Today, a panel of the Federal Circuit (Judges Moore, O’Malley, and Hughes) heard oral argument in Genentech v. Amgen. The case is on appeal from the District of Delaware, where the court denied Genentech’s motion for preliminary injunction to halt sales of Amgen’s bevacizumab biosimilar product, MVASI. As we have previously reported, the issue in the appeal is whether Amgen was required under the BPCIA to provide a new Notice of Commercial Marketing (“NCM”) concerning its bevacizumab aBLA, as modified by a supplement to amend the site of manufacture, when it had previously provided NCM for the original version of the application.
During Genentech’s opening argument, questions focused on the issue of where to draw the line between a BLA supplement that would require a new NCM, as Genentech advocates is required here, versus so-called “minor” supplements where a new NCM would not be required. Genentech argued that any supplement that would require FDA pre-approval would be of the nature to require a new NCM. In other words, Genentech emphasized that only supplements that are “so significant” as to the change the “scope of the license,” as opposed to “ministerial” changes, would require a new NCM. Both Judges Moore and O’Malley pushed back on these arguments, suggesting that such a rule would neither be administrable in practice nor have a basis in the statutory text, which they indicated requires only that NCM be provided with respect to a “biological product” (42 U.S.C. § 262(l)(8)(A)).
During Amgen’s rebuttal, the panel questioned whether finding that a single NCM is effective as to all future supplements might allow a biosimilar applicant to make a substantive change to its process at the “last minute” and avoid having to provide any notice to the reference product sponsor. Amgen responded by emphasizing that there is a distinction between the purpose of the NCM provision and the other notice provisions of the BPCIA. Amgen argued that the NCM provision is about timing, that is, a “heads up” as to when commercial marketing of the biosimilar may commence, whereas the other notice provisions under (l)(2) provide for substantive disclosures concerning the specifications for the biosimilar product, including manufacturing information.
Both sides addressed the effect, if any, of the Supreme Court’s decision in the seminal case of Sandoz v. Amgen, which noted that: “[T]he biosimilar’s specifications may change during the application process. . . . In contrast, nothing in §262(l)(8)(A) turns on the precise status or characteristics of the biosimilar application.” Genentech argued that the Supreme Court’s discussion in that decision was focused on an application that had not yet been approved and, therefore, did not resolve the issue before the Federal Circuit in this appeal. Amgen countered by arguing that the Supreme Court’s decision recognized that the specifications for a product may change throughout the application approval process, but that the Court found such changes had no effect on the timing of NCM under the statute.
Stay tuned to Big Molecule Watch as we await the Federal Circuit’s decision.
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