Court Ends Amgen's ‘Pointless'Biosimilar Suit Against Sandoz

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By John T. Aquino

July 25 — A federal district court July 22 dismissed Amgen's litigation over Sandoz's biosimilar of Amgen's Neulasta, saying subsequent events had rendered the litigation pointless ( Amgen, Inc. v. Sandoz, Inc. , 2016 BL 236421, D.N.J., Civil Action No. 16-1276 (SRC)(CLW), nonprecedential 7/22/16 ).

The decision is the latest in a series of disputes between Sandoz, which is trying to get regulatory approval for products that are similar to and less expensive than Amgen's biologics, and Amgen, which is working to preserve the exclusivity of its own products for as long as possible.

In this litigation, Amgen alleged March 4 that Sandoz began the exchange of patent information concerning its Neulasta biosimilar under the Biologics Price Competition and Innovation Act (BPCIA) only to stop and then “threaten” Amgen that if it didn't file patent infringement litigation by March 4 on two patents identified as potentially infringed by the biosimilar, its remedies for infringement would be limited (10 LSLR 06, 3/18/16).

The U.S. District Court for the District of New Jersey concluded that issuing an order compelling Sandoz to comply with the steps in the information exchange process under the BPCIA “would be completely pointless now, because Sandoz has already complied, on Amgen's preferred timeline” and because Amgen had already sued Sandoz for infringement of two Amgen patents with its Neulasta biosimilar in the U.S. District Court for the Northern District of California (10 LSLR 11, 5/27/16).

On July 20, in a separate development, the Food and Drug Administration delayed a decision on Sandoz’s application for a Neulasta biosimilar, requesting answers to more questions (10 LSLR 15, 7/22/16). Neulasta combats the lack of white blood cells, which is a common side effect of chemotherapy.

Amgen Asked for Declaratory Judgments

A biosimilar is a complex, large-molecule biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product (RP) or a branded biologic. So far the FDA has approved two biosimilars under the BPCIA, which is part of the Affordable Care Act—Sandoz's Zarxio, a biosimilar of Amgen's cancer treatment Neupogen (9 LSLR 328, 3/20/15), and Pfizer's and Celltrion's Inflectra, a biosimilar of Johnson & Johnson's blockbuster arthritis treatment Remicade (10 LSLR 08, 4/15/16).

The abbreviated biologics license application (aBLA) for a biosimilar relies in part on data submitted by the reference product sponsor (RPS) for the RP's FDA approval. This reliance can reduce the applicant's costs and the price of the biosimilar. Under the BPCIA, a biosimilar applicant is directed to send the RPS a copy of the aBLA and engage in the patent dance, an exchange of information between the two to help the RPS determine whether the biosimilar will produce claims of patent infringement and thus avoid burdening the court and parties with unnecessary litigation. Based on the completed list of patents, the RPS may file infringement litigation within 30 days.

Amgen told the court in its complaint that, by insisting that it must file its infringement action against Sandoz's Neulasta biosimilar by March 4, Sandoz's interpretation of the BPCIA was incorrect because the 30-day provision refers to infringement litigation initiated as a result of completed patent lists, which, because of Sandoz's actions, didn't exist.

Amgen asked the court to declare that Sandoz hadn't complied with the patent information exchange provisions of the BPCIA and that not filing a patent infringement action by March 4 didn't deprive Amgen of all remedies available for patent infringement under 35 U.S.C. §271(e)(4) and for orders compelling Sandoz to comply with the BPCIA. It also requested compensation and damages as a result of Sandoz's actions or inactions and for attorneys' fees and costs.

‘No Concrete Dispute Left.'

In a nonprecedential opinion authored by Judge Stanley R. Chesler, the court agreed with Sandoz's argument in its motion to dismiss, saying that Amgen hadn't established that the court had subject matter jurisdiction over the case by demonstrating that there was an actual controversy between the parties under Fed. R. Civ. P. 12 (b).

“Sandoz correctly notes that any declaratory relief the Court grants on this issue would not impact Sandoz's behavior in the dispute currently before this Court,” Chesler wrote, noting that the parties had exchanged patent information under the statute and, consequently, “There is no concrete dispute left for the Court to decide as to the information exchange steps of the BPCIA, based on the facts presented here.”

In addition, Chesler wrote, it would be improper for the court to grant the other declaratory forms of relief Amgen has requested, which included declarations as to the consequences of Sandoz's failure to comply with the information exchange provisions and which remedies should be available to an RPS in Amgen's position. “Granting these forms of relief would violate the clear prohibition on the issuance of advisory opinions,” Chesler wrote, citing Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 213 (2000).

Amgen was represented by Marino, Tortorella & Boyle, P.C., Chatham, N.J., and Paul Weiss Rifkind Wharton & Garrison LLP, New York; and Sandoz by Hill Wallack LLP, Princeton, N.J.

An Amgen spokeswoman didn't immediately respond to Bloomberg BNA's request for comment.

To contact the reporter on this story: John T. Aquino in Washington at

To contact the editor responsible for this story: Randy Kubetin at

For More Information

The court's opinion is at

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