Myths About India’s Patent Rules They don’t discourage innovation, but supplementary measures are needed T K Arun The Supreme Court ruling denying pharma multinational Novartis a patent for a new, crystalline form of its wonder drug for blood cancer, Imatinib, sold as Glivec, has given a fresh lease of life to a number of myths. These distort the public discourse. Myth number one is the court verdict shows that India’s patent laws and their enforcement are hostile to innovation and will prevent new medicines from being introduced. India’s patent law changed in 2005 to comply with India’s commitment to the World Trade Organisation, to allow patents on drugs. The earlier patent regime only recognised process patents. This means that Indian pharma companies could produce molecules patented by foreign pharma giants, using novel ways of manufacture. This has benefited not only Indian pharma companies but also people at large around the world. India is one of the biggest producers of off-patent drugs (patents are given for 20 years and when they lapse, non-patent holders can start producing and selling the drug). The change in the patent law means that drugs that are granted patents in India can no longer be duplicated by Indian companies. It is only natural that Indian pharma companies would try to stop grant of patents. Conversely, companies that do research and create new molecules have a vested interest in getting patents and extending the life of the patent as much as possible. A common technique employed, called evergreening of patents, is to make some modification to the original patented drug, claim it is a new product deserving a patent in its own right, and secure a fresh patent. India’s 2005 law guards against such evergreening, by laying down conditions, in Section 3(d), that require the incremental invention to possess both novelty and a significant increase in drug efficacy for it to be eligible for a patent. All that happened with the Glivec verdict is that the Supreme Court established that Novartis failed to show eligibility for patenting under 3(d) for the beta crystalline form of Imatinib Mesylate. It is useful to quote the relevant part of the judgment: “Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that the beta crystalline form of Imatinib Mesylate will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what could be achieved with Imatinib free base.” On this ground, the court turned down Novartis’s plea. This failure of Novartis to establish a technical case for its plea cannot be interpreted as the Indian patents regime being hostile to innovation. On the contrary, the verdict goes on to say that, “It will be a grave mistake to read this judgment to mean that Section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime.” However, activists have tended to see the judgment as a weakening of the patents system, which they see as being good for the consumer. This is myth number two. It is widely believed that the way to reduce prices for patients is to bust patents and allow all and sundry to make the drug in question. If a company does not have an incentive to produce new drugs, in the form of a temporary monopoly over its sale, why should it undertake the risky and expensive task of carrying out extensive R&D that might or might not produce anything valuable? So a regime that makes product patents infructuous will work against innovation and fewer new cures would be found. The surer, better alternative to weakening the patent regime is price control. The Doha Declaration on Public Health authorises WTO members to take appropriate measures to make drugs affordable to their people. Price control is one such measure. It needs to be used more liberally across the spectrum of patented drugs. This will allow patent holders to retain their monopoly but prevent them from using the monopoly to gouge consumers. Big pharma should welcome price control. It would protect them from any charge of discriminatory pricing across countries (fear of which makes Novartis retain a high nominal price while effectively giving away for free billions worth of patented drugs). Where the controlled price should be set can be fixed through negotiation. Myth number three is that patents are the only way to spur innovation. The Gates Foundation offers a few million dollars as a prize for whoever comes up with a vaccine for some disease, on the condition that the vaccine would bear no intellectual property charge. Joseph Stiglitz has proposed such prizes being instituted by governments to encourage research in desired areas. India has more than its fair share of myths and can do without new, health-scare ones.

source - Times of india, Pune Edition

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