Blog Big Molecule Watch July 22, 2021

Summary Judgment Practice Scheduled in Amgen v. Hospira Pegfilgrastim Case

As we previously reported, Judge Connolly of the District of Delaware stayed the dispute between Amgen and Hospira last month, pending a determination on whether the Court should entertain summary judgment practice on the issue of noninfringement.

Last week, the parties submitted a joint letter to the Court on the issue of summary judgment practice.  Defendants argued for early summary judgment practice, while Plaintiffs opposed, seeking an opportunity for additional discovery.

On July 14, 2021, the Court issued an order rejecting the Plaintiffs’ proposal, concluding that “additional discovery sought by Plaintiffs is not necessary for summary judgment practice to move forward.”  Judge Connolly noted that “the purpose of the June 11 [Markman] hearing was to provide both sides an opportunity to adduce whatever evidence they deemed necessary for the Court to construe the salt concentration limitation,” a key term in the dispute, and to “streamline the case for a potential summary judgment motion based on that construction.”

The Court’s July 14 order further set the briefing schedule for summary judgment, with Defendants’ Opening Brief to be filed by August 6, 2021, and Plaintiffs’ answer due on September 3.

On July 16, 2021, Plaintiffs filed a short letter to Judge Connolly seeking clarification of the July 14 order—Plaintiffs noted that they “did not understand the purpose of the claim construction hearing was to present evidence as to the comparison of the construed claims to the accused process (the second step of the infringement analysis),” but rather understood the purpose of the claim construction hearing was to present any evidence relevant to claim construction.  On that basis, Plaintiffs sought clarification as to whether they will have an opportunity to present evidence as to their doctrine of equivalents argument, and, if they will not, requested the ability “to further address the proper scope of briefing” on summary judgment.

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