The late Gilda Radner's character, Emily Latella, would consistently misapprehend something ("violins on television," "saving Soviet jewelry"), give a guest editorial on Weekend Update, and when corrected would say "Never mind!" While rare, all courts have such "never mind" moments, and the latest one for the Federal Circuit occurred in Amgen Inc. v. Sandoz Inc. earlier this year, regarding the doctrine of equivalents, which the Court corrected yesterday on Amgen's petition for rehearing regarding the panel opinion.
The case involved biosimilar litigation over Amgen's Neupogen® product (filgrastim), "a recombinant analog of granulocyte-colony stimulating factor ('G-CSF'), a naturally-occurring human glycoprotein that stimulates the production of neutrophils and stem cells and their release into the bloodstream" used to treat neutropenia inter alia, in patients undergoing cancer chemotherapy. Amgen asserted two patents (after a tortured procedural course involving the proper application of the "patent dance" provisions of the Biologic Price Control and Innovation Act (42 U.S.C. § 262(l) (see "Gotta Dance? Apparently Not -- A Biosimilar Update"; "Amgen v. Sandoz"; "Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)"; and "Sandoz Inc. v. Amgen Inc. (2017)")), those patents being U.S. Patent Nos. 6,162,427 and 8,940,878. The District Court construed the claims in such a way that Amgen conceded that Sandoz did not infringe, and Amgen appealed.
The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges O'Malley and Reyna. There was nothing remarkable about the opinion, which agreed with the District Court's claim construction and that Sandoz did not literally infringe under that interpretation of the scope and meaning of the claims. Where the opinion got interesting (and where the en banc court felt the need to grant in part Amgen's petition to rehear the case) was when the panel dismissed Amgen's argument that infringement could be found under the doctrine of equivalents by stating:
The doctrine of equivalents applies only in exceptional cases and is not "simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims" [italics added].
Citing its pre-Warner Jenkinson precedent in London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991).
Amgen took issue with this statement, and in its petition for rehearing en banc reminded the Court that the term "exceptional" has a specific meaning in the statute, as explicated in another context (35 U.S.C. § 285) by the Supreme Court in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. Earlier this week the Court issued an order where this portion of the opinion was modified to read:
The doctrine of equivalents applies only in exceptional cases and is not "simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims."
Prudence suggests the Court would have done itself a better service if it had struck the entire sentence, because the sentiment remains that the doctrine is not "readily available to extend protection beyond the scope of the claims." Indeed, the doctrine is readily available to extent protection beyond the literal scope of the claims is warranted; if the Court wants to know why it should be readily evident by now that the reason is that the Supreme Court has said so, in Winans v. Denmead, 56 U.S. 330 (1854); Seymour v. Osbourne, 78 U.S. 516 (1870); Graver Tank & Mfg. Co. v. Linde Air Prod. Co. 339 U.S. 605 (1950); Warner-Jenkinson v. Hilton Davis Chemical Co., 520 U.S. 17 (1997); and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002). This judicial sentiment to the contrary by the Federal Circuit is reminiscent of language that arguably was at least in part responsible for energizing the Supreme Court to review more closely the Federal Circuit's stewardship of the Court's patent jurisprudence (inter alia, in Warner-Jenkinson and Festo) and we all see where that has gotten us (see, e.g., "The Proper Role of the Federal Circuit").
What is particularly disheartening is that this was a precedential decision, available for review by the entire Court. Whilst comprising just 6 words in a 16-page opinion, it is unfortunate that the impact of those 6 words was unappreciated (or worse, that concerns about them were disregarded) by the members of the Court. The precedential value (or risk) of these words in the decision is (for the time being) past, but the circumstances under which they arose in the first place may remain with the patent community for some time.
