Busy Month Ahead for BPCIA Interpretation Questions

Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Sandoz (filgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News

February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. ApotexAmgen v. Hospira, and Janssen v. Celltrion:

Amgen v. Apotex (Fed. Cir.)

As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing schedule for the appeal, which Amgen opposed. The Federal Circuit granted Apotex’s motion to expedite–in part. While expedited, the schedule is a couple weeks longer than what Apotex had requested:

  • Amgen’s response brief will be due February 4, 2016
  • Apotex’s reply brief and the joint appendix will be due February 12, 2016
  • The case will be placed on the next available oral argument calendar.

Apotex’s opening brief is available here.

Amgen v. Hospira (D. Del., J. Andrews)

In November 2015, Hospira moved to dismiss Count I of Amgen’s Amended Complaint, which requests “declaratory judgment that Hospira’s refusal to give legally effective notice of commercial marketing violates 42 U.S.C. § 262(l)(8)(A).” (Amgen had amended its original complaint to drop Amgen’s Count II, which had requested “declaratory judgment that Hospira’s failure to provide manufacturing information violates 42 U.S.C. § 262(l)(2)(A),” which Hospira had previously moved to dismiss as well).

Oral argument on Hospira’s Motion to Dismiss Count I of the Amended Complaint is scheduled for February 16, 2016.

Janssen v. Celltrion (D. Mass., J. Wolf)

A status conference hearing has been scheduled for February 9, 2016 in this case, where the parties’ cross-motions for summary judgment (covered previously here, here, and here) on the BPCIA claims are pending.

 

Amgen v. Sandoz

February is also decision time for Sandoz to file a petition for certiorari in the Supreme Court in Amgen v. Sandoz: Sandoz received an extension to file a cert. petition by February 16, 2016.  The original January 14, 2016 deadline passed without Amgen filing or seeking an extension to file a cert. petition.  Sandoz may still file one before February 16, 2016, but could also decide not to file one.

 

Stay tuned for further developments and updates here on Big Molecule Watch.

 

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