The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Sixth Edition)

Cover
BrownWalker Press, 01.05.2020 - 240 Seiten
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
 

Ausgewählte Seiten

Inhalt

Introduction
1
Patent Enforcement and Infringement
55
Medical Device Patents
76
Exclusivity for Brand Name
101
Hatch Waxman Act
115
Generics for Biologic Drugs
151
Product Hopping Patents 166
166
Orange Book Listing and Delisting
175
Take Home Message
192
Glossary of Terms
199
Index
211
Urheberrecht

Andere Ausgaben - Alle anzeigen

Häufige Begriffe und Wortgruppen

Autoren-Profil (2020)

Martin A. Voet was formerly Senior Vice President and Chief Intellectual Property Counsel for a Fortune 500 pharmaceutical company with over 25 years of experience. He is currently Adjunct Professor at USD School of Law and consultant to the pharma industry. He has degrees in chemistry, business and law, coupled with practical experience in patenting pharmaceutical and biological products, litigating with generic companies and providing hands-on planning for pharmaceutical product Life-cycle Management.

Bibliografische Informationen