A new HIV medication class action lawsuit claims Gilead Sciences paid the generic drug-manufacturer Cipla to keep its competing HIV treatment off the market, creating an illegal monopoly for its own Truvada medication that deprived customers of lower cost options.

The antitrust case was brought Sept. 17 by the Jacksonville Police Officers and Fire Fighters Health Insurance Trust in Jacksonville, Florida in U.S. District Court for the Northern District California, San Francisco Division. Both Gilead and Cipla are named as defendants.

At the core of the claim is what the plaintiffs call an “unexplained payment” from Gilead to Cipla, a payment that “likely came in the form of a license to produce another drug, Atripla, a license to produce drugs for Hepatitis C in India, or both,” the Jacksonville trust says.

In exchange for the licensing deal, Cipla would refrain from selling a generic version of Gilead’s Truvada with the same active ingredients, the class action lawsuit claims.

History Between Gilead Sciences and Cipla Over Truvada

The U.S. Food and Drug Administration approved Truvada in July 2012 to be sold as a pre-exposure prophylaxis, or pre-treatment that, along with safe sex practices, could reduce the risk of sexually acquired human immunodeficiency virus, or HIV, in adults at high risk. Studies have shown that Truvada does, in fact, significantly reduce the risk of contracting HIV.

Truvada is also the only drug approved as a pre-exposure prophylaxis in the United States, the class action lawsuit points out.

Less than a month later, in August 2012, Gilead Sciences filed a lawsuit against Cipla for allegedly infringing on Gilead’s patents for the active ingredients in Truvada – emtricitabine and tenofovir disproxil fumarate. Two years after that, the companies informed the court they had reached a settlement. The terms of the settlement were not made public, according to the class action, but in their court filings announcing a deal had been made, lawyers for Gilead Sciences and Cipla referred to a “license agreement.”

After the settlement, Cipla amended its abbreviated new drug application for Atripla – a medication to treat HIV infection – to include what’s called a Paragraph IV certification for emtricitabine and tenofovir disproxil fumarate, the key Truvada ingredients.

According to the FDA, a company can seek Paragraph IV approval to market a generic drug before the brand name’s patents have expired if it can certify the patent is “in the generic applicant’s opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product.”

Gilead did not file suit against Cipla over that move, the class action lawsuit notes.

Plaintiffs Argue Gilead Sciences Actions Unlawful

“The way Gilead chose to respond to these various threats of competition was to offer valuable consideration to Cipla in exchange for its agreement not to challenge the patents on emtricitabine,” the class action lawsuit says. “The result of these agreements was that Cipla declined to enter the market ‘at risk,’ dropped its challenge to the emtricitabine patents, and agreed not to compete against Truvada until some date in the future.”

That violated federal antitrust laws, unfair business practices and various state laws, the Jacksonville health insurance trust argues.

And the result of Cipla giving up on manufacturing a generic version of Truvada has been that patients needing the medication have no choice but to pay the price Gilead Sciences has chosen to charge because there are no alternatives, the class action lawsuit claims.

“But for Gilead’s unlawful agreements, the price of Truvada would have been significantly lower, and lower-priced co-packaged equivalents would have been available,” the Jacksonville complaint says.

Jacksonville Trust Seeks to Represent Large Class

The Jacksonville Police Officers and Fire Fighters Health Insurance Trust, a self-funded healthcare provider, is seeking the court’s approval to represent a class of all other self-insured or mixed-insured group health plans in the United States that paid for Truvada on behalf of their members from January 25, 2018 to the present.

According to the trust, an exact calculation of the “damages” to the plaintiffs is not yet available, but the class action lawsuit says it is “at least in the hundreds of millions of dollars.”

In the U.S., Gilead Sciences has taken in about $6 billion in revenue from Truvada sales since 2018, the trust claims.

“A significant portion of that amount represents overpayments by plaintiff and class members,” the lawsuit says.

The Gilead Sciences Class Action Lawsuit is Jacksonville Police Officers and Fire Fighters Health Insurance Trust, et al. v. Gilead Sciences Inc., et al., Case No. 3:20-cv-06522 in the U.S. District Court for the Northern District California, San Francisco Division.