AbbVie loses patent plea for Hep C drug

New Delhi: The Indian Patent Office has refused to grant a secondary patent to AbbVie for its blockbuster Hepatitis C drug combination glecaprevir/pibrentasvir, sold globally under the brand name Maviret. Civil rights activists said the move will ensure continued access to affordable treatment for millions of patients in India and globally.

In the order dated May 7, 2026, the Patent Office refused the application under Section 15 of the Patents Act, 1970, after the US company failed to contest pre-grant oppositions filed by civil society groups, and subsequently informed the Patent Office that it wished to abandon the application. ET has seen a copy of the order.

“This decision is significant as refusal of the patent application means that AbbVie has not been able to obtain secondary patent for the composition of glecaprevir/pibrentasvir, which if granted would have extended AbbVie’s patent monopoly by five years,” said KM Gopakumar, senior researcher and legal advisor at Third World Network.

AbbVie’s patent application was filed in 2018. The company sought protection for a specific bilayer tablet formulation of glecaprevir/pibrentasvir, a highly effective pan-genotypic treatment for Hepatitis C Virus (HCV) infection.

“This decision is significant as refusal of the patent application means that AbbVie has not been able to obtain secondary patent for the composition of glecaprevir/pibrentasvir, which if granted would have extended AbbVie’s patent monopoly by five years,” said KM Gopakumar, senior researcher and legal advisor at Third World Network.

AbbVie’s patent application was filed in 2018. The company sought protection for a specific bilayer tablet formulation of glecaprevir/pibrentasvir, a highly effective pan-genotypic treatment for Hepatitis C Virus (HCV) infection.

Left untreated, it can lead to cirrhosis and liver cancer. While effective treatments exist, their affordability remains a decisive factor in whether patients can access them.

Both TWN and Delhi Network of Positive people filed pre-grant oppositions against the application under Section 25(1) of the Patents Act. The provision allows any party to formally challenge a pharmaceutical patent application before it is granted.

According to the documents assessed by ET, AbbVie was formally notified of both oppositions in November 2025, but chose not to file any reply or evidence in response.

When a hearing was scheduled for May 4, 2026, AbbVie’s agent informed the Patent Office that the company wished to formally abandon the application and would not attend.

The Patent Office, finding that AbbVie had failed to address the objections raised, refused the application under Section 15 of the Act. Both pre-grant oppositions were simultaneously disposed of consequently.

An email query sent to AbbVie remained unanswered till as of press time on Monday.

AbbVie had previously entered into a voluntary licensing agreement with the Medicines Patent Pool (MPP), an international public health organisation that negotiates licences with pharmaceutical companies to facilitate affordable generic supply to lower-income countries. However, India was excluded as a sales territory from the MPP licence. While Indian manufacturers were permitted to produce the generic medicine, they were barred from selling it to Indian patients .

 

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