1736 records matched your query
04052aam a2200457 i 4500 001 435C73FA4EAA11EDAB62559A42ECA4DB 003 SILO 005 20221018010048 008 220712t20222022ilua b 001 0 eng 010 $a 2022031822 020 $a 1639051147 020 $a 9781639051144 035 $a (OCoLC)1341210408 040 $a DLC $b eng $e rda $c DLC $d CLU $d WLL $d GWL $d IaU-L $d SILO 042 $a pcc 043 $a n-us--- 050 00 $a KF3133.D78 $b P74 2022 245 00 $a Pre-ANDA litigation : $b strategies and tactics for developing a drug product and patent portfolio / $c Kenneth L. Dorsney, editor-in-chief. 246 3 $a Pre-Abbreviated New Drug Application litigation 246 30 $a ANDA litigation 250 $a Third edition. 264 1 $a Chicago, Illinois : $b American Bar Association, Intellectual Property Law Section, $c [2022] 300 $a xxix, 1110 pages : $b illustrations ; $c 26 cm. 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"-- $c Provided by publisher. 504 $a Includes bibliographical references and index. 505 0 $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. 650 0 $a Drugs $z United States $x Patents. 650 0 $a Drugs $x Law and legislation $z United States. 650 0 $a Patent laws and legislation $z United States. 650 0 $a Drug approval $z United States. 650 0 $a Drug development $z United States. 650 0 $a Pharmacy $x Law and legislation $z United States. 650 0 $a Pharmaceutical industry $z United States. 650 0 $a Biotechnology $z United States $v Patents. 700 1 $a Dorsney, Kenneth L., $e editor. 710 2 $a American Bar Association. $b Section of Intellectual Property Law, $e sponsoring body. 775 08 $i Revision of: $t Pre-ANDA litigation. $b Second edition. $d Chicago, Illinois : American Bar Association, Section of Intellectual Property Law, [2018] $z 9781641051187 $w (OCoLC)1031425323 $w (OCoLC)1031425323 776 08 $i Online version: $t Pre-ANDA litigation $b Third edition. $d Chicago, Illinois : American Bar Association, [2022] $z 9781639051151 $w (DLC) 2022031823 941 $a 1 952 $l OVUX522 $d 20230517010354.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=435C73FA4EAA11EDAB62559A42ECA4DBInitiate Another SILO Locator Search