Biosimilars and Temporary Restraining Orders

by Dennis Crouch

Genentech and City of Hope v. Immunex and Amgen (Fed. Cir. 2020)

Genentech’s bevacizumab (Avastin) is a large-molecule biologic cancer chemotherapy.  The FDA approved (licensed) Amgen’s biosimilar (aka generic) version – that is sold as Mvasi.  As a biosimilar, the approval process was quicker and cheaper for Amgen because the FDA relied upon some of the data originally provided by Genentech.

Under the Biologics Price Competition and Innovation Act (BPCIA), the biosimilar producer must provide the innovator company with notice at least 180-days before marketing the product:

The [biosimilar] 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).

42 U.S.C. § 262(l)(8)(A).  Here, Amgen provided notice, but then supplemented its FDA application to add an additional manufacturing facility and to make a change to its drug label.

Genentech thought that the 180 day notice should be reset based upon the supplemented application. However, Judge Connolly (D.Del.) denied Genetech’s motion for a temporary restraining order.  The Federal Circuit allowed immediate appeal — implicitly finding that the denial of a TRO was an order to refuse an injunction that is immediately appealable under 28 U.S.C. § 1292(a)(1). [See Below for my criticism of this.]

On appeal, the Federal Circuit has affirmed based upon its statutory interpretation of Section 262(l)(8)(A) (quoted above).  In particular, the court looked at the statutory notice requirement — requiring notice of “commercial marketing of the biologic product.”  Here, the “biologic product” – as also defined in the statute – is separate and distinct from its manufacturing facility or its product label.  When Amgen changed those details it did not alter the biologic product. Thus, the original notice was sufficient.

 Genentech’s interpretation, which would impose several timing requirements where each supplement necessarily triggers another notice requirement, is inconsistent with the statute and with Sandoz II. [Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017).]  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.

Slip Op.

= = = =

In my brief search on Westlaw, I could not find any other case where the Federal Circuit heard an interlocutory appeal of a denial of a temporary restraining order.  In a 1999 decision, the Federal Circuit refused to hear such an interlocutory appeal on a TRO denial. Nikken USA, Inc. v. Robinson-May, Inc., 217 F.3d 857 (Fed. Cir. 1999) (nonprecedential).  In Nikken, the patentee had requested both a temporary restraining order and a preliminary injunction.  The district court quickly denied the TRO (finding validity + infringement issues) but did not immediately rule on the preliminary injunction.  When the patentee appealed the TRO denial, the Federal Circuit acted sua sponte to deny appellate jurisdiction. Id., See Office of Personnel Management v. American Fed’n of Gov’t Employees, AFL-CIO, 473 U.S. 1301 (1985) (“the established rule is that denials of temporary restraining orders are ordinarily not appealable”).

Thus, the rule is that denial of a TRO motion is not immediately appealable while denial of a preliminary injunction motion is immediately appealable. You could imagine situations where at TRO motion is effectively a PI and thus may be immediately appealed. Here, however, Federal Circuit did not consider the TRO/PI divide but rather simply stated: “We have jurisdiction under 28 U.S.C. § 1292(a)(1).”

Here, because the appellee won on appeal there won’t be any party challenging appellate jurisdiction and so the situation for this case is moot, but does create a precedential foothold for appeals of temporary restraining orders.

= = = =

In looking at the briefing at the district court level, the patentee asked for a TRO and also requested a “statutory prohibition” which it vehemently denied was a request for a preliminary injunction.  The defendants characterized the plaintiffs’ motion as one for preliminary injunction. The different classification approaches stem from the hard-to-meet test for preliminary injunctive relief — the preliminary-injunction four-factor test is even harder than the test for a permanent injunction because it additionally requires a showing of a likelihood of success on the merits.  The district court did not decide this particular dispute because it held that the movant (Genentech) would lose the motion regardless.

Based upon all of this, there is a good argument that appellate jurisdiction exists under 28 U.S.C. § 1292(a)(1), but that argument was never actually made. And, the Federal Circuit failed its duty to consider its own jurisdiction over the appeal.