Two insurers recently filed antitrust suits against Gilead Sciences Inc., alleging that it struck agreements with other pharmaceutical companies to slow generic versions of its antiretroviral medications
The Foster City, Calif.-based drugmaker is one of the top makers of HIV medications, several of which include combinations of multiple antiretroviral drugs to slow progression of the virus. Lawsuits filed this week by Humana and Centene allege that as patents for Gilead’s antiretroviral drugs were set to expire, it struck agreements with other companies to produce combination antiretroviral therapies, barring them from using generic versions of the drugs.
For instance, in 2004, Gilead entered into an agreement with Bristol Myers Squibb (BMS) to combine Gilead’s Truvada medication with BMS’ Sustiva, into a medication called Atripla. The agreement with BMS included a “no-generics restraint” clause which would have prevented the companies from using generic versions of each other’s drugs in Atripla.
A few years later, it struck an agreement with Janssen to combine its Endurant drug and Truvada into a treatment called Complera, which also included a no generics restraint clause.
Finally, the lawsuits also call into question alleged “pay-for-delay” deals, which would have delayed potential generic competitors from bringing their drugs to market. In 2013, Gilead settled a lawsuit with Teva Pharmaceuticals, which had planned to create a generic drug using tenofovir disoproxil fumarate, a prodrug of tenofovir. This would have eaten into the profits Gilead made from that drug under the name Viread.
After the settlement, Teva agreed not to launch the generic until 2017, while Gilead agreed to give Teva a head start before it launched its own generic version of the drug. They struck a similar settlement in 2014, with Teva agreeing to wait to launch generic versions of Truvada and Atripla until 2020.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In both cases, the insurers are seeking a permanent injunction, a declaration that the companies’ conduct violates antitrust laws, and treble damages.
In an emailed statement, Gilead senior director of media relations Chris Ridley said the lawsuit “distorts and misstates Gilead’s history, its collaborations with its partners, and its settlement agreements.”
“Gilead believes this lawsuit and its antitrust allegations are without merit,” he wrote.
This isn’t the first time Gilead has faced antitrust lawsuits related to these agreements. Earlier this year, CVS and Rite Aid sued Gilead, Bristol-Myers Squibb and Teva, alleging that they suppressed and delayed generic competition for Gilead’s HIV drugs.
Meanwhile, combination antiretroviral drugs for HIV remain costly, and roughly 1.2 million people in the U.S. have HIV. A month’s supply of brand-name Truvada still costs more than $2,000, according to GoodRx, while Atripla costs just shy of $4,000. According to the lawsuits, many of these medications cost less than $10 to produce.
The cases, both filed in the U.S. District Court for the Northern District of California, are:
- Humana Inc. v. Gilead Sciences, Inc. et al
- Centene Corp. v. Gilead Sciences, Inc. et al
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