Work with Universities Allied for Essential Medicines (UAEM) to expand public access to valuable scientific data
UAEM is a global, student-driven, nonprofit, grassroots organization focused on health justice, including protecting and expanding access to medicines and ensuring that universities’ biomedical research efforts serve the public interest. One important element of UAEM’s work is pushing universities—and drug companies, government labs, and other entities that conduct clinical trials—to share the results of their trials with the public, via the ClinicalTrials.gov website, as a 2007 federal law requires. In the winter of 2021, UAEM and the NYU TLP Clinic partnered in a Freedom of Information Act (FOIA)-based investigation of the (so-far meager) efforts of the Food & Drug Administration (FDA) and National Institutes of Health (NIH) to enforce that federal law. In April 2021, the FDA announced it had finally undertaken a long-overdue, first-of-its-kind enforcement action.
Media: STAT News (April 28, 2021).
Work with PrEP4All to expand access to HIV medicines & COVID-19 vaccines
PrEP4All is a group of activists, scientists, and healthcare providers dedicated to igniting political action to put life-saving HIV and COVID-19 medications into the hands of everyone who needs them.
A centerpiece of PrEP4All’s work is demanding wider access to a once-a-day pill that prevents HIV infection: HIV prophylaxis, also known as “PrEP.” The NYU TLP and Yale MFIA and GHJP clinics currently represent PrEP4All in this effort.
In March 2019, PrEP4All and the Yale clinics helped break the story that it is the Centers for Disease Control and Prevention (CDC), a public agency, that invented and patented HIV PrEP, not Gilead Sciences, Inc., the drug company that holds a monopoly on PrEP in the United States.
In December 2019, PrEP4All and the NYU clinic filed a petition challenging Gilead’s applications for patent term extension on U.S. Patent Nos. 7,390,791 and 7,803,788, which cover Descovy and other HIV drugs that contain tenofovir alafenamide (TAF).
In January 2021, PrEP4All and the NYU clinic jointly published a report, “§ 1498: A Guide to Government Patent Use.” The report, subtitled “A Path to Licensing and Distributing Generic Drugs,” provides practical information on how the U.S. government can use a long-standing U.S. federal statute, 28 U.S.C. § 1498, to authorize use of any patented technology—including patented HIV drugs—by or for the government and the American public.
Publications and Filings:
- March 12, 2019 Statement on CDC’s Patents for PrEP (and 2-page summary thereof).
- May 16, 2019 Letter of Amy Kapczynski and Christopher Morten to the House Oversight Committee in connection with HOC’s hearing, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments.”
- November 18, 2019 Post in Health Affairs Blog by Christopher Morten and Amy Kapczynski: “United States v. Gilead: Can a Lawsuit Yield Better Access To PrEP?”
- December 4, 2019 Petition to the United States Patent and Trademark Office challenging Gilead’s applications for patent term extension on U.S. Patent Nos. 7,390,791 and 7,803,788.
- December 9, 2019 Petition to the United States Patent and Trademark Office.
- January 2021 report, “§ 1498: Guide to Government Patent Use. A Path to Licensing and Distributing Generic Drugs.”
- March 2021 white paper, “Recommendations for Statutory Reform of the Patent Term Extension System to Increase Public Accountability and Fight Soaring Drug Prices.”
Media: Washington Post (March 26, 2019), STAT News (April 10, 2019), Washington Post (April 24, 2019), Bloomberg News (May 17, 2019), STAT News (July 2, 2019), Financial Times (August 18, 2019), Washington Post (November 7, 2019), NBC News (November 7, 2019), New York Times (November 8, 2019), Science (November 8, 2019), Washington Post (December 5, 2019), STAT News (December 6, 2019), The Guardian (December 9, 2019), STAT News (December 12, 2019), STAT News (December 13, 2019), Life Sciences Intellectual Property Review (December 16, 2019), STAT News (January 26, 2021).
