Tuesday, September 22, 2015

Amgen Sues Hospira, Claims That Biosimilar Version of Epogen Infringes

In Amgen v. Sandoz, a fractured panel of the Federal Circuit held that an applicant seeking approval of a biosimilar under the abbreviated BPCIA pathway is not required to participate in the so-called “patent dance,” and that if a biosimilar applicant fails to provide the reference product sponsor with its application and the other patent dance information, then the reference product sponsor’s only recourse is to bring a declaratory judgment action for patent infringement.
On September 18, Amgen did just that, filing a lawsuit against Hospira alleging that Hospira’s planned marketing of a biosimilar version of Amgen’s biologic Epogen (epoiten alfa) infringes Amgen patents.   The complaint is available here. 

Amgen states that this “is one of the first actions for patent infringement under 35 USC 271(e)(2)(C), which was enacted in 2010 as part of the” BPCIA.
According to the complaint, Hospira submitted its Biologic License Application (BLA) under the expedited subsection (k) pathway, relying on Amgen’s demonstration of the safety and efficacy of Epogen, but has failed to comply with the patent provisions of the BPCIA.  For example, Hospira has not provided Amgen with manufacturing information that “would have given Amgen the opportunity to evaluate the manufacturing processes used by Hospira to determine whether those processes would infringe any patents held by Amgen.”  This is essentially the same complaint Amgen had with respect to Sandoz's application for expedited approval of a biosimilar filigrastim based on Amgen’s Neupogen product.
Amgen is also seeking a declaratory judgment that Hospira is required to provide Amgen with legally effective notice of commercial marketing of its biosimilar product, and information describing the processes or products used to manufacture the biosimilar product.  In Amgen v. Sandoz, the Federal Circuit held that a biosimilar applicant must provide notice to the reference sponsor on or after the date that the FDA approves its biosimilar application, but according to the complaint Hospira has refused to do so.



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