The Hindu Business Line : Exclusive marketing rights for Novartis' cancer drug cancelled

Natco Pharma had challenged the grant of EMRs to Novartis. The grant of EMRs to Novartis had forced several Indian pharmaceutical companies such as Ranbaxy, Cipla, Sun, Hetero, Torrent and Emcure to withdraw their generics from the market.

Hyderabad , Feb. 21

IN yet another blow to the Swiss pharmaceutical giant Novartis AG in the Indian pharmaceuticals market, the Indian Patents Office has terminated the exclusive marketing rights (EMRs) granted to the company on November 10, 2003 for Gleevac (Imatinib Mesylate), a life saving anti-cancer drug, with effect from January 25, 2006.

Interestingly, on January 25 this year, the Swiss company had lost a patent claim for the anti-cancer drug — Imatinib Mesylate — before the office of the Indian Controller of Patents & Designs, following serious objections through pre-grant opposition route raised by Natco Pharma Ltd, a Hyderabad-based pharma company.

The Controller of Patents had refused to proceed further with Novartis patent application for Gleevac, which is used in the treatment of chronic myeloid leukaemia.

Interestingly, the Indian Patents Office has now decided to cancel the EMRs granted to Novartis based on the same grounds raised by the Office of Controller of Patents & Designs.

Citing the order of Office of the Controller of Patents & Designs dated January 25 in a notification dated February 17, the Indian Patents Office said, "Therefore, as per Section 78 of the Patents (Amendment) Act 2005 read with Section 24B of the Patents Act 1970 as amended by the Patents (Amendment) Act 2002, the said Exclusive Marketing Right granted to Novartis AG is hereby terminated with effect from January 25, 2006."

Natco Pharma, which launched a generic version of Gleevac under the brand `Veenat', had challenged the grant of EMRs to Novartis.

The grant of EMRs to Novartis had forced several Indian pharmaceutical companies such as Ranbaxy, Cipla, Sun, Hetero, Torrent and Emcure to withdraw their generics from the market.

Though the price difference between Gleevec and its clones was around twelve-fold, the domestic pharmaceutical companies were restrained from manufacturing and marketing the cheaper clones due to a Court order.

This case is currently pending before the Supreme Court.

The Office of Controller of Patents on January 25 ruled that the patent applied for by Novartis AG did not qualify as an invention on the grounds that it was merely a modification of the key component in the drug, for which a patent had already been filed in 1993.

Therefore, according to the Controller of Patents, this key component can not be eligible for protection under new patent regime of India that was introduced in March 2005 to comply with the WTO agreement on trade related aspects of intellectual property rights (TRIPS) that recognises patents for chemical products filed there after 1995, the year the WTO came into existence.

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