On August 23, 2019, Gilead Sciences, Inc. petitioned the PTAB for inter partes review of three patents behind its blockbuster TRUVADA® HIV-prevention drug. The patents, U.S. Patent No. 9,044,509 (‘509), 9,579,333 (‘333), and 9,937,191 (‘191) were all filed by the U.S. Department of Health and Human Services, and the federal agency is still listed as the assignee. Gilead has an exclusive license from the HHS to manufacture Truvada. Because Gilead charges between $1,600 and $2,000 per month for a 30 day supply for patients in the U.S., critics have attacked Gilead for price gouging, limiting the number of people within the target demographic of obtaining the potentially life-saving drug, the only one on the market known to stop HIV infection. Critics are further infuriated that the price in the U.S. is far above that in overseas markets, like Australia, where it only costs $8 per month.
Gilead has countered that it offered 2.4 million bottles of pills for up to 200,000 people for free. Further, it has coupon co-payment programs for those with private insurance. Additionally, Gilead has filed the IPR petitions as a way to invalidate the three Truvada patents, especially in reaction the U.S. Department of Justice’s investigation of false claims over sourcing of ingredients of Truvada, and two other HIV drugs manufactured by Gilead. Our previous discussion on this blog is here.
The PTAB is expected to make a decision to institute the IPRs sometime later this year. We will update the blog as developments occur.