Gilead must face pay-for-delay case over HIV drugs, judge rules

A Gilead Sciences, Inc. office is shown in Foster City, California
A Gilead Sciences, Inc. office is shown in Foster City, California, U.S. May 1, 2018. REUTERS/Stephen Lam
  • Plaintiff claims Gilead paid off Indian generic drugmaker not to compete in Truvada market
  • Company facing other lawsuits over business practices surrounding HIV drugs

(Reuters) - Gilead Sciences Inc must face a proposed class action lawsuit accusing it of paying off Indian generic drugmaker Cipla Ltd not to compete with its HIV preventive drug Truvada, a federal judge has ruled.

U.S. District Judge Jeffrey White in Oakland, California, ruled Friday that a Florida police health plan, the Jacksonville Police Officers and Fire Fighters Health Insurance Trust, could proceed with its lawsuit even though it could not yet allege precise details about the confidential 2014 settlement between the companies.

The judge wrote that circumstances surrounding the settlement — including Gilead's announcement just months later that it would grant Cipla a potentially lucrative license to sell generic versions of its blockbuster hepatitis C drug Sovaldi in developing countries — provided enough support to the trust's case to survive motions by Gilead and Cipla to dismiss it.

"We are pleased that the court agreed that we had plausibly alleged an anticompetitive agreement between Gilead and Cipla, and we look forward to proving our claims," Henry Quillen of Whatley Kallas, a lawyer for the plaintiff, said in an email.

Lawyers for the Gilead and Cipla did not immediately respond to requests for comment.

According to the 2020 lawsuit, Gilead was able to maintain its monopoly on Truvada — a combination of two other drugs, which the company also sold separately under the names Viread and Emtriva — until 2020 by reaching anticompetitive settlements with generic manufacturers, despite "glaring weaknesses" in the patents protecting it.

Gilead sued Cipla in 2012 after it applied to the U.S. Food and Drug Administration to sell generic versions of Truvada, Viread, Emtriva and another drug called Atripla. While terms of the eventual 2014 settlement were not disclosed, the trust alleged that it "likely" included the Sovaldi license and a license to sell generic Atripla at some point in the future.

In return, Cipla refrained from competing with Truvada by not selling generic versions of Viread and Emtriva in a single package, which it could have received approval to do, according to the trust.

White, in allowing the case to go forward, acknowledged that the lawsuit "would be considered speculative in other contexts" but said that courts had allowed similar claims to proceed in other reverse-payment cases.

California-based Gilead is facing a separate class action accusing it of violating antitrust laws by striking deals to prevent generic versions of its drugs from being used in multi-drug cocktails.

Gilead made $73 million from Truvada in the first six months of this year, down sharply from $243 million for the same period last year as the generic market has grown. HIV drugs still accounted for well over half of the company's $12.8 billion revenue during the period, thanks to newer drugs including Biktarvy and Genvoya.

The case is Jacksonville Police Officers and Fire Fighters Health Insurance Trust v. Gilead Sciences Inc, U.S. District Court, Northern District of California, No. 20-cv-06522.

For the trust: Henry Quillen of Whatley Kallas

For Gilead: Christopher Curran of White & Case

For Cipla: Peter Giunta of K&L Gates

Read more:

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at