Court Denies Hospira’s Motion to Dismiss BPCIA Notice Claims in Amgen v. Hospira

Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Hospira (epoetin alfa)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. District Court Decisions

 

The District Court (D. Del., J. Andrews) has denied Hospira’s Motion to Dismiss in Amgen v. Hospira.

As we’ve covered previously (see our posts here and here), Hospira moved to dismiss Count I of Amgen’s amended complaint, in which Amgen seeks both a declaratory judgment that Hospira’s alleged refusal to provide Amgen with 180-days’ post-licensure notice of commercial marketing violates the notice provision (l)(8)(A) of the BPCIA, as well as injunctive relief requiring Hospira to provide Amgen with a legally effective notice of commercial marketing under (l)(8)(A).  Following oral argument on the motion to dismiss,  the Court indicated that it would likely wait until the Federal Circuit issued its decision in the then-pending appeal in Amgen v. Apotex before ruling on Hospira’s motion. After the Federal Circuit issued its opinion in Amgen v. Apotex on July 5, 2016, Amgen and Hospira submitted letters to the District Court offering opposing views of how the opinion might affect Hospira’s pending motion.

Today, Judge Andrews issued an order denying Hospira’s motion to dismiss.  The Court noted that while Hospira was correct to point out that the Federal Circuit in Amgen v. Apotex “did not squarely address whether (8)(A) creates a private right of action,” and did not directly address Amgen’s request for a declaratory judgment regarding its (8)(A) claim in that case, “[t]he rationale underpinning Apotex applies with equal force to the declaratory judgment claim at issue here.”  The Court explained: “The Federal Circuit has already recognized the availability of injunctive relief for violations of (8)(A). If presented with the question raised by Defendant’s motion, it would make sense to come to the same conclusion regarding the availability of declaratory relief.”

Stay tuned to the Big Molecule Watch for further updates.

Download PDF

Comments are closed.