Last month, the United States government, acting on behalf of its Department of Health and Human Services (HHS), filed suit in Delaware against Gilead Sciences, Inc. and Gilead Sciences Ireland UC for infringing four patents covering inventions developed by scientists at the Centers for Disease Control and Prevention.  The patents all cover methods for a type of medical regimen known as "pre-exposure prophylaxis" (PrEP) for the prevention of HIV.  More specifically, each of the four patents'  claims recite:

• A process for protecting a primate host from a self-replicating infection by an immunodeficiency retrovirus comprising . . . .

• A process for inhibiting establishment of a human immunodeficiency virus self-replicating infection of human immunodeficiency virus infection in a human comprising . . . .

The lawsuit is highly noteworthy for many reasons.  It is very unusual -- not unheard of, but very unusual -- for the U.S. government, acting as a patent owner, to sue a company for patent infringement.  Second, the Complaint is extremely detailed in explaining the history of events leading to the invention as well as the history of interaction between HHS and Gilead leading to the filing of the Complaint.  Third, it does not take much reading between the lines to see that one of the government's goals is to make the PrEP regimen as readily available and cost effective in the U.S. as it already is in many European and other countries, with Gilead being alleged as a primary roadblock in that path.

Gilead is of course well-known for discovering Truvada® (a fixed dose combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC)) as well as Descovy® (a combination of FTC and tenofovir alafenamide fumarate (TAF)).  Truvada® and Descovy® are regularly used in treating active HIV infections with the goal of reducing the active virus load to undetectable levels.  The Complaint notes that Gilead's patents on these products expire in 2021.

The Complaint explains that the CDC developed innovative pre-clinical models that proved to be keys in testing and proving the CDC scientists' concepts in the claimed inventions.

Still further, the Complaint goes to significant length to explain that Gilead provided absolutely no support in developing the inventions, aside from providing certain drug compounds under an MTA.  Indeed, the Complaint addresses and squarely shoots down Gilead's public statement claiming credit for the development of the PrEP regimine.

The Complaint notes the significant benefits achieved by Truvada® and Descovy® for treating established HIV infections, but focuses on the efforts that were being made in the 1990s and 2000s to discover a way to prevent HIV infection from becoming established.  In particular, the Complaint provides a great summary of the substantial -- yet unsuccessful -- R&D that had been and was being undertaken to develop a vaccine and/or post-exposure prophylaxis treatment of HIV prior to the invention, as well as the reasons why PrEP was then-deemed unachievable.  In this respect, the Complaint is like a great survey article on the history of HIV treatment research, but the document is written in a much more readable manner than most survey articles.