Gilead says submitted petitions to USPTO requesting review of HHS patents
Gilead announced that it has submitted petitions to the U.S. Patent and Trademark Office requesting an inter partes review of patents granted to the U.S. Department of Health and Human Services for HIV pre-exposure prophylaxis and post-exposure prophylaxis. An inter partes review re-examines the claims in a patent to determine whether they are valid. The company stated: "We strongly believe that the patents granted to HHS since 2015 for PrEP and PEP are not valid. Published materials clearly show that well before HHS claims to have invented the concepts of PrEP and PEP in 2006, others had conceived of using an antiretroviral therapy, including Truvada, for both forms of prophylaxis. For example, guidelines published in 2004 recommended administering combination antiretrovirals - including Truvada - to certain categories of 'high risk' individuals before an HIV exposure, while the Center for Disease Control and Prevention's own 2005 guidelines recommended Truvada for prophylaxis immediately after exposure. The ongoing dialogue about these patents is a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP. Resolving the patent issues will refocus the public dialogue about PrEP on what matters most: the real-world obstacles that prevent people at risk for HIV from accessing effective prevention. Those with the greatest need for PrEP face significant social and structural barriers, such as limited access to affordable healthcare, low awareness of PrEP, stigma, discrimination, and insurance benefit design that places a significant cost-sharing burden on patients. Gilead remains committed to increasing access to PrEP for everyone in need and we will continue to invest in a wide range of programs to help accelerate access and awareness."