By Robert T. McMullen, JD Candidate L’22
The U.S. Department of Health and Human Services (HHS) took an extraordinary step in November 2019, suing Gilead Sciences, Inc. (Gilead) for patent infringement in Delaware federal court. Thus far, HHS is winning, and the lasting impact of this lawsuit could mean lower prices and greater access to medications for all Americans.
HHS’s complaint came after repeated attempts to try and license its patents to Gilead, which Gilead rejected. There are four patents in question, all of them relating to Truvada, an HIV treatment medication developed by Gilead. HHS discovered a new and unexpected use of Truvada: HIV Pre-Exposure Prophylaxis (PrEP). In other words, taking this medication would prevent a person from contracting HIV if they were exposed to the virus.
HHS’s complaint also focuses on another HIV treatment medication developed by Gilead, Descovy. This drug is almost identical to Truvada and, thus, can also be used for PrEP. Truvada is a medication made of a combination of two drugs, tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Similarly, Descovy is made of a newer form of tenofovir, tenofovir alafenamide (TAF), as well as the preexisting formulation of FTC. TAF is simply a more efficient form of tenofovir, with only one-tenth of TAF needed compared to the original form of tenofovir, TDF.
The United States Patent and Trademark Office (USPTO) granted HHS patents based on its discovery of using Truvada for PrEP. At a basic level, HHS’s patents covering Truvada for PrEP extend to the use of Descovy for the same purpose. Because taxpayers funded this discovery, HHS argues that using Truvada or Descovy for PrEP should not be priced at the exclusive premium Gilead charges for its patented uses. Currently, Gilead charges $1,780/month for Truvada in the United States, but in Australia, the same medication costs $8/month.
Gilead’s response argues that (1) the HHS patents are invalid based on prior art and (2) HHS breached its contract with Gilead. However, argument one failed before the Patent Trial and Appeal Board (PTAB). In an attempt to have the USPTO invalidate the four HHS patents, Gilead filed a request for Inter Partes Review (IPR) in August 2019, four months before HHS filed its complaint.
In an IPR, the PTAB looks at prior art not originally considered by the patent examiner to reevaluate the grant of the patent in question. The PTAB must first decide to institute an IPR before an official review can commence, and Gilead did not even get that far. In February 2020, in two rounds of decisions, the PTAB denied Gilead’s request to institute IPRs on all four of the HHS patents. PTAB decisions on whether or not to institute IPRs are final and cannot be appealed to any authority. 37 C.F.R. § 42.71(c) (2020).
Gilead has stated it plans to prove the invalidity of the patents in the Delaware litigation on the same or additional evidence and pursue the breach of contract claims. Gilead will have quite the uphill battle as to the validity of HHS’s patents. Generally, fact finders (i.e., judges and juries) are deferential to the experts at the USPTO when it comes to patent validity. Moreover, HHS now has four PTAB decisions rejecting Gilead’s requests for an IPR on HHS’s patents. These essentially represent a second “seal of approval” on HHS’s patents by the USPTO, garnering even more favor as to the validity of their patents.
Gilead will still have its breach of contract claims, and those will have to be litigated. Unfortunately, that litigation may last as long as the life of the Gilead patents covering Truvada and Descovy. Generic Truvada will launch starting September 30, 2020 even though Gilead’s patent will not expire until 2021. This was the result of a settlement between Gilead and Teva Pharmaceuticals Industries Ltd., a generics manufacturer. To combat this incoming generic, Gilead is spending enormous resources to market Descovy as the new PrEP option to Truvada users and prescribers (e.g., TV commercials, website advertisements, pharmacy pamphlets). Gilead’s goal is to switch all Truvada users to Descovy before generics become available because its patent on Descovy does not expire until 2026.
HHS’s ongoing litigation is a warning to drug manufacturers who consider refusing government licenses. HHS does not want monetary damages or injunctions against Gilead. This lawsuit is about public health, improving drug access, and lowering drug prices. HHS wants to bring Gilead to the table for negotiations to make sure these drugs are available to all those who need it, thus stopping the spread of HIV and eradicating the virus. Personally, I am writing this blog post from my home in the middle of the CoVID-19 pandemic, so I can think of no better time for the U.S. Government to take a stand.