Even as final arguments in the controversial Novartis case, in which the Swiss multinational pharmaceutical company has challenged the manner in which Section 3(d) of India's Patents Act is applied, have started in the Supreme Court, the public interest groups have expressed concern that any win by Novartis will prove to be shutting down of the ‘pharmacy of the developing world’. The next hearing in the case will take place on September 6, 2011.
Section 3(d) of India's Patents Act prohibits 'evergreening' - the practice of multinational pharmaceutical companies to extend their patent terms by making small, trivial changes to existing medicines and thereby preventing access to generic affordable drugs. Under Section 3(d), patents will not be granted for new uses or new forms of existing medicines. However, some new forms of existing medicines may get patents if the company can demonstrate a significant increase in efficacy.
In 2006, when the Indian patent office ruled that Novartis did not deserve a patent for imatinib mesylate (Gleevec) on the grounds that the application claimed a new form of an old drug, the company embarked on a series of lawsuits. In 2007 in its constitutional challenge against Section 3(d) before the Madras High Court, Novartis also argued that increased bioavailability of the salt form of imatinib meant increased efficacy, entitling it to a patent on imatinib mesylate. But at the time, Madras High Court clarified efficacy to mean "therapeutic effect in healing a disease".
The Indian Patent Appellate Board (IPAB) – where appeals for unsuccessful patent applications are heard subsequently applied this interpretation, and held that the salt form of imatinib mesylate did not meet the test of therapeutic efficacy, and therefore confirmed the rejection of Novartis’s patent application. Unhappy with this standard, Novartis is now before the Supreme Court to argue against the interpretation of efficacy by the Madras High Court and IPAB.
If Novartis succeeds, India may end up granting far more patents than required under international trade rules or envisioned by India’s lawmakers, with huge ramifications on generic production and the availability of affordable medicines for people across the developing world, according to International humanitarian medical organisation Médecins Sans Frontières (MSF).
A two-member bench consisting of Justice Dhalveer Bhandrai and Justice Deepak Verma is hearing the case.