Gilead Statement on Complaint Against Federal Government in The Court of Federal Claims

Foster City, Calif. – April 24, 2020 – Gilead has filed a breach of contract lawsuit against the Federal Government in the Court of Federal Claims alleging violation of four Material Transfer Agreements (MTAs) and a Clinical Trial Agreement (CTA) by the U.S. Centers for Disease Control and Prevention (CDC). The MTAs and CTA are contracts that governed the terms of the more than 15-year collaboration between Gilead and CDC on various research studies relating to the use of antiretroviral agents for the prevention of HIV infection.

Per these contracts, Gilead agreed to provide the CDC with significant quantities of Gilead compounds free of charge. The government, in return, agreed to promptly notify Gilead of any inventions, discoveries or ideas that resulted from the research. In the case of the CTA, the government promised not to seek patent protection in connection with any alleged inventions that derive from the use of the study drug in the trial.

Despite these contractual obligations, in 2006 the U.S. Department of Health and Human Services (HHS) improperly filed for patent protection, without providing the required notification to Gilead. Subsequent to this 2006 filing and over the following eight years, the CDC entered into additional and separate collaboration agreements with Gilead and never notified Gilead of the patent application, as it was contractually required to do. Starting in 2015, HHS was granted four patents relating to the use of the Gilead-provided medicine for pre-exposure prophylaxis (PrEP). The government recently filed suit against Gilead for infringement of these patents, which we strongly believe are invalid and should not have been granted.

Gilead’s complaint alleges that, as a result of the multiple breaches of contract, Gilead has incurred unnecessary attorneys’ fees and has suffered reputational harm due to the government’s inflammatory and selective allegations asserted in the patent infringement lawsuit. Its complaint seeks a declaration of contract breach, as well as damages.

Gilead greatly values its collaboration with HHS and CDC, which now spans more than 15 years. Notwithstanding this dispute, Gilead will continue to work with federal agencies, including HHS and the CDC, on efforts to end the HIV epidemic and also to help patients and communities fighting COVID-19. We remain firmly committed to our own efforts, and to supporting the government’s efforts, to substantially increase access to PrEP for people at risk for HIV through our historic donation of PrEP medication for uninsured individuals and through ongoing efforts to address the social and structural barriers to care.