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.
Significance of the Rejection
"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.
Legal Grounds and Procedure
The rejection was under Section 15 of the 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.
Impact on Access to Medicines
The decision's significance is amplified by AbbVie's licensing agreement with Medicines Patent Pool, under which India was excluded as a sales territory. This exclusion meant that Indian patients could not benefit from the licensed generic versions, making the patent rejection even more crucial for ensuring affordable treatment options.
About the Author: Rupali Mukherjee is a business journalist with around two decades of experience tracking key consumer-focused sectors like consumer durables, retail, consumer goods, aviation, automobiles, and advertising, as well as economic ministries of the Union government. Now, she writes primarily on pharmaceuticals and healthcare, and on issues of consumer interest. She also looks at trends that are shaping consumer behavior and the broad consumer landscape.
