July 28, 2026 marked eight years of the National Viral Hepatitis Control Program (NVHCP). Launched under the National Health Mission, the program aims to eliminate Hepatitis C from India by 2030 through free testing and access to generic versions of direct acting-antivirals (DAAs). One of the most effective drugs for curing patients of Hepatitis C virus (HCV) currently in the market is AbbVie’s Mavyret. It is recognised as the first and only DAA approved to treat both acute and chronic HCV in patients aged three years and older, with or without compensated cirrhosis. It has received renewed approvals by the EU (here) and the US FDA (here), and has been in WHO’s Model List of Essential Medicines.
In May, 2026 the Indian Patent Office refused the patent application on Mavyret after said application was abandoned by AbbVie. News reports (see here, here) were quick to claim that this refusal opens the doors for entry of generic version of Mavyret in India. There are several reasons why it doesn’t. This is the same rhetoric that had followed after the IPO’s refusal of Venetoclax, which I wrote about here. This is also not Indian patent law’s first tryst with a Hepatitis C treatment.
In this post, I discuss this and some more concerns on references by the opposition to Sections 3(d) and 3(i) of the Patents Act; how this application is only a part of a larger story of AbbVie’s Hepatitis C patents in India; and, why it is important for public health discourse to talk about pharma patents in their complete market context. One patent abandonment, while eventually helpful for access to medicines, doesn’t do as much as is being expected. Public health programs like the NVHCP will have to wait some more years for affordable access to this compound.
Hepatitis C and Politics of Drug Access
Hepatitis C virus is a bloodborne virus that infects the liver, in chronic forms it might cause liver cancer. The disease is generally curable but screening and timely access to medicines are key problems (see here). There are 11 HCV strains, or genotypes, which are variations in the virus (for more see here). These genotypes also have unusual sub-type variations in Asia and Africa (see here) that can be identified in clinical testing and might have resistance to available therapies.
The development of pan-genotypic direct acting-antivirals (DAAs), that are single or combination drugs designed to be effective against a majority of these genotypes, was a significant medical development. Gilead’s Sofosbuvir (SOF), sold under the brand name Sovaldi, was one such early DAA. Some proclaimed that SOF transformed chronic HCV care by making it possible to fully cure patients, while public health campaigners argued that it was a repackaged drug industry technique from a patent point of view. The drug price was prohibitively high at $1000 per pill, despite the fact that drug development was supported by public funding and infrastructure.
The SOF patent application in India was initially rejected after pre-grant oppositions by Natco, I-MAK and DNP+ citing Section 3(d). The prodrug patent was also rejected in Argentina, Brazil, Thailand, Egypt, China and Ukraine (see here, here). Gilead appealed the Indian decision and won in 2016; then offered voluntary licenses to 11 Indian generic manufacturers. The license agreements excluded many middle-income countries, by one estimate leaving out 46% of global HCV patients (see here, here, here). We had followed these developments on the oppositions, IPO’s rejection, lack of transparency in procedure and the unaffordability of this wonder drug.
In late 2017, Mavyret broke Gilead’s monopoly (see here). Market competition made Gilead launch authorised generic versions of SOF combination drugs, Harvoni and Epclusa despite their patents not expiring till 2030 and 2032. Mavyret reduces the treatment time from 12 weeks to 8 weeks and is offered at a comparatively lower price. In some cases, it is also a useful treatment for patients who have been previously treated without success, and can be administered to patients with renal failure. It continues to be an AbbVie blockbuster drug till this year. It is a high-value medication with obvious benefits for public health programs, but a cost that is still high for LMICs. For this, a voluntary licensing scheme was created; this time excluding sales in India – more on this below.
Indian Patent Application Abandoned
On January 22, 2018, AbbVie filed patent application no. 20187002543 titled “Solid Pharmaceutical Compositions for Treating HCV”. This was a secondary patent, claiming protection over a bilayer tablet formulation of a combination of two known antiviral compounds, Glecaprevir and Pibrentasvir (G/P). In this patent application, the protection was sought for a specific formulation of the G/P combination (which is the Mavyret tablet).
The FER was forwarded on February 24, 2020. Reply to the FER was filed on November 23, 2020. Subsequently, this application was opposed by the Delhi Network of Positive People (DNP+), a registered trust of HIV+ people who campaign for community empowerment, increasing medical literacy and access to generics; and Low Cost Standard Therapeutics (LOCOST), a Vadodara-based NGO that manufactures and procures essential medicines to make them available at affordable costs.
