremental innovations also be included with proper checks to weed out cases of “evergreening” or mere tweaking of drugs. This would allow Indian companies to patent an improved version of an otherwise expensive drug patented by a MNC, thus breaking the monopoly and allowing for cheap access to the poor.
Drug discovery is a costly and drawn out process and unless there is an incentive there will not be investments. However on the other side of the argument is the contention that innovation has trickled down to minor tweaks of existing drugs to extend monopolies.
Patents provide investment protection for drug companies but they also mean artificially high prices due to the monopoly. Given that health insurance is still a new concept and over 80 per cent of the population pays for health benefits, the present decision is a landmark one in safeguarding their interests.
The fact that the field of drug development is not a level playing field would suggest that it would be a wiser decision to hold costs considerations above that of drug R&D. Perhaps a new committee with a judicious mix of members could take a look at the issue again.