Book
My book is The US Patent System: A Practical Guide to the Law, Practice and Procedure, published by Edward Elgar in April 2026. It provides a practical overview of important aspects of U.S. patent law, practice, and procedure, and is intended as a useful guide for those working with the patent system. It reflects both long experience in patent practice and more recent work in invention development and intellectual property strategy.
Michael A. Sanzo
The US Patent System: A Practical Guide to the Law, Practice and Procedure
Edward Elgar
ISBN: 978-1-03538-266-8
Publication date: April 2026
Selected Publications
The following publications are a selective sample of my writing in patent law, biotechnology, and science.
Legal
Sanzo, M.A., The Promise and Problem of Biologics, Santa Clara High Tech. L.J. 34(1):78-109 (2017). A legal and policy analysis of biologics and biosimilars, examining why these therapies are both medically promising and economically challenging, and proposing ways to improve incentives for affordability and innovation.
Sanzo, M.A., Halloween Special: Cheating the Grim Reaper and Patenting the Process, IPWatchdog (Oct. 31, 2024). A short essay using historical “safety coffin” patents to illustrate how inventions are often shaped not only by practical needs, but also by the fears and preoccupations of their time.
Sanzo, M.A., The Patenting of Gene-Based Diagnostic Assays in a Post Mayo and Myriad World, The John Marshall Review of Intellectual Property Law · Jan (2016). An analysis of how Supreme Court decisions have affected the patenting of gene-based diagnostic methods and the broader implications for diagnostic biotechnology companies.
Sanzo, M.A., The Status of Patent Eligibility in the Area of Biotechnology: Practical Considerations for Patent Prosecutors, Biotechnology Law Report 35(5):225-238 (2016). The article analyzes how the Supreme Court’s Mayo, Myriad, and Alice decisions, and their application by the Federal Circuit culminating in CellzDirect, have reshaped patent eligibility in biotechnology. It offers practical drafting strategies for prosecutors navigating an increasingly restrictive §101 landscape.
Sanzo, M.A., Antitrust Law and Patent Misconduct in the Proprietary Drug Industry, Villanova Law Review 39:1209 (1994). An examination of how antitrust law addresses patent misconduct in the proprietary pharmaceutical industry, including fraud in patent procurement, tying arrangements, anticompetitive licensing restrictions, and improper patent acquisitions and cross-licensing practices.
Scientific
Sanzo, et al., Isolation of a protein fraction which binds preferentially to chick middle repetitive DNA, Biochemistry 23:6491–6498 (1984).
Sanzo, et al., Binding of tissue plasminogen activator to human aortic endothelial cells, Biochemical Journal 269:475–482 (1989).
Sanzo, M.A., “The use of competitive affinity chromatography for the isolation of proteins which promote transcription,” Journal of Biochemical and Biophysical Methods 21:185–196 (1990).
Links to Selected References
US Patent System- Principal Chapters
The Promise and Problem of Biologics
Halloween Special: Cheating the Grim Reaper and Patenting the Process
The Patenting of Gene-Based Diagnostic Assays in a Post Mayo and Myriad World
Antitrust Law and Patent Misconduct in the Proprietary Drug Industry