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© 2026 International In-house Counsel Journal Ltd. | ISSN 1754-0607 | Picture Credits: Freepix, Unsplash and by permission of the authors

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Orange Book Listings Under Scrutiny: What’s In, What’s Out, and Why It Matters
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
Portrait image of Tom Irving
Tom Irving
Partner, Marbury Law Group, USA
Ways to Avoid Having your Patents Cellected*
Intellectual PropertyPharmaceutical
The Court of Appeals for the Federal Circuit caused frustrations when it decided to affirm the U.S. Patent Office’s findings that claims in four patents were unpatentable because they are...Read more
Portrait image of Tom Irving
Tom Irving
Partner, Marbury Law Group, USA
REMS Patents: Listability and Other Issues
Intellectual PropertyHealthcare
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
Portrait image of Tom Irving
Tom Irving
Partner, Marbury Law Group, USA
A Current Look at the State of Inequitable Conduct and Other Equitable Concerns
Intellectual PropertyPharmaceutical
Inequitable conduct is an “equitable defense to patent infringement that, if proved, bars enforcement of a patent. ” Therasense, Inc. v. Becton, Dickinson & Co. , 649 F. 3d 1276,...Read more
Portrait image of Tom Irving
Tom Irving
Partner, Marbury Law Group, USA