Amgen Sues Hospira for Biosimilar Statute Violations

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By John T. Aquino

Sept. 22 — Amgen Inc. filed suit Sept. 18 claiming Hospira Inc. infringed Amgen patents and violated the biosimilar statute in an effort to begin marketing its biosimilar of Amgen's anemia drug Epogen (epoetin alfa) prematurely.

According to Amgen's complaint in the U.S. District Court for the District of Delaware, Hospira gave Amgen notice of commercial marketing when the Food and Drug Administration accepted its biologic license application (BLA) for its Epogen biosimilar for filing. Amgen pointed out, however, that a three-judge panel of the U.S. Court of Appeals for the Federal Circuit held in July in Amgen v. Sandoz that the 180-day notice clock for commercial marketing can't begin ticking until the FDA has approved the biosimilar for marketing.

Amgen argued that the purpose of the 180-day notice requirement of the Biologics Price Competition and Innovation Act (BPCIA) is to give Amgen, as a biologic reference product sponsor (RPS), the time to seek an injunction stopping the launch of the biosimilar until the court decides any disputed patent issues.

“If Hospira is allowed to proceed based on its invalid notice of commercial marketing (or no notice at all), the 180-day period that the statute requires before commercial marketing would begin to run when the precise nature of the dispute between the parties, and even the need for litigation on certain patents, has not yet crystallized,” Amgen said. It said the FDA could complete its review of the Hospira Epogen biosimilar before November.

A biosimilar is a biological product that is approved for market by the FDA based on a showing that it is highly similar to an already-approved biologic product, known as the reference product.

Appeals Pending in Fed. Cir. Ruling

Amgen also alleged that Hospira violated the BPCIA by refusing to engage in good-faith negotiations under 42 U.S.C. §262(l)(4)(A) to agree on which, if any, of its patents would be infringed by Hospira's Epogen biosimilar.

The purpose of the BPCIA patent information exchange provision is to prevent hasty and unjustified patent litigation, Amgen said, and Hospira's noncompliance with the statute allows Amgen to allege patent infringement of its U.S. Patent Nos. 5,856,298 and 5,756,349, which cover Epogen.

Amgen said Hospira hasn't provided the manufacturing information about its biosimilar as required by 42 U.S.C. §262(l)(2)(A). It acknowledged that the Federal Circuit panel held in Amgen v. Sandoz that the requirement that the biosimilar applicant provide its BLA and other manufacturing information to the RPS under Section 262(l)(2)(A) isn't mandatory. Amgen noted that it has filed a petition for an en banc rehearing of the decision and, consequently, has included a count in its complaint against Hospira for violation of Section 262(l)(2)(A).

Sandoz has similarly petitioned for an en banc rehearing for the Federal Circuit to reconsider the panel's interpretation of when the 180-day notice requirement starts.

Amgen's lawsuits against Sandoz and Hospira on interpretation of the BPCIA come when the FDA is beginning to approve biosimilars, five years after the BPCIA was passed as part of the Affordable Care Act.

The first biosimilar approved by the FDA under the BPCIA was Zarxio, approved in March. Amgen's litigation and the Federal Circuit panel's ruling delayed Zarxio's release until Sept. 3, which is 180 days after FDA approval of the biosimilar for market.

Can't Just Pick Statute's Good Parts

In its complaint, Amgen described the balance Congress attempted to strike in the BPCIA: the biosimilar applicant is able to enjoy an abbreviated pathway to FDA approval using the RPS's data and license. To protect the interests of the RPS, the biosimilar applicant must provide the RPS with a copy of the BLA and manufacturing information for the biologic within 20 days of the FDA's acceptance of its application. Within 60 days, the RPS responds with a list of all patents the RPS reasonably believes the biosimilar might infringe. The list is to be narrowed down with subsequent exchanges of information.

According to the complaint, Hospira informed Amgen on Feb. 23 that its BLA had been accepted for filing by the FDA and that the communication constituted its notice of commercial marketing. It provided a copy of its BLA to Amgen but not the manufacturing information that Amgen said would have allowed it to create and narrow down the potentially infringed patent list. Hospira has refused to engage in the good-faith negotiations concerning the patent list required by the BPCIA, Amgen alleged.

“Hospira’s scheme to follow only those parts of the BPCIA it considers helpful to it, and to evade the parts it considers unhelpful to it, is unlawful and inequitable,” Amgen alleged.

Injunctions, Damages Sought

Amgen asked the court for declaratory judgment that Hospira's refusal to give legally effective notice of commercial marketing violated 35 U.S.C. §262 (l)(8)(A) and that Hospira's failure to provide manufacturing information violates Section 262(l)(2)(A).

In its prayer of relief, Amgen requested orders stopping Hospira from commercially marketing its Epogen biosimilar and continuing to seek FDA review “until Amgen is restored to the position it would have been in had Hospira met its obligations under the BPCIA.” It also sought judgment of infringement of the '298 and '394 patents under both 35 U.S.C. §271 (e)(2)(C) and 35 U.S.C. §271(a) and a judgment compelling Hospira to pay Amgen damages for Hospira's infringement.

Pfizer Inc. will acquire Hospira in a deal expected to be completed in September. A Pfizer spokesman told Bloomberg BNA in a Sept. 22 e-mail that the company had received Amgen's complaint and was reviewing it.

The complaint was filed by Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Del., with Marshall, Gerstein & Borun LLP, Chicago, and Amgen attorneys of counsel.

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

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

The complaint is at


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