The pre-grant oppositions were based on lack of novelty, inventive step, patentability; insufficient description of invention and non-disclosure of foreign applications. It was alleged that claims with respect to pharmaceutically acceptable polymers, surfactants and dosage formulations were vague and broad. Prior art, in the form of published research as well as ceased and abandoned patents relating to the claimed compounds, defeated the claim of novelty. The G/P compound and combination, use of polymers and surfactants, dosage strength and bilayer tablet technology were already known to persons skilled in the art.
The opposition also refers to Sections 3(d) and 3(i). It was argued that significant enhancement of therapeutic efficacy was not proved. Demonstrable enhanced efficacy or a therapeutic advantage was not reflected in the application through experimental data. Such an analysis under Section 3(d) has become quite common in Indian patent refusals. We have noted in several posts here on the doctrinal uncertainties about what qualifies as and how to prove ‘enhanced efficacy’.
The reference to Section 3(i) states, “Claim(s)1-27 fall(s) within the scope of such clause ( i ) of section 3 of Patents Act 1970 as amended by Patents (A) Act 2005 in respect of term solid dosage form and as stated in examples and as described in description.” In my opinion, these claims largely relate to product composition and quantities; put simply, they are product claims, not method claims. The understanding that pharmaceutical dosage formulation claims are not to be equated with methods of treatment even if there is some minor reference to administration of the drug, has been established by the Delhi High Court in several cases, notably Bayer and Nestle.
This order, of course, does not provide any further clarity on Section 3 jurisprudence. AbbVie did not respond to outstanding objections. It informed the IP Office of the decision to abandon the patent application; consequently, leading to its refusal under Section 15.
The full Mavyret story is larger than one Mavyret patent
So, what exactly does this patent refusal do? Not much. In November, 2018 the Medicines Patent Pool (MPP) and AbbVie signed a royalty-free license agreement to develop and sell generic G/P medicines in some LMICs. Several high-prevalence HCV countries like China, Pakistan, Egypt and India were excluded from the list. India was specifically listed as a ‘manufacturing only’ country with the effect that generic G/P pills could be made, but not sold, in India. This was the first time that the Indian market was so excluded, in a manner which the MPP’s own Expert Advisory Group called a ‘disappointment’.
This voluntary scheme stays in force until expiry of key patents, which for most territories is around early 2030s. Exhibit D of the voluntary license notes five patents filed in India. At the moment, two of these patent applications relating to Pibrentasvir (1310/DELNP/2013 and 201818021052) are under examination. Two secondary patent applications relating to the G/P combination (201817002543 and 201817004313) have been abandoned by the applicant. One patent, IN 504022, on Glecaprevir has been granted and will expire in 2030.
The express exclusion of sales in Indian market, the granted patent on Glecaprevir and the still uncertain status on the patents on Pibrentasvir will hold back Mavyret generic entry. It is also worth noting that the prosecutions on Pibrentasvir patent applications have been on-going at the IPO since 2013 and 2018. A forestalled patent prosecution procedure is as effective as a granted patent in discouraging generics manufacture. Delayed processing at the IPO itself creates a pseudo-monopoly around the drug.
What’s Next?
I have written previously (and incidentally on another AbbVie blockbuster drug) about why patent refusals, though an important criterion, are not a panacea for Indian generics manufacture. I see similar issues in the Indian HCV market. Mavyret is a useful example of how in addition to making generics, the focus should also be on what’s happening in the surrounding ecosystem.
Since 2018, the listed drugs in the NVHPC have been Sofosbuvir, Sofosbovir + Velpatasvir, Daclatasvir and Ribavirin, procured through centralised tenders. Although the present health scheme uses a broad-spectrum combination, the absence of G/P deprives Indian HCV patients of a choice of reduced timespan of treatment and possibilities of treatment with drug resistance considerations.
Strategic choices by AbbVie for the Indian market which have been the opposite of Gilead’s, the explicit market exclusion in the voluntary agreement and the slow proceedings at the IPO have created a territory where the generic version of an important medicine, despite being manufactured, stays out of reach and does nothing to reduce the public health burden.
Thanks to Bharathwaj for comments and discussions on earlier drafts.
