India patent battle over Tarceva opens new CL front

The latest attempt to claim a compulsory license, adopting a mechanism introduced via the World Trade Organization's agreement on Trade-Related Intellectual Property Rights (TRIPs), has hit Swiss drug major Roche's patent in India for Tarceva (erlotinib). The Indian firm lobbying for the opportunity to manufacture a generic version of the lung cancer drug is Natco Pharma, according to an Internet report by The Hindu's BusinessLine. The copycat drug would be exported to Nepal, the company said. If the application is successful, Roche would be entitled to royalties in compensation.

Tarceva's patent is also under fire from another Indian generics firm, Cipla, which has filed court papers claiming that Roche's patent is invalid. Cipla is also reported to be planning to launch its version of erlotinib. Roche has confirmed it is contesting the Natco move and is expected to announce a law suit against Cipla in the event the latter launches a generic version of the oncology agent.

Under a mechanism approved under the TRIPs agreement, a compulsory license can be issued in a case where a less-developed country lacks the infrastructure to produce a drug locally and where there would otherwise be grounds for a local patent grab by the government. Commentators in India queried Natco's decision to apply for the license as an export-only deal, but the relative povery of Nepal versus India means that the TRIPs mechanism would take longer to implement, Natco said.