Yesterday, in Amgen v. Hospira, Amgen filed a redacted copy of Amgen’s amended opening brief in support of its motion for preliminary injunction (PI).  As we previously reported, Amgen filed a revised brief because the Supreme Court’s decision in Sandoz v. Amgen impacted the issues raised in Amgen’s original PI motion.

Amgen’s revised brief asserts that “the Supreme Court held that paragraph (8)(A) notice may be given ‘either before or after receiving FDA approval,’ but it did not disturb the Federal Circuit’s holding that notice is mandatory.”  The brief states that Hospira contends that an April 2015 letter served as (8)(A) notice.  Amgen argues, however, that “in view of subsequent events, that letter could not provide legally effective notice under (8)(A).”  While the brief is redacted, Amgen points to the subsequent event of FDA’s complete response letter, which according to Amgen “effectively reject[ed] Hospira’s aBLA.”  Amgen argues that after Hospira resubmitted its aBLA in December 2016, it has not provided (8)(A) notice of its intention to begin commercial marketing.  Amgen states, “[i]n deciding that notice can be given before FDA approval, the Supreme Court did not address what constitutes sufficient notice.”  Amgen’s brief, thus, poses the question: whether intervening regulatory events prior to licensure (e.g., complete response letters, substantive changes to the aBLA, etc.) can nullify a previously provided notice of commercial marketing, thereby requiring the applicant to provide a new notice at least 180 days before commercial launch.

On June 26, 2017, Hospira filed its brief in opposition to Amgen’s PI motion.  This brief was filed under seal and is not yet publicly available in redacted form.  We will continue to monitor this litigation.  Stay tuned to Big Molecule Watch for further updates.