Description
This practitioner's guide walks the practitioner through the stages of drug approval, identifying the critical issues in the process and advising the client about the issues and areas of concern or exploitation. It discusses the areas that impact the interaction of patents and Food and Drug Administration law, including litigation.
Features
- Covers the generic drug industry exclusively, blending generic drug patent and FDA issues
- Dissects each complex issue into its parts and cross-references it to other issues
- Offers a practical guide that includes complete citations to cases
- Provides case studies, illustrations, and timelines
- Provides an excellent teaching tool for associates, partners, law clerks, judges, and financial managers
- Provides comprehensive background in patent and Federal Drug Administration (FDA) regulatory law, integrating them into one cohesive bundle
- Provides step-by-step process for understanding, strategizing, and litigating generic drug patent infringement