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 neither party are provided in this post.  Synopses of the briefs in favor of Hikma were provided here, and synopses of the briefs in favor of Amarin were provided here.

New York Intellectual Property Law Association

This brief argues that the Court should “preserve ordinary inducement and pleadings standards,” and reminds the Court of its history of having “consistently rejected bespoke pleadings standards.”  And while not being submitted in support of either party, amicus argues that the Federal Circuit “correctly articulated the ordinary inducement pleading standard” below.  Amicus assert that both parties have argued for modified (Hikma) or heightened (Amarin) pleadings standards to be applied; amicus argue that:

This Court should reinforce that there is no special or specific standard for inducement, no heightened or permissive pleading standard, and no prescriptive rules about what can or cannot be considered under either standard.  There are just the broadly applicable general standards—the same inducement standard and the same pleading standard this Court has long embraced.

Amicus argues that “for decades, courts have stuck with a commonsense, common law standard, without the need to ratchet the standard up or down to account for differences in factual circumstances, technological subject matter, or even the area of law (e.g., patent versus copyright).”  And the “[c]ourt has declined . . . invitations repeatedly” for bespoke pleadings standards, citing as an example Berk v. Choy, 607 U.S. ___, 2026 WL 135974, at *4 (Jan. 20, 2026) (citing cases).  Further:

Neither party appears to question that the complaint adequately alleges both direct infringement by physicians and Hikma’s scienter for purposes of an inducement claim.  The only issue is whether, in this mix of facts and circumstances, the complaint has also plausibly alleged active steps to induce infringement—which, as explained above, is a question bound up with the nature of the industry, relationships between Hikma and physicians, and degree of Hikma’s scienter.

“Swinging too far in either direction—too rigid or too lax a standard—would instead unsettle the ‘balance’ Congress struck in the Hatch-Waxman Act . . . between . . . (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market’” according to amicus, citing Caraco Pharm. Lab’ys, Ltd. v. Forest Lab’ys, Inc., 527 F.3d 1278, 1282 (Fed. Cir. 2008) (citation omitted).

The brief maintains that “[a]micus NYIPLA takes no position on the circumstances under which the user of a skinny label may be found to have induced infringement, nor whether Amarin successfully states a claim here.”  Perhaps somewhat surprisingly, the brief concludes with an analysis of the grounds for the Federal Circuit’s opinion and the conclusion that the appellate court had not erred because it had “announced the correct, ‘run-of-the-mill’ standard for pleading inducement.”

Public Interest Patent Law Association

This amicus takes the position that “the Hatch-Waxman regime combined with limits on statutory inducement strikes the proper balance between innovation and affordable health care.”  Nevertheless, the brief contains warnings regarding whether “uncertainty over equivalence and marketing statements raises compliance costs and creates confusion, resulting in a chilling of the marketplace” and that “increased costs for generic manufacturers will ultimately trickle down to consumers.”  These include placing limits on Section viii, which amicus argues “would allow U.S. drug companies to raise prices for American consumers.”  The brief also raises First Amendment concerns based on potential limits on commercial speech such as advertising that have arisen below.

“Inducement liability has long required purposeful encouragement of infringement, not mere awareness that infringement might occur through lawful commerce” the brief asserts, citing Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003), and Congress legislated in reliance on this “settled understanding,” citing Takeda Pharms. U.S.A. v. West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015).  Section 271(b) was intended to “safeguard conduct Congress expressly authorized to facilitate timely generic entry” provided that it is properly applied, but “[t]reating lawful Section viii marketing, truthful competitive statements, or FDA-required disclosures as evidence of inducement collapses the specific intent requirement into mere foreseeability.”  As a consequence, “[g]eneric manufacturers may face liability for engaging in lawful competition,” and “[f]aced with unpredictable exposure, manufacturers may delay or abandon carved-out approvals altogether—undermining Congress’s chosen mechanism for introducing lower-cost medicines while patients on discrete uses remain in force.”

And the brief obliquely set out the specter of the “patent thicket” meme (the liberal use of “monopoly” in the brief being a hint to this amicus’ biases), stating that “[s]econdary method of use patents tend to require less innovation and provide limited benefits to patients” (apparently willing to ignore examples such as Rogaine as inconveniences to their argument).  This is perhaps the argument that may have the most resonance with the Court with the least justification; it is ironic that significant efforts have been undertaken in the past decade to find secondary uses for known drugs, which have the benefit for being known to be safe and effective and for which side or adverse effects have been identified through population use (having a number of patients that have been administered the drug being much greater than any clinical trial could possibly have).

But accepting the premise, the brief argues that such patents “should not be further strengthened” inter alia because “such patents are frequently deployed strategically to delay competition.”  The solution for this amicus is that “[r]obust Section viii entry under the Hatch-Waxman Act, by good faith actors, should be preserved” to avoid “entrenching monopoly practices and rendering the statutory provision effectively meaningless.”

Intellectual Property Owners Association

This brief contends that the Federal Circuit used the correct legal standard in the pleadings, specifically as set forth in Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), and Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556-557 (2007), and that there is neither statutory basis nor need for special pleadings standards for Section viii carve-