Activists in the U.S. are asking authorities to break Gilead’s patents on Truvada in an effort to help end the HIV epidemic. Now, a court in the U.K. has done just that, potentially allowing for widespread use of generics as a pre-exposure prophylaxis.
The U.K.’s High Court overturned a patent extension for Truvada, meaning “that unbranded versions of the drug can be legally prescribed,” National AIDS Trust chief executive Deborah Gold said in a statement.
She added that the development “represents a huge cost saving to buying a drug that would save public money, even at full price.” National AIDS Trust is calling on NHS England to fund the medicine by April 2019, arguing that a current trial program isn't reaching everyone at need.
A Gilead spokesperson told pharmaphorum that the company is disappointed with the decision and will appeal. Teva, Accord, Lupin and Mylan brought the patent challenge.
Truvada's EU patent expired last year, according to the company’s annual SEC filing. Gilead secured supplementary protection certificates in several countries, which have come under legal challenges. The company’s U.S. patent expires in 2021, according to the filing. Gilead also has a patent settlement with Teva, allowing that company to launch a U.S. generic at an undisclosed date.
Gilead's Truvada can be taken regularly as an HIV prevention tool, and activists in the U.S. recently penned a New York Times op-ed calling on the government to break Gilead’s patents to ensure equal access. Part of the activists’ “national strategy” to end the HIV epidemic includes “insisting that federal agencies use their statutory authority to break Gilead’s undeserved monopoly," they wrote.
Less than 10% of people in the U.S. who could benefit from the drug in the PrEP setting are getting it, according to the authors.
At the time, a Gilead representative said the company is "committed to ensuring that people who are at high risk for HIV infection have access to Truvada for PrEP." He noted that the company supports "comprehensive payer coverage" and maintains an access program for "qualified uninsured and underinsured people" in the U.S. The company also supports education programs, according to the spokesman.
Gilead this year launched a TV advertising campaign recommending viewers talk to their doctors about HIV prevention options.
Truvada brought in about $3.1 billion in sales around the world last year.