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.
| Erscheinungsdatum | 20.09.2024 |
|---|---|
| Mitarbeit |
Anpassung von: Søren Chr. S. Andersen, Filipe Baptista, Carly van der Beek, Matthew S. Bodenstein, Álvaro de Castro, Katrina Crooks, Nevyn Fournel, Luca Giove, Dominik Göbel, Bethan Hopewell, George J. H. Huang, Lichen Jia, Erdem Kaya, Kian Hoe Khoo, Cathal Lane, Jason Liu, Mathew A. Lucas, Tobias Matschke, Jacek Myszko, Harald Nemec, Philippa Owens, John Christopher ‘J.C.’ Rozendaal, Armin Sarvan, Denis Schertenleib, Yoshinori Shimizu, Marco Stief, Otto Swens, Tom H. Wittop Koning, Jie An Yang, Stephen Zou, Maciej Zwoliński |
| Sprache | englisch |
| Maße | 160 x 240 mm |
| Gewicht | 779 g |
| Themenwelt | Recht / Steuern ► EU / Internationales Recht |
| Schlagworte | Labelling law • Medical use • Patent claims • Patent Law • Pharmaceutical Industry • Skinny labels |
| ISBN-10 | 3-406-81753-X / 340681753X |
| ISBN-13 | 978-3-406-81753-3 / 9783406817533 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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