Gilead Perspective on HHS Lawsuit

As you may have seen, yesterday the U.S. Department of Health and Human Services (HHS) filed a lawsuit against Gilead alleging infringement of its patents related to HIV prevention. 


First and foremost, we would like to assure you that this litigation in no way impacts our collaboration with HHS on its Ready, Set, PrEP program utilizing our donation of PrEP medications. We remain firmly committed to supporting this program and our shared goal of ensuring more uninsured people at risk for HIV in the United States can benefit from PrEP.


While we agree with HHS on the need to expand the number of people benefiting from PrEP, we fundamentally disagree with HHS on the validity of its patents. HHS improperly filed for these patents without fulfilling its obligation to disclose prior public knowledge of PrEP and PEP in its first application to the U.S. Patent and Trademark Office (USPTO). Our goal is to resolve this issue through an inter partes review (IPR) that we requested in August 2019. An IPR is an administrative proceeding through the USPTO that enables the quickest way to resolve this issue and, for that reason, we plan to ask the court to stay HHS’ lawsuit until the IPR has been undertaken.


Please see our full statement on this matter.


Most importantly, this patent dispute does not change our unwavering commitment to increase awareness of PrEP, broaden access to our medications and collaborate with you to address the many social and structural barriers that impact PrEP uptake in the United States.


Please don’t hesitate to reach out with any questions and we look forward to our continued partnerships. 


Amy Flood

Senior Vice President, Public Affairs