The hearing taking place in Chennai is part of efforts by Novartis - the world's third-largest pharmaceuticals company and the No. 2 global manufacturer of generics - to gain a patent for its life-saving medicine Glivec.

Patients in India diagnosed with various rare cancers, including Philadelphia chromosome-positive chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) had little chance for survival before Glivec. These patients can now resume everyday lives thanks to Glivec, with 99% of patients receiving Glivec in the country receiving it at no cost thanks to a generous access program financed by Novartis.

At issue is why a patent for Glivec - granted in nearly 40 countries, including China - was denied in India in 2006. Novartis believes Glivec is an important innovation and that Indian patent laws do not comply with the intellectual property standards the country agreed to when it joined the World Trade Organization (WTO) in 1995.

Novartis is also challenging a section of Indian patent law called "Section 3(d)," that does not permit to patent innovative medicines with therapeutically relevant safety advantages. A report from the Mashelkar Committee, commissioned by the Indian government and comprised of Indian experts, supports many of the concerns about Indian patent law expressed by Novartis, mentioning that the laws are not complying with international agreements like the Trade-Related Aspects of Intellectual Property Rights (TRIPS) from the WTO.

"Internationally compatible patent laws would spur investments in biomedical R&D activities in India, a promising field for the rapidly growing Indian economy, and help patients, the government and industry," said Thomas Wellauer, head of Corporate Services and a member of the Executive Committee of Novartis. "Only if patents are respected can research-based organizations continue making long-term, risky investments in new medicines for patients."

Copies of Glivec have been available in India for some time. However, generics are not the solution to improving access since a year's treatment with generic versions is four to five times higher than the annual average salary in India. Generic versions of Glivec would remain on the market in India regardless of the outcome of this legal action.

"This case in India is not about patient access. Lost in this debate is that patents help patients by stimulating the long-term research and development efforts needed to develop breakthrough therapies like Glivec," Vice-Chairman and Managing Director, Novartis India Limited Ranjit Shahani said.

"Furthermore, India is seeking to expand its research-based pharmaceutical industry. This can only grow if patents are respected, allowing for collaborations with international companies and encouraging R&D investments," he added.

"India has an independent judicial system, equally accessible to individuals and companies and one that ensures a fair process," Shahani noted.

"Acknowledging innovation by granting a patent is unrelated to making medicines available," Ph.D., Head of Corporate Research at Novartis Paul Herrling pointed out.

"Medicines can be made available through both the safeguards in international agreements and, in the case of essential and life-saving medicines, special pricing arrangements in poor countries must be made. We play an important role as well through our Glivec access programs worldwide," he noted.