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October 30, 2019

Background on the Amicus Brief
On October 25, 2019, eight HIV/AIDS research, policy, and advocacy organizations filed an amicus brief in the U.S. District Court, in San Francisco, CA, in support of the plaintiffs in Staley v. Gilead. (An amicus brief is a brief submitted to the court by someone not a direct party in the case to provide the court with additional information or insight.) The amici curiae (friends of the court) are Treatment Action Group (TAG), AIDS Action Baltimore (AAB), The Foundation for AIDS Research (amfAR), AVAC, Health GAP (Global Access Project), Housing Works, The SERO Project, and The U.S. PLHIV Caucus. The purpose of the brief is to ensure the court understands what happens when pharmaceutical companies use their power to maintain the inflated cost of HIV/AIDS medications by delaying and preventing generic competition.

In May 2019, a number of individuals and organizations filed suit against Gilead, Bristol-Myers Squibb, Janssen, and Japan Tobacco, Inc. The Complaint alleges that the defendant pharmaceutical companies engaged in a number of unlawful anticompetitive practices to delay and prevent generic competition and thereby inflate the prices of cART drugs to unreasonably high levels. Specifically:

  1. Gilead and other pharmaceutical companies included “No Generics” agreements when contracting to create new fixed-dose combination (FDC) pills. This meant neither Gilead nor the other companies would use generic (and thus cheaper) drugs in their FDCs, even after the patents on the component brand name drugs expired.
  2. Gilead deliberately delayed the development of a second prodrug of tenofovir – TAF – for a decade to increase the period of patent exclusivity for both TDF and TAF by including both drugs in the branded FDCs they co-licensed with Bristol-Myers Squibb, Janssen, and Japan Tobacco Inc. Gilead then developed TAF and brought it to market as part of a series of new branded FDCs, claiming that TAF was safer than TDF, and further delaying the market entry of generic TAF.
  3. Gilead included an anticompetitive “Most Favored Entry” clause in a settlement when sued by a generic drug manufacturer. This clause delayed that manufacturer’s ability to market a generic drug and discouraged other manufacturers from challenging Gilead’s patents. By limiting the number of generic drugs on the market, Gilead ensured both generic and brand name drug prices remained higher than necessary.

In September 2019, Defendants filed motions to dismiss (MTDs). They argued that even assuming Plaintiffs’ allegations are true, they are insufficient to state a valid legal claim against the Defendants.

The amici HIV/AIDS research, policy, and advocacy organizations’ brief was submitted in support of the Plaintiffs’ opposition to the motions to dismiss and to provide the Court will additional context as it decides whether to allow the case to proceed..

What does the amicus brief say?
The amicus brief gives the Court a better understanding of the wider context of the case that the Plaintiffs and Defendants would not otherwise provide. It discusses the ongoing HIV epidemic in the United States (1M+ living with HIV; ~40,000 new diagnoses a year), the relationship between cheaper drug prices and better personal and public health outcomes, and the link between generic competition and lower drug prices. The brief highlights the critical fact that high drug prices are one of the primary reasons why only 53% of people living with HIV in the U.S. achieve viral suppression, markedly less than comparable developed countries. Furthermore, financial barriers to access are one of the main reasons why only 10% of the people who could benefit from preventive HIV treatment use it. High drug prices are especially burdensome for communities of color and people living in the South; these communities and areas experience disproportionately high rates of new infections and progressive HIV disease.

Finally, the brief supports Plaintiffs’ argument that the Defendants’ actions directly contributed to this untenable status quo in the U.S. HIV drug market – a status quo characterized by high prices, fewer options, and reduced innovation. The brief urges the Court to allow the case to proceed because the allegations are sufficient to state a valid legal claim that Gilead and its co-defendants engaged in unlawful anticompetitive actions to delay and prevent generic competition in the US combination antiretroviral therapy (cART) market.

Along with the brief, amici filed a motion asking the judge to allow the filing of the brief (a necessary step for amicus briefs in a case like this). The Defendants, with the exception of Japan Tobacco, indicated that they had no objection to the filing of the amicus brief; Japan Tobacco declined to consent to the filing.

Why did we file the amicus brief?
First, it is extremely important for the court to understand the real-world implications of this case and how many people are directly impacted by Gilead and its co-defendants’ actions. This isn’t hypothetical harm; real people are being injured.

Second, showing the judge there is strong outside interest will drive home the wider social importance of the case.

What could happen with Defendants’ Motions to Dismiss?
Defendants have filed Motions to Dismiss. They argued that even if Plaintiffs’ alleged facts are assumed to be true, they are insufficient to establish a legal case against the Defendants. Plaintiffs have filed an opposition to these motions to dismiss; the amici brief supports this opposition. Judge Chen has scheduled oral argument on these motions for January 16, 2020. Amici do not have the opportunity to present at oral argument.

A court will generally issue its ruling on a motion to dismiss anywhere between a few weeks to several months after oral argument. There are three potential outcomes at this juncture. Judge Chen could:

  • Grant Defendants’ Motions to Dismiss, with prejudice. This means that the case is over, though Plaintiffs can appeal.
  • Grant Defendants Motions to Dismiss, without prejudice (with leave to amend). This means that Plaintiffs have the opportunity to revise their Complaint to address the judge’s concerns, then refile the case.
  • Deny Defendants Motions to Dismiss

What happens if Defendants’ Motions to Dismiss are denied?
If the Motions to Dismiss are denied, the case will move forward to discovery. Discovery is the phase of litigation where the parties develop the factual record through requesting large numbers of documents from each other, taking depositions of company executives, etc. Discovery can take many months; in this case the parties have suggested that discovery is unlikely to be complete before at least the beginning of 2021.

After discovery is complete, the plaintiffs and defendants will likely both file for summary judgement. In motions for summary judgment, the parties argue that, given the set of undisputed facts that have been revealed in discovery, they are entitled to win as a matter of law. Amicus briefs at the trial court level are more commonly filed at the summary judgment stage. So, if this case reaches that stage, it could present another opportunity for amici to file a brief (whether Judge Chen accepts the current brief or not).

There are two potential outcomes at the summary judgment stage:

  • Either side could win, followed by appeals
  • Neither side could win, meaning the case will proceed to trial

What role, if any, will amici and potential new amici play during discovery?

Amici cannot participate in the official discovery process. However, amici could submit another brief at the close of discovery once the parties have moved for summary judgment.

More Information
Our counsel at Stanford Law School’s Juelsgaard Intellectual Property and Innovation Clinic, Professor Phillip R. Malone and students Mondee Lu and Annie Wanless, created a webpage for documents relating to the case, including the Consolidated Class Action complaint; the Defendants’ motions to dismiss (MTD) the complaint; the Plaintiffs’ opposition to the MTDs; redacted versions of the original agreements between Gilead, Bristol-Myers Squibb, Japan Tobacco, Inc. (JTI), and Janssen; and our amicus brief and motion to file. This page will be updated as needed.

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