Amgen's Epogen Biosimilar Suit Against Pfizer Unit Goes Forward

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By John T. Aquino

Aug. 8 — Amgen's litigation alleging that a Pfizer subsidiary's biosimilar of Amgen's anemia drug Epogen violates the biosimilar statute will go forward, a federal district court held Aug. 5 ( Amgen, Inc. v. Hospira, Inc. , 2016 BL 253727, D. Del., Civil Action No. 15-839-RGA, 8/5/16 ).

Amgen Inc. had alleged in the U.S. District Court for the District of Delaware that Hospira Inc. infringed its patents by giving Amgen notice of commercial marketing of its biosimilar under the Biologics Price Competition and Innovation Act (BPCIA) prematurely (9 LSLR 19, 10/2/15).

Hospira moved to dismiss, arguing that the BPCIA didn't give Amgen the right for a private cause of action for a declaratory judgment—asking a court to declare a defendant has violated the plaintiff's rights.

The U.S. District Court for the District of Delaware noted that the U.S. Court of Appeals for the Federal Circuit had interpreted the BPCIA in July in Amgen v. Apotex (10 LSLR 14, 7/8/16) and recognized injunctive relief is available for violating a provision of the BPCIA.

“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,” the district court said.

Epogen generated $1.8 billion in global sales in 2015, according to Amgen's financials . Each day the approval of a biosimilar is delayed continues Amgen's exclusivity for this product.

Claims Hospira's Notice Legally Ineffective

A biosimilar is a complex, large-molecule biological product that is approved by the FDA 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 only 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 Celltrion's Inflectra, a biosimilar of Johnson & Johnson's blockbuster arthritis treatment Remicade (10 LSLR 08, 4/15/16).

Under the BPCIA, a biosimilar applicant is to provide the RP with an 180-day notice of commercial marketing of its biosimilar, which gives the RP sponsor time to decide whether the biosimilar infringes any of its patents.

According to Amgen's complaint, Hospira informed Amgen on Feb. 23, 2015, that its abbreviated biologic license application (BLA) had been accepted for review by the FDA and that the communication constituted its notice of commercial marketing.

The Federal Circuit held in July in Amgen v. Sandoz (9 LSLR 19, 10/2/15) that the 180-day notice requirement is mandatory and begins when the FDA approves the biosimilar for marketing and not when it accepts the application for review.

Amgen sought both a declaratory judgment of infringement and that Hospira’s actions concerning the Epogen biosimilar violated 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. The district court postponed its decision until the Federal Circuit issued its ruling in Apotex.

Court: Apotex Rationale Applies

After the Apotex decision was handed down, Hospira wrote the district court that, while the Federal Circuit had confirmed that the commercial marketing provision is mandatory and enforceable by injunction, “it did so without considering whether there is a private right of action to enforce compliance with paragraph (8)(A).”

The court, in an opinion authored by Judge Richard G. Andrews, noted that Hospira was correct to point out that the Federal Circuit in Apotex “did not squarely address whether (8)(A) creates a private right of action,” and didn't directly address Amgen’s request for a declaratory judgment regarding its (8)(A) claim in Apotex.

However, “[t]he rationale underpinning Apotex applies with equal force to the declaratory judgment claim at issue here,” Andrews wrote in denying Hospira's motion to dismiss.

A Pfizer spokeswoman told Bloomberg BNA in an Aug. 8 e-mail, “We remain confident in our IP [intellectual property] position with respect to these patents.”

Amgen was represented by Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Del., and Marshall, Gerstein & Borun LLP, Chicago, and Hospira by Proctor Heyman Enerio LLP, Wilmington, Del. and Willkie Farr & Gallagher 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 court's opinion is at

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