Gilead's Initial Challenge Against U.S. Government PrEP Patents for Truvada Fails

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Gilead Sciences Is Currently Engaged in a Public Dispute with the U.S. Government over Patents for an HIV Drug Used for Preventive Purposes. According to a recent report by FiercePharma, Gilead’s initial attempt to invalidate patents held by the federal government has failed.

According to reports, the United States Patent and Trademark Office (PTO) denied Gilead Sciences’ attempt to challenge two patents held by the U.S. Department of Health and Human Services (HHS) for “pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for HIV.” These patents relate to the preventive use of Gilead’s HIV drug Truvada against HIV infection. Gilead had argued that the patents were invalid because such preventive use was obvious at the time HHS sought patent protection.

In August last year, Gilead pointed out that public materials clearly indicate that before the U.S. Department of Health and Human Services (HHS) claimed to have invented the concepts of PrEP and PEP in 2006, others had already proposed using antiretroviral therapy, such as Truvada, for two forms of HIV prevention. As early as 2004, guidelines recommended providing combined antiretroviral drugs to "high-risk" individuals for pre-exposure prophylaxis against HIV. Furthermore, in 2005, the U.S. Centers for Disease Control and Prevention (CDC) recommended Truvada for post-exposure prophylaxis immediately following potential HIV exposure.

However, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) did not accept this argument. After reviewing the case, the administrative patent judges concluded that Gilead Sciences had “failed to meet its burden of establishing a reasonable likelihood of prevailing” in the patent challenge, and therefore decided not to institute inter partes review (IPR).

According to Law.com, the ruling pertains to two of the four patents challenged by Gilead Sciences. The PTAB’s decisions on the challenges to the other two patents are also expected to be issued this month.

In its statement, Gilead Sciences stated that this decision does not imply that these patents are valid. On the contrary, the PTAB “did not find the limited evidence we were permitted to introduce in the IPR sufficient to justify a full hearing on the merits through its expedited proceedings.”

Notably, after Gilead Sciences filed a patent challenge with the Patent Trial and Appeal Board (PTAB), the U.S. Department of Health and Human Services (HHS) turned around and sued the company for patent infringement. HHS stated that over the past three years, the agency had attempted to license these patents to Gilead, but the company repeatedly refused. In the lawsuit, HHS alleged that Gilead had profited from taxpayer-funded research.

Despite facing setbacks, Gilead Sciences firmly maintains that it can still prove the invalidity of the patents at issue in the litigation. The statement indicated that the company “has additional defenses to the government’s lawsuit beyond those related to intellectual property and will vigorously defend itself.”

Nevertheless, while Gilead Sciences and the U.S. Department of Health and Human Services (HHS) were disputing patent rights, they remained partners in a free medication program launched last December that is distributing HIV pre-exposure prophylaxis (PrEP) drugs to uninsured patients across the United States. In May last year, Gilead agreed to donate 2.4 million bottles of PrEP medications annually.

Gilead’s patent dispute with the U.S. government over the use of its drugs for HIV pre-exposure prophylaxis inevitably brings to mind the recent widespread debate across various sectors regarding the patent issues surrounding remdesivir, the much-discussed “miracle” antiviral drug. Remdesivir was originally developed by Gilead for the treatment of Ebola virus infection. It is a nucleotide analog prodrug that inhibits RNA-dependent RNA polymerase (RdRp), thereby blocking viral replication by suppressing RdRp-mediated synthesis and exerting its antiviral effects.

Notably, the drug has demonstrated efficacy against the novel coronavirus (2019-nCoV) spreading across China, propelling remdesivir into the spotlight as a widely anticipated star medication. On February 5, remdesivir completed the registration and approval process for clinical trials, with enrollment of the first cohort of patients already in place. The first batch of severely ill patients infected with the novel coronavirus will begin receiving the medication on February 6.

Reference: Gilead loses first PrEP patent challenge but vows to defend against HHS lawsuit