Gilead Suit Over PrEP Patents Can Go Forward, Judge Rules

The legal wrangling between Gilead Sciences and the federal government over patents on pre-exposure prophylaxis is continuing and getting more complicated.

The pharmaceutical company and the government have each filed suit accusing the other of wrongdoing where the patents on PrEP are concerned. The government has sought dismissal of Gilead’s suit, but a federal judge ruled December 30 that Gilead’s suit can go forward.

The U.S. Department of Health and Human Services holds the patents on the scientific findings behind PrEP — the daily dosage of a drug to prevent the user from acquiring HIV through sex. Gilead is the maker of Truvada and Descovy, the only drugs approved for use as PrEP.

The federal government, on behalf of HHS, sued Gilead in November 2019, alleging patent infringement because the company had profited from the sale of these drugs for PrEP without obtaining licenses for the patented science. Gilead filed its suit in April 2020, saying the government breached its contract with the company by obtaining those patents without notifying Gilead. The company had provided Truvada (Descovy was developed later) for use in clinical trials by Centers for Disease Control and Prevention, which is part of HHS, to see if it could prevent HIV. Gilead alleged its reputation has been harmed by the patent infringement lawsuit, which has also cost it money in the form of legal fees.

The government said Gilead’s suit should be dismissed because of the overlapping issues between the two suits, which were filed in different courts, and because the timing of the harms Gilead says it suffered fell outside the statute of limitations. The government’s suit was filed in U.S. District Court in Delaware, Gilead’s in the U.S. Court of Federal Claims.

Senior Judge Charles Lettow of the U.S. Court of Federal Claims disagreed with the government’s arguments for dismissal. “While the Delaware suit and the pending case have similar factual backgrounds, the mere presence of overlapping facts is insufficient” to justify dismissal, he wrote. Gilead’s claims in its suit are not based on exactly the same facts that it would cite in its defense in the government’s suit, he explained.

Also, the federal government asserted that Gilead’s suit should be dismissed based on the six-year statute of limitations. It said the harms Gilead is alleging began when the government applied for patents in 2006. But Lettow said the harms would have begun either with patent issuance in 2015 or the CDC’s assertion of its patent rights in 2016, both less than six years before the suit was filed.

Lettow gave the government until January 27 to file an answer to Gilead’s suit.