There are two landmark developments roiling India’s drugmakers, The Business Standard reports. The first application for a compulsory license to be filed in India has put a key provision of the Indian Patents Amendment Act under a microscope. The application has been filed by Natco Pharma for Roche’s Tarceva, a lung cancer treatment. The second development involves Cipla - India’s top drug maker - which wants to sell a generic version in what could be the first instance of violation of a patent in the country.

Natco’s Adi Narayana told the paper the company is seeking a compulsory license in order to export 30,000 tablets to Nepal, and Natco has offered Roche a 5 percent royalty. The industry sees this as a litmus test for compulsory licensing as the law stipulates a two-year waiting period for exports after a patent is granted. The Tarceva patent was granted in July last year.

“This is a test case and we are watching and waiting to see the government’s response to the application,” says Leena Menghaney, India coordinator of Doctors Without Borders, who thinks India’s compulsory licensing provisions are restrictive and discourage generic competition. “No other country has a three-year waiting period, not even the US,” she points out.

Natco, by the way, is a small generics manufacturer that shot into the limelight with a case against Novartis over the blood cancer drug Gleevec, the first major tussle with a global pharma firm since the introduction of the product patent regime. In the landmark case against the Swiss drugmaker that is now before the Supreme Court, Natco has challenged the composition of the patent office’s appellate board, which is hearing the Gleevec case.

The patents office has yet to convene a hearing on the compulsory licence with Roche. While Narayana says Natco applied for the compulsory license as “a law-abiding company, not wanting to invite trouble,” Cipla is taking a risk by planning to launch its version of Tarceva “very soon”. Cipla Joint However, Cipla’s managing director, Amar Lulla, tells the paper he feels there is no risk because the patent is very weak.

Legal opinion suggests that Cipla could seek revocation of the patent through a counter claim when Roche files a suit for infringement. The patent for erlotinib was initially sought by Pfizer in the US. Roche, OSI Pharmaceuticals and Genentech have an agreement for the global development and commercialisation of the lung cancer inhibitor.