In 2005, as the Indian Parliament debated at length the impact of complying with the WTO’s TRIPS Agreement, one issue was uppermost in their minds; the impact of granting patents on access to affordable generic medicines. And, the one medicine that exemplified the concern was imatinibmesylate, sold by Novartis as Glivec. Members of Parliament cited Novartis’ high costs (Rs 1,20,000 per person per month) against the generic versions (Rs 8 – 10,000 per person per month) and decided to include a critical public health safeguard, Section 3(d).
It seems fitting then that it is the legal battle on this very medicine that has finally affirmed this public health safeguard and the requirement for its “strict and narrow interpretation.”
Novartis has been attempting to water down this crucial safeguard in the Indian law since 2006, after its attempt to get a patent for the beta crystalline form of imatinibmesylate was rejected at the Patent Office and again by the Intellectual Property Appellate Board on the basis of Section 3(d). After failing to have the provision struck off the law books at the Madras High Court, Novartis continued its campaign against the provision at the Supreme Court, attempting to weaken its interpretation.
Section 3(d) prohibits patents on new forms of known medicines unless there is a significant increase in efficacy. Novartis tried to argue that the physio-chemical properties of the new form of the imatinib molecule i.e. better flow properties, better thermodynamic stability and lower hygroscopicityresulted in improved efficacy. The Supreme Court has firmly rejected this contention, holding that in the case of medicines, efficacy means “therapeutic efficacy” and these properties, while they may be beneficial to some patients, do not meet this standard. The Supreme Court also held that patent applicants must prove the increase in therapeutic efficacy, based on research data in vivo in animals.
With Section 3(d) and the Supreme Court firmly behind the intent of this provision, India now has one of the strictest patent laws in the world, that will hopefully encourage genuine innovation from pharmaceutical companies and provide the right check and balance to the runaway patent systems of the West. In the words of the Supreme Court, Section 3(d) leaves “the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.”
The Supreme Court’s decision is a tribute to the hard fought battles of people living with cancer, with HIV and many other diseases who have campaigned tirelessly for the right to health to be placed before the profits of pharmaceutical companies.
Counsel for the Cancer Patients Aid Association in the Novartis case
The article appeared in the Business Standard on 2 April 2013