Pre-ANDA litigation: strategies and tactics for developing a drug product and patent portfolio
"This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"--
Saved in:
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Chicago, Illinois
American Bar Association, Intellectual Property Law Section
[2022]
|
| Edition: | Third edition |
| Subjects: | |
| Summary: | "This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"-- |
| Physical Description: | xxix, 1110 Seiten Illustrationen 26 cm |
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 Third edition | ||
| 264 | 1 | |a Chicago, Illinois |b American Bar Association, Intellectual Property Law Section |c [2022] | |
| 300 | |a xxix, 1110 Seiten |b Illustrationen |c 26 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 505 | 8 | |a 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 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 -- Pharmaceutical supply chain : patent considerations -- 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 -- Drug approval considerations and patent linkage system in China -- Pharmaceutical regulation and approval in foreign countries | |
| 520 | |a "This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"-- | ||
| 650 | 4 | |a Abbreviated New Drug Application | |
| 650 | 4 | |a Drugs / United States / Patents | |
| 650 | 4 | |a Drugs / Law and legislation / United States | |
| 650 | 4 | |a Patent laws and legislation / United States | |
| 650 | 4 | |a Drug approval / United States | |
| 650 | 4 | |a Drug development / United States | |
| 650 | 4 | |a Pharmacy / Law and legislation / United States | |
| 650 | 4 | |a Pharmaceutical industry / United States | |
| 650 | 4 | |a Biotechnology / United States / Patents | |
| 650 | 7 | |a Biotechnology |2 fast | |
| 650 | 7 | |a Drug approval |2 fast | |
| 650 | 7 | |a Drug development |2 fast | |
| 650 | 7 | |a Drugs / Law and legislation |2 fast | |
| 650 | 7 | |a Drugs / Patents |2 fast | |
| 650 | 7 | |a Patent laws and legislation |2 fast | |
| 650 | 7 | |a Pharmaceutical industry |2 fast | |
| 650 | 7 | |a Pharmacy / Law and legislation |2 fast | |
| 651 | 7 | |a United States |2 fast | |
| 700 | 1 | |a Dorsney, Kenneth L. |0 (DE-588)1218108266 |4 edt | |
| 710 | 2 | |a American Bar Association |b Section of Intellectual Property Law |e Sonstige |0 (DE-588)5197369-8 |4 oth | |
| 775 | 0 | 8 | |i Revision of |t Pre-ANDA litigation |b Second edition |d Chicago, Illinois : American Bar Association, Section of Intellectual Property Law, [2018] |
| 776 | 0 | 8 | |i Online version |t Pre-ANDA litigation |b Third edition |d Chicago, Illinois : American Bar Association, [2022] |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-033993185 | ||
Record in the Search Index
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| author2 | Dorsney, Kenneth L. |
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| author_facet | Dorsney, Kenneth L. |
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| bvnumber | BV048617923 |
| contents | 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 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 -- Pharmaceutical supply chain : patent considerations -- 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 -- Drug approval considerations and patent linkage system in China -- Pharmaceutical regulation and approval in foreign countries |
| ctrlnum | (DE-599)BVBBV048617923 |
| edition | Third edition |
| format | Book |
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| geographic | United States fast |
| geographic_facet | United States |
| id | DE-604.BV048617923 |
| illustrated | Illustrated |
| index_date | 2024-07-03T21:13:16Z |
| indexdate | 2024-07-10T09:43:08Z |
| institution | BVB |
| institution_GND | (DE-588)5197369-8 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033993185 |
| open_access_boolean | |
| owner | DE-M382 |
| owner_facet | DE-M382 |
| physical | xxix, 1110 Seiten Illustrationen 26 cm |
| publishDate | 2022 |
| publishDateSearch | 2022 |
| publishDateSort | 2022 |
| publisher | American Bar Association, Intellectual Property Law Section |
| record_format | marc |
| spelling | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio Kenneth L. Dorsney, editor-in-chief Third edition Chicago, Illinois American Bar Association, Intellectual Property Law Section [2022] xxix, 1110 Seiten Illustrationen 26 cm txt rdacontent n rdamedia nc rdacarrier 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 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 -- Pharmaceutical supply chain : patent considerations -- 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 -- Drug approval considerations and patent linkage system in China -- Pharmaceutical regulation and approval in foreign countries "This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"-- Abbreviated New Drug Application Drugs / United States / Patents Drugs / Law and legislation / United States 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 Biotechnology fast Drug approval fast Drug development fast Drugs / Law and legislation fast Drugs / Patents fast Patent laws and legislation fast Pharmaceutical industry fast Pharmacy / Law and legislation fast United States fast Dorsney, Kenneth L. (DE-588)1218108266 edt American Bar Association Section of Intellectual Property Law Sonstige (DE-588)5197369-8 oth Revision of Pre-ANDA litigation Second edition Chicago, Illinois : American Bar Association, Section of Intellectual Property Law, [2018] Online version Pre-ANDA litigation Third edition Chicago, Illinois : American Bar Association, [2022] |
| spellingShingle | Pre-ANDA litigation strategies and tactics for developing a drug product and patent portfolio 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 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 -- Pharmaceutical supply chain : patent considerations -- 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 -- Drug approval considerations and patent linkage system in China -- Pharmaceutical regulation and approval in foreign countries Abbreviated New Drug Application Drugs / United States / Patents Drugs / Law and legislation / United States 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 Biotechnology fast Drug approval fast Drug development fast Drugs / Law and legislation fast Drugs / Patents fast Patent laws and legislation fast Pharmaceutical industry fast Pharmacy / Law and legislation fast |
| 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_exact_search_txtP | 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 | Abbreviated New Drug Application Drugs / United States / Patents Drugs / Law and legislation / United States 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 Biotechnology fast Drug approval fast Drug development fast Drugs / Law and legislation fast Drugs / Patents fast Patent laws and legislation fast Pharmaceutical industry fast Pharmacy / Law and legislation fast |
| topic_facet | Abbreviated New Drug Application Drugs / United States / Patents Drugs / Law and legislation / United States 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 Biotechnology Drug approval Drug development Drugs / Law and legislation Drugs / Patents Patent laws and legislation Pharmaceutical industry Pharmacy / Law and legislation United States |
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