Class Action Lawsuit Over Truvada, Other Gilead HIV Drugs Allowed To Proceed

A federal judge has cleared the way for an antitrust class action lawsuit over Truvada, Stribild and other Gilead HIV drugs to move forward, involving allegations that drug makers engaged in a scheme that was designed to create an essential monopoly on the critical treatments.

The complaint was brought by AIDS activists and patients, alleging that Gilead violated antitrust laws through deals that prevented generic versions of HIV drugs from hitting the market in the U.S. in recent years.

While striking down some provisions of the plaintiffs’ claims, U.S. District Judge Edward Chen of the Northern District of California issued a ruling (PDF) on March 3, which allows the class action lawsuit against Gilead and other drug makers to move forward.

The pharmaceutical companies had filed four motions to dismiss the claims. While Judge Chen granted some aspects of the motions, indicating the plaintiffs had not adequately shown there was a specific combination antiretroviral therapy (cART) market, the Court allowed plaintiffs to amend their filings to define a market for each standalone drug, meaning they could define a market for Truvada, Stribild, Atripla, Complera and similar drugs as distinct, individual markets.

Judge Chen, however, refused to dismiss the cases outright, and cleared the way for the class action lawsuit over Truvada and other Gilead HIV drugs to proceed through the court system, indicating that adequate allegations were raised that Gilead violated antitrust laws.

The class action lawsuit, and others like it, note that the defendants constructed a web of joint development agreements, preventing each co-conspirator from competing against Gilead’s tenofovir disoproxil (TDF) based drugs. This also included allowing other drug makers to combine some of their HIV treatments with Gilead drugs, specifically the booster drug Cobicistat, in order to enjoy the latter’s much longer patent protection period.

These fixed-dose-combination (FDC) drugs allowed all of the companies involved in the scheme to continue to sell their medications at inflated prices for years, without generic competition.

In addition, the lawsuit claims Gilead has known for years that a less toxic version of the drugs could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF). However, the drug maker allegedly placed its desire to increase profits ahead of consumer safety, and withheld the safer alternative for years, until the patent protections expired on TDF drugs and generic equivalents were introduced that have cut into sales.

“Plaintiffs add that, although Gilead has now rolled out TAF, it has done so in an anticompetitive way, including, e.g., by making agreements with the other defendants to protect TAF, even after the patents on that drug expire, through No-Generics Restraints,” Judge Chen noted.

The company did not begin to sell TAF-designed drugs until 2015, which extended Gilead’s essential monopoly on HIV treatments until 2032. TDF drug patents began expiring last year, allowing generic versions to become available. However, Gilead now markets TAF drugs as a safer and superior alternatives, even though the drug maker delayed development of TAF until the profits generated from the brand-name TDF medications were eroded by generic competition.

While this complaint focuses on antitrust claims against Gilead, there are also a growing number HIV drug lawsuits and class action complaints being pursued by former users of Truvada, Stribild and other Gilead medications, in which plaintiffs allege that they suffered side effects that may have been avoided if the less toxic TAF versions had not been withheld. Plaintiffs claim that they have been left with acute kidney injuries, chronic kidney disease, kidney failure, bone fractures, dental injuries and other complications associated with bone density loss caused by TDF-based drugs.