Hospira Opposes Amgen’s PI Motion in Amgen v. Hospira

Amgen v. Hospira (epoetin alfa)  •  Biologics Litigation  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News

On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI).  As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Amgen filed a revised brief in support of its PI motion.  Amgen argued that Hospira’s original paragraph (8)(A) notice of commercial marketing was no longer legally effective because Sandoz subsequently received a complete response letter from FDA “effectively rejecting Hospira’s aBLA,” and that Hospira should be required to provide a new notice at least 180 days before commercial launch of its epoetin alfa biosimilar product.

In its response, Hospira argues that there is no basis in the BPCIA or in the Supreme Court’s Sandoz opinion for a requirement that a biosimilar applicant send a new notice of commercial marketing upon receiving and responding to an FDA complete response letter.  Hospira accuses Amgen of “rehash[ing] the same rationale that the Supreme Court squarely rejected in Sandoz,” i.e. that “the properties of a biosimilar product can be known” only after receiving FDA approval and thus notice of commercial marketing cannot be effective until that time.  Hospira argued that Amgen’s position that the timing of paragraph (8)(A) notice should be linked “to the submission of additional data and information to the FDA” such as Hospira’s response to the FDA letter is inconsistent with the Supreme Court’s observation that “nothing in § 262(l)(8)(A) turns on the precise status or characteristics of the biosimilar application.”

Hospira also argued that Amgen is not entitled to a preliminary injunction because, among other things, “if Amgen loses sales to Hospira” following launch of Hospira’s biosimilar product, it is not a legally cognizable “harm,” but rather “the intended consequence of the BPCIA.”

Amgen’s reply brief is due today.  The outcome of Amgen’s motion will provide further clarity about how courts will interpret the BPCIA and its notice of commercial marketing requirement in light of the Supreme Court’s Sandoz decision.  We will continue to monitor this litigation.

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