Over the weekend I read the new, third edition of "The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management," by Martin A. Voet ($28.95 at Amazon). Mr. Voet was formerly Senior Vice President and Chief Intellectual Property Counsel for Allergan.
Like the first two editions, the book is short (162 pages), easy to read, and packed with information about patent law and FDA regulations relating to innovator and generic pharmaceuticals. With the third edition, published earlier this year, the book has been updated to include discussions of the Biologics Price Competition and Innovation Act, which established a pathway for the approval of biosimilars; the pending patent reform legislation; and recent court decisions such as Novo Nordisk (NYSE:NVO) v. Caraco (NYSEMKT:CPD), concerning Patent Use Codes, and Ortho-McNeil v. Lupin, concerning patent term extensions.
I highly recommend this book to anyone working in the legal, regulatory, business development and R&D groups at pharmaceutical companies--both innovator and generic. Outside counsel working in this field will also find the book helpful, as it concisely ties together many disparate legal and regulatory considerations that are critically important to pharmaceutical companies.
The Chapter list is as follows:
- Overview of Patents
- Patent Enforcement and Infringement
- Pharmaceutical, Biological and Medical Device Patents
- Overview of FDA
- Drug Product Exclusivity
- Hatch Waxman Act
- Putting it All Together: Product Life-Cycle Management
- Conclusions and Final Thoughts