Bottle of Truvada pills sitting on a bathroom sink

United States v. Gilead: The Fight for PrEP

By Phebe Hong

The Department of Health and Human Services’ patent suit against Gilead made headlines earlier this month (as described here and here). The government seeks damages for Gilead’s alleged infringement of HHS patents covering PrEP drugs for HIV prevention. The suit could set novel precedent in the realm of drug patent litigation – after all, very rarely does the government assert a patent against a large pharmaceutical company.

Below, I provide a breakdown of HHS’ complaint, in addition to Gilead’s initial responses to the allegations:

CDC is the inventor of the combination PrEP regimen used for prevention of HIV claimed in the patents-in-suit (¶ 93–118). The complaint documents that in the early 2000s, studies looking at single-agent PrEP regimens largely failed. However, in May 2005, CDC began testing a combination PrEP regimen in animal experiments that was “unexpectedly effective” in protecting against HIV transmission.

CDC’s discovery of the combination PrEP regimen was innovative and novel (¶ 135–43). HHS states that the CDC research on the PrEP regimen was “received with excitement by the scientific community” and even nominated for an award for excellence in science. Such evidence demonstrating a “long-felt but unsolved need” is a secondary consideration of non-obviousness that supports the validity of HHS’ patents. In contrast, Gilead argues the patents are invalid because the concept of using agents like Truvada as a form of prophylaxis was well-established prior to the CDC’s claims.

Gilead’s only contribution to PrEP regimen studies was drug donation (¶ 119–27). HHS alleges that Gilead had a “lack of interest” in the initial PrEP studies. Besides donating the study drug, Gilead did not financially support these studies – in fact, the National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation provided the majority of research funding (¶ 154). The complaint cites a 2013 New Yorker article in which Gilead’s VP of Medical Affairs stated at the time that he did not “view PrEP as a commercial opportunity” (¶ 173).

CDC’s four patents, covering processes for protecting humans from infection by viruses such as HIV, are valid(¶ 196–223). The complaint points to another company, Mylan, that tried to bring a validity challenge against a similar patent owned by HHS in Europe. The patent was upheld as valid (¶ 227), forcing Mylan into a licensing agreement with HHS in order to market generic versions of Truvada outside of the United States. HHS uses the example as a “warning” to Gilead, which has sold Truvada for PrEP without paying any licensing royalties to CDC.

Gilead willfully infringed CDC’s patents by selling Truvada and Descovy (¶ 253–79). HHS notes that Gilead must have been aware of CDC’s patents as early as 2008, when the filing of patent applications was noted in several scientific publications on PrEP regimens. The complaint states that Gilead must have been aware of potential infringement at the very least by 2015, when the government invited Gilead to discuss licensing rights to the patents.

PrEP access is a crucial part of President Trump’s new initiative to end the HIV epidemic (¶ 182–88). President Trump previously announced his goal of reducing new HIV infections by 90% by 2030. To achieve this, PrEP regimens play a “key focal point” for prevention efforts. Unfortunately, the high cost of Truvada (about $1,800 per month) is a barrier to access. HHS likely seeks to use a successful settlement or litigation outcome to drive down Truvada costs, thereby increasing access to PrEP.

For more, read HHS’ full complaint and Gilead’s response statement.

Phebe Hong

Phebe Hong

Phebe Hong is a 2L at Harvard Law School. She graduated from Harvard College with a degree in Human Developmental and Regenerative Biology. Prior to law school, she worked as a consultant advising pharmaceutical and biotechnology companies. She is a Research Assistant at the Program on Regulation, Therapeutics, and Law (PORTAL) and an Articles Editor for the Journal of Law and Technology. Her research interests include FDA regulation of biologics and pharmaceutical patent law.

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