Natco Pharmaceuticals, the Hyderabad-based generic pharmaceutical company, has filed a ‘pre-grant opposition’ with the Indian Controller General of Patents, Designs & Trademarks to prevent the granting of a patent to U.S. pharmaceutical major Gilead Sciences for its breakthrough drug for treatment of Hepatitis C, Sovaldi, which is proposed to be introduced here.
Confirming the same, Natco Pharmaceuticals said it had filed the opposition about 10 days ago on the grounds that the patent would not be valid as the pro-drug and compound, sofosbuvir, was a known product and ‘not inventive’ enough.
Under India’s patent laws, a third party can dispute the validity of a pending patent application.
The grant of a patent can be opposed under 11 grounds that include lack of novelty and inventive step.
Indian Pharmaceutical Alliance (IPA) and Initiative for Medicine and Access to Knowledge (I-MAK) have also filed pre-grant opposition on similar grounds earlier.
Sofosbuvir is considered a breakthrough as it is a once-daily regimen expected to replace the injection-based therapy. It is a direct-acting anti-viral (DAA), and reduces treatment time to 12 weeks from 24-48 weeks. The existing treatment has several side-effects while sofosbuvir has none.