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Wednesday, March 27, 2019
GHJP Joins PrEP4All in Calling on CDC To Use Its Patents for PrEP
On March 27, 2019, the Yale Global Health Justice Partnership (GHJP) joined the PrEP4All Collaboration (PrEP4All) in calling on the Centers for Disease Control and Prevention (CDC) to use its patents on HIV pre-exposure prophylaxis (PrEP) to promote universal access to PrEP within the United States. GHJP and PrEP4All call on the CDC to stop letting its patents for PrEP, a public asset, go to waste while the HIV AIDS epidemic continues. They also state that the CDC could and should force Gilead Sciences, Inc. (Gilead), the maker of Truvada tablets, to take a license to these patents and pay a royalty to the U.S. government, and that the resulting royalty revenue should be used to promote public access to PrEP.
HIV/AIDS remains a public health crisis in the U.S. and around the world. There is no cure or vaccine, but a pill combining two HIV drugs, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), effectively prevents infection if taken once daily. Gilead sells such a pill under the brand name Truvada. Yet fewer than 10% of at-risk individuals in the United States receive Truvada PrEP. The primary barrier is price: Gilead charges over $2,000 per month for pills that cost less than $6 per month abroad.
Yet it was CDC, not Gilead, that first discovered that the combination of FTC and TDF successfully prevents HIV infections. And it is CDC, not Gilead, that owns patents on the method of preventing HIV in an HIV-negative individual with Truvada.
GHJP, in conjunction with attorneys from the Media Freedom and Information Access (MFIA) Clinic at Yale Law School, partnered with PrEP4All to evaluate the CDC’s patents for PrEP. Christopher Morten, a licensed patent attorney, Fellow at GHJP, and Lecturer in the MFIA Clinic, prepared a statement that presents detailed analysis of the patents.
“As explained in the statement, the CDC’s patents for PrEP appear to be valid and enforceable,” Morten said. “Moreover, the CDC’s patents appear to cover the method of preventing HIV in an HIV-negative individual by taking a daily tablet of Truvada—precisely the method that Gilead instructs physicians and users of PrEP to follow.”
GHJP has also prepared a two-page summary of Morten’s statement on the CDC’s patents.
“The CDC was the one that ‘invented’ this means to prevent HIV infections, and the public is being deprived of the benefits of that investment.”—Professor of Law and Faculty Co-Director of GHJP Amy Kapczynski
The CDC’s patents for PrEP do not expire until 2027 and beyond. “The CDC was the one that ‘invented’ this means to prevent HIV infections, and the public is being deprived of the benefits of that investment. These patents give the CDC the power to bring prices down, because Gilead needs its permission to sell this drug,” said Amy Kapczynski, Professor of Law at Yale Law School and Faculty Co-Director of GHJP. “If the CDC asserted its patents against Gilead, the revenue generated could be used to fund a program to create universal access to PrEP within the United States, which could dramatically reduce new HIV infections.”
The first of the CDC’s patents for PrEP was granted in 2015, almost four years ago. “The CDC’s continued neglect of this public asset is mystifying,” said Gregg Gonsalves, Assistant Professor at the Yale School of Public Health, Associate (Adjunct) Professor of Law at Yale Law School, and Faculty Co-Director of GHJP. “The CDC must assert its patents, and Gilead must negotiate in good faith with the CDC to reach a licensing agreement.”
GHJP joins PrEP4All in calling on CDC to insist on an agreement that includes at least the following elements:
- Payment by Gilead of royalty revenues not just for future use of the CDC’s patents for PrEP but also for past infringement.
- A licensing structure under which Gilead continues to pay royalties even in the event that Gilead obtains FDA approval for PrEP with a newer branded product, Descovy (emtricitabine and tenofovir alafenamide) tablets.
- A bar prohibiting Gilead from increasing the price of Truvada or Descovy as a result of the licensing agreement.
- Transparent payment of royalties by Gilead and transparent investment of the royalty revenue by CDC.
- Use of CDC’s royalty revenue to fund “wrap-around” services and programs, such as laboratory tests and clinical care, that enable vulnerable Americans to access PrEP.
- Provision by CDC of low-cost PrEP, whether low-cost branded Truvada or a generic alternative, to public health programs and clinics serving vulnerable communities.
On March 26, 2019, the Washington Post published a story that describes Gilead’s apparent infringement of CDC’s patents, GHJP’s analysis of the patents, and PrEP4All’s call for action by CDC.
On May 16, 2019, Kapczynski and Morten submitted a letter to the House of Representatives Committee on Oversight for its hearing “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments.”
The Yale Global Health Justice Partnership (GHJP) is a program hosted jointly by Yale Law School and Yale School of Public Health that tackles contemporary problems at the interface of global health, human rights, and social justice. The GHJP is pioneering an innovative, interdisciplinary field of scholarship, teaching, and practice, bringing together diverse leaders from academia, non-governmental, and community-based organizations to collaborate on research projects and the development of rights-based policies and programs to promote health justice.
The Media Freedom and Information Access Clinic is a law student clinic at Yale Law School dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression by providing pro bono legal services, pursuing impact litigation, and developing policy initiatives. MFIA is a program of the Abrams Institute for Freedom of Expression at Yale Law School, and is funded by the Abrams Institute for Freedom of Expression, the Stanton Foundation, the John S. and James L. Knight Foundation, and the Laura and John Arnold Foundation.