Pharmaceutical and Biotech Patent Law (2026) provides the necessary legal, scientific, and technical information to allow practitioners to help clients obtain, defend, and challenge patents in these important areas of business. Packed with detailed checklists and regularly updated to reflect emerging changes in the field, this treatise helps readers navigate complex and thorny patent problems in the complex pharmaceutical and biotech fields.
Highlights of this new edition include:
- An expanded discussion of the concept of inventorship, with further analysis of “factual uncertainty” and “general uncertainty surrounding experimental science” in relation to the Federal Circuit’s 2025 decision in Regents of the University of California v. Broad Institute, Inc. (Section 4:1.2)
- Updates to Chapter nine, including notes on the Federal Circuit’s lesson regarding the binding nature of statements made during the prosecution of Azurity Pharmaceutical v. Alkem Laboratories which disavow claim scope (Section 9:2.3) and a discussion of the relevance of separately claimed elements (Section 9:3.4)
- Broader coverage of cell and gene therapy disputes, including an update in the Regenxbio Inc. v. Sarepta Therapeutics, Inc. Litigation and a synopsis of Restem, LLC v. Jadi Cell, LLC. (Section 14:3.3)
- The addition of Chapter 16, Patent Issues Relating to Diagnostics
- Updates to the Table of Authorities and Index
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