Pre-ANDA litigation: strategies and tactics for developing a drug product and patent portfolio
Saved in:
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Chicago
American Bar Association
[2018]
|
| Edition: | Second edition |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Literaturangaben und Index |
| Physical Description: | xxvii, 1007 Seiten |
| ISBN: | 9781641051187 |
Staff View
MARC
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| 245 | 1 | 0 | |a Pre-ANDA litigation |b strategies and tactics for developing a drug product and patent portfolio |c Kenneth L. Dorsney, editor-in-chief |
| 250 | |a Second edition | ||
| 264 | 1 | |a Chicago |b American Bar Association |c [2018] | |
| 300 | |a xxvii, 1007 Seiten | ||
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| 650 | 4 | |a Patent laws and legislation |z United States | |
| 650 | 4 | |a Drug approval |z United States | |
| 650 | 4 | |a Pharmacy |x Law and legislation |z United States | |
| 650 | 4 | |a Biotechnology |z United States |x Patents | |
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Record in the Search Index
| _version_ | 1804179024688185344 |
|---|---|
| adam_text | PRE-ANDA LITIGATION
/
: 2018
TABLE OF CONTENTS / INHALTSVERZEICHNIS
COORDINATING NEW DRUG APPLICATION (NDA) AND PATENT PORTFOLIO STRATEGY
PRECLINICAL R&D
PRECLINICAL PATENT CONSIDERATIONS
CLINICAL TRIALS AND REGULATORY CONSIDERATIONS
CLINICAL TRIAL/PATENT CONSIDERATIONS
TRADEMARK (TM) AND NONPROPRIETARY NAME CONSIDERATIONS
INVESTIGATIONAL NEW DRUG (IND) AND NEW DRUG APPLICATIONS (NDA)
REGULATORY EXCLUSIVITY
OVERVIEW OF THE NDA REVIEW PROCESS
ORANGE BOOK LISTABLE PATENTS
POSTMARKETING REGULATORY REQUIREMENTS AND LIFE CYCLE MANAGEMENT
CONTINUED PATENT PORTFOLIO DEVELOPMENT BEFORE THE PATENT OFFICE
ACQUIRING AND IN-LICENSING PHARMACEUTICAL PRODUCTS : DUE DILIGENCE
ISSUES
PRE-LITIGATION INVESTIGATIONS AND DUE DILIGENCE
MARKET ENTRY BUSINESS CONSIDERATIONS FOR GENERIC COMPANIES
SELECTION OF GENERIC DRUG CANDIDATES
INTELLECTUAL PROPERTY CONSIDERATIONS RELATED TO GENERIC PRODUCTS
PREPARATION OF NONINFRINGEMENT/INVALIDITY LEGAL OPINIONS
PREPARING YOUR ANDA WITH AN EYE TOWARD APPROVAL AND LITIGATION
SECTION VIII CARVE-OUTS
OBTAINING ANDA APPROVAL AND RIGHT TO MARKET
PROVIDING NOTICE TO THE NDA HOLDER
EVALUATING SCENARIOS FOR LAUNCH, INCLUDING MARKETING AND MANUFACTURING
DEVELOPMENTS
INTERPLAY BETWEEN INTER PARTES REVIEW (IPR) AND ANDA LITIGATION
CITIZEN PETITIONS
EXPEDITED REGULATORY PATHWAYS
REMS 101 FOR ANDA LITIGATORS AND COUNSELORS
REGULATORY COMPLIANCE : INSPECTIONS AND THEIR CONSEQUENCES
BIOLOGIC DRUGS AND THE BIOLOGICS PRICE COMPETITION AND INNOVATION ACT
PHARMACEUTICAL REGULATION AND APPROVAL IN FOREIGN COUNTRIES
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
|
| any_adam_object | 1 |
| author2 | Dorsney, Kenneth L. |
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| author_facet | Dorsney, Kenneth L. |
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| dewey-full | 346.7304/86 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 346 - Private law |
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| dewey-search | 346.7304/86 |
| dewey-sort | 3346.7304 286 |
| dewey-tens | 340 - Law |
| discipline | Rechtswissenschaft |
| edition | Second edition |
| format | Book |
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| id | DE-604.BV045265390 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T08:13:18Z |
| institution | BVB |
| isbn | 9781641051187 |
| language | English |
| lccn | 018016836 |
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| owner_facet | DE-M382 |
| physical | xxvii, 1007 Seiten |
| publishDate | 2018 |
| publishDateSearch | 2018 |
| publishDateSort | 2018 |
| publisher | American Bar Association |
| record_format | marc |
| spelling | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, editor-in-chief Second edition Chicago American Bar Association [2018] xxvii, 1007 Seiten txt rdacontent n rdamedia nc rdacarrier Literaturangaben und Index Drugs United States Patents Patent laws and legislation United States Drug approval United States Pharmacy Law and legislation United States Biotechnology United States Patents Dorsney, Kenneth L. edt Erscheint auch als Online-Ausgabe, EPUB 978-1-64105-119-4 LoC Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030653247&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Drugs United States Patents Patent laws and legislation United States Drug approval United States Pharmacy Law and legislation United States Biotechnology United States Patents |
| title | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio |
| title_auth | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio |
| title_exact_search | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio |
| title_full | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, editor-in-chief |
| title_fullStr | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, editor-in-chief |
| title_full_unstemmed | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, editor-in-chief |
| title_short | Pre-ANDA litigation |
| title_sort | pre anda litigation strategies and tactics for developing a drug product and patent portfolio |
| title_sub | strategies and tactics for developing a drug product and patent portfolio |
| topic | Drugs United States Patents Patent laws and legislation United States Drug approval United States Pharmacy Law and legislation United States Biotechnology United States Patents |
| topic_facet | Drugs United States Patents Patent laws and legislation United States Drug approval United States Pharmacy Law and legislation United States Biotechnology United States Patents |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030653247&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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