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.