ANDA litigation :  strategies and tactics for pharmaceutical patent litigators / 
 Abbreviated New Drug Application litigation 
Kenneth L. Dorsney, editor-in-chief. 
 - Second edition. 
 - 1 online resource (xxvii, 957 pages) :  forms 
<br/><br/>Includes bibliographical references and index. 
<br/><br/>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. 
<br/><br/><label>ISBN: </label>9781634254588 (hbk.) 
<br/><br/><label>LCCN: </label>2016018814 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Biotechnology--Patents.--United States<br/>Drugs--Patents.--United States<br/>Patent suits--United States.<br/>Pharmacy--Law and legislation--United States.
<br/><br/><label>Subjects--Index Terms: </label>Abbreviated New Drug Application. 
<br/><br/><label>LC Class. No.: </label>KF3133.B56  / A86 2016 
<br/><br/><label>Dewey Class. No.: </label>346.7304/86