India – Supreme Court Rejects Novartis Cancer Drug Patent Application

• By: Staff Editor
• Date: March 31, 2013

International companies looking to protect their intellectual property in India were dealt a blow today when the country's Supreme Court denied a patent application for a best-selling cancer drug from the Swiss drugmaker Novartis. On the other hand, medical charities and poor countries that depend on generic drugs were cheering the decision.

Background
Novartis has been trying to get its bestselling anti-cancer drug, Glivec, patented in India. The drug is already patented in other countries such as the United States. According to Livemint, India had, in 2006, refused to grant a patent to the drug as it wasn’t considered a new molecule, rather just a modified version of a drug already in the market. The crux of Novartis’ legal appeal was that the drug was a significant improvement on the existing medicine as it is more easily absorbed by the body.

Glivec costs cancer patients around USD 4000 per month, while the generic version available in India costs just USD 73 per month.

Reason for Rejecting the Patent Drug Application

The Indian Supreme Court, in its judgment, said that Glivec did not “satisfy the test of novelty or inventiveness" that is required by India’s patent law, specifically section 3(d) of Indian Patents Act.

Section 3(d) of Indian Patents Act denies patents to new version of known substances unless the newer version is more therapeutically effective than the known one. In its judgment, the Supreme Court also specified that Section 3(d) was meant for pharmaceutical and chemical companies and prevents spurious patent applications. Therapeutic effectiveness, according to the law, does not cover physical characteristics such as shelf life, stability, storage conditions and so on.

The decision by the Supreme Court, which enforces Section 3(d), is likely to put a dampener on “evergreening” – a pharma industry practice used to seek fresh patents for making only small changes to an existing compound.

Pharma Industry Reaction
Novartis has condemned the judgment and in a statement said that the Supreme Court’s decision will hamper drug research and development efforts in India.

"This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options," said Ranjit Shahani, managing director of Novartis India.

Medical Charities, Generic Companies Cheer Court Decision

The AFP reported that Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), said: “The ruling has come as a big relief. It will save a lot of lives -- not only in India but across the developing world.” Ms. Menghaney also argued that “The ruling doesn't mean no patents will be granted in India, but the abusive practice of seeking many patents for one drug will be curbed.”

Generic drug manufacturers such as Cipla also praised the court’s decision. According to the AFP, Pratibha Singh, a lawyer acting on behalf of generics group Cipla, said the judgment "makes it clear you cannot patent a drug by just making some minor modifications -- the key Section 3(d) of the patent law has been upheld by the court.”