Judge in US v. Gilead Responds to Calls for Transparency; Presses Gilead and DOJ to Justify Excessive Redactions and Sealing in Key Public Filings

Wilmington, DE - March 28, 2023 - On March 20, Judge Maryellen Noreika, presiding judge in the landmark patent infringement case United States v. Gilead Sciences, called for a hearing to review both the U.S. government and Gilead Sciences' reasons for excessive secrecy in their public case filings. The hearing will take place on April 4. This move follows a March 14 letter sent to the judge by Columbia Law School's Science, Health & Information Clinic on behalf of PrEP4All and the Public Interest Patent Law Institute (PIPLI), which flagged pervasive and unjustified redactions by Gilead and the U.S. government alike, requested justification for the parties' secrecy, and requested submission of new, less heavily redacted versions of their filings. Judge Noreika's call for a hearing marks a win for PrEP4All, PIPLI, and public interest and transparency advocates more broadly, as it indicates that she is concerned that the U.S. government and Gilead have improperly shielded much of their evidence and legal arguments from public view. PIPLI and PrEP4All applaud the Judge's rapid response to their letter calling for transparency.

United States v. Gilead is now in its fourth year of litigation and is nearing trial and judgment. The case is a first-of-its kind patent infringement suit brought by the U.S. government against a brand-name drug company. It concerns HIV PrEP-the use of antiretroviral medications to prevent HIV-negative individuals from acquiring HIV. HIV PrEP was invented and patented by U.S. government scientists. Gilead had been infringing the government's patents for years, as it raked in billions from PrEP, but the patents and Gilead's infringement of them flew under the radar until PrEP4All broke the story in 2019. Following advocacy from PrEP4All, including a House Oversight Committee hearing featuring PrEP4All co-founder Aaron Lord, the government took the unprecedented step of suing Gilead for patent infringement, a move which could translate into billions of dollars in back royalties being paid to the government.

PrEP4All has called on the U.S. government to use any and all proceeds from the case to end the domestic HIV epidemic and ensure universal access to PrEP.

"Communities in need of PrEP access have a right to see key details of the arguments being made in this case. Gilead's gamesmanship of the US patent system is perhaps the single biggest reason that we have failed to get PrEP to more than 25% of the 1.2 million Americans who most need it. Advocates are watching this case closely to ensure that Gilead is held accountable for infringing on patents arising from taxpayer funded research and to advocate for back royalties to be invested directly into efforts to scale up a National PrEP Program in the U.S.," explained PrEP4All Executive Director Jeremiah Johnson.

In January 2022, PrEP4All and 24 other advocacy organizations sent a public letter to the Department of Justice and Department of Health & Human Services requesting an update on the status of the case. The government did not respond. PrEP4All has been following the progress of the suit via public court filings but has been disappointed to see that the parties' extensive redactions made it impossible to understand all of the issues in dispute in the case.

The letter of PrEP4All and PIPLI has already yielded some new information that had previously been hidden from the public. On March 17, Gilead filed a less-heavily redacted version of its opening summary judgment brief, which reveals some previously secret information about its Irish subsidiary.

Alex Moss, Executive Director at PIPLI remarks on the broader importance of the case, "A win for the government in this case would send a strong signal that the government can and will successfully defend itself from patent infringement by huge pharmaceutical companies. Gilead has taken advantage of taxpayer-funded research, and, based on what we can see from significant redactions in their filings, may be attempting to avoid paying taxes by giving ownership to patents and trademarks to its Irish subsidiary. It's time for Gilead's free ride to end and for the public to see a proper return on its investment in PrEP research."

"It's important that we as advocates be able to monitor developments in the case. Existing case law in the Third Circuit is exceptionally clear on sealing and the public right to access," said April Yu, student attorney in Columbia's Science, Health & Information Clinic. Christopher Morten, director of the clinic, elaborated, "the presumption of public access requires motions to seal, specific reasons for sealing, and if they are sufficient, judicial opinions explaining why sealing is appropriate. Judge Noreika seems to agree with our assessment that both parties must do more to justify their requests for secrecy."

PrEP4All and PIPLI encourage other community organizations and advocates to watch the case closely. Advocates are entitled to attend the April 4 hearing on secrecy and to attend the trial itself, which is currently set to begin on May 1.

"Visibility increases the likelihood that justice will be served in this case," says Mr. Johnson, "Even with a ruling in favor of the government's complaint, advocates will have to work closely to make sure any royalties are invested in an effective National PrEP Program that ensures our communities see the benefit of PrEP. We invite partner organizations to join us in elevating these recent developments in the case and calling for justice to be served when the case comes to trial in May."