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March-In Rights at a Crossroad: What Biopharma Needs To Know Under Trump Administration

Abstract

Few pieces of legislation have shaped the modern innovation landscape as profoundly as the Bayh-Dole Act of 1980. By allowing universities, small businesses, and non-profit organizations to retain ownership of inventions developed with federal funding, Bayh-Dole transformed how research moved from the lab bench to the marketplace. It created a fertile environment for university–industry collaboration and fueled the growth of the biotechnology and pharmaceutical industries, giving rise to some of the most significant medical breakthroughs of the past half century. Yet the same framework that helped build the modern innovation economy now sits at the center of a growing debate over whether its balance between private incentives and public benefit still holds.

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Authors

Portrait image of Joanna Brougher
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA

Joanna is a seasoned patent attorney with deep expertise in biotechnology, pharmaceuticals, and medical devices. Her practice spans the full spectrum of patent law, from preparing and prosecuting U.S. and foreign patent applications to navigating complex proceedings such as Inter Partes Reviews (IPRs) before the Patent Trial and Appeal Board (PTAB). Joanna is dedicated to helping clients develop and protect innovative technologies, providing strategic patent portfolio management, competitive intelligence, freedom-to-operate analyses, and patentability, validity, and infringement opinions. Her work encompasses a diverse range of cutting-edge technologies, including small molecule drugs, biologics, cell-based technologies, drug formulations, delivery systems, immunotherapeutics, medical devices, diagnostic tests, and immunology applications, particularly in vaccines and antibodies. In addition to her legal practice, Joanna serves as an Adjunct Professor at Cornell Law School and the University of Pennsylvania School of Medicine, having previously taught at the Harvard School of Public Health. She frequently lectures on intellectual property topics and is a prolific author, with numerous articles on patent law and healthcare. Joanna has published two books: Intellectual Property and Health Technologies: Balancing Innovation and the Public's Health and Billion Dollar Patents: Strategies for Finding Opportunities, Generating Value, and Protecting Your Inventions. Joanna regularly speaks at domestic and international conferences, addressing critical areas of patent law, such as inventorship determinations, Orange Book listings, and strategies for building strong patent portfolios. Her thought leadership and extensive experience make her a sought-after expert in navigating the complexities of innovation and intellectual property protection in the life sciences.

Portrait image of Bhavya Bhardwaj
Bhavya Bhardwaj
Student, University of Pennsylvania, USA

Bhavya Bhardwaj is a dedicated and innovative graduate student in Bioengineering at the University of Pennsylvania, specializing in the dynamic fields of molecular biology and infectious disease research. With over four years of rich and diverse research experience spanning India and the United States, Bhavya has cultivated deep expertise in cutting-edge molecular diagnostics, immunobiology, and translational medicine. Although not formally specializing in regulatory affairs, Bhavya possesses a keen passion for the intersection of law and life sciences - particularly in patent law, technology transfer, and regulatory compliance. Through visionary interdisciplinary projects and insightful policy discussions such as her impactful work on march-in rights, Bhavya aspires to contribute meaningfully to advancing equitable innovation and fostering responsible, transformative biomedical research.

Companies

BioPharma Law Group PLLC logo

BioPharma Law Group PLLC

BioPharma Law Group, PLLC is a boutique law firm led by Joanna T. Brougher, a seasoned patent attorney with deep expertise in biotechnology, pharmaceuticals, and medical devices. The firm provides comprehensive intellectual property services across the full spectrum of patent law, including U.S. and foreign patent prosecution, strategic portfolio management, competitive intelligence, freedom-to-operate analyses, and patentability, validity, and infringement opinions. Joanna also represents clients in complex proceedings before the Patent Trial and Appeal Board (PTAB), including Inter Partes Reviews (IPRs). The firm supports innovation in a broad range of cutting-edge technologies, from small molecules and biologics to cell-based therapies, immunotherapeutics, medical devices, diagnostics, and vaccine and antibody platforms. In addition to IP matters, BioPharma Law Group advises clients on domestic and international legal and contractual issues related to clinical trials, technology licensing, research collaborations, manufacturing, consulting, and the full suite of agreements that support life sciences R&D and commercialization.

University of Pennsylvania

The University of Pennsylvania (Penn) is a prestigious Ivy League private research university located in Philadelphia, Pennsylvania. Founded in 1740 by Benjamin Franklin, Penn has a rich history as one of America’s oldest institutions of higher learning, committed to advancing knowledge across disciplines. Penn offers world-class education through 12 distinguished schools, including the renowned Wharton School of Business, the School of Engineering and Applied Science, the School of Nursing, and its top-tier School of Medicine. The university is known for its vibrant urban campus, which melds historic and modern architecture, and its commitment to fostering interdisciplinary research and innovation. Penn’s academic environment is enriched by a dedicated faculty, a low student-to-faculty ratio, and a dynamic community of scholars from around the world. With an annual research budget exceeding $1.3 billion, Penn is a global leader in biomedical sciences, technology, social sciences, and the humanities. Penn is equally committed to community engagement and service, offering numerous volunteer opportunities and academic programs that address social challenges. Its alumni and faculty include numerous Nobel laureates, political leaders, and pioneers in various fields, underscoring Penn’s tradition of shaping influential leaders and innovators.

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