Abstract: Are Risk Evaluation and Mitigation Strategy (REMS) patents Orange Book listable (or even should be)? A straightforward question with a lot of disagreement. This paper discusses recent litigation on...Read more
The Food and Drug Administration’s (FDA) Orange Book, officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, plays a key role in the U.S. pharmaceutical patent and exclusivity system. The...Read more
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.
