"India, which amended its patent laws for TRIPS-compliance in 2005, introduced a clause to ensure that pharmaceuticals did not block the entry of low-cost generic drugs. A year ago this clause blocked Novartis’ patent application for its anti-cancer drug Gleevec. Now, in a major case that will have a profound effect on the affordability of essential medicines in India, Novartis is challenging this unique Indian provision
A division bench of the Madras High Court is set to hear a case that could potentially have a profound effect on the affordability of essential medicines in India and throughout the developing world. Swiss pharmaceutical giant Novartis AG is challenging the constitutional validity of a key provision in India’s Patents Act; a provision designed to ensure that frivolous 20-year patent monopolies are not granted at the cost of public health. If Novartis succeeds in this unprecedented challenge, India’s status as the primary supplier of low-cost essential medicines to the developing world will be jeopardised. More fundamentally, if it succeeds, it will mark the first time in history that a multinational corporation succeeds in legally abrogating a country’s sovereign right to implement its obligations under the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) in a manner consistent with the protection of public health.
The legal provision at issue – Section 3(d) of the Patents Act – is a provision unique to Indian law, and stipulates that modifications of already-known medicines cannot be patented unless such modifications make the drugs significantly more effective. This provision was designed to prevent an all-too-common practice in the pharmaceutical industry known as ‘evergreening’, whereby patent owners patent trivial modifications of already existing drugs to artificially extend their monopolies beyond the 20-year period granted it on the original patent. Pharmaceutical companies have been engaging in such practices in other countries, effectively blocking the entry of low-cost generics for years...
Armed with this provision, the Cancer Patients Aid Association (CPAA) in September 2005 filed an opposition against Novartis’ patent application for its anti-cancer drug Gleevec, claiming that this application only concerned a modification of an already-known drug that did not improve its efficacy. Subsequently, in a landmark decision, the Patent Office in Chennai declared in January 2006 that Novartis’ patent application for Gleevec was insufficient to meet the requirements of Section 3(d), and denied Novartis a patent...
In March 2006, the Indian Network for People Living with HIV/AIDS and the Manipur Network of Positive People filed an opposition against GlaxoSmithKline’s (GSK’s) patent application for Combivir, an important fixed-dose combination of two of the most widely used antiretroviral medicines in the developing world. The substance of GSK’s patent application proved to be exceedingly silly, and is demonstrative of exactly the type of frivolous patenting that Section 3(d) was enacted to prevent. Essentially, GSK sought a 20-year monopoly for combining two already known drugs – lamivudine and zidovudine, neither of which are patentable in India – with something called a ‘glidant’, of which the preferred variety is silicon dioxide, better known to most people as sand. To be fair, it was not just sand that is the subject of GSK’s ‘invention’. It also included corn starch, talc, calcium carbonate (better known as chalk) and a host of other simple, commonplace substances that drug makers routinely add when making a drug in pill form. Remarkably enough, as with Novartis and Gleevec, GSK had already obtained a patent for this in the United States, the United Kingdom, and several other countries.
In the face of the strong opposition filed by the activist groups, and the sheer frivolity of its patent application, GSK announced in March 2006 that it would be withdrawing its patent application for Combivir, thereby allowing several Indian generic manufacturers to continue making their versions of this essential drug combination without fear of liability."