Filgrastim and Pegfilgrastim Litigation Updates

Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  Below is a summary of these developments.

Amgen v. Adello: New BPCIA Complaint

First, on March 8, 2018, Amgen filed a complaint against Adello Biologics in the District of New Jersey alleging infringement under the BPCIA of 17 patents in view of Adello’s submission of an aBLA for a biosimilar of Neupogen®.  According to the complaint, Adello did not engage in the patent dance procedures of 42 U.S.C. § 262(l).  Rather, the complaint alleges, Adello “refused to provide its aBLA and manufacturing information to Amgen as contemplated by the BPCIA” and “purported to provide notice, pursuant to 42 U.S.C. § 262(l)(8)(A), of its intent to commercially market a proposed biosimilar to NEUPOGEN® … ‘upon receiving FDA approval and no earlier than 180 days from September 11, 2017.”  Adello’s deadline for responding to the complaint is May 17, 2018.  The case has been docketed as 2:18-cv-03347 and has been assigned to Judge Cecchi.

This is the third patent litigation under the BPCIA relating to a filgrastim biosimilar, following Amgen’s suits against Sandoz regarding its Zarxio® biosimilar, and against Apotex regarding its still-unapproved Grastofil™ product. Both Sandoz and Apotex prevailed in their cases on non-infringement grounds before the district court, and Apotex’s district court win was affirmed on appeal late last year.

Amgen v. Sandoz: Appeal docketed

Last month, in the Amgen v. Sandoz cases concerning Sandoz’s Zarxio® biosimilar and still-unapproved pegfilgrastim biosimilar candidate (LA-EP2006), Amgen filed appeals to the Federal Circuit from the district court’s summary judgment order of non-infringement in favor of Sandoz.  The appeals have been consolidated and docketed under Case No. 18-1551.  Amgen’s opening brief is due by April 13, 2018.

Amgen v. Coherus: Court grants motion to dismiss

As we previously reported, in December, Magistrate Judge Burke recommended that the court dismiss Amgen’s BPCIA complaint against Coherus concerning its proposed pegfilgrastim biosimilar with prejudice.  According to the Report and Recommendation, Amgen clearly and unmistakably surrendered claim scope concerning combinations of salts different from the particular combinations of salts recited in the claims during prosecution of the application for the patent-in-suit and was therefore barred under the doctrine of prosecution history from asserting that Coherus’s proposed product infringed under the doctrine of equivalents.

Yesterday, Judge Stark entered a Memorandum Order adopting, over Amgen’s objections, the Report and Recommendation and granting Coherus’s motion to dismiss for failure to state a claim upon which relief may be granted. The court’s Order also denied Amgen leave to amend its complaint, stating: “Given the Court’s conclusions about the clear and unmistakable disclaimer in the prosecution history, necessitating dismissal of Amgen’s claim for infringement under the doctrine of equivalents, and given Amgen’s acknowledgment that Coherus does not literally infringe, amendment of the complaint would be futile.”  The court’s Order further instructed the parties to submit a joint status report by March 28, 2018 to advise the court as to the parties’ positions about how the case should proceed.

Although Coherus has not yet received FDA approval for its proposed biosimilar, earlier this month Coherus reported that it “[a]nticipate[s] U.S. commercial launch in the second half of 2018, dependent on regulatory review and approval timing.”

Amgen v. Mylan: Parties select mediator

In the Amgen v. Mylan case concerning Mylan’s proposed pegfilgrastim biosimilar, the court’s case management order, entered earlier this year, indicated that the “parties agree to mediate this dispute and hope to conduct the mediation by May 11, 2018, subject to the availability of the parties, their counsel, and the mediator.  The parties are working together to find a mutually agreeable mediator, and will submit the name of a proposed mediator to the Court by January 31, 2018, or otherwise inform the Court of the status if they are unable to identify a mediator by that date.”  After requesting a number of extensions, the parties earlier this month filed a stipulation with the court to engage in mediation on May 23, 2018 before retired district court Judge John J. Hughes.

According to the case management order, the parties are scheduled to conduct fact and expert discovery over the next year, and trial will commence on or about mid-year 2019, to be set by further order of the court.