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FTO (Freedom to Operate) in the Pharmaceutical Industry / I. Introduction
FTO (Freedom to Operate) in the Pharmaceutical Industry / I. Introduction
Contents
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1–8
Titelei/Inhaltsverzeichnis
1–8
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9–11
I. Introduction
9–11
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12–15
II. Key features of innovation in the pharmaceutical industry
12–15
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A. Huge and growing market
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B. High R&D investment
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C. High Failure rates
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D. Significance of patents as safeguard of innovator’s profits
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16–33
III. How to achieve freedom to operate (FTO)
16–33
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A. Overviews of FTO analysis preparations
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B. Building up the multidisciplinary FTO team
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C. The FTO search
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D. Pharmaceutical Technical Considerations
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E. Pharmaceutical Patent Information
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F. Period of silence
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G. Interpreting potentially adverse patents
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1. Difference of analysis between patent and patent application
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a) The scope of possible amendment
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b) Patentability
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2. File wrapper
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3. Doctrine of equivalents
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4. Status searches
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5. Patent term extension
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a) Term extension
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b) The scope of the extended patent
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H. Dealing with Adverse Patents
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1. Legal / IP management strategies
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a) License-in / Cross-license
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b) Oppose / invalidate third-party patents
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c) Seek compulsory license
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2. R&D strategies
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a) Modify product
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b) Invent around
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3. Business Strategies
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a) Wait-and-see
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b) Merge and/or acquire (M&A)
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34–57
IV. Structure and operation of FTO-licensing markets in the pharmaceutical industry
34–57
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A. FTO-licensing and EU competition law
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1. Licensing and technology transfer in general
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2. Royalty obligations in general
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3. Previous view on royalty obligation based on the price of the final product
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a) Case: Windsurfing International v Commission of the European Communities
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b) The previous Guidelines: Commission Regulation (EC) No. 773/2004
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c) License
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4. Royalties on products produced without using licensed technology
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a) Issues
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b) TTBER and the Guidelines on the issue
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c) Analysis on Article 4(1)(a) and relevant Guidelines
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(i) Competitors Prices
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(ii) Launch Timing and Sequence
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(iii) Cross-national spillovers
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(iv) Products Characteristics
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(v) Country Fixed Effects
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B. FTO-licensing between a venture business company for innovative drug development and a pharmaceutical company
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1. Introduction
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2. Reasons for the growing interest for licensing-in/out the pharmaceutical industry
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3. The type of drugs a venture business company develops
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4. The reality of licensing-in/out
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5. Analysis of current situation
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a) Needs/Seeds mismatching
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b) Unclear relationship of right
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c) Geographical distance
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d) Risk of insufficient FTO performed by a bio-venture company
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6. Some proposals
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a) More attention to the FTO analysis and licensing by a bio-venture company
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b) The FTO by a pharmaceutical company at earlier stage of the development
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58–60
V. Conclusion
58–60
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61–64
List of Works Cited
61–64
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FTO (Freedom to Operate) in the Pharmaceutical Industry , page 9 - 11
I. Introduction
Autoren
Hirotaka Nonaka
DOI
doi.org/10.5771/9783845294018-9
ISBN print: 978-3-8487-5221-8
ISBN online: 978-3-8452-9401-8
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