TY - BOOK AU - Dorsney,Kenneth L. ED - American Bar Association. TI - ANDA litigation: strategies and tactics for pharmaceutical patent litigators SN - 9781634254588 (hbk.) AV - KF3133.B56 A86 2016 U1 - 346.7304/86 23 PY - 2016///] CY - Chicago, Illinois PB - American Bar Association, Section of Intellectual Property Law KW - Biotechnology KW - United States KW - Patents KW - Drugs KW - Patent suits KW - Pharmacy KW - Law and legislation KW - Abbreviated New Drug Application N1 - Includes bibliographical references and index; The statutory and regulatory scheme -- The drug approval process--an overview -- Notice and prefiling considerations -- The litigation timeline -- Initiating litigation -- Use of reissue proceedings in Hatch-Waxman litigation -- Inter partes review in ANDA litigation -- Examining subject-matter jurisdiction over declaratory judgment claims filed in combination with patent infringement claims under section 271(e)(2)(a) -- Responding to the complaint -- Discovery -- Experts -- Claim construction -- Summary judgment -- Remedies -- Settlement -- Antitrust -- Pretrial preparation -- Trial -- Posttrial -- Appeals to the Court of Appeals for the Federal Circuit -- Hatch-Waxman practice in the Supreme Court of the United States -- Managing an ANDA litigation -- Pharmaceutical regulation and litigation in foreign countries UR - https://app.vlex.com/#/sources/40482 ER -