EU hearing on Novartis’ India patent row today

MUMBAI: A hearing on the simmering tussle between Swiss pharma major Novartis and the Indian government over the latter’s rejection of patent to cancer drug Gleevec is slated in the European Union parliament on Tuesday.

Medecins Sans Frontieres (MSF), which has taken sides against Novartis in this issue, will make a presentation on how the issue will adversely affect millions of patients. The patent was rejected under section 3 (d) of Indian patent law. Under the section, any new use or a new variant of an old substance cannot be patented unless it is found to have significant improved efficacy.

In January 2006, Novartis contended that section 3(d) of the Indian Patent Act does not conform to the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This was following the rejection of its patent application for Gleevec (imatinib mesylate) by the Chennai patent office on the grounds that it was not an innovation.

“Novartis is challenging the rights of millions of patients for affordable medicines by challenging section 3 (d) of Indian Patent Act. If the monopoly of a drug continues by making trivial changes, it will severely affect millions of patients who depend on Indian industry for cheaper versions of drugs,” Leena Menghaney, MSF campaigner, India, said. 

Novartis sells the $2-billion blood cancer drug, Gleevec, at Rs 14.4 lakh per patient per year, while generic versions of the drug are available in India for about Rs 96,000 ($2100) per patient per year.

“Our case in India is solely about safeguarding intellectual property, not about patients’ access to medicines. Novartis is not challenging any provisions of the Indian patent law that were put in place to promote access. In fact, Novartis supports the TRIPS conditions that promote access for developing countries,” Ranjit Shahni, managing director, Novartis India, said.