Ronald Machen Jr., former U.S. attorney for D.C. and now a Wilmer Hale partner. Photo: Diego M. Radzinschi/ ALM

The pharmaceutical giant Gilead Sciences Inc. just days ago accused the United States of violating collaboration agreements in a new civil court complaint in Washington that comes as the company is winning praise from the Trump administration for a drug that shows early promise for treating patients suffering from the novel coronavirus.

Gilead's case in the U.S. Court of Federal Claims, filed by lawyers from Wilmer Cutler Pickering Hale and Dorr, confronts agreements between the United States and Gilead concerning HIV treatment and prevention. The complaint alleged the federal government had asserted "patents that it secretly obtained in violation of the collaboration agreements that Gilead entered into and executed in good faith."

The case arrived just days before the president and leading U.S. health officials lauded Gilead for a drug that an early study suggested could be effective in treating patients with the COVID-19 respiratory disease.

"Gilead has, it's really one of a number of companies that are coming up with some pretty positive things," President Donald Trump told reporters in remarks Wednesday addressing the new study about the drug remdesivir. Dr. Anthony Fauci, the infectious diseases expert who is playing a leading role in the government's pandemic response, said "we think it's really opening the door to the fact that we now have the capability of treating. And I can guarantee you, as more people and more companies, more investigators get involved, it's going to get better and better."

Gilead, like many pharmaceutical companies, has long collaborated with federal agencies—including the U.S. Health and Human Services Department and the Centers for Disease Control—on drug treatment. But like any relationship, conflict can arise, and the litigation—which is related to a suit the United States filed against Gilead last November in Delaware—confronts potential pitfalls of private-public collaboration.

A representative from Gilead was not immediately reached for comment Thursday about the timing of the lawsuit.

"Gilead greatly values its collaboration with HHS and CDC, which now spans more than 15 years," the company said in a statement that announced the lawsuit. "Notwithstanding this dispute, Gilead will continue to work with federal agencies, including HHS and the CDC, on efforts to end the HIV epidemic and also to help patients and communities fighting COVID-19."

The FDA is working with Gilead on making remdesivir "easily available to those who need it," Fauci said Wednesday.

"With regard to getting to the market, it will obviously have to be approved by the FDA for licensure," Fauci said. "And the FDA is very well aware that this is something that is very important, so I'm sure they're going to be moving very expeditiously."

The Wilmer team on Gilead's new lawsuit is headlined by Ronald Machen Jr., a former Obama-era U.S. attorney for the District of Columbia and now co-chair of the firm's white-collar defense and investigations practice. Six other Wilmer lawyers—including partners in the firm's Boston and New York offices—appeared on the complaint in the Federal Claims court, a speciality venue where companies file claims seeking money damages for, among other things, property and patents. The case is assigned to Senior Judge Charles Lettow of the U.S. Court of Federal Claims, a former Cleary Gottlieb Steen & Hamilton partner who joined the bench in 2003.

Gilead's suit said the government had breached "material transfer agreements" and a clinical trial agreement.

"Per these contracts, Gilead agreed to provide the CDC with significant quantities of Gilead compounds free of charge. The government, in return, agreed to promptly notify Gilead of any inventions, discoveries or ideas that resulted from the research," the company said in a statement about the case.

In November, the U.S. Justice Department sued Gilead in the U.S. District Court for the District of Delaware seeking millions of dollars in damages for alleged violations of related HHS patents.

"Gilead has ignored CDC's clear contributions and baselessly denied the validity of CDC's patents. Gilead's only contribution to CDC's patented research was providing samples of the drugs that CDC used for testing purposes," the government asserted in the complaint.

The Wilmer lawyers said in the new Federal Claims lawsuit that the government, in the Delaware case, acknowledged "the HHS patents resulted from the research that CDC conducted pursuant to at least one" of the material transfer agreements. The Delaware lawsuit has caused Gilead "reputational harm," the Wilmer lawyers claimed in the Federal Claims complaint.

The government is represented in the Delaware case by lawyers from the Justice Department's civil division in Washington and by a team of assistant U.S. attorneys in Wilmington, Delaware. Gilead is represented by the Wilmington firm Richards, Layton & Finger.

Gilead is seeking an unspecified amount of damages in the Federal Claims case.

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