by Dennis Crouch
Hikma’s recent petition for rehearing en banc against Amarin asks the Federal Circuit to reconsider its “skinny label” jurisprudence. Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. 2024)
These cases typically involve the following scenario:
- a drug formulation with multiple approved uses;
- the formulation/compound patents are all expired as are patents on one or more uses; but
- at least one method of use claim is still under patent (e.g., take 100 mg each day to treat hypertension…).
The FDA will approve a generic version of the formulation, but the approved label will only mention the non-patented uses. Thus, it is a “skinny label” because the patented uses listed on for the branded formulation have been “carved out.”
Of course, everyone understands that it is the same drug and will be just as safe and effective as the branded. The generic manufacturer, along with doctors, patients, pharmacies, insurance companies, and hospitals, . . . they all understand the carveout as simply a patent legalese. While technically an ‘off label’ prescription, it is still for an approved use considered safe and effective. In my experience, these folks typically do not strongly support the patent system and would have no compunction against using the cheaper drug for the patented use — so long as they do not get tagged.
Background on the Amarin case: Amarin markets Vascepa (icosapent ethyl), which was initially approved by the FDA in 2012 to treat severe hypertriglyceridemia (triglycerides ≥500 mg/dL). In 2019, Amarin obtained a second FDA-approved indication for Vascepa to reduce cardiovascular risk in certain patients. Amarin holds method patents on this cardiovascular (CV) indication. Hikma sought approval for a generic version of Vascepa, but with a “skinny label” that carved out the patented CV indication under 21 U.S.C. § 355(j)(2)(A)(viii). After launching its generic, Hikma issued press releases referring to its product as the “generic version of Vascepa” and noting Vascepa’s total sales figures, which were largely attributable to the patented (but unmentioned) CV use. None of Hikma’s statements direct others toward the patented CV use, but conspiracy minded jurists could quickly connect these dots. If you know what I mean, nudge nudge, wink wink.
The basic question in the case is whether these actions by Hikma qualify as the “clear expression or other affirmative steps taken to foster infringement” typically required by precedent. Quoting DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (en banc in relevant part).
Amarin sued Hikma for induced infringement of its CV patents. The district court granted Hikma’s motion to dismiss, finding that neither Hikma’s skinny label nor its public statements plausibly alleged a case of active inducement. On appeal, the Federal Circuit panel reversed. The court held that while Hikma’s label alone may not induce infringement, Amarin had plausibly alleged inducement based on the totality of Hikma’s label, press releases, and website content.
Amarin’s rehearing petition presents two questions for en banc review:
- Implied Active Inducement: Can a patentee state a claim that a defendant “actively induces infringement” of a patented method under 35 U.S.C. § 271(b) without identifying any alleged statement by the defendant that even mentions, let alone encourages, practicing the claimed method?
- “Generic Version” Safe Harbor: Where it is undisputed that a generic drugmaker has “carved out” a patented method of use from its labeling under 21 U.S.C. § 355(j)(2)(A)(viii), does the generic drugmaker induce infringement of the patented method by (a) referring to its product as a “generic version” of a branded drug approved for the patented method; and (b) quoting sales figures for the branded product—without mentioning the patented method?
Amarin’s primary argument is that the panel decision conflicts with longstanding precedent on induced infringement under 35 U.S.C. § 271(b). The petition emphasizes that inducement liability requires “the taking of affirmative steps to bring about the desired result.” Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011). It further notes the quoted statement above from DSU Med, that inducement requires “clear expression or other affirmative steps taken to foster infringement.”
Rather than clear expression, the theory here (according to petitioner) is that the decision relied on passive inducement and an inference of encouragement. The petition contends that the decision conflicts with Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. 2015). In Takeda, the Federal Circuit explained that “vague label language cannot be combined with speculation about how physicians may act to find inducement.” The petition also cites GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) (“GSK”), where the majority rejected the notion that “simply calling a product a ‘generic version’ or ‘generic equivalent'” is enough to show inducement. See also AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012) (courts should avoid relying on “market realities” of generic substitution to support an inducement claim because that approach would “vitiate” Congressionally authorized skinny-label approach.)
One difficulty for the Hikma is the procedural posture – the case was dismissed for failure to state a claim — and the patentee is simply asking for an opportunity to get more discovery on Hikma’s alleged activities. The petition cites the plausibility standards for pleading under Twombly and argues that this area should be particularly policed for indirect infringement cases that often lead to expensive discovery in even “anemic cases.”
Request for Government Views: Amarin suggests that the Federal Circuit should invite the views of the Solicitor General before deciding whether to grant en banc review. The government brief in Teva v. GSK wrote that the mere “potential for
inducement liability in these [skinny label] circumstances may significantly deter use of the section viii pathway.” US brief Supporting Respondents, Teva Pharms. USA, Inc. v. GlaxoSmithKline LLC, 143 S. Ct. 2483 (2023).
The Federal Circuit panel that decided the case included Chief Judge Moore, Circuit Judge Lourie, and District Judge Albright, who was sitting by designation. At the district court level, the case was initially heard by Magistrate Judge Jennifer Hall (who has since been elevated to District Judge), with District Judge Richard Andrews making the final ruling on the motion to dismiss. Hikma’s petition was filed by a team from Winston & Strawn LLP, including Charles Klein, Claire Fundakowski, Eimeric Reig-Plessis, and Alison King, the same team that handled the original appellate case. Amarin Pharma and its co-plaintiffs are represented in the appeal by former USPTO solicitor Nathan Kelley and Nathanael Andrews of Perkins Coie.
“..speculation about how physicians may act…” IMO ought be given more weight, since Physicians are high-skill-level actors and should be presumed to know about the wink wink nudge nudge. I tend to think physicians are not all that un-predictable. It is an opportunity to create another judicial droctrine perhaps, by expounding in legalese akin perhaps to the POSITA of the Graham/Deere analysis, the courts really can tell us I believe, how a physician of ordinary skill is likely to act when presented with the facts here. I hope they do. Or maybe I hope they don’t