We have right to patent blood cancer drug: Novartis to SC

Swiss pharma giant Novartis AG today told the Supreme Court it had the right to patent its blood cancer drug as it was a completely new medicine and not an attempt to evergreening it.

The apex court commenced its final hearing over the plea of Novartis AG seeking exclusivity of its blood cancer drug Glivec and its right to get its drug patented in India.

Novartis submitted that it has done lots of research to bring out Glivec and it was a completely new drug and not an attempt towards evergreeing of patent rights.

Senior counsels TR Andhyarujina and Gopal Subramanium appearing for Novartis submitted before a bench of justices Dalveer Bhandari and Deepak Verma that blood cancer drug Glivec has special quality and is 30% more efficient than other drugs.

They also refuted allegations of various social organisations that it was just an attempt by Novartis to evergreen its patent right.

Evergreening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew it by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.

Under it, either they take a new patent or stretch the time permissible under the law.

Earlier, the Indian patent authorities had denied the exclusivity claims of Novartis and later it was also upheld by the appellate board IPAB.

Novartis has challenged the order of Chennai-based Intellectual Property Appellate Board (IPAB), which rejected its appeal against patent department's decision on Glivec.

The Comptroller General of Patent and Design had denied patent on several grounds including Sections 3(d) and 3(b) of the Indian Patent Law.

Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy.

Section 3(b) restricts patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.

In 2003, Novartis had obtained exclusive marketing rights (generic versions of Glivec were stopped from being made) for the drug, based on its patent application.

While the Swiss firm had challenged the patent office's verdict in the Madras High Court, its appeals were transferred to IPAB, which held in July 2009 that Glivec did not meet the requirement of increased therapeutic efficacy.

Cipla, the Cancer association, Hetro Drugs, Natco and Ranbaxy had filed their pre-grant opposition, which were accepted by the Assistant Controller of Patents & Designs in January 2006.