An Indian drugmaker has filed a patent challenge with the FDA against the best-selling cancer med. And already, some patent experts and generic drugmakers are predicting this development will cause problems for Novartis in India, where the company is fighting a rejection of its Gleevec patent application. Novartis already lost one battle in which a court ruled its Gleevec patent lacks innovation.
India’s Sun Pharmaceuticals has filed a so-called Paragraph IV challenge with the FDA in which a generic maker seeks to invalidating a patent, prove there’s nothing novel about the med, or propose to introduce a version without infringing on the patent, as LiveMint reminds us. A Novartis spokesman confirms the Sun challenge, and vows the drugmaker will defend its intellectual property.
Sun is reportedly looking to invalidate the existing patent and experts say a victory will strengthen generic companies in their claims against Novartis in India, where Novartis has challenged the patent office’s decision to turn down its application. “This very disclosure in the US will make Novartis’ appeal against the patent office’s decision to reject its (Gleevec) patent application unacceptable,” Gopakumar Nair, a patent expert in Mumbai, tells LiveMint.
Moreover, some say a successful challenge would open a large generics market for Indian companies in the US. “If the US, which is comparatively liberal in granting patents, invalidates the Gleevec patent, it will look ridiculous for any (of the) patent court(s) in the world, which are (usually) more cautious, to grant a patent for this drug,” Shamnad Basheer, an associate at Oxford IP Research Center in the UK, tells LiveMint.
Rajeev Nannapaneni, ceo at Natco Pharma, which is opposing Novartis at India’s Intellectual Property Appellate Board, tells LiveMint that “the US patent challenge gives us a most important message that the Gleevec patent has been questioned not only in India, but elsewhere also.”
A Novartis spokesman writes us to say such views are premature: “Sun filed the Paragraph IV certification against a Gleevec patent that expires in the US in 2019. The basic compound patent, which expires in 2015 in the US, is not being challenged. So the earliest a generic could be launched - and this is only if Sun is successful in its challenge - would be after the expiry of the compound patent in 2015. We have full confidence in the integrity of these patents.”
