India drugs giant rejects Novartis patent accusations

NEW DELHI (AFP) - Leading Indian drug company Biocon on Friday rejected allegations by Novartis that it infringed on the Swiss pharmaceutical giant's patent for its blockbuster diabetes drug Galvus.

Novartis announced on Thursday it was seeking an injunction in the Delhi High Court to stop Biocon from launching a generic version of Galvus, also known as Vildagliptin.

The suit against Biocon is the latest legal salvo in a campaign by global drugmakers against the nation's huge copycat drugs industry that the pharmaceutical companies say reduces incentives to produce cutting-edge medicines.

"Biocon has a reputation for respecting all valid IP (intellectual property) and intends to operate within the parameters of applicable IP laws in India and elsewhere," the Indian company said in an emailed statement to AFP.

"Biocon has not been issued any injunction on Vildagliptin; nor has Biocon launched the product in India. There is no impact on our immediate plans for this product," added Biocon.

The Bangalore-based company, which is Asia's largest insulin maker, did not elaborate.

India's generic drug industry is a major supplier of cheaper copycat medicines to treat diabetes, cancer and other diseases afflicting its vast poor population who cannot afford expensive branded versions, as well as to other parts of the world.

India also has some of the world's toughest patent laws as the government seeks to make life-saving therapies available locally to lower-income citizens.

Galvus, one of Novartis' top-selling drugs globally with sales of US$1.2 billion (S$1.52 million) last year, is used to treat Type 2 diabetes, which typically strikes later in life and is associated with obesity and sedentary lifestyles.

India has one of the largest number of diabetes sufferers in the world, making it a lucrative market for drugmakers.

Novartis said in an emailed statement it filed the case earlier in the week seeking the injunction against Biocon for alleged "infringement of the Indian basic compound patent" of Vildagliptin.

The patent on Vildagliptin expires in 2019 and it is "fully prepared to defend" it, the company said.

The firm added the court had ordered Biocon not to "manufacture, sell or export Vildigliptin for commercial purposes" until the next hearing, slated for April 28.

Earlier this month, it said, the Delhi High Court granted Novartis a preliminary injunction against another leading Indian generic firm, Wockhardt Ltd, for alleged patent infringement involving the same diabetes drug.

"A robust and predictable intellectual property (IP) system is an essential pillar of an innovative" pharmaceutical sector, Novartis added.

Wockhardt has challenged Novartis's patent before India's Intellectual Property Appellate Board.

Last year, India's Supreme Court rejected a bid by Novartis for patent protection for an updated version of its leading leukaemia drug Glivec, arguing the compound was a significant improvement because it is more easily absorbed by the body.

In a ruling that went to the heart of patent law in a country known as the "pharmacy to the world", the court said the compound "did not satisfy the test of novelty or inventiveness" required by India's strict legislation.

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