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03970aam a2200553 i 4500 001 24D54E0A2E9411E9B5CB1E4197128E48 003 SILO 005 20190212010150 008 180412s2018 ilua b 001 0 eng 010 $a 2018016836 020 $a 1641051183 020 $a 9781641051187 035 $a (OCoLC)1031425323 040 $a DLC $b eng $e rda $c DLC $d OCLCO $d OCLCF $d WLL $d UOL $d CLU $d SILO 042 $a pcc 043 $a n-us--- 050 00 $a KF3133.D78 $b P74 2018 082 00 $a 346.7304/86 $2 23 245 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 Second edition. 263 $a 1805 264 1 $a Chicago, Illinois : $b American Bar Association, Section of Intellectual Property Law, $c [2018] 300 $a xxvii, 1007 pages : $b illustrations ; $c 26 cm 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 (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. 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. 650 7 $a Biotechnology. $2 fast $0 (OCoLC)fst00832729 650 7 $a Drug approval. $2 fast $0 (OCoLC)fst00898661 650 7 $a Drugs $x Patents. $2 fast $0 (OCoLC)fst00898859 650 7 $a Patent laws and legislation. $2 fast $0 (OCoLC)fst01054823 650 7 $a Pharmacy $x Law and legislation. $2 fast $0 (OCoLC)fst01060303 651 7 $a United States. $2 fast $0 (OCoLC)fst01204155 653 $a Abbreviated New Drug Application 655 7 $a Patents. $2 fast $0 (OCoLC)fst01423842 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. $d Chicago, Illinois : ABA Section of Intellectual Property Law, [2014] $z 9781627227315 $w (OCoLC)889577474 $w (OCoLC)889577474 941 $a 1 952 $l OVUX522 $d 20190314022106.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=24D54E0A2E9411E9B5CB1E4197128E48Initiate Another SILO Locator Search