Amgen Sues Pfizer and Hospira for Patent Infringement related to Hospira’s Filgrastim Biosimilar

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Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar.  The action is related to newly granted U.S. Patent No. 10,577,392, which is directed to methods of purifying proteins used in the manufacture of a biological product.

The complaint alleges that, pursuant to 42 U.S.C. § 262(l)(7), Amgen provided a timely supplement to its paragraph 3(A) list that included U.S. Patent No. 10,577,392 as a newly issued patent.  The complaint alleges that Hospira failed to comply with to 42 U.S.C. § 262(l)(7) because it did not provide Amgen with a “statement in accordance with paragraph 3(B)” within 30 days of the supplement to the 3(A) list, and to date has still not provided the 3(B) statement.  Amgen further points to 42 U.S.C. § 262(l)(9)(B) as for grounds to bring the suit.  42 U.S.C. § 262(l)(9)(B) provides that:

B) Subsequent failure to act by subsection (k) applicant If a subsection (k) applicant fails to complete an action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph (7), or paragraph (8)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of Title 28 for a declaration of infringement, validity, or enforceability of any patent included in the list described in paragraph (3)(A), including as provided under paragraph (7).

The parties are also currently engaged in BPCIA litigation in Delaware with respect to Hospira’s filgrastim biosimilar and related U.S. Patent No. 9,643,997 (parent to U.S. Patent No. 10,577,392).  As we previously reported, the trial date in this case was postponed and is set to begin on May 17, 2021.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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