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Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? / New Drug Approval Regulations
Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? / New Drug Approval Regulations
Contents
Chapter
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Page
2–10
Titelei/Inhaltsverzeichnis
2–10
Details
11–12
Acronyms and Abbreviations
11–12
Details
13–15
I. Introduction
13–15
Details
16–20
II. Background
16–20
16–18
A. Pharmaceutical Industry – The Development of a New Drug.
16–18
Details
18–19
B. New Drug Approval Regulations
18–19
Details
19–20
C. Generic Drugs Approval.
19–20
Details
21–41
III. Case Studies-Facts
21–41
21–32
A. Taxotere
21–32
21–23
1. General
21–23
Details
23–27
2. Patent Portfolio
23–27
Details
a) Process
Details
b) Formulation
Details
c) Combination Therapy
Details
d) New Uses
Details
e) Derivatives
Details
27–30
3. Use of Procedural Provisions: Supplementary Protection Certificates (SPCs)/Patent Term Extension
27–30
Details
30–32
4. Conclusion
30–32
Details
32–41
B. Xalatan
32–41
32–33
1. General
32–33
Details
33–37
2. Patent Portfolio
33–37
Details
a) Process
Details
b) Formulation
Details
c) Combination Therapy
Details
d) New Uses
Details
e) Delivery Devices
Details
f) Packaged Product
Details
37–39
3. Use of Procedural Provisions
37–39
Details
a) Divisional of Basic Patent
Details
b) Supplementary Protection
Details
39–41
4. Conclusion
39–41
Details
42–72
IV. Discussion
42–72
42–45
A. Lifecycle Management: Criticism and Supports
42–45
Details
45–66
B. Further Filing Strategy: Commercial Value
45–66
45–62
1. Innovation Tracks
45–62
Details
a) Formulations
Details
b) Combinations
Details
c) Process
Details
d) New Uses
Details
e) Delivery Devices
Details
62–66
2. Xalatan SPC Request: a Case for Competition Law?
62–66
Details
66–69
C. Patent Strategy and Innovation
66–69
Details
69–72
D. Summary: Taxotere v Xalatan
69–72
Details
72–72
E. Conclusion and Suggestions
72–72
Details
73–76
V. Final Remarks
73–76
Details
77–84
List of works cited
77–84
77–80
Periodical Materials in English
77–80
Details
80–80
Periodical Material in German
80–80
Details
80–80
Non Periodical Material
80–80
Details
80–81
Table of books
80–81
Details
81–82
Table of Cases
81–82
81–81
European Union
81–81
Details
81–81
EPO Board of Appeal
81–81
Details
81–81
France
81–81
Details
81–81
Germany
81–81
Details
Italy
Details
82–82
United Kingdom
82–82
Details
82–82
United States
82–82
Details
82–83
Statutes
82–83
Details
83–83
Speeches and Reports
83–83
Details
83–83
Press release
83–83
Details
83–84
Others
83–84
Details
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Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? , page 18 - 19
New Drug Approval Regulations
Autoren
Monica Donghi
DOI
doi.org/10.5771/9783845251288-18
ISBN print: 978-3-8487-0991-5
ISBN online: 978-3-8452-5128-8
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doi.org/10.5771/9783845251288-18
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