The case, decided this morning, is Amgen Inc. v. Sanofi, opinion by Chief Judge Prost, joined by Judges Taranto and Hughes. The patents in suit relate to monoclonal antibodies used to reduce LDL cholesterol, and most of the opinion is devoted to a discussion of the written description and enablement doctrines, on which grounds the court reverses and remands for a new trial. (I'll be teaching enablement and written description in my patent law class next week, so maybe I'll use this case as an example for class discussion.) Of more interest to readers of this blog, however, is the court's discussion of injunctive relief. The district court had entered judgment for the plaintiffs, Amgen, and entered a permanent injunction against Sanofi's "Praluent" product, even though (according to the district court) one of the four eBay factors--the public interest--weighed against entry of the injunction. The Federal Circuit, echoing its May 1 decision in Nichia v. Everlight (see discussion here), concludes that this was error--though at the same time, it cautions that the public interest doesn't require that courts never enter injunctions in cases involving pharmaceuticals (pp. 21-23):
Finally, we address the district court’s permanent injunction removing Appellants’ Praluent from the market. As noted earlier, we stayed this injunction pending resolution of this appeal. Because we vacate the district court’s judgment as to written description and enablement and remand for a new trial, we also vacate the permanent injunction.
We write to note, however, that the district court’s permanent injunction analysis in this case was improper for two distinct reasons. First, the district court misapplied eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006). In that case, the Supreme Court explained that:
[A] plaintiff seeking a permanent injunction must satisfy a four-factor test before a court may grant such relief. A plaintiff must demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.
Id. at 391 (emphases added). Here, the district court concluded that issuing a permanent injunction would disserve the public interest. Despite that finding, the court issued a permanent injunction. J.A. 33–34. That was in clear violation of eBay. If a plaintiff fails to show “that the public interest would not be disserved by a permanent injunction,” then the district court may not issue an injunction. eBay, 547 U.S. at 391.
Second, the district court also erred in its analysis of the “public interest” factor. In reaching its conclusion that the injunction would disserve the public, the district court weighed “being a patent holder and a verdict winner” on the one hand and “taking an independently developed, helpful drug off the market” on the other. J.A. 33. It then “conclude[d] that the public interest of having a choice of drugs should prevail.” J.A. 33–34.
But eliminating a choice of drugs is not, by itself, sufficient to disserve the public interest. Under such an approach, courts could never enjoin a drug because doing so would always reduce a choice of drugs. That, of course, is not the law. See 35 U.S.C. § 271(e)(4)(B) (“[I]njunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product.”). We previously rejected such reasoning in WBIP, LLC v. Kohler Co. and explained that:
The district court’s decision is based on its reasoning that having more manufacturers of a lifesaving good in the market is better for the public interest. But this reasoning is true in nearly every situation involving such goods, such that, if it alone is sufficient, it would create a categorical rule denying permanent injunctions for life-saving goods, such as many patented pharmaceutical products. As the Supreme Court has warned, categorical rules regarding permanent injunctions are disfavored.
829 F.3d 1317, 1343 (Fed. Cir. 2016). Just as a patent owner does not automatically receive an injunction merely by proving infringement, see eBay, 547 U.S. at 394, an accused infringer cannot escape an injunction merely by producing infringing drugs. Accordingly, a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.
I've argued before that, although I don't think it is appropriate to award injunctions to the prevailing plaintiff in virtually every patent case, as was the understanding of U.S. law prior to eBay (and is still the practice in many countries, at least outside of the FRAND context), I also wouldn't read eBay quite so literally as to require the plaintiff to prevail on all four eBay factors--a result that seems to me rather contrary to traditional notions of equitable balancing, among other problems. For discussion, see here. But it appears that the two panels of the Federal Circuit have now taken the literal approach--though arguably the statements above in Amgen are dicta, since the court reversed and remanded the judgment in favor of the plaintiffs anyway.