I-MAK & Delhi Network of Positive People File Opposition to Prevent AbbVie Patent Grant on Hepatitis C Treatment as Thousands Convene for AIDS Conference, I-MAK Builds on Successful India Patent Challenges to Block Monopoly on Unmerited Pibrentasvir Patent
On July 21, the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) filed a pre-grant patent opposition with the Indian Patent Office in Delhi against pibrentasvir (PIB), part of the drug combination that forms AbbVie’s hepatitis C (HCV) product, Mavyret. Filed on the eve of the 2018 International AIDS conference, the opposition has significant implications for millions of patients and families struggling to afford and access hepatitis C treatment: if granted, a pibrentasvir patent could block generic entrants from supplying the product in India and other low and middle-income countries, where the majority of people with HCV live.
Building on I-MAK’s prior patent challenges to branded HIV and HCV treatments in India, the filing argues that pibrentasvir is based on previously-patented compounds with similar structures, and that because the drug relies on obvious and established science, the Indian Patent Office should not grant AbbVie a monopoly for the treatment.
“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. “AbbVie’s patent application for PIB is based on obvious, existing science and does not meet the strict efficacy standards of India’s patent law. The Indian Patent Office should apply the letter of the law and recognize the unmerited grounds for a patent on PIB.”
The opposition filing is part of a global strategy by I-MAK and its partners to challenge unmerited patents on medicines that are most critical to addressing global health crises created by HIV and HCV. Since its founding in 2006, I-MAK’s legal work and research has reached across 49 countries and 20 treatments for eight diseases, including hepatitis C, HIV, leukemia, tuberculosis, diabetes, cancer, and blood-related disorders.
“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,” said Paul Lhungdim, Project Coordinator at DNP+.
Though Mayvret just launched in quarter three of 2017, it has already generated roughly $1.5 billion in revenue, garnering nearly 50 percent of the market share in the U.S., making it one of the significant branded competitors to Gilead’s Hepatitis C franchise.
“Despite having earned millions of dollars in the United States and Europe selling the drug at high prices, AbbVie has made absolutely no effort to-date to signal when and how the treatment combination will be available, and whether it will be affordable in India and other low and middle-income countries,” said Priti Krishtel, co-founder and co-executive director at I-MAK. “Given AbbVie’s track record, it is likely the company will employ aggressive tactics and charge high prices to patients in need. By filing this pre-grant opposition, we seek to ensure AbbVie is not granted a monopoly for an unmerited patent that could block treatment from millions.”
The key grounds for the I-MAK and DNP+ challenge to the PIB compound patent are:
- Earlier patents filed by AbbVie itself and Enanta Pharmaceuticals already disclose compounds that are similar in structure and useful for treating HCV. The slight changes made to the PIB compound over these earlier patents should be considered obvious, making the PIB patent unmerited under India’s legal standards.
- AbbVie has failed to provide any comparative data in its patent application that is sufficient to meet India’s legal requirements that a new form of an existing compound, which PIB is when compared to AbbVie’s own earlier patented compounds, shows an enhancement of efficacy. Under India’s legal requirements, such patents should be determined not patentable.
The opposition documents can be found here:
Mayvret is a combination of the NS4A protease inhibitor (glecepravir) and the NS5A inhibitor (pibrentasvir). It was first approved by the EMA and U.S. FDA in late-July and early-August 2017, respectively. The combination was added as a recommended regimen in both to the AASLD and EASL guidelines, but has not yet been added to the WHO Essential Medicines List. Mavyret is a once daily treatment only available as a fixed dose combination. Depending on whether or not the patient is treatment naive and if the patient presents with cirrhosis, treatment lasts from eight to twelve weeks.
In addition to working to improve access to hepatitis C medicines in India, I-MAK has successfully challenged patents on four HIV drugs in India. As a result, prices for these lifesaving generic medicines are now 51-89 percent lower than the branded versions. These wins have helped supply low- and middle-income countries worldwide with low-cost generics, saving an estimated US$500 million – money that could be reinvested to treat more than one million people.
Since 2006, I-MAK has been working to increase access to medicines around the world. I-MAK’s legal work and research spans 49 countries, eight diseases and 20 therapies. I-MAK’s wins on high-impact cases on HIV drugs has saved health programs worldwide over $1 billion. In order to stay independent and exclusively represent the interests of patients and consumers, I-MAK does not accept funding from branded or generic pharmaceutical companies. Click here for more on I-MAK’s impact around the world.