Amgen Says Neulasta Biosimilar Application Infringes Patent

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May 16 — Sandoz's filing of an application for a biosimilar of Amgen's cancer treatment Neulasta infringed Amgen's patent, Amgen alleged May 12 in federal district court.

Amgen said in its complaint filed in the U.S. District Court for the Northern District of California that the parties began the Biologics Price Competition and Innovation Act's (BPCIA) patent exchange information process—known as the “patent dance”—and as a result, Amgen concluded that two patents will be infringed by Sandoz's biosimilar.

Amgen's global sales in 2015 were $4.75 billion, according to the company'sfinancials, and the longer Amgen can delay Neulasta biosimilars proposed by Sandoz and Apotex Inc. (10 LSLR 08, 4/15/16), the less competition it will have.

Amgen's complaint filed in federal district court in California was in contrast to its litigation against Sandoz filed in March in the U.S. District Court of New Jersey, which is also about Sandoz's proposed Neulasta biosimilar (10 LSLR 06, 3/18/16). The New Jersey litigation isn't a patent infringement suit but instead asks the court to enforce the patent dance process.

Not Their First Rodeo

A biosimilar is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic product, known as a reference product (RP). The BPCIA provides an abbreviated approval pathway for a biosimilar in which it partly relies on the data used for the RP's approval by the Food and Drug Administration. In return, the biosimilar applicant has certain obligations to the patent owner.

The disputes in the federal district courts in New Jersey and California are the latest between Amgen and Sandoz over the BPCIA's patent dance provisions.

Amgen's lawsuit over Sandoz's interpretations of the statute regarding the first biosimilar approved by the FDA—Zarxio, Sandoz's biosimilar of Neupogen—resulted in a ruling by the U.S. Court of Appeals for the Federal Circuit that the patent dance is optional but also that the BPCIA's 180 days' notification of intent to market the biosimilar can only start when the FDA approves the biosimilar and not, as Sandoz argued, when the FDA accepts the biosimilar application for consideration (9 LSLR 828, 7/24/15).

Sandoz asked the Supreme Court to review the latter portion of the ruling on Feb. 16 and a decision on whether the court will grant review (certiorari) is expected soon (10 LSLR 04, 2/19/16).

Patents Identified in BPCIA List

According to the complaint, Sandoz submitted an abbreviated biologics license application (aBLA) for a biosimilar of Neulasta (pegfilgrastim) to the FDA prior to October 2015, which was before Amgen's U.S. Patent Nos. 8,940,878 and 5,824,784, which cover Neulasta, expire on Oct. 8, 2031, and Oct. 20, 2015, respectively. Neulasta decreases the incidence of infection in patients receiving myelosuppressive anti-cancer drugs.

The FDA accepted Sandoz's aBLA for review on Oct. 26, 2015. According to Amgen, in November 2015, the parties began exchanging patent information as part of the patent dance. The parties agreed on April 12 that the ’878 patent and the ’784 patent were properly included in any immediate infringement action that Amgen could file under 42 U.S.C. §262(l)(3), Amgen said.

“Under 35 U.S.C. §271(e)(2)(C), it is an act of infringement to submit an application seeking approval of a biological product with respect to patents identified in the lists of patents described in 42 U.S.C. §262(l)(3), or could have been, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent,” Amgen wrote, citing the Federal Circuit's decision in Amgen, Inc. v. Sandoz, Inc.

‘Piggybacking' on Amgen's Efforts?

Amgen added that, if the FDA approves the Sandoz aBLA and Sandoz sells or uses the pegfilgrastim biosimilar in the U.S., Sandoz also will infringe one or more claims of the ’878 patent under 35 U.S.C. §271(g).

“Defendants are piggybacking on the fruits of Plaintiffs’ trailblazing efforts,” Amgen wrote.

A Sandoz spokesman declined to comment on pending litigation.

The complaint was filed by Sidley Austin LLP, San Francisco, and Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York.

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 complaint is at

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