October 20, 2021

Volume XI, Number 293

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Appeal of Discovery Order in BPCIA Patent Infringement Case Dismissed for Lack of Jurisdiction and Writ of Mandamus for Compelling Discovery Denied

AMGEN v. HOSPIRA:  August 10, 2017.  Before Dyk, Bryson and Chen.

Takeaway:

  • The lack of immediate appeal over orders denying discovery of paragraph (l)(2)(A) information under BPCIA does not render such orders “effectively unreviewable” on appeal from a final judgment to qualify for interlocutory review.
  • The reasonableness requirement of paragraph (l)(3)(A) of BPCIA does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A).

Procedural Posture:

Amgen appealed D. Del.’s order denying a motion to compel discovery in a BPCIA patent infringement case and alternatively sought a writ of mandamus ordering the district court to compel discovery.  CAFC dismissed the appeal and denied the writ.

Synopsis:

  • Appellate Jurisdiction: The CAFC dismissed Amgen’s appeal of the district court’s discovery order for lack of jurisdiction.  The lack of immediate appeal over orders denying discovery of paragraph (l)(2)(A) information under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) does not render such orders “effectively unreviewable” on appeal from a final judgment.  The district court’s discovery order did not satisfy the third condition of being an appealable collateral order.  Where there is no clear-cut statutory purpose that would be undermined by denying immediate appeal, Congress’s decision not to provide for interlocutory review simply means that immediate appeal is not available.
  • Writ of Mandamus: The CAFC denied Amgen’s petition for a writ of mandamus ordering the court to compel discovery.  Amgen had not established a clear and indisputable right to discovery of the information.  Amgen declined to pursue alternative avenues available under BPCIA to obtain the information.  The CAFC rejected Amgen’s argument that by withholding information, an applicant could prevent the sponsor from identifying and suing on patents that the sponsor believes could reasonably be asserted.  The reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A).  Had Amgen listed such a patent, Hospira would have been obligated to respond with “a detailed statement” describing the factual and legal basis of the applicant’s opinion regarding the invalidity, unenforceability or non-infringement of such patent.  Further, the composition of Hospira’s cell-culture media was “of no relevance” to the asserted patents.
Copyright © 2021, Hunton Andrews Kurth LLP. All Rights Reserved.National Law Review, Volume VII, Number 299
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About this Author

Gregory L. Porter, Intellectual Property Attorney, Andrews Kurth, Law Firm
Partner

Greg Porter has extensive experience representing and advising companies in all aspects of patent and trade secret law, including acting as lead counsel in successful jury trials and preliminary injunction hearings, as well as advising on patent procurement and designing around competitor's patents. Greg also has counseled Fortune 500 clients on the creation and management of their patent portfolios.

Over the years, Greg has successfully litigated cases in a diverse range of technologies from oil field tools to polymers and computer networking. Greg has drafted and...

713-220-4621
Zaed Billah, Andrews Kurth Law Firm, Patent Litigation Attorney
Associate

Zaed has a decade of experience with patent litigation in U.S. District Courts and the U.S. International Trade Commission. He also has substantial experience with inter partes review proceedings in the U.S. Patent and Trademark Office and with appeals before the U.S. Court of Appeals for the Federal Circuit.

Zaed’s litigation responsibilities include taking and defending fact and expert depositions, writing motions and briefs, examining witnesses at trial, and preparing witnesses for deposition and trial. His recent litigations...

212-908-6125
Qi Zhao patent law attorney Andrews Kurth Law Firm
Associate

Qi has over eight years of experience in assisting clients on patent matters. She has handled more than 100 opinion matters in the areas of pharmaceuticals, chemicals and medical devices. She prepares infringement, validity and freedom-to-operate opinions relating to filings of Abbreviated New Drug Applications and 505(b)(2) New Drug Applications by a generic drug manufacturer. She also prepares and prosecutes patent applications in various technical areas, including small molecule pharmaceuticals, biologics, antibodies, vaccines, diagnostic assays, personalized medicine, food products,...

202.662.2392
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