Sarah Gabriele, JD, LLM, MBE

Sarah Gabriele, JD, LLM, MBE

Research Specialist

Sarah Gabriele is a Research Specialist with PORTAL. Her research interests lie at the intersection of competition and innovation, with a particular focus on pharmaceutical policy. She is interested in the impact of patents and patent litigation on competition, access, and innovation, as well as funding dynamics for research and development of new drugs.

Gabriele holds a law degree (JD Equivalent) from the University of Trento in Italy and a Master of Laws (LLM) in intellectual property law from Washington University in St. Louis. She also received a Master of Bioethics (MBE) from Harvard Medical School. At Harvard, she was a student fellow with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. After graduating from law school, she completed a traineeship in intellectual property law at Hogan Lovells in Milan.

Featured Work

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The Strength and Importance of Government-Funded Patents for Approved Drugs

Gabriele SME, Martin MJ, Kesselheim AS, Tu SS - Nature Biotechnology

  • Innovation Incentives and Competition
In this examination of the role of US federal funding in late-stage drug development, 2.5% of small molecule drug patents listed in the FDA Orange Book were found to cite government funding. However, these government-funded patents were more likely to be primary patents and to receive patent term extensions, indicating their strength and value. Recognizing the public’s investment in drug discovery should both inform efforts to address high drug prices and reemphasize the importance of robust federal funding for biomedical research.
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Simple graphic of magnifying glass examining papers to signify reviewing research publications.

Patent Portfolios Protecting 10 Top-Selling Prescription Drugs

Horrow C, Gabriele SME, Tu SS, Sarpatwari A, Kesselheim AS - JAMA Internal Medicine

  • Innovation Incentives and Competition
Nearly 75% of the US patents and patent applications protecting the 10 highest-revenue brand-name drugs in 2021 were filed after FDA approval. These post-approval patents, particularly those on parts of the drug other than the active ingredient, can contribute to dense patent thickets that warrant closer scrutiny by the USPTO to limit delays to generic and biosimilar competition.
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The Problem of Limited-Supply Agreements for Medicare Price Negotiation

Gabriele SME, Feldman WB - JAMA

  • Innovation Incentives and Competition
  • Price, Value, and Access
Limited supply agreements should factor into CMS’ assessment of “bona fide competition” for Medicare drug price negotiation. These agreements, in which a generic manufacturer agrees with a branded drugmaker to release its product at a reduced volume, should be disclosed during price negotiation and should not exempt a drug from negotiation.
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