By Kevin E. Noonan –

In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances shaded by underlying biases).  Synopses of the briefs in favor of Amarin are provided in this post.  A prior post provided synopses of the briefs in favor of Hikma, and a subsequent post will provide synopses of those in favor of neither party.

AbbVie and BMS

These amici argue that generic drugmakers know and should not “support and profit” from “pervasive end-user (i.e., physician) infringement.”  This case, in the view of amici, is a “classic case” of induced infringement, and that selling goods (of any kind, presumably) with knowledge of end-user infringement and “taking no steps to mitigate or prevent it” suffices to state a plausible claim for induced infringement.  The comparison the brief makes is “aiding and abetting” unlawful actions of another.  The brief bases the predicate harm to Amarin on Hikma’s knowledge that 75% of the prescriptions filled for their generic drug for the treatment of the CV indication.  It is Hikma’s inaction with regard to informing its customers – drug wholesalers and physicians – not to prescribe CV patients with Hikma’s generic version of the drug that provides the plausibility to support Amarin’s complaint.  For these amici, the evidence adduced by Amarin and relied upon by the Federal Circuit (“Hikma’s website, investor statements, or press releases”) while consistent with Hikma’s liability was unnecessary in view of their inaction in the face of infringement that they profited from.

In the view of these amici, the allegations against Hikma made here by Amarin were “even stronger” than in prior cases (such as Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011); Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005); and even more recently, Cox Communications, Inc. v. Sony Music Entertainment, No. 24-171, 607 U.S. __, slip op. (Mar. 25, 2026)) where the Court found infringement inducement liability.  The brief makes a distinction between the authorized Section viii carved-out indication and “the infringing uses of the patented indication.”  These amici accuse Hikma of seeking “a categorical rule that would effectively expand the section viii carveout to foreclose inducement claims whenever a skinny label is present, regardless of the defendant’s knowledge of pervasive and systemic infringement and its decision not to try to mitigate or prevent it.”  And as for policy implications, “[i]mposing liability here would create a narrow and administrable rule that is consistent not just with well-established patent law, whereas reversing would “trigger deleterious reverberations throughout all of these areas of law and frustrate the clear congressional purpose of Section 271(b) of the Patent Act.”

Imposing such liability is not unfair to Hikma, according to these amici, because using “readily available measures” it could have informed its customers of the limitations of what its drug should be used to treat, and its own prescription data would have identified infringing entities to whom these restrictions should have been told (making reference to practices in other countries applicable to this situation).  Amici characterize this as “a classic case of induced infringement,” based on Hikma’s inaction while in possession of knowledge of infringing activities of its end users (citing Grokster and A&M Records, Inc. v. Napster, Inc., 239 F.3d 1004, 1022 (9th Cir. 2001), for the sufficiency of this evidence).

The brief concludes with a historical overview of aiding and abetting law and the frank comparisons and similarities to inducement of infringement in this case, the brief citing Grokster and Global-Tech as well as Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476, 485-86 n.6 (1964); Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176, 188 (1980); Thomson-Houston Elec. Co. v. Ohio Brass Co., 80 F. 712, 721 (6th Cir. 1897); and Chas. H. Lilly Co. v. I.F. Laucks, Inc., 68 F.2d 175, 181 (9th Cir. 1933); and that “[k]nowledge of downstream infringement has long been central in patent and other intellectual property cases, citing Bowker v. Dows, 3 F. Cas. 1070 (C.C.D. Mass. 1878); Henry v. A. B. Dick Co., 224 U.S. 1 (1912), overruled as superseded by statute; Motion Picture Patents Co. v. Universal Film Mfg. Co., 243 U.S. 502, 517–18 (1917); and Harper v. Shoppell, 28 F. 613, 615 (C.C.S.D.N.Y. 1886).  Finally, the brief argues that a more recent case, Twitter v. Taamneh, 598 U.S. 471 (2023), supports the position advocated here.

Judge Michel and Scholars

Former Federal Circuit Chief Judge Paul Michel, joined by 9 scholars,* filed an amicus brief that argued that new indications while yielding “great public benefits” still required “the incentives of patent protection.”  In addition, these amici argue that Section viii “was never intended to be a safe harbor for infringing method of use patents.”  Finally, they argue that “allowing this case to proceed past the Rule 12 stage will not deter Section viii carve-outs.”

