HHS sues Gilead for patent infringement over PrEP

On Nov. 6, the federal government announced filing suit against Gilead Sciences over HHS’ claims to patents for pre-exposure prophylaxis (PrEP) therapy to HIV. “HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV,” stated HHS Secretary Alex Azar. “However, Gilead must respect the US patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”

While there are many instances of pharma companies taking advantage of federally funded drug research, it is rare for the feds to go after pharma. But the PrEP situation is unusual on several levels. HIV prevention research began (or can be traced back to) HIV therapy research, which was conducted in the 1980s and 1990s on a near-crisis pace as the AIDS epidemic raged in much of the world (and still does in some parts). Later, the United States Patent and Trademark Office granted four patents to HHS that protect Center for Disease Control’s work and the taxpayers’ investment, according to HHS, although it’s not clear whether these pertain to tenofovir, one of two active ingredients in Truvada and Descovy, or to other aspects of HIV prevention.

One aspect of the dispute looks like fairly conventional legal wrangling over patents that go one between drug researchers and pharma companies: Gilead contended (in an August press release) that “Published materials clearly show that well before HHS claims to have invented the concepts of PrEP and PEP [post-exposure prophylaxis] in 2006, others had conceived of using an antiretroviral therapy, including Truvada, … for both forms of prophylaxis.” Gilead has filed for inter partes review of the HHS patents.

The other aspect of the dispute is the atypical market for HIV prevention: many patients are indigent and/or drug users, and their healthcare, such as it is, is funded by Medicare or Medicaid. In its press releases, Gilead beats its chest claiming that its treatments cost “$0-$5” for Medicare patients, “$4-$9” for Medicaid, and “$0-$35” for private insurance; meanwhile, the list price of the drugs are $1,800 to $2,100 per month—meaning that insurers (including, obviously, HHS agencies) pay the difference.

Yet another aspect of the PrEP situation is the impression that Gilead is trying to move prescriptions from Truvada to Descovy because the former’s patents run out sooner. Gilead recently gave a clinical presentation of study results showing “non-inferior efficacy” of Descovy, and avoiding some potential side effects of Truvada, but some AIDS advocacy groups are dubious.

It is purely speculative to suggest that HHS, and the Trump administration, is positioning itself to weigh into the intense debate over high drug prices of any sort by, for instance, claiming so-called march-in rights to drugs that reached commercialization through federally funded research at some point. For now, it looks as if the dispute over Gilead’s rights will be in the courts for a long time.