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ANDA litigation : strategies and tactics for pharmaceutical patent litigators
- Available as
- Physical
- Summary
-
"The third edition of abbreviated new drug application strategies and tactics for pharmaceutical litigators"--
Details
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- Creator
- Kenneth L. Dorsney, editor-in-chief
- Format
- Books
- Language
- English
- Contributors
- Publication
-
- Third edition
- Chicago, Illinois : American Bar Association, Intellectual Property Law Section, [2020]
- Physical Details
-
- xxv, 999 pages : illustrations, forms ; 26 cm
- ISBNs
- 164105624X, 9781641056243, 9781641056250, 9781641056250
- OCLC
- on1157353407
- Includes bibliographical references and index.
- The statutory and regulatory scheme -- The drug approval process : an overview -- Notice and prefiling considerations -- The litigation timeline -- Hatch-Waxman actions in multidistrict litigation -- Biologics litigation : the biosimilars wars -- Iinitiating 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 -- Post-trial -- 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