The brief agrees with the Federal Circuit as this case being “nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b)” at a “nascent stage” of litigation and “this staging is critical” because it negates Hikma’s argument that the case is about Section viii carve-outs.  Amici believe that the issue before the Court is “about substantially more than skinny labels.  It is about the totality of the allegations necessary to state a plausible claim for induced patent infringement—including, but not limited to, allegations about the content of the skinny label itself—necessary to state a plausible claim for induced patent infringement.”  The brief reminds that the standard for induced infringement is an “intent-based liability” standard, citing Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 930 (2005); Global-Tech Appliances, Inc. v. SEB SA, 563 U.S. 754, 760 (2011); Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 642 (2015); Cox Commc’ns, Inc. v. Sony Music Entertainment, 607 U.S. ___, 2026 WL 815283, at *6 (U.S. Mar. 25, 2026); and  Grokster, 545 U.S. at 936.  An important distinction drawn in the brief is that “matters of intent must be proven inferentially, based on the totality of the circumstances.”

As other amici have discussed, “direct infringement inevitably is enabled by generic drug entry into the marketplace” and the “economic incentives for doing so are ample and obvious.”  And, the brief goes on, “a generic manufacturer need not do much to actively encourage further, and more entrenched, infringement of method-of-treatment patents.”  Under those circumstances, “a complaint such as Amarin’s need not plead much in terms of a generic manufacturer’s actions—including, but scarcely limited to, its skinny label—to establish a plausible claim that the accused infringer has expressed an affirmative intent that the generic drug be used to induce infringement of a method-of-treatment patent.”

Under these circumstances, the Federal Circuit was correct with regard to Amarin’s pleadings, amici argue.  The alternative would be “that the Section viii skinny-label carve-out insulates a defendant from liability for induced infringement,” if the Court were to reverse that decision, and “the consequences for our Nation’s innovation economy would be profoundly negative,” because “a system of incentives reflected in the patent bargain would be seriously undercut if a defendant were immunized from liability simply by claiming a narrow indication in its label, while at the same time engaging in other conduct demonstrating an intent to encourage healthcare practitioners to administer the drug for infringing, off-label uses.”

Also included in the brief is a review of drugs having later-discovered indications and the costs incurred to bring that indication to market (and the need for patenting incentives to incur such costs).

These amici take a moment to disagree with assertions in the 76 Scholars brief that determining inducing infringement is “simple, clear, easily determined matter, . . . particularly at this nascent pleading stage.”

*Kristina M.L. Acri, The Colorado Collee; Michael Doane, University of Akron; Bowman Heiden, UC-Berkeley; Joshua Kresh, University of Akron; Emily Michiko Morris, University of Akron; Kristen Jakobsen Osenga, University of Richmond School of Law; Douglas Park, University of Akron; Mark F. Schultz, Senior Scholar IPPI; Ted M. Sichelman, University of San Diego School of Law.

Regeneron

Regeneron argues that the Court’s Twombley and Iqbal precedent (combined with the Federal Rules of Civil Procedure) provide “a neutral, workable pleading standard,” as well as a “flexible standard that keeps the Federal Court system open without constant Congressional intervention.”  In this case, the Federal Circuit applied the pleading standards “exactly as Twombly and Iqbal require.”

Whether a plaintiff satisfies the pleading standard for induced infringement requires “an evaluation of all the alleged facts” (emphasis in brief), wherein “no facts are excluded from the analysis, and no specific facts or words need be recited.”  This situation would be changed should the Court adopt Hikma’s position, amici argue, wherein “some facts (e.g., “general” marketing statements) would not be considered in determining whether a defendant either intended to cause or actually did cause infringement” (emphasis in brief).  And “at the same time . . . petitioners’ position would require a plaintiff to plead certain ‘magic words’—namely it would require a plaintiff to allege that the defendant expressly called for a specific, patented use of its product.”  Regeneron “urges” the Court not to “either (i) exclude[e] certain kinds of factual allegations from the analysis or (ii) require[e] a plaintiff to plead that a defendant has expressly mentioned the patented use.”

