Gilead, Bristol-Myers Squibb Facing Antitrust Class Action Over Alleged Anti-Competitive Grip on HIV Drug Market

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Gilead Sciences and Bristol-Myers Squibb have for years unlawfully conspired to restrain the market for HIV treatment drugs in the United States, a proposed class action lawsuit alleges. 

The 125-page antitrust complaint alleges more specifically that Gilead has acquired and maintained since December 2004 monopoly control in the market for antiretroviral therapy (cART) regimen drugs, in part by enlisting the help of co-conspirators such as Bristol-Myers Squibb to delay market entry for generic competition. Gilead’s conduct allowed the company to significantly overcharge direct buyers such as the plaintiff, a Northeast retail and online pharmacy operator, and ultimately harmed patients, the suit claims. 

Modern cART drug regimens are made of a “cocktail” of drugs most often consisting of two “nucleotide-nucleoside analogue reverse transcriptase inhibitors” (NRTIs) taken alongside at least one antiretroviral drug of another class, such as an “integrase inhibitor,” or “third agent,” the lawsuit says. To facilitate patient compliance with taking several drugs in cART regimens, multiple antiretroviral drugs are often coformulated into a single pill known as a “fixed dose combination,” the suit explains. 

One of the principal NRTIs used in cART regimens, Tenofovir, is predominantly manufactured by Gilead, whose drugs products are used by roughly 611,000 of the 1.2 million HIV patients nationwide as of 2015, according to the complaint. 

“Tenofovir is the most common NRTI used in cART regimens in the United States, and is a piece of almost all cART regiments [sic],” the case explains. “Gilead’s ownership of Tenofovir therefore allowed Gilead and its co-conspirators to monopolize the market for cART regiments.” 

Eight years after Gilead’s release of its patented formulation of the compound tenofovir disoproxil (TDF), the company, with the threat of generic competition looming, entered into “horizontal agreements” with co-conspirators Bristol-Myers Squibb and Janssen Pharmaceuticals, the case claims. Essentially, the companies agreed to not make competing fixed dose combination drugs with generic versions of Gilead’s products even after Gilead’s tenofovir disoproxil patents expired in exchange for certain considerations, according to the complaint.

Through joint development agreements, the lawsuit says, Gilead and its co-conspirators then switched the market from TDF-based fixed dose combination drugs to new tenofovir alafenamide (TAF)-based fixed dose combination drugs to be used “much later” once competition from generic TDF was imminent:

“Gilead’s booster drug, Cobicistat, had a longer patent term. Gilead allowed BMS and Janssen to coformulate fixed dose combination drugs that combined BMS’s and Janssen’s HIV drug products with Cobicistat, and Gilead agreed not to market a competing fixed dose combination drug after BMS’s and Janssen’s patents expired. 

When generic competition to TDF became imminent, Gilead amended the No-Generics Restraints to preclude its co-conspirators from competing not only against Gilead’s then-marketed TDF-based formulation, and therefore TDF, but also against new TAF-based formulations. Gilead then reformulated the original TDF-based fixed dose combination drug with TAF. The reformulated fixed dose combination drug with TAF will not have competition until at least 2032.”

The horizontal agreements between Gilead and its co-conspirators covered in 2018 more than 75 percent of all sales of NRTIs, more than 50 percent of all sales of third agents and more than 75 percent of all sales of booster drugs used in a cART regiment in the U.S., the lawsuit alleges.

“In the absence of Defendants’ and non-party co-conspirators’ unlawful conduct, generic versions of cART regimen drugs would have launched sooner,” the suit contends. “Competition from generics would have driven prices down to competitive levels.”

Per the lawsuit, Gilead earned in 2017 $14 billion from its HIV “pipeline,” and the company’s net sales grew “exponentially” by the following year on the performance of its HIV drugs. According to the complaint, Gilead, by 2019, commanded 75 percent of the HIV drug market, dominating with sales of three of the four best-selling HIV drugs: Atripla, Stribild and Truvada, on which the lawsuit says Gilead holds a monopoly, charging reportedly “between $1,600 and $2,000 for a one-month supply.”

In 2016, Gilead raised the wholesale acquisition price for two of its older drugs, Complera and Stribild, by seven percent, or $2,508 and $3,469 per month, respectively, the lawsuit says. In March 2019, the company then increased its list prices for the majority of its best-selling HIV medications by 4.9 percent, according to the suit. 

In a statement to Law360, Gilead said the proposed class action “distorts and misstates” Gilead’s history and its collaborations with its partners to develop new medicines. 

“Gilead believes this lawsuit and its antitrust allegations are without merit and intends to file a motion to dismiss,” the company said. “The allegations against Gilead are misguided and do not accurately reflect antitrust laws or Gilead’s history or innovative collaboration and competition in HIV medicines.” 

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