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Orange Book Listings Under Scrutiny: What’s In, What’s Out, and Why It Matters

January 1970

Abstract

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 Hatch-Waxman Act requires innovative drug companies to list certain patents covering their FDA-approved products in the Orange Book, and requires generic drug companies to certify how their drugs relate to those listed patents when seeking regulatory approval. A critical feature of this system is that, under certain circumstances, the listing of a patent in the Orange Book can lead to an automatic 30-month stay of FDA approval for the generic drug. This statutorily-mandated delay in generic approval provides significant market protection for innovator companies that would otherwise be irreparably harmed by generic entry prior to expiration of properly-listed patents.

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 Tom Irving
Tom Irving
Partner, Marbury Law Group, USA

Tom Irving has some 48 years of experience in intellectual property law. His U.S. pharma practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, reissue, and reexamination. In addition to advising on procuring strong U.S. patents, Tom counsels clients on a wide range of mainly pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability, supplemental examination, and validity analysis, including Obviousness-Type Double Patenting and Safe Harbor protection under 35 U.S.C. section 121.. He has served as lead counsel in numerous patent interferences, reissues, and reexaminations; as lead counsel in numerous AIA post-grant proceedings; and as an expert witness in patent litigation and patent procurement.

Portrait image of Michelle E. O'Brien
Michelle E. O'Brien
Partner, Marbury Law Group, USA

Michelle E. O’Brien has more than 20 years of experience representing both domestic and foreign clients of all sizes in the areas of patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of Ms. O’Brien’s technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products including new chemical entities and formulations, as well as novel solid forms including polymorphs, cocrystals, and amorphous forms of compounds. Ms. O’Brien’s expertise includes all aspects of preparing and prosecuting U.S. and foreign patent applications, such as patent drafting and prosecution, as well as more complex matters such as reissue and reexamination proceedings, appeals hearings, Post-Grant Reviews (PGR), and Inter Partes Reviews (IPR) before the Patent Trial and Appeal Board (PTAB). Her litigation expertise focuses on patent infringement cases including, for example, Hatch-Waxman litigation involving Abbreviated New Drug Applications, and includes all stages from pre-discovery through trial. Ms. O’Brien’s current practice includes building and maintaining clients’ patent portfolios, as well as analyzing competitors’ patent portfolios, preparing patentability, validity, and infringement opinions, conducting pre-litigation and product-clearance analyses, challenging and defending patents in post-grant proceedings before the PTAB (PGRs and IPRs), and litigating patent infringement lawsuits. Ms. O’Brien also provides pre-litigation counseling to clients in order to maximize the value of their patent portfolios and avoid the valid rights of others, relying on her broad background and extensive experience. Ms. O’Brien also lectures both domestically and abroad on various patent law topics, such as inventorship, inequitable conduct, Patent Term Extension (PTE) and Patent Term Adjustment (PTA), and patenting and litigating solid forms of compounds.

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.

Marbury Law Group logo

Marbury Law Group

Marbury Law Group: STRATEGIC INTELLECTUAL PROPERTY COUNSELING Marbury attorneys transform your ideas and innovations into valuable IP assets. Our attorneys manage large, medium, and small patent portfolios, and recognize your need for prompt, high quality strategic advice. We help start-up and emerging technology companies leverage their intellectual assets to achieve their business goals. In fact, many of our team members have worked at start-ups, and understand the demands facing start-up and emerging technology companies. Our attorneys work with your technical personnel to harvest potential intellectual property from your innovative development work. We have the technical skills to understand your technology and how your innovations can provide you with competitive advantages. Our diverse technical backgrounds, graduate engineering degrees, former industry, and USPTO experience allow us to quickly grasp, describe, and claim the inventions in your patent applications. Our lower overhead allows us to offer flat fees and keep our billing rates significantly lower than those of “big-law” firms, which allows us to take the time to understand the technology behind each invention and to provide cost effective answers, strategies, and patent applications. Furthering your business is our priority. Your business plan becomes the focus of our IP counseling and strategic advice. Let us put our knowledge and experience to work for you.

Marbury Law Group

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