In this amicus‘s view, the Court being persuaded to reverse the Federal Circuit’s decision would undermine this precedent and involve creating heightened pleading rules.  Adapting such “special pleading” rules would be inconsistent with patent protection in their view.

AIPLA

The brief filed by the American Intellectual Property Association argues that inducing infringement liability is enshrined in the statute and requires a “totality of the circumstances” analysis (a comprehensive recitation of the development of inducement of infringement through its codification in 35 U.S.C. § 271(b) is provided that provides historical context), while more recent cases (Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 760 (2011); Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 843 F.3d 1315, 1332 (Fed. Cir. 2016) (quoting Astornet Techs. Inc. v. BAE Sys., Inc., 802 F.3d 1271, 1279 (Fed. Cir. 2015)) are provided in support of its argument.  The brief also cites cases where defendant’s advertising that encouraged consumers to practice patented methods were used to support an inducement of infringement liability determination; Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1220, 1222 (Fed. Cir. 2014).  Application of an “affirmative acts” standard is set forth in Power Integrations as assessed by the Federal Circuit to consistently require “all facts and circumstances” to be considered in making such a determination.

Amicus posits that the Hatch-Waxman Act does not exempt or absolve “skinny label” entrants from liability.  The Court should not change the pleadings standard or create “special pleading” standards this amicus contends; like other amici, the AIPLA believes that the Court’s Twombley and Iqbal precedent is appropriately flexible enough to properly evaluate an inducement of infringement allegation.  The Twombley/Iqbal standard “permits plaintiffs who allege specific affirmative acts, knowledge, and intent to proceed to discovery, where the factual record may be developed to support the allegations, while screening out complaints resting on bare awareness and speculation” (citing Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352, 1364 (Fed. Cir. 2017), as an example of the latter situation).  The Federal Circuit correctly applied that standard in this case, taking into account the totality of the circumstances including but not limited to the terms of the skinny label, this amicus argues.

The brief also provides a response to Hikma’s argument that the Federal Circuit’s decision would “effectively nullify” Section viii as being unfounded because that pathway “has never been entirely free from the risk of inducement liability.”

This amicus further reminds the Court that should correction be needed, that task should be left to Congress not the courts.

Academic Medical Centers*

The brief takes the position that the law is in a “delicate balance” between the branded drug makers (citing F.T.C. v. Actavis, Inc., 570 U.S. 136 (2013); Caraco Pharma. Labs., Ltd. V. Novo Nordisk A/S, 566 U.S. 399 (2012); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990)) and generic entrants.  Amici assert that generic drugmakers have used the Section viii portion of the Hatch-Waxman Act to carve out a non-patented indication for an unpatented drug (using amantadine as a relevant example of the benefits and incentives of finding new indication for “old” drugs).

This balance has been lost, they contend, due to “judicial interpretation, measures by federal regulators and states, and the influence of pharmacy benefit managers,” which constitutes “a travesty to patients waiting for tomorrow’s cures.”  Using Section viii can be taken too far, amici argue, and should a generic company get such a “free pass” without consequence for otherwise infringing uses it would “destroy all incentives to research new uses of an old drug,” inter alia because “[t]here would be no way for a party to recoup their investment and drug companies would simply stop researching new uses of old drugs as the end of patent exclusivity approaches.”

The Court reversing the Federal Circuit judgment below “would undermine any remaining semblance of balance in the statutory scheme” and provide generic drugmakers with “a free pass from even an allegation of infringement,” amici argue.

The brief then sets forth for the Court a detailed survey of the drug market as “a complex payer” and provides a description of this complexity (which involves prescribing decisions being made by PBMs and others than the patient or provider).  This information in any particular case can be obtained only by discovery, which could be foreclosed should the Court reverse the Federal Circuit’s decision here.  Analogously, the brief provides that what constitutes “active inducement” requires context, citing Barry v. Medtronic, Inc., 914 F.3d 1310, 1317-18 (Fed. Cir. 2019), and GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1327-28 (2021), as examples, which can include the relevant market, as illustrated in Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936-37 (2005).

Finally, the brief asserts that “law and policy counsel in the case that affirming and remanding” would permit the factual record to be better developed in order for the courts to determine whether active inducement had occurred.

*The Dana-Farber Cancer Institute, Memorial Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and Allied Diseases, Sloan-Kettering Institute for Cancer Research, and The Johns Hopkins University on behalf of the Johns Hopkins University School of Medicine.

