AbbVie faces hepatitis C patent challenge in India

In India, a non-profit organisation and an advocacy group have united to take on a patent covering pibrentasvir, part of the drug combination that forms AbbVie’s hepatitis C product Mavyret.

Non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+), which advocates for access to treatment for people living with HIV, filed a pre-grant patent opposition with the Indian Patent Office on Saturday, July 21.

According to a press release from the organisations, if the pibrentasvir patent is granted it could block generic entrants from supplying the product in India.

“If unmerited patents make pibrentasvir unavailable and unaffordable, millions of people around the world will go without treatments they need against hepatitis C,” said Tahir Amin, co-founder and co-executive director at I-MAK.

The organisations claimed that AbbVie’s patent application is “based on obvious, existing science and does not meet the strict efficacy standards of India’s patent law”.

Earlier patents filed by AbbVie already disclose compounds that are similar in structure and useful for treating hepatitis C, said the organisations. They claimed that the slight changes made to the pibrentasvir compound should be considered obvious.

The opposition is part of I-MAK’s global strategy to challenge “unmerited patents”.

Earlier this week, LSIPR reported that in the US, the Patent Trial and Appeal Board rejected I-MAK’s tenth challenge to Gilead-owned patents covering the company’s hepatitis C medicines.

I-MAK has successfully challenged patents on four HIV drugs in India.

Prices for these generic medicines are 51% to 89% lower than the branded versions, claimed I-MAK, adding that these wins have helped supply low- and middle-income countries worldwide with low-cost generics, saving an estimated $500 million.

Paul Lhungdim, project coordinator at DNP+, said: “It is not enough for medicine to be available. It must be affordable for the people who need it. DNP+ will continue to oppose unmerited patent applications that allow companies like AbbVie to keep medicines out of reach of our community and charge exorbitant prices from governments in many middle- and high-income countries.”

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