Pre-ANDA litigation: strategies and tactics for developing a drug product and patent portfolio
Saved in:
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Chicago, Ill.
American Bar Association, Section of Intellectual Property
2014
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Literaturangaben und Index |
| Physical Description: | XXIII, 796 S. graph. Darst. |
| ISBN: | 9781627227315 |
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, ed.-in-chief |
| 264 | 1 | |a Chicago, Ill. |b American Bar Association, Section of Intellectual Property |c 2014 | |
| 300 | |a XXIII, 796 S. |b graph. Darst. | ||
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| 650 | 4 | |a Drug approval |z United States | |
| 650 | 4 | |a Drug development |z United States | |
| 650 | 4 | |a Pharmacy |x Law and legislation |z United States | |
| 650 | 4 | |a Pharmaceutical industry |z United States | |
| 650 | 4 | |a Biotechnology |z United States |v Patents | |
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Record in the Search Index
| _version_ | 1804152704530907136 |
|---|---|
| adam_text | PRE-ANDA LITIGATION
/
: 2014
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
PATENT PROSECUTION
ACQUIRING AND IN-LICENSING PHARMACEUTICAL PRODUCTS : DUE DILIGENCE
ISSUES
PRE-LITIGATION INVESTIGATIONS AND DUE DILIGENCE
MARKET ENTRY BUSINESS CONSIDERATIONS FOR GENERIC COMPANIES
INTELLECTUAL PROPERTY CONSIDERATIONS FOR GENERIC PRODUCT OPPORTUNITIES
PREPARATION OF NONINFRINGEMENT/INVALIDITY LEGAL OPINIONS
ANDA PREPARATION (WITH AN EYE TOWARD APPROVAL AND LITIGATION) AND THE
FDA REVIEW
OBTAINING ANDA APPROVAL AND RIGHT TO MARKET
PROVIDING NOTICE TO THE NDA HOLDER
EVALUATING SCENARIOS FOR LAUNCH, INCLUDING MARKETING, AND MANUFACTURING
DEVELOPMENTS
CITIZEN PETITIONS
EXPEDITED REGULATORY PATHWAYS
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 |
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| dewey-full | 346.7304/86 |
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| 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 |
| format | Book |
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| id | DE-604.BV042192463 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T01:14:57Z |
| institution | BVB |
| isbn | 9781627227315 |
| language | English |
| lccn | 014034612 |
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| physical | XXIII, 796 S. graph. Darst. |
| publishDate | 2014 |
| publishDateSearch | 2014 |
| publishDateSort | 2014 |
| publisher | American Bar Association, Section of Intellectual Property |
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| spelling | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, ed.-in-chief Chicago, Ill. American Bar Association, Section of Intellectual Property 2014 XXIII, 796 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Literaturangaben und Index Recht Drugs Law and legislation United States Drugs United States Patents Patent laws and legislation United States Drug approval United States Drug development United States Pharmacy Law and legislation United States Pharmaceutical industry United States Biotechnology United States Patents USA Dorsney, Kenneth L. edt LoC Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027631521&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 Recht Drugs Law and legislation United States Drugs United States Patents Patent laws and legislation United States Drug approval United States Drug development United States Pharmacy Law and legislation United States Pharmaceutical industry 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, ed.-in-chief |
| title_fullStr | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, ed.-in-chief |
| title_full_unstemmed | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, ed.-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 | Recht Drugs Law and legislation United States Drugs United States Patents Patent laws and legislation United States Drug approval United States Drug development United States Pharmacy Law and legislation United States Pharmaceutical industry United States Biotechnology United States Patents |
| topic_facet | Recht Drugs Law and legislation United States Drugs United States Patents Patent laws and legislation United States Drug approval United States Drug development United States Pharmacy Law and legislation United States Pharmaceutical industry United States Biotechnology United States Patents USA |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027631521&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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