The Indian Patent Office has refused to grant US pharmaceutical firm AbbVie a Hepatitis C patent for its combination therapy glecaprevir/pibrentasvir, marketed globally as Mavyret.
The patent was rejected under Section 15 of the Patents Act after AbbVie failed to file reply statements or evidence in response to pre-grant oppositions and later informed the patent office that it wished to abandon the application altogether.
This hepatitis C patent loss will prevent AbbVie from securing a secondary patent on the drug composition, which, if approved, could have extended the company’s market exclusivity for another five years.
Public health advocacy group Third World Network commented that the decision demonstrated India’s patent law’s dedication to preventing unnecessary patent monopolies that delay access to medicines.
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The contrast between U.S. and Indian pharmaceutical patent laws is sharp. In the US, they grant a 20-year patent term from the earliest filing date. The system also actively supports a layered patent system, where brand-name manufacturers secure additional patents on formulations, manufacturing processes, or methods of treatment, extending their protection beyond the original compound patent.
Patent Term Extensions can add up to five years for regulatory delays, and non-patent exclusivities such as New Chemical Entity status and Orphan Drug designation provide additional shields against generic competition. This shows us that the US system is designed to reward innovation and maximize market exclusivity.
India takes a different approach. Section 3 (d) of the Patents Act prohibits patents on new forms of known substances unless they demonstrate significantly enhanced therapeutic efficacy. This is a direct check on companies that extend their monopolies through minor modifications. Compulsory licensing provisions under Section 84 allow generic manufacturers to produce patented drugs when they are unaffordable or inaccessible.
This shows us that while the US system prioritizes the innovator, India’s framework places public health access at the center.
AbbVie’s failure was due to two major reasons. First, the company did not respond to pre-grant oppositions and ultimately abandoned the application, a significant misstep. India’s system allows, and in fact encourages, opponents to challenge applications before grant.
And secondly, the application sought a secondary patent on a combination therapy, the type of ever-greening (extending patent period by making minor changes) India's Section 3(d) was designed to prevent. The drug's active components were already known, and without demonstrable evidence of enhanced therapeutic efficacy, the patent had little prospect of surviving India's strict patent standards.
For multinational pharmaceutical companies seeking patent protection in India, the AbbVie’s case acts as a clear case study. Filing secondary patents on known compounds without evidence of enhanced therapeutic efficacy is unlikely to succeed. Companies should engage proactively with pre-grant oppositions rather than abandoning applications. Most importantly, firms must distinguish between genuine innovations and reformulations designed to extend exclusivity.
AbbVie is an American pharmaceutical company headquartered in Chicago that focuses on discovering and delivering innovative medicines in immunology, oncology, neuroscience, and aesthetics. Recently, in April, AbbVie shared promising results from a Phase 2 clinical trial testing a new combination treatment for ovarian cancer.
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