Infringement of Second Medical Use Claims

A skinny label application permits a generics manufacturer to seek market approval solely for the unpatented uses of the drug by excluding or carving out the patented use from the Summary of Product Characteristics and the product leaflet (or from its label). As the practice becomes more widespread globally, questions arise about the different national approaches towards ‘skinny labels’ and conformity with patent law.

With contributions from highly qualified and experienced patent litigators from across the globe, this book provides a comprehensive legal study on the current legal situation of skinny labelling in Europe, the United States, Australia, and Asia, giving key information in particular on

• interpretation of patent claims,
• direct and indirect infringement, an
• applicable domestic legislation.

This book is ideal for in-house counsel in the pharmaceutical industry and legal practitioners.