ANDA litigation : strategies and tactics for pharmaceutical patent litigators /
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
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.
9781634254588 (hbk.)
2016018814
Biotechnology--Patents.--United States
Drugs--Patents.--United States
Patent suits--United States.
Pharmacy--Law and legislation--United States.
Abbreviated New Drug Application.
KF3133.B56 / A86 2016
346.7304/86
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.
9781634254588 (hbk.)
2016018814
Biotechnology--Patents.--United States
Drugs--Patents.--United States
Patent suits--United States.
Pharmacy--Law and legislation--United States.
Abbreviated New Drug Application.
KF3133.B56 / A86 2016
346.7304/86
