In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar product Mvasi in Genentech, Inc. v. Immunex Rhode Island Corp.

The issue arose over the notice of commercial marketing requirement under 42 U.S.C. § 262(l)(8)(A):

(8) Notice of commercial marketing and preliminary injunction

(A) Notice of commercial marketing

The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).

Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin.  Amgen's biosimilar, Mvasi, was granted FDA approval on September 14, 2017, and Amgen provided notice of intent to commercially market on October 6, 2017.  However, Amgen did not market at that time, but filed supplements to its abbreviated biologic licensing application (aBLA) in August 2018, wherein Amgen added a new manufacturing facility and amended its label.  Amgen decided to launch on July 8, 2019, and Genentech moved in district court for a temporary restraining order (TRO) to prevent launch, on the grounds that the aBLA supplements triggered a requirement for a new notice of intent to commercially market.  The District Court denied the motion and Genentech appealed.

The Federal Circuit affirmed, in an opinion by Judge Moore joined by Judges O'Malley and Hughes.  The panel held that the plain meaning of the statute "makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing the biological product" (emphasis in opinion).  There was no evidence that the product had changed and thus the court held that "Genentech . . . had notice of Amgen's intent to commercially market Mvasi as required under Section 262(l)(8)(A) as early as October 6, 2017."  Genentech's argument was that the phrase "licensed under subsection (k)" in the statute is defined "by particular manufacturing facilities and labeling" and that the supplements Amgen submitted involved adding a manufacturing facility and amending the Mvasi label, and this constituted a distinct biological product that triggered a requirement for a new notice.  The panel recognized Section 262(k), not Section 262(l)(8)(A) specifies the disclosure required for licensure, and that Section 262(l)(8)(A), in contrast, involves timing of notice and when the biosimilar product is marketed.

The opinion expressly relied on the Supreme Court's decision in Sandoz v. Amgen that construed the licensing requirement Section 262(l)(8)(A) narrowly to merely mean that the biosimilar product must be licensed on the date of first commercial marketing.  (It could be argued, of course, that in that case the word is surplusage because no drug can be marketed without FDA approval.)  But the Court had been clear that "Section 262(l)(8)(A)'s notice requirement is separate from Section 262(k)'s licensure requirements" and the Federal Circuit's opinion applied the law in the same way here, stating "[a] biosimilar applicant that has already provided Section 262(l)(8)(A) notice regarding its biological product need not provide another notice for each supplemental application concerning the same biological product."

There has been discussion elsewhere regarding the unconventionality (if not the potential procedural impropriety) of the Federal Circuit hearing the appeal on denial of a motion for a temporary restraining order (this being the first time the Court has done so), especially in view of precedent where the Court denied such relief, see, Nikken USA, Inc. v. Robinson-May, Inc., 217 F.3d 857 (Fed. Cir. 1999).  While that decision was consistent with Supreme Court precedent, see Office of Personnel Management v. American Fed'n of Gov't Employees, AFL-CIO, 473 U.S. 1301 (1985) (and arguably this one is not), the Nikken decision was nonprecedential.  Under such circumstances, it is unlikely that policy concerns did not play a role.  After all, the decision was consistent with facilitating an early appearance of Amgen's Mvasi biosimilar on the market which should reduce pubic drug costs, which has been the policy goal and justification for the biosimilar licensing provisions of the BPCIA since its inception.  An argument could be made that refusing to take the appeal would have led to the same result, but by speaking to the issue the Court made it less likely that any such attempts to delay marketing would occur for other biosimilars in future.  That outcome in itself might be sufficient justification for the Court to resolve this issue here.

Genentech, Inc. v. Immunex Rhode Island Corp. (Fed. Cir. 2020)
Panel: Circuit Judges Moore, O'Malley, and Hughes
Opinion by Circuit Judge Moore