Generic Challenge:. Martin a. Voet

Experimental Use Exception

       Non-Obvious

       Inventorship

       Proof of Invention

       America Invents Act

       Inter Partes Review (IPR)

       Post-expiration Patent Royalties

       Take Home Message

Chapter 2

Patent Enforcement and Infringement

       Patent Enforcement

       Burden of Proof

       Trials in the U.S.

       Trials outside the U.S.

       Patent Infringement

       Infringement and Validity Opinions

       To Litigate or Not to Litigate

       Patent Strategies

       Damages and Injunctions

       Inducement of Infringement

       Off-label Use Patent Infringement

       Defenses to a Claim of Infringement

       FDA Safe Harbor

       Patent Exhaustion

       Inequitable Conduct

       Take Home Message

Chapter 3

Pharmaceutical, Biologic and Medical Device Patents

       Pharmaceutical Patents Generally

       Hierarchy of Pharmaceutical Patents

       Compound Patents

       Medical Use Patents

       Formulation Patents

       Biologics Patents

       Medical Device Patents

       Take Home Message

Chapter 4

Overview of FDA

       FDA Generally

       Origins of FDA

       Current FDA

       OGD

       PDUFA

       FDASIA

       Pediatric PRVs

       OPDP

       FDAMA

       FDA Off-label Use Issues

       FDA Orange Book

       Drug Industry Regulation

       Drug Development

       Pre-clinical Development

       Clinical Development: Phases I–IV

       Well-controlled Studies

       Accelerating NDA Approvals

       Types of Drug Filings

       Biologically Derived Drugs

       Antibiotics

       Medical Devices

       Right-to-try State Laws

       Drug Agencies Outside the U.S.

       Europe

       Japan

       Take Home Message

Chapter 5

Exclusivity for Brand Name Innovative Drug Products

       Exclusivity in General

       Patent