Coalition Letter: January 31, 2020 letter of the Treatment Action Group (TAG) and 30+ advocacy and civil society groups in support of PrEP4All’s December 4, 2019 petition.
- COVID-19 treatments:
In May 2020, PrEP4All and the NYU clinic published a report, “The U.S. Government’s Apparent Co-Ownership of Patents Protecting Remdesivir,” showing that the U.S. government likely co-invented and co-owns core patents on the COVID-19 treatment remdesivir.
Media: Washington Post (May 26, 2020), Law360 (May 27, 2020), The Intercept (June 2, 2020), BMJ (June 3, 2020), New York Times (July 28, 2020), CNN.com (September 9, 2020), STAT News (December 7, 2020), San Francisco Chronicle (January 27, 2021).
- July 2, 2020 Op ed by Christopher Morten, Christian Urrutia, and James Krellenstein in STAT, “A powerful law gives HHS the right to take control of remdesivir manufacturing and distribution.”
- COVID-19 vaccines:
In April 2021, the NYU clinic published a report, “U.S. 10,960,070: The U.S. Government’s Important New Coronavirus Vaccine Patent,” that analyzes a foundational patent on coronavirus vaccines owned by the U.S. government. The report concludes that Moderna is infringing the patent and that the company could owe the U.S. government damages in excess of $1 billion, based on Moderna’s 2021 revenue projections alone.
Publication: “U.S. 10,960,070: The U.S. Government’s Important New Coronavirus Vaccine Patent” (April 14, 2021).
Media: New York Times (March 21, 2021), Washington Post (March 25, 2021), STAT News (March 25, 2021), Financial Times (April 21, 2021), Common Dreams (April 23, 2021), LA Times (April 30, 2021).
Coalition Letter: On March 24, 2021, a coalition of six organizations (led by PrEP4All) and 15 leading experts on public health and health policy sent a public letter to HHS, NIH, and NIAID, calling on them to leverage the NIH’s coronavirus patent to expand access to COVID-19 vaccines.
Seife v. Food and Drug Administration et al., No. 1:17-cv-3960 (S.D.N.Y.), No. 20-4072 (2d Cir.)
Pending litigation with Yale MFIA and the First Amendment Clinic at Cornell Law School on behalf of Charles Seife against the Food and Drug Administration under the Freedom of Information Act. The suit seeks clinical trial data on a controversial prescription drug, Sarepta’s eteplirsen (Exondys 51) product, and addresses the proper scope of information that may be withheld by federal agencies as trade secrets and “confidential commercial information.”
Comment submitted to HHS, identifying a gap in the HIPAA Privacy Rule that subjects transgender and other people to discrimination in health care
In April 2021, Ethan Lin (JD ’21) of NYU’s Technology Law & Policy Clinic submitted a public comment to the Department of Health of Health & Human Services (HHS) concerning the Health Insurance Portability & Accountability Act (HIPAA) Privacy Rule. The comment identifies an important gap in the existing rule: it permits, and encourages, frictionless sharing of protected health information from health care provider to health care provider, without notice or consent to patients. For many patients, opting out is effectively impossible. Because protected health information, such as prescription drug records, can “out” transgender, HIV+, and other people disproportionately subject to discrimination from health care providers, it can discourage them from seeking care. The comment recommends revisions to the HIPAA Privacy Rule to correct the gap.
Counseling the Open Source Hardware Association (OSHWA) on Intellectual Property Matters
During the Spring 2021 Semester, two student attorneys in the Technology Law and Policy (TLP) Clinic at NYU Law—Arthi Naini (’22) and David Wechsler (’21)—represented the Open Source Hardware Association (OSHWA) and counseled the organization on intellectual property matters. Naini and Wechsler advised OSHWA on updates to its open source hardware certification program. Wechsler (with support from Naini) also co-wrote a blog post with Michael Weinberg, a member of OSHWA’s board of directors, on the popular patent law blog PatentlyO. The blog post was sparked by a recent Federal Circuit decision, GlaxoSmithKline v. Teva, that suggested an interpretation of patent law that could be detrimental to OSHWA, its members, and the broader open source community.
