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Novartis case at Madras High Court awaits judgment

Our Bureau

Mumbai June 6 Even as Novartis' case on the rejection of its patent application on cancer drug Glivec comes up for its first hearing at the Intellectual Property Appellate Board, the company continues to fight another case at the Madras High Court where it contests certain provisions in the Indian Patent Law. A judgment on this case is also expected shortly.

The Swiss drug-maker had contested some of the considerations based on which the Patent Office rejected Novartis' patent application in the first place.

This includes Section 3 (d) of the Patents Act 1970 as amended by the Patents (Amendment) Act 2005.

The constitutional provision does not recognise "incremental innovations" made on a drug molecule. Novartis maintains that incremental innovations also bring in better efficacy, among other things.

Repercussions

The outcome of this case will have its repercussions on the pharmaceutical industry, as companies seek patents on incremental developments of existing drug molecules. Patents allow the company exclusive rights to make and sell a medicine.

The AIDS-drugs segment will be adversely impacted, say healthcare advocates. Indian drug-makers produce less expensive generic copies of AIDS medicines that support patients across the world.

Glivec litigation

In Glivec's case, the medicine has attracted global reactions and a flurry of litigation, ever since it was given an Exclusive Marketing Right in 2003, in a build up to the product-patent regime in 2005.

Glivec or Gleevec is the brand name under which Novartis sells its cancer drug imatinib mesylate. Used in the treatment of chronic Myeloid Leukemia, Glivec's price has been at the heart of the controversy.

Higher price

The international price of Novartis' drug costs a patient about $27,000 for a one-year course, while the generic price is about $2,700.

That estimates to about Rs 1 lakh a month for Novartis' Glivec, while copycat versions cost the patient about Rs 10,000-odd per month.

Novartis, however, maintains that it gives the drug free through a patient-specific programme.

Close to 7,200 patients have been given free Glivec, costing the company more than Rs 1,200 crore, a company official said.

Related Stories:
Novartis cancer drug case shifts to new board
`Novartis to continue with Glivec case'
Patent law should have guidelines to follow: Novartis

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