Cancer drug has right to patent, Novartis tells apex court

The final hearings have commenced at the Supreme Court regarding Swiss drug-major Novartis’ blood cancer drug Glivec.

A landmark case, it will have ramifications on the implementation of the amended Indian Patents Acts, including aspects of interpreting and assessing the efficacy of a medicine seeking a product patent.

Novartis had filed a Special Leave Petition in the SC in 2009, challenging the denial of a patent to its cancer drug Glivec (imatinib mesylate) in a beta crystal form. The final now hearing will be on continuously through the next few days, lawyers familiar with the case told Business Line.

This time around, Novartis AG told the apex court that Glivec is entitled to a patent in India due to the drug’s novelty and increased therapeutic efficacy. A product patent allows a drug to sell the product exclusively for 20 years.

Two years ago, Novartis had moved the SC challenging the decision of the Intellectual Property Appellate Board that had denied Glivec’s patentability by upholding objections under Section 3(d) of the amended Patent Law – under which a patent is granted only if a product proves to be more efficacious than the existing drug molecules.

The denial was based on Sections 3(d) and 3(b) of the Indian Patent Law and Novartis believes “that Section 3(d), the Indian legal paragraph intended as a hurdle for ‘evergreening’, is not applicable to the breakthrough medicine Glivec,” Novartis had said then in a statement.

The patent application on Glivec (in its beta crystalline form) had been initially rejected by the Indian Patent Controller’s office in January 2006, a decision that Novartis has since contested at various courts. The price at which Novartis’ medicine is sold, as compared to less expensive generic versions in the market has also come in for attention from stake-holders, though Novartis has in the past countered that price should not be a consideration when considering patentability.

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