Complete formalities on Novartis patent claim: SC

The Supreme Court today directed the Centre, pharma major Cipla, Ranbaxy Lab, Hetero Drugs, Natco Pharma and others to complete their pleadings in the matter of Swiss firm Novartis AG challenging denial of patent for its blood cancer drug Glivec.

A Bench comprising Justice Dalveer Bhandari and Deepak Verma directed the parties to complete the formalities of filing reply and rejoinder within eight weeks.

The Bench also declined the plea of senior advocate Rohinton Nariman, appearing for the Swiss firm, to hear the case soon as Novartis AG was suffering loss.

"We are suffering from seven years. The company has spent billions of dollar in research and development of the drug. It should be urgently heard," said Nariman.

The Apex Court was hearing a petition filed by Novartis AG challenging order of Chennai-based Intellectual Property Appellate Board (IPAB), which in July 2009 rejected its appeal against patent department's decision to deny patent.

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) of the Patent Law 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.

Novartis had obtained an exclusive marketing right (generic versions of Glivec were stopped from being made) in 2003 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 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.