Wrong Medicine?

It will have long-term negative consequences for research and development into better medicines for patients in India and abroad." This is how Novartis, headquartered in Basel, Switzerland, reacted to the much-awaited High Court ruling on August 6 in Chennai, which dismissed its writ petition challenging the constitutionality of Section 3(d) of the Patents (Amendment) Act 2005, and deferred to the World Trade Organization (WTO) forum to resolve the matter. "We disagree with this ruling; however, we likely will not appeal to the Supreme Court," says Ranjit Shahani, Vice-Chairman & Managing Director, Novartis India.

The case relates to Novartis' patent right for its anti-cancer product Glivec. Provisions under section 3(d) of the Act exclude incremental innovation. "It is clear there are inadequacies in the Indian patent law that will have negative consequences for patients and public health in India," says Paul Herrling, Head of Corporate Research at Novartis. "If Indian patent law does not recognise these important advances, patients will be denied new and better medicines."

According to Novartis, during the India Trade Policy Review in May 2007, wto urged India to strengthen its intellectual property rights system. Shahani says: "Novartis originally filed the appeal in India because the Indian patent office rejected the Glivec patent application. Because the patent rejection was based on Section 3(d), we challenged this specific provision in India."

Clearly, Novartis is miffed why a patent for Glivec was denied in India even though it was granted in nearly 40 countries, including Russia, Taiwan and China. The Glivec patent appeal will be decided separately by the newly-operational Intellectual Property Appellate Board (IPAB).