Juelsgaard Intellectual Property and Innovation Clinic students Mondee Lu, ’20, and Annie Wanless, ’21, recently submitted an amicus brief on behalf of eight HIV research, policy, and advocacy organizations in Staley v. Gilead, an antitrust case in federal court in the Northern District of California. The case alleges that Gilead and three other pharmaceutical companies engaged in a variety of anticompetitive actions to keep the cost of HIV treatment unreasonably high, largely by preventing the development of generic HIV drugs and delaying their entry into the U.S. market. The Clinic worked with amici to submit a brief that highlights the dire impact of these alleged actions on health outcomes for people with HIV in America.

Amici – Treatment Action Group, AIDS Action Baltimore, the Foundation for AIDS Research (amfAR), AVAC, Health GAP (Global Access Project), Housing Works, the SERO Project, and the US PLHIV Caucus – work to ensure lifesaving and preventive HIV treatments are accessible and affordable for all who need them.

Increasing access to cheaper generic drugs is a key part of this strategy. But the complaint in this case alleges that Gilead and its co-conspirators took illegal actions, including agreements that unlawfully extended the patent life on their drugs, that limited access to treatment, delayed or prevented generic HIV treatment from reaching the market in a timely fashion, and kept prices artificially high. The companies’ alleged actions to inflate drug prices have had profoundly negative consequences for the people and communities amici serve.

Gilead and the other pharmaceutical company defendants have asked the court to dismiss the case. The Clinic worked closely with the amici to prepare a brief that supports the plaintiffs’ opposition to these motions to dismiss. Amici’s brief brings to the court’s attention the real world impacts of the alleged anticompetitive conduct, including exorbitant prices, fewer drug options, less innovation, diminished competition, and worse health outcomes for people with HIV in America. The Clinic submitted the brief to provide the court with amici’s unique and informed perspectives about the critical importance of this case.

Over one million people in the United States live with HIV. Advances in treatment mean people with HIV can live long healthy lives, and people at risk of HIV can take preventive treatment (called PrEP) that reduces the risk of infection by 90%. Yet despite the existence of such treatment, over 40,000 Americans are newly diagnosed with HIV each year and 17,000 Americans progress from HIV to AIDS each year. Moreover, less than 10% of people who would benefit from PrEP filled prescriptions last year.

Today, 80% of people on an HIV treatment regimen in the United States take at least one Gilead product every day. And because Gilead has patent exclusivity on the only PrEP treatments available, 100% of people who use PrEP take Gilead products. Some of these products should have already faced competition, resulting in lower prices and better health outcomes. But Gilead’s alleged anticompetitive actions continue to stifle this potential competition and keep the end of the HIV epidemic out of reach.

Amici see firsthand how Gilead’s alleged restraints on competition affect U.S. consumers. While countries like Denmark and the United Kingdom have made strides towards generic HIV treatment substitution, Gilead’s alleged actions have denied American consumers the generic competition needed to make similar progress towards more affordable treatment. HIV treatment prices remain higher in the United States than almost anywhere else in the world – up to ten times higher than in comparable developed countries.

These manipulated prices lead to poor health outcomes in the United States because affordability is closely tied to access to treatment. Because of high costs as well as fragmented health systems, only 53% of Americans with HIV are able to access sustained HIV treatment necessary to achieve viral suppression  – a status that improves health outcomes and eliminates the risk of transmitting the virus to others. In Western Europe, by contrast, 74% of people with HIV achieve this status. Amici’s brief argues that the current lawsuit should be allowed to proceed in order to stop Gilead’s distortion of the HIV treatment market and to bolster positive health outcomes.

The Clinic and its amici submitted this brief to help the court understand that the outcome of this case will have huge ramifications for the future of HIV treatment and prevention efforts in the United States. The lives and well-being of over one million Americans depend on these markets functioning openly and competitively.

For more information about the amici brief and the case, visit the Clinic’s Staley v. Gilead case page.

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