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.
This statement includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including our inability to predict with certainty the ultimate outcome of the breach of contract litigation or the patent infringement litigation between Gilead and the Federal Government as described herein. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s website at www.3m0r.site, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.