Novartis cancer drug denied patent in India

Written by Corporate Bureau | Mumbai | Updated: Jul 5 2009, 07:02am hrs
Chennai-based Intellectual Property Appellate Board (IPAB), constituted by the central government to hear appeals against decisions relating to patents and trade marks, has ruled against a patent application by Swiss pharma major Novartis for its cancer drug Glivec (imatinib mesylate). IPAB ruled that Novartiss patent application covering Glivec is not patentable, since it fails to satisfy the requirements under Section 3(d) of the Indian Patents Act. This section requires that in order to be patentable, a pharmaceutical derivative must demonstrate significantly enhanced efficacy over and above the prior known molecule.

Novartis patent application on Glivec had earlier been rejected by the Indian Patent Office in January 2006. Glivec was the first pharmaceutical product in the country to be given an exclusive marketing right in 2003, in a run-up to the introduction of the product patent regime in the country in January 2005. The product has been mired in litigation, ever since. The pharma industry and several non-profit organisations were closely watching the developments, since this constituted a benchmark case for future patented products.

We are pleased that the IPAB acknowledged that our patent application fulfils all international patentability criteria. Unfortunately, the IPAB upheld the objections under Section 3(d), a legal provision unique to Indian patent law, which constitutes a hurdle to innovation in the pharmaceutical field, a Novartis statement said.

The statement went on to say that Glivec, our life-saving breakthrough drug for cancer, has been granted a patent in nearly 40 countries - including China, Russia, Taiwan and all major developed countries - and we believe the same should be the case in India.

Since the Glivec International Patient Assistance (GIPAP) programmes inception in 2002, Novartis has provided Glivec at no cost through GIPAP to more than 37,000 patients in 80 countries, the company said. In India, more than 11,000 patients currently receive their medicine through GIPAP.

We are concerned about the patent systems in India and are looking to have systems that support innovation in the pharmaceutical field. We are currently reviewing the decision and will look at the various options available to us, Novartis added.

After its patent application was rejected in 2006, Novartis approached the Madras High Court, challenging the rejection of its application. In August 2007, the high court dismissed Novartis writ petition challenging the constitutionality of Section 3(d). The hearing on Glivecs patent rejection was later shifted to the IPAB in April 2007.