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16 January 2020AmericasSarah Morgan

Gilead hit with antitrust suit over HIV drugs

Gilead and its alleged co-conspirators Bristol-Myers Squibb, Japan Tobacco, and Johnson & Johnson have been accused of engaging in a long-running scheme to suppress competition in the market for HIV prevention therapies.

A Medicare recovery specialist, MSP Recovery Claims, sued the companies at the US District Court for the Southern District of Florida yesterday, January 15, claiming that Gilead had entered into collusive and illegal horizontal agreements with its co-conspirators to block competition against tenofovir disoproxil, an antiretroviral drug.

“Through an array of anticompetitive practices—including horizontal agreements constituting per se violations of the antitrust laws—Gilead acquired and maintained a monopoly for drugs that comprise the modern HIV treatment regimen known as ‘combination antiretroviral therapy’ (cART),” alleged the suit.

This scheme reportedly enabled Gilead and its co-conspirators to “unlawfully extend patent protection for their drugs, impair entry by generic competitors, and charge exorbitant, supra-competitive prices for the drugs that people living with HIV need to survive”.

According to the claim, Gilead now dominates the cART market, with more than 80% of US patients on an HIV treatment regimen taking one or more of Gilead’s products daily.

“Gilead maintains a stranglehold on the cART market even though Tenofovir was discovered more than 30 years ago,” said the claim, adding that Gilead and the other defendants co-formulated tenofovir disoproxil with the co-conspirators’ third agents into single pills known as fixed-dose-combination drugs (FDCs).

“As part of its unlawful scheme, Gilead also agreed to shield BMS and Janssen’s HIV drugs from imminent generic competition by allowing them to co-formulate FDCs that combined their vulnerable products with a Gilead booster drug, Cobicistat, which enjoyed much longer patent protection,” alleged the suit.

‘Devastating effects’

MSP Recovery Claims further claimed that in a “relentless effort to reap monopolistic profits”, Gilead amended its no-generics pacts to preclude its co-conspirators from competing Gilead’s then-marketed tenofovir disoproxil and a new formulation of the compound, tenofovir alafenamide (TAF).

“Gilead’s refusal to get an HIV indication for standalone TAF also imposed a regulatory barrier to generic competition,” added the Medicare recovery specialist.

As Gilead didn’t seek that indication for standalone TAF, potential competitors were then forced to re-perform time-consuming and expensive clinical trials that Gilead had already performed, it alleged.

“Forgoing this HIV indication cost Gilead hundreds of millions of dollars in sales of standalone TAF every year; however, blocking its competitors’ entry into the HIV treatment market proved far more valuable,” concluded the claim.

Now, MSP Recovery Claims has asked the court to remedy the “devastating effects” of the defendants’ anticompetitive conduct which has reportedly stifled innovation, causing tens of thousands of people living with HIV to “needlessly suffer debilitating side effects from inferior products”.

A spokesperson for BMS said: “We are reviewing the complaint and believe it asserts nearly identical claims to a suit filed last year in California. BMS believes those allegations are without merit and has moved to dismiss those claims. We are awaiting the court’s ruling on that motion.”

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5 March 2020   Drugmakers including Gilead Sciences must face antitrust claims related to HIV drugs, after the US District Court for the District of Florida on Monday, March 3 refused to fully throw out a class-action suit implicating the company.
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29 April 2020   Gilead has escalated its dispute with the US federal government by filing a new lawsuit accusing it of improperly filing for patents covering HIV drug Truvada.
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18 May 2023   The government lost its high stakes and unusual royalties dispute with the big pharma firm | New status report claims that the court should have allowed the jury to take four inter partes petitions into account.

More on this story

Americas
5 March 2020   Drugmakers including Gilead Sciences must face antitrust claims related to HIV drugs, after the US District Court for the District of Florida on Monday, March 3 refused to fully throw out a class-action suit implicating the company.
Big Pharma
29 April 2020   Gilead has escalated its dispute with the US federal government by filing a new lawsuit accusing it of improperly filing for patents covering HIV drug Truvada.
Big Pharma
18 May 2023   The government lost its high stakes and unusual royalties dispute with the big pharma firm | New status report claims that the court should have allowed the jury to take four inter partes petitions into account.