Helping the Internet Archive Answer Congressional Questions on the Digital Millennium Copyright Act (DMCA)
In the Fall 2020 semester, student attorneys in the NYU School of Law Technology Law and Policy (“TLP”) Clinic helped the Internet Archive prepare and submit answers to questions from U.S. Senator Thom Tillis on potential reforms of the Digital Millennium Copyright Act (“DMCA”). Internet Archive’s answers stressed the importance of the DMCA’s safe harbor provisions to it and other nonprofit digital libraries.
Clinical Trial Cost Transparency at the National Institutes of Health: Law and Policy Recommendations
This August 2020 white paper by NYU Technology Law & Policy Clinic student attorneys Ariella Barel (NYU Law ’20) and Laurel Boman (NYU Law ’21) explains why and how the National Institutes of Health can and should begin to share disaggregated data on the costs of the clinical trials it runs and funds. It also explains how Congress could legislate to make cost sharing mandatory.
Seife & Lurie v. U.S. Department of Health and Human Services et al., No. 1:18-cv-11462 (S.D.N.Y.)
Successful litigation with the NYU Technology Law & Policy Clinic and Yale MFIA on behalf of Charles Seife and Peter Lurie against the Food and Drug Administration, National Institutes of Health, and Department of Health and Human Services under the Administrative Procedure Act. Our court victory expanded the public’s legal right to obtain information on clinical trials of prescription drugs and medical devices via the ClinicalTrials.gov website.
Media: STAT News (December 11, 2018), Law360 (December 10, 2018), FDALawBlog (December 11, 2018), STAT News (February 25, 2020), Endpoints News (February 26, 2020), Science (February 26, 2020), BMJ (March 2, 2020), National Law Review (March 5, 2020), FDALawBlog (March 9, 2020), Law360 (March 16, 2020), NYU Scope (April 3, 2020), STAT News (August 4, 2020), STAT News (August 18, 2020), BMJ (August 24, 2020), AJMC (February 2021).
The Andy Warhol Foundation v. Goldsmith, No. 19-2420 (2d Cir.)
On February 28, 2020, the NYU Law Technology Law & Policy Clinic filed an amicus brief on behalf of artists Latipa (née Michelle Dizon) and Việt Lê. The brief, filed in support of appellee the Warhol Foundation, explains why fair use in copyright law should protect—and, indeed, does already protect—a broad range of artistic and cultural practices that includes critique and recontextualization.
Google LLC v. Oracle America, Inc., No. 18-956 (U.S. Supreme Court)
On January 13, 2020, the NYU Law Technology Law & Policy Clinic filed a merits-stage amicus brief on behalf of a coalition of small, medium, and open source technology organizations led by Mozilla in Google v. Oracle. The brief, filed in support of petitioner Google, asks the Supreme Court to reverse the Federal Circuit’s holdings that copyright law stands in the way of reimplementation. Our brief explains how the Federal Circuit’s decisions harm competition, particularly small and open source developers, and conflict with longstanding copyright precedents.
Media/Blogs: Mozilla Blog (January 13, 2020), The Hill (January 13, 2020), ADTmag (January 14, 2020)
In re Avandia Marketing, Sales Practices & Products Liability Litigation, No. 18-2259 (3d Cir.)
In November 2018, Yale’s Collaboration for Research Integrity and Transparency (CRIT) and Public Justice filed a joint amicus brief arguing that documents that likely contain information on GSK’s false marketing of its diabetes medication rosiglitazone (Avandia) should be unsealed and made available to the public. The Third Circuit issued a favorable decision in May 2019, clarifying the legal standard for sealing and reaffirming the public interest in access to court documents.
Preventing the Use of Courts to Shield Essential Health Information: Rethinking Confidentiality in Medical Product Litigation
This white paper edited by Jeanie Kim and Margaret McCarthy provides a guide for lawyers seeking to fight overprotection of secrecy in pharmaceutical and other medical product cases.