Infringement of Second Medical Use Claims: A global study focusing on skinny labels

Marco Stief; Tobias Matschke

doi:10.17104/9783406837609

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Bibliographic data

Edition: 1/2024
ISBN-Print: 978-3-406-81753-3
ISBN-Online: 978-3-406-83760-9
ePub ISBN: 9783406847189
Publisher: C.H.BECK Recht - Wirtschaft - Steuern, München
Language: English
Pages: 382
Product type: Edited Book

Cover No access
Title No access
Imprint No access
Preface No access
Authors No access
Table of contents No access
1. 1. 1. I. Generics No access
    2. II. Biosimilars No access
  2. B. Protection of second medical use claims under the European Patent Convention No access
2. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
3. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extract from court decision No access
4. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. 1. I. Significance of skinny labelling in the assessment of second medical use claims’ infringement No access
    2. II. Significance of a prescribing practice in the assessment of second medical use claims’ infringement No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
5. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
6. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
7. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Infringement of second medical use claims – direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Strategies and considerations No access
  6. F. Legal remedies No access
  7. G. Infringement of second medical use claims and biosimilar products No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
8. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct patent infringement No access
    2. II. Indirect patent infringement No access
  4. 1. I. Off-label prescribing in the Netherlands No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. 1. I. Carve out No access
    2. II. Carve in No access
    3. III. Effective measures No access
  7. 1. I. Trigger for (threat of) infringement No access
    2. II. Legal remedies available to patentee No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
9. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Product limited by purpose No access
    2. II. Swiss-type claims No access
    3. III. Swiss-type and product-by-use claims – scope of protection No access
    4. IV. Direct v indirect infringement. Indirect/supplementary protection under general civil law/unfair competition law No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
10. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. C. Direct and indirect infringement of second medical use claims No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
11. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. C. Direct and indirect infringement of second medical use claims No access
  4. 1. I. Madrid courts – Venlafaxine (2006–2010) No access
    2. II. Barcelona courts – Pregabalin (2015–2016) No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. 1. I. General decisions on medical use claims No access
    2. II. Specific decisions on skinny labelling No access
12. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct infringement No access
    2. II. Indirect infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. 1. I. Infringement of second medical use patent for literal infringement and infringement under doctrine of equivalents No access
    2. II. Patentability of second medical use patent No access
    3. III. Indirect use No access
13. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Bringing an infringement claim No access
    2. II. Direct patent infringement No access
    3. III. Indirect patent infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. 1. I. Injunctions No access
    2. II. Damages No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decision No access
14. 1. A. Introduction to the new European system No access
  2. 1. I. The Court of First Instance No access
    2. II. Court of Appeal No access
  3. C. Jurisdiction No access
  4. D. Direct and indirect infringement under the UPC No access
  5. E. Applicable law regarding infringement of second-medical-use patents and cross-label-use No access
  6. F. Skinny label under UPC: a delicate balance No access
  7. G. Procedure and duration of proceedings No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
1. 1. A. Introduction and executive summary No access
  2. 1. I. Legislative background and statutory framework No access
    2. II. Abbreviated new drug applications, the section viii carve-out, and skinny labeling No access
  3. 1. I. Direct infringement No access
    2. II. Inducement standard, generally No access
  4. 1. I. Careful generic labeling can usually (but not always) avoid liability for induced infringement No access
    2. II. The Federal Circuit’s latest (confusing) pronouncement on skinny labels: GSK v Teva No access
  5. 1. I. Legislative background and abbreviated pathway for biosimilars No access
    2. II. Carve-outs in biosimilar skinny labeling No access
  6. 1. I. Brand strategy for reducing the likelihood of a successful carve-out No access
    2. II. Generic strategy for increasing the likelihood of a successful carve-out No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
1. 1. A. Executive summary No access
  2. 1. I. Method of treatment claims No access
    2. II. Swiss-style claims No access
    3. III. EPC 2000 claims No access
  3. 1. I. Introduction No access
    2. II. Direct patent infringement No access
    3. III. Indirect patent infringement No access
  4. 1. I. Method of treatment claims No access
    2. II. Swiss-type claims No access
    3. III. EPC 2000 claims No access
  5. 1. I. Biosimilar products in Australia No access
    2. II. Patent infringement by biosimilar products No access
  6. F. Strategies and considerations No access
  7. 1. I. Interlocutory injunctions No access
    2. II. Permanent injunctions No access
    3. III. Monetary compensation No access
    4. IV. Other remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
1. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. 1. I. Direct infringement No access
    2. II. Indirect infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. 1. I. Administrative remedies No access
    2. II. Judicial remedies No access
  8. 1. I. Provisions about medical use patent No access
    2. II. Provisions about direct infringement No access
    3. III. Provisions about indirect infringement No access
    4. IV. Provisions about legal remedies for infringement No access
  9. J. Extracts from court decisions No access
2. 1. A. Executive summary No access
  2. 1. I. Introduction: skinny labelling of generic and biosimilar products in Japan No access
    2. II. Claim format No access
    3. III. Claim interpretation for second medical use No access
  3. 1. I. Legal requirement for a patent infringement No access
    2. II. Direct patent infringement No access
    3. III. Indirect Infringement No access
  4. D. Infringement of second medical use claims and skinny label products No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. 1. I. Injunction No access
    2. II. Claim for damages No access
    3. III. Claim for unjust enrichment No access
    4. IV. Measures to restore credibility No access
    5. V. Pursuing criminal liability No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decisions No access
3. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. C. Direct and indirect infringement of second medical use claims No access
  4. 1. I. Labelling requirements No access
    2. II. Patent linkage No access
    3. III. The UK approach to skinny labelling No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. 1. I. The patent litigation process No access
    2. II. Alternative dispute resolution No access
  8. H. Statutory provisions No access
  9. J. Summaries of court decisions No access
4. 1. A. Executive summary No access
  2. B. Scope of protection and interpretation of second medical use claims No access
  3. C. Direct and indirect infringement of second medical use claims No access
  4. 1. I. AstraZeneca v TSH Biopharm No access
    2. II. Merck Sharp & Dohme Corp. v TSH Biopharm No access
  5. E. Infringement of second medical use claims and biosimilar products No access
  6. F. Strategies and considerations No access
  7. G. Legal remedies No access
  8. H. Statutory provisions No access
  9. J. Extracts from court decision No access

Infringement of Second Medical Use Claims

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Table of contents