PhARMA and BIO

The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) filed an amicus brief arguing that Hikma is seeking (improperly) a “special immunity” for generic drugs that would upset Congress’s balance in the Hatch-Waxman Act between “permitting generics to enter the market and encouraging the research and development of additional indications” that would amount to “bright-line immunity for generic drug manufacturers to encourage infringing use through their promotional materials and statements to investors.”  This would result in disrupted investment and discourage discovery of new uses for existing drugs (making the point ignored by other amici that “novel indications may prove even more consequential than the first,” providing examples (including that “half of all approved uses and three-quarters of industry-funded clinical trials occurred post-approval” for cardiovascular drugs like Vascepa; this is also true for “small-molecule drugs used to treat conditions related to oncology, cardiology, and immunology,” where the numbers are 35% for initial approval and 65% for subsequent approved indications).  There are similar outcomes for rare diseases reported by amici.  The amici also note the “massive investments in post-approval needed for the development of such drugs,” which will (at best) “be inhibited if generic manufacturers are permitted to infringe patented uses.”  And:

Pharmaceutical companies cannot rationally invest in developing new uses if, on the other side, they will be denied the opportunity to obtain meaningful judicial review of whether a generic manufacturer induced infringement.  Petitioners’ position thus undermines the legal protections that are necessary for pharmaceutical companies to justify continued investment in developing lifesaving new treatments.

Hikma’s request to the Court is for “more than this fair balance” between generic drug entry for unpatented indications and branded drugmaker protection for patented indications according to the brief.  “The practical effect of Petitioners’ standard would be that a skinny label could be deemed non-inducing as a matter of law regardless of any other allegations showing inducement in a particular case, and generic manufacturers would be granted license to make public statements about the patented use without risk of inducement liability” according to these amici.

The brief also reminds the Court that:

Nor is there any crisis in generic manufacturing requiring this Court’s intervention.  The Hatch-Waxman Act skyrocketed generic uptake in the United States—from 19% of prescriptions to 90%, [according to the 40th Anniversary of the Generic Drug Approval Pathway].  Other metrics reinforce the prevalence of generics.  For example, more than 80% of approved medications have generic versions available on the market, up from only 35% in the time before Hatch-Waxman [according to] PhRMA, What is Hatch-Waxman? (June 2018).  And generics often enter the market immediately upon patent expiration and are adopted rapidly—some capture as much as 90% of the market within three months.  Id.

Accordingly, amici argue that “[t]here is thus no cause to contort either patent law or pleading standards to provide generic manufactures like Petitioners with additional market advantages beyond those fairly afforded by Congress.”

Sanofi

Sanofi argues that it is critical for maintaining the balance Congress struck between generic drug entry and incentives for additional indications by branded drugmakers to “police” the line between them.  This amicus also promotes a “plausibility” analysis for induced infringement that is sensitive to context which should include “market realities.”  In contrast to other amici who have analogized induced infringement with the Court’s aiding-and-abetting cases, this amicus argues they are fundamentally different because in those cases “the actor being held secondarily liable is typically less culpable than the primary wrongdoer,” whereas in inducing infringement (in the Section viii context) “the secondary offender—here, the generic manufacturer—who is most culpable and the primary infringer’s intent is irrelevant.”

Inducing infringement is part of the Congressional bargain, according to the brief, playing a “critical role” in incentivizing continued discoveries through preserving patent protection for “pioneer” drug innovators.  This is true because “[c]osts for research, development, and approval of innovative new uses for existing drugs are immense,” citing statistics that “investments associated with developing supplemental indications ranged from $149.3 million to $905.3 million” compared with estimates of $2 million for generic copies.  This is so in the context of “factual market realities” the create a preference for generic substitution “even for off-label uses.”  This is particularly the case where there are “powerful incentives to fill market demand for infringing uses, particularly where, as here, infringing uses are far more popular than non-patented uses.”

Finally, amicus argues that while “[a] generic manufacturer can actively induce infringement through express statements promoting the infringing use” they can also induce infringement “through more subtle communication or without communication at all [by] nuanced conduct that promotes an infringing use” and the brief provides examples of such subtleties.