Novartis fighting two-pronged legal battle in India on Galvus patent

Courtesy of Novartis

Novartis ($NVS), already in a legal battle to try to keep India's Wockhardt from launching a generic of its diabetes blockbuster Galvus, says it is now trying to prevent Biocon from doing the same thing.

According to Reuters, Novartis said Thursday that it had filed an injunction in Delhi's High Court to stop Biocon from launching a generic version of Galvus (vildagliptin). "A robust and predictable intellectual property (IP) system is an essential pillar of an innovative life science industry," Novartis said.

Biocon responded that it did respect "valid" intellectual property in India and that it had not "launched the product in India." It also said it has yet to see an injunction from the court.

Novartis is jealously guarding Galvus, which last year earned $1.2 billion for the Swiss drugmaker. It is also already suing Wockhardt over the drug. In March, the Delhi High Court issued a preliminary injunction against the Indian drugmaker for infringing the basic compound patent on Galvus.

Patent protection in India has been a hot-button item for Big Pharma, which is pushing governments to take a harsher stance on the country's treatment of intellectual property. India already appears on the U.S.'s Priority Watch List, a distinction for those countries whose IP protection practices Washington believes bear close monitoring.

Makers of branded drugs are most concerned about India's ability to issue compulsory licenses, making drugmakers give over their technology on the grounds that a lifesaving drug is too expensive for India's poor. India so far has granted only one, but it has more under consideration. After a protracted legal battle, India granted Natco a compulsory license in 2012 for Bayer's cancer drug Nexavar. Natco soon hit the market with a pill that it priced at $170 a month, compared with Bayer's $5,500-a-month cost, followed by India's Cipla which is selling a version for $130 a month.

While Bayer lost the fight to stop the generic from being sold in India, it continues to fight to stop it from getting out of the country. Last week the Delhi High Court sided with Bayer, which had taken legal action to have customs officials seize Natco's copy if it were headed for export. Further hearings on the action have been set for August. Bayer argued that the compulsory license did not give Natco the right to sell outside of India. Natco responded by saying it can't help it if distributors it sells to choose to export the kidney cancer drug.

- read the Reuters story
- get more from the Deccan Herald

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