[Book Review] Pharmaceutical, Biological and Chemical Patents: A Handbook
Jocelyn Bosse
[Book Review] Pharmaceutical, Biological and Chemical Patents: A Handbook
Jocelyn Bosse Monday, August 03, 2026 - Book review, Germany, Jocelyn Bosse, patents, pharmaceutical patents
This is a review of the book, Pharmaceutical, Biological and Chemical Patents: A Handbook (Hart Beck Nomos 2026), by Marco Stief, Maximilian Haedicke and Annelie Wünsche.
It's not obvious until you move past the cover, but the book focuses on German patent law. It draws on the relevant principles laid down in the German Patent Act (Patentgesetz - PatG) and the European Patent Convention (EPC), as interpreted by the case law from the Federal Court of Justice (Bundesgerichtshof – BGH) and regional courts. The case law discussed in the book is current up to March 2025.
The book is available in hardback.
This volume follows an earlier German-language version of the book published in 2022. With its market size and high litigation volume, Germany plays a major role in the development of patent law and has a growing influence on the development of European and international patent law. However, the authors emphasise that the international impact of German case law can be hindered by the language barrier, which motivated their efforts to produce this English-language volume.
Structure of the Book
Just as the German courts are known for their bifurcation, with patent validity and infringement addressed in separate proceedings, these topics are tackled in separate parts of the book. Translations of the key PatG provisions appear at the start of each section, alongside any relevant EPC provisions.
Part I of the book focuses on the requirements for a valid patent, including the case law on technical character, novelty, inventive step, and enabling disclosure. The book provides extra detail on the aspects of these requirements that are relevant to its pharmaceutical and life sciences subject matter, such as the case law on dosage regimens and second medical use patents. The key case law comes from the BGH.
Part II examines the rules on patent infringement, including interpretation of the claims and the scope of protection (including the doctrine of equivalents), what constitutes "use" of the patented subject matter, remedies, and further detail on injunction proceedings. The jurisprudence in this part comes from the BGH as well as the regional courts.
Since the book dedicates much of its attention to pharmaceuticals, and the earlier version of the book was developed during the COVID-19 pandemic, it appropriately dedicates the shorter Part III to the case law on compulsory licensing. Although this is a popular topic of academic and political debate, there has only been a small number of cases in Germany, but these decisions provide useful guidance on the requirements for the grant of a compulsory licence and how the courts assess equitable remuneration. Part III closes with some brief remarks about the alternative measure of suspending patent rights in the interests of public welfare and security; by comparison, compulsory licences are clearly the milder remedy to address future epidemics or emergencies.
These first three parts make up less than 300 pages. The bulk of this large volume comprises English translations of the key cases that were referenced throughout the first three parts. The cases appear in alphabetical order and contain the full details of the outcome, facts, and reasoning of the court.
Comments
This volume will be a very useful resource for any readers who are interested in understanding the German patent law principles, whether for scholarly interest or international practice. However, it is clear that patent practitioners are the main audience for this work.
The book has a consistent, well-signposted structure to each section. This means that a person in a hurry to discover how the German courts have dealt with a particular legal issue will be able to navigate the book quickly to locate their answer - if the courts have provided one - with the full details of the court's reasoning. The volume also includes a good amount of the technical detail underpinning each case, which will be useful for comparing fact patterns.
The contents of the book are driven by the German case law, drawing on European decisions where appropriate, to elaborate on the statutory principles as they relate to pharmaceutical, (bio)chemical and life science patents. Perhaps the only downside of this approach is that aspects of the PatG with no German case law receive scant attention in the book.
This is not a criticism: the authors set out to provide access to German jurisprudence to an English speaking audience. It is not their fault if litigation has not produced judgments in these fields, and it would exceed their stated purpose to venture beyond the doctrinal analysis and into the domain of academic argumentation or comparative analysis. But it does mean that the discussion is dominated by patents for pharmaceuticals and healthcare without much to say about other areas of biology and the life sciences that are highly active but less litigious in Germany, such as plant breeding. It should also be noted that supplementary protection certificates (SPCs) are beyond the scope of the book, with only occasional references to SPCs in certain key cases.
These gaps are the necessary result of the authors choosing their areas of focus and sticking to them, rather than getting distracted by topics that are beyond the scope of their brief. This allows the book to be comprehensive in its chosen subject matter and jurisdiction, which is ultimately to its strength. The authors have definitely succeeded in producing a book that will improve the understanding of the German patent law amongst the English-speaking patent community. Gut gemacht.
Details
Publisher: C.H. Beck, Nomos, Hart
Extent: 1250 pages
Format: Hardback
ISBN: 9781849464901 (Hart), 9783406648557 (C.H. Beck), 97833848703005 (Nomos)
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