FTO (Freedom to Operate) in the Pharmaceutical Industry

Hirotaka Nonaka

doi:10.5771/9783845294018

Summary

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.

Search publication

Bibliographic data

Copyright year: 2018
ISBN-Print: 978-3-8487-5221-8
ISBN-Online: 978-3-8452-9401-8
Publisher: Nomos, Baden-Baden
Series: Munich Intellectual Property Law Center - MIPLC Studies
Volume: 34
Language: English
Pages: 64
Product type: Book Titles

Titelei/InhaltsverzeichnisPages 1 - 8 Download chapter (PDF)
I. IntroductionPages 9 - 11 Download chapter (PDF)
Download chapter (PDF)
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
Download chapter (PDF)
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)
Download chapter (PDF)
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. ConclusionPages 58 - 60 Download chapter (PDF)
List of Works CitedPages 61 - 64 Download chapter (PDF)

Bibliography (22 entries)

Journal Articles Open Google Scholar
Stanley P. Kowalski, Freedom to Operate: The Preparations, IPHANDBOOK OF BEST PRACTICES (last visited September 5, 2016), http://www.iphandbook.org/handbook/ch14/p02/. Open Google Scholar
European Federation of Pharmaceutical Industries and Associations, The Pharmaceutical Industry in Figures, 2016 Edition (last visited September 5, 2016), http://www.efpia.eu/uploads/Modules/Documents/the-pharmaceutical-industry-in-figures-2016.pdf. Open Google Scholar
M. Dickson, J.P. Gagnon, The Cost of New Drug Discovery and Development (June 20, 2009), http://www.discoverymedicine.com/Michael-Dickson/2009/06/20/the-cost-of-new-drug-discovery-and-development/. Open Google Scholar
Tudor I. Oprea, Current trends in lead discovery: Are we looking for the appropriate properties? 16 J. COMP.MOL.DES. 325, (2002). Open Google Scholar
Ryoko Iseki, Patent term extension in Japan: an academic and comparative perspective, in PHARMACEUTICAL INNOVATION, COMPETITION AND PATENT LAW (Josef Drexl & Nari Lee eds., Edward Elgar Pub 2013) Open Google Scholar
Matsui, S. and T. Aoki, “Tokkyoseido no kokusaiteki seigouka to iyakuhinbunya no tokkyoken kikan enchoseido ni mirareru hiseigou (International Harmonization of the Patent System and Disconformities in the Patent Right Term Extension System in the Drug Field)”, AIPPI, 2008, 53(6), 2 and 14 Open Google Scholar
Anatole Krattiger, Freedom to Operate, Public Sector Research, and Product-Development Partnerships: Strategues and Risk-Management Options, IPHANDBOOK OF BEST PRACTICES (last visited September 6, 2016), http://www.iphandbook.org/handbook/ch14/p01/ Open Google Scholar
Philip Mendes, Licensing and Technology Transfer in the Pharmaceutical Industry (last visited September 7, 2016), http://www.wipo.int/export/sites/www/sme/en/documents/pdf/pharma_licensing.pdf Open Google Scholar
John LaMattina, What Is The Rationale For The Pricing Of New Drugs? (Sep. 10, 2012, 11:55AM), http://www.forbes.com/sites/johnlamattina/2012/09/10/on-the-pricing-of-new-drugs/#500d64ed4b8e Open Google Scholar
Takatori et al., Seiyakukigyou to baiobentyâ to no araiansu: nichibeiou seiyakukigyou no hikaku bunseki (An alliance between a pharmaceutical company and bio venture company: Comparison and analysis of pharmaceutical companies in Japan, US and EU) (Nov., 2009), http://www.jpma.or.jp/opir/research/rs_048/paper-48.pdf. Open Google Scholar
Kenji Tomita, Seiyakusangyou ni okeru raisensu-in/auto no muzukashisa (Difficulties in licensing-in/out in the pharmaceutical industry) DousishaShogaku, Dai-66-kan, Dai-1-gou (Jul., 2014), https://doors.doshisha.ac.jp/duar/repository/ir/16560/017066010015.pdf. Open Google Scholar
Kenzo Takada, Seiyakugaisya tono raisensu keiken kara mita koutaiiyakuhin kaihatsu (The development of antibody pharmaceuticals in the sense of licensing-out the technology to a larger pharmaceutical company), Yakugaku Zasshi, 133(1), 61-66. Open Google Scholar
Books Open Google Scholar
ROBIN JACOB, IP AND OTHER THINGS: A COLLECTION OF ESSAYS AND SPEECHES (2015). Open Google Scholar
H. JACKSON KNIGHT, PATENT STRATEGY (3rd ed. Wiley 2013) Open Google Scholar
JANICE M. MUELLER, PATENT LAW (4th ed. Wolters Kluwer 2013) Open Google Scholar
PHILIP W. GRUBB, PETER R. THOMSEN, PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY: FUNDAMENTALS OF GLOBAL LAW, PRACTICE AND STRATEGY (Oxford University 5th ed. 2010) Open Google Scholar
GIICHI MARUYAMA, CHITEKIZAISAN SENNRYAKU, GIJYUTU DE JIGYOU WO TSUYOKUSURUTAME NI (THE IP STRATEGY: STRENGTHENING THE BUSINESS BY MEANS OF THE TECHNOLOGY) (Diamond sya 2012) Open Google Scholar
JONATHAN D.C. TURNER, INTELLECTUAL PROPERTY AND EU COMPETITION LAW (2nd ed. Oxford 2015). Open Google Scholar
ARIEL EZRACHI, EU COMPETITION LAW: AN ANALITYCAL GUIDE TO THE LEADING CASES (4th ed., 2014). Open Google Scholar
PATRICIA M. DANZON, ANDREW J. EPSTEIN, WORKING PAPER SERIES: EFFECTS OF REGULATION ON DRUG LAUNCH AND PRICING IN INTERDEPENDENT MARKETS (Working paper 14041, National Bureau of Economic Research 2008). Open Google Scholar