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.

4 thoughts on “Biosimilars and Temporary Restraining Orders

  1. 2

    As far as I can tell, this wasn’t actually an appeal from the denial of a TRO.

    The Federal Circuit opinion says this (my emphasis)–it refers to TRO motion and a second “emergency motion” of some kind:

    Genentech, Inc. and City of Hope (collectively, Genen-tech) filed an emergency motion and a motion for a temporary restraining order based on Immunex Rhode Island Corporation’s and Amgen Inc.’s (collectively, Amgen) alleged failure to comply with the notice requirement of 42 U.S.C. § 262(l)(8)(A). Genentech appeals the United States District Court for the District of Delaware’s denial of the motions. Genentech, Inc. v. Immunex Rhode Island Corp., 395 F. Supp. 3d 357, 366 (D. Del. 2019).
    —–

    The cited, appealed-from district court opinion is here. link to scholar.google.com

    Most of the substance of the opinion is in section II, titled “II. THE STATUTORY PROHIBITION MOTION” The court explains: “Genentech seeks by its Statutory Prohibition Motion an order prohibiting Amgen from marketing Mvasi until 180 days after Amgen provides Genentech with a new notice of its intent to commercially market Mvasi.” And it goes on to treat that motion somewhat like a motion for a preliminary injunction, which it denies for much the same reasons the Federal Circuit would later give for affirming on appeal.

    Then in 2 paragraphs at the very end, in a section called “III. THE MOTION FOR A TEMPORARY RESTRAINING ORDER,” the court explains that its analysis denying Genentech’s “statutory prohibition motion” necessarily means that Genentech doesn’t get a TRO either.

    Genentech’s “statutory prohibition motion” was effectively a motion for a preliminary injunction. Denials of preliminary injunctions are appealable.

    Thus, Genentech’s opening brief to the Federal Circuit says this (which the other side–probably correctly–seemed not to dispute):

    Because the district court’s order denied Genentech’s request for an injunction against Amgen’s commercially marketing Mvasi, Appxl, and because Genentech timely noticed an appeal, jurisdiction exists in this Court pursuant to 28 U.S.C. §§ 1292(a)(l) and (c)(l), see Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1301 (Fed. Cir. 2005); Gulfstream Aerospace Corp. v. Mayacamas Corp., 485 U.S. 271, 287-88 (1988).

    The post correctly notes that, per OPM v. AFGE, “the established rule is that denials of temporary restraining orders are ordinarily not appealable,” but I don’t think that describes this appeal.

    1. 2.1

      I probably should have re-read the last 2 paragraphs of the post before posting the above. I wasn’t aware that Genentech vehemently denied that its motion was a preliminary injunction motion. Even so, per the district court opinion, the purpose of the vehement denial seems to have been to support an argument that the district court had no discretion to deny an injunction (by balancing, e.g., irreparable harm) if Genentech was right on the merits. Regardless of the label, Genentech sought injunctive relief, and the district court ruled on it after following all the procedures that go with a preliminary injunction. Regardless of the legal test, at least for jurisdictional purposes, this seems indistinguishable from a preliminary injunction motion.

      1. 2.1.1

        As House committee hearings on drug prices have noted, when a major drug is making millions a day, it is worth trying all possible ways to delay generic competition, and this was another new stretch attempt the Fed. Cir. quickly shot down.

  2. 1

    Is the exceptional remedy of a temporary restraining order even appropriate for patent infringement, particularly patent infringement that has not yet even occurred? Especially since TROs can even be granted ex parte. This is not a situation of a threatened violent crime, a likely flight from jurisdiction of a seller of black-market goods, or other traditional TRO grounds.

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