Novartis just can't win with Indian patent regulators. The patent office has once again rejected the Swiss drugmaker's request for patent protection, this time for an alfa crystal form of its blockbuster cancer remedy Glivec/Gleevec.
Novartis has been wrangling with the patent office there for several years, aiming to get Glivec, as it is known in India, covered somehow. Its initial app--for a beta crystal form of the medicine--met with steadfast refusal. Novartis challenged the decision in Madras High Court, and so far has gotten nowhere. A final ruling on Novartis' appeal is expected soon, the Business Standard reports.
Novartis had also asked for a patent on this other form of Glivec. But Indian drugmakers, including Sun Pharma and Okasa, filed documents opposing the patent. The reasoning: giving Glivec coverage would be "frivolous patenting." The alfa form isn't superior to the beta form that didn't get patented, the opposition reasoned, so why should alfa get protection?
As you know, India has been working to update its patenting system to conform to World Trade Organization guidelines. But regulators still seem reluctant to patent drugs from foreign drugmakers, especially when the patented forms would drive out cheap copies that have been sold by domestic drugmakers.
- see the Business Standard story