FTO (Freedom to Operate) in the Pharmaceutical Industry

Hirotaka Nonaka

doi:10.5771/9783845294018

Zusammenfassung

Die FTO-Lizensierung in der Pharmaindustrie verdient aufgrund der wirtschaftlichen Bedeutsamkeit des Marktes, der hohen Kosten von Forschung und Entwicklung, einer extrem niedrigen Erfolgsrate sowie der einfachen Duplizierbarkeit des Medikaments besonderes Augenmerk. Unter Berücksichtigung dieser speziellen Aspekte erklärt der Autor zunächst, wie man eine FTO-Recherche korrekt ausführt und einen entsprechenden FTO-Lizenzvertrag abschließt. Anschließend zeigt er zwei Probleme auf: die Frage des Wettbewerbs innerhalb der EU, vor allem die unangemessene Umsetzung der Richtlinie, sowie die Unterscheidung zwischen Bio-Venture- und Pharmaunternehmen. Für diese Probleme schlägt der Autor Lösungen vor.

Hirotaka Nonaka ist Rechts- und Patentanwalt in Tokio (Japan) und vor allem im Bereich Rechtsstreitigkeiten im Zusammenhang mit geistigem Eigentum sowie in der Beratung tätig.

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Bibliographische Angaben

Copyrightjahr: 2018
ISBN-Print: 978-3-8487-5221-8
ISBN-Online: 978-3-8452-9401-8
Verlag: Nomos, Baden-Baden
Reihe: Munich Intellectual Property Law Center - MIPLC Studies
Band: 34
Sprache: Englisch
Seiten: 64
Produkttyp: Monographie

Inhaltsverzeichnis

KapitelSeiten

Titelei/InhaltsverzeichnisSeiten 1 - 8 Download Kapitel (PDF)
I. IntroductionSeiten 9 - 11 Download Kapitel (PDF)
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1. A. Huge and growing market
2. B. High R&D investment
3. C. High Failure rates
4. D. Significance of patents as safeguard of innovator’s profits
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1. A. Overviews of FTO analysis preparations
2. B. Building up the multidisciplinary FTO team
3. C. The FTO search
4. D. Pharmaceutical Technical Considerations
5. E. Pharmaceutical Patent Information
6. F. Period of silence
7. 1. 1. a) The scope of possible amendment
    2. b) Patentability
  2. 2. File wrapper
  3. 3. Doctrine of equivalents
  4. 4. Status searches
  5. 1. a) Term extension
    2. b) The scope of the extended patent
8. 1. 1. a) License-in / Cross-license
    2. b) Oppose / invalidate third-party patents
    3. c) Seek compulsory license
  2. 1. a) Modify product
    2. b) Invent around
  3. 1. a) Wait-and-see
    2. b) Merge and/or acquire (M&A)
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1. 1. 1. Licensing and technology transfer in general
  2. 2. Royalty obligations in general
  3. 1. a) Case: Windsurfing International v Commission of the European Communities
    2. b) The previous Guidelines: Commission Regulation (EC) No. 773/2004
    3. c) License
  4. 1. a) Issues
    2. b) TTBER and the Guidelines on the issue
    3. 1. (i) Competitors Prices
      2. (ii) Launch Timing and Sequence
      3. (iii) Cross-national spillovers
      4. (iv) Products Characteristics
      5. (v) Country Fixed Effects
2. 1. 1. Introduction
  2. 2. Reasons for the growing interest for licensing-in/out the pharmaceutical industry
  3. 3. The type of drugs a venture business company develops
  4. 4. The reality of licensing-in/out
  5. 1. a) Needs/Seeds mismatching
    2. b) Unclear relationship of right
    3. c) Geographical distance
    4. d) Risk of insufficient FTO performed by a bio-venture company
  6. 1. a) More attention to the FTO analysis and licensing by a bio-venture company
    2. b) The FTO by a pharmaceutical company at earlier stage of the development
V. ConclusionSeiten 58 - 60 Download Kapitel (PDF)
List of Works CitedSeiten 61 - 64 Download Kapitel (PDF)

Literaturverzeichnis (22 Einträge)

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