Pharmaceutical, Biological and Chemical Patents: Why “Small” Technical Details Decide Big Legal Outcomes
In pharmaceutical, biotechnology, and chemical innovation, patents are not merely legal instruments—they are strategic assets that define market exclusivity, research investment protection, and long-term competitive advantage. In Europe especially, where patent interpretation can hinge on highly technical scientific distinctions, understanding the legal framework behind substance protection is essential.
Pharmaceutical, Biological and Chemical Patents: A Handbook, published by Hart Publishing in January 2026, provides a focused and practical analysis of how patent law applies to complex scientific inventions. It examines key legal questions such as novelty, scope of protection, and how structural variations—including polymorphism and enantiomerism—are evaluated under European and German patent law.
Why this handbook is particularly relevant today
The pharmaceutical and biotechnology sectors are undergoing rapid transformation, driven by advances in molecular engineering, personalized medicine, and global regulatory harmonization. As companies develop new formulations and therapeutic uses, the legal interpretation of “novelty” and “state of the art” becomes increasingly critical.
This handbook helps professionals understand how even subtle differences in molecular structure can influence patent validity and enforceability. It also addresses second medical use patents, a topic of growing importance as existing compounds are repurposed for new therapeutic applications.
Practical value for legal and scientific professionals
Based on European and German jurisprudence, the book provides clear explanations supported by case law examples and real-world scenarios. It is particularly valuable for patent attorneys, in-house counsel, pharmaceutical companies, biotechnology firms, and institutional libraries supporting advanced research and legal practice.
For organizations operating in or entering the European market, this handbook offers essential guidance for navigating the intersection between scientific innovation and legal protection.
Book details
Title: Pharmaceutical, Biological and Chemical Patents: A Handbook
- Authors: Marco Stief, Maximilian Haedicke, Annelie Wünsche
- Publisher: Hart Publishing
- Published: January 2026
- Format: Hardback
- Language: English
- ISBN: 9781849464901
Who should read it
Patent attorneys, intellectual property lawyers, pharmaceutical and biotechnology professionals, in-house counsel, legal researchers, and academic or institutional libraries building advanced IP and life sciences collections.
If your organization is involved in developing, protecting, or commercializing pharmaceutical, biological, or chemical innovations—particularly in Europe—this handbook is an essential reference.
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