US pharma co denied patent on hepatitis C combo therapy

The Indian Patent Office rejected a patent application filed by US pharmaceutical company AbbVie for its hepatitis C combination therapy glecaprevir/pibrenta...

What Happened

The Indian Patent Office rejected a patent application filed by US pharmaceutical company AbbVie for its hepatitis C combination therapy glecaprevir/pibrentasvir, marketed globally under the brand name Mavyret (also spelled Maviret).
The Patent Office's order dated May 7, 2026 declined the application under Section 15 of the Patents Act, 1970 — after AbbVie chose not to contest pre-grant oppositions filed by civil society groups and formally abandoned the application.
AbbVie was notified of two pre-grant oppositions in November 2025 but submitted no reply or evidence. When a hearing was scheduled for May 4, 2026, AbbVie's representative informed the Patent Office of the company's intent to abandon the application.
The rejection means AbbVie will not receive a potential five-year monopoly extension on the combination therapy in India beyond its original patent term, paving the way for generic manufacturers to produce affordable versions.
Hepatitis C affects an estimated 6–8 million people in India; Mavyret is a pan-genotypic Direct-Acting Antiviral (DAA) regimen with a very high cure rate (above 95%), but at high brand prices, it was unaffordable for most patients.
Civil society groups involved in the pre-grant opposition argued the combination therapy did not meet India's patentability standards as it represented a combination of already-known compounds without demonstrating significantly enhanced therapeutic efficacy.

Static Topic Bridges

Section 3(d) of the Patents Act, 1970 — The Anti-Evergreening Provision

Section 3(d), introduced through the Patents (Amendment) Act, 2005 (which implemented TRIPS obligations), is India's most distinctive contribution to global pharmaceutical patent law. It bars patents on new forms of known substances unless they demonstrate significantly enhanced efficacy.

Section 3(d) states that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" is not patentable.
The provision is explicitly designed to prevent "evergreening" — the practice of pharmaceutical companies securing extended patent protection through minor modifications (new salt forms, polymorphs, enantiomers, combinations) of existing drugs without meaningful therapeutic improvement.
"Efficacy" under Section 3(d), as interpreted by the Supreme Court in Novartis AG v. Union of India (2013), refers specifically to therapeutic efficacy — not physical properties like solubility, stability, or bioavailability.
Section 3(d) applies only to pharmaceutical substances — it is not applicable to other technology sectors.

Connection to this news: While AbbVie's application was rejected procedurally (abandonment) rather than on a Section 3(d) merits ruling, the pre-grant oppositions that prompted the abandonment likely included Section 3(d) arguments — that the combination of two known DAA compounds (glecaprevir + pibrentasvir) did not demonstrate efficacy enhancement that would justify a fresh patent monopoly.

Novartis AG v. Union of India (2013) — The Landmark Glivec Case

The Supreme Court's 2013 ruling in the Novartis Glivec case is the definitive judicial interpretation of Section 3(d) and a landmark in global pharmaceutical patent jurisprudence.

Novartis sought a patent for the beta-crystalline form of imatinib mesylate (Glivec/Gleevec), a cancer drug, arguing that its 30% higher bioavailability constituted enhanced efficacy.
The Supreme Court rejected the patent, holding that "efficacy" in Section 3(d) means therapeutic efficacy — a pharmacokinetic property like bioavailability is not the same as improved patient outcomes.
The ruling set a precedent making it significantly harder for multinational pharma companies to patent incremental modifications of known drugs in India.
The case is internationally significant: it established India as the first major jurisdiction to litigate and win on the definition of "efficacy" in the patent-public health nexus.

Connection to this news: The Glivec precedent created the legal and normative environment in which civil society groups confidently file pre-grant oppositions against combination drug patents. AbbVie's decision to abandon the application rather than contest the opposition reflects the strength of this precedent — litigation under Indian patent law is genuinely risky for pharmaceutical evergreening strategies.

TRIPS Agreement and India's Flexibilities

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), adopted in 1994 as part of the WTO framework, sets minimum standards for intellectual property protection including patents.

Article 27 of TRIPS requires patents to be available for any invention in all fields of technology, provided they are new, involve an inventive step, and are capable of industrial application — without discrimination by field.
The Doha Declaration on TRIPS and Public Health (2001): WTO members affirmed that TRIPS should be interpreted in a manner that supports public health and promotes access to medicines for all. It clarified that countries have the right to grant compulsory licences and determine grounds for such licences.
TRIPS Flexibilities include: compulsory licensing, parallel imports, Bolar exception (allowing generic manufacturers to conduct trials before patent expiry to prepare for post-patent market entry), and — through national legislation like Section 3(d) — stricter patentability standards.
Section 3(d) is itself a TRIPS Flexibility: India used the policy space in TRIPS Article 27 to define patentability more strictly than the minimum required, making it WTO-compliant while protecting public health.

Connection to this news: The rejection of AbbVie's Mavyret patent is a textbook application of TRIPS Flexibilities — India's patent law, shaped by the Doha Declaration's public health rationale, allows civil society pre-grant oppositions that create a credible challenge mechanism against evergreening. AbbVie's abandonment is an implicit concession that Indian courts would not be a favourable venue for this application.

Pre-Grant Opposition Mechanism — India's Unique Patent Safeguard

India's Patents Act provides for two forms of opposition to patent applications: pre-grant opposition (Section 25(1)) and post-grant opposition (Section 25(2)).

Pre-grant opposition (Section 25(1)): Any person can file an opposition to a patent application at any time after publication but before the grant of the patent. Grounds include: anticipated prior art, obviousness, non-patentable subject matter (including Section 3(d) violations), insufficient disclosure.
Post-grant opposition (Section 25(2)): Can be filed within 12 months of patent grant by any "interested person."
India's pre-grant opposition system is among the most open globally — it allows civil society organisations, patient groups, and generic manufacturers to participate in the patent examination process.
Notable past pre-grant oppositions: Sofosbuvir (Sovaldi, Gilead, hepatitis C) — patent rejected; Bedaquiline (TB drug, J&J) — patent not extended following opposition; Glivec (Novartis) — eventually rejected by Supreme Court.

Connection to this news: The AbbVie Mavyret case is the latest in a series of successful civil society pre-grant opposition campaigns in India. The pattern — multinational files patent extension application, civil society groups oppose, company abandons rather than litigate — demonstrates the effectiveness of India's pre-grant opposition system as a public health safeguard.

Key Facts & Data

Drug in question: Mavyret (glecaprevir 100 mg + pibrentasvir 40 mg fixed-dose combination) — a pan-genotypic Direct-Acting Antiviral (DAA) for all 6 hepatitis C genotypes.
Manufacturer: AbbVie Inc. (US), originally developed through AbbVie-Enanta Pharmaceuticals collaboration.
Indian Patent Office order date: May 7, 2026; rejection under Section 15, Patents Act, 1970.
Pre-grant oppositions filed: November 2025 by civil society organisations; AbbVie did not respond.
Hepatitis C burden in India: approximately 6–8 million people infected; India has the third largest burden globally.
Mavyret cure rate: >95% across all genotypes in clinical trials (8–12 week regimen).
Novartis v. Union of India (Glivec case): decided by Supreme Court on April 1, 2013.
TRIPS Agreement adopted: 1994 (Marrakesh Agreement establishing WTO).
Doha Declaration on TRIPS and Public Health: adopted November 14, 2001.
Past similar rejections in India: Sofosbuvir (Gilead), Bedaquiline (J&J), Imatinib (Novartis).
Section 3(d) Patents Act 1970 introduced via Patents (Amendment) Act, 2005, effective January 1, 2005.