NEW DELHI: The Indian Patent Office has refused to grant a patent to US pharmaceutical firm AbbVie on its Hepatitis C combination therapy glecaprevir/pibrentasvir, marketed globally as Mavyret. The combination therapy is considered a key treatment for Hepatitis C, and the availability of affordable generic versions remains critical for widening patient access. “The order demonstrates the importance of India’s patent safeguards, including pre-grant opposition, in preventing unnecessary patent monopolies that can delay access to medicines,” public health advocacy group Third World Network (TWN) said. The decision is significant as the rejection prevents AbbVie from securing a secondary patent on the composition of glecaprevir/pibrentasvir, which, if approved, could have prolonged the company’s market exclusivity by another five years, a TWN lawyer said. The rejection was under Sec 15 of Patents Act. The order records that AbbVie did not file reply statements or evidence in response to the pre-grant oppositions, and later informed the patent office that it wished to abandon the application. The decision’s significance is amplified by AbbVie’s licensing agreement with Medicines Patent Pool, under which India was excluded as a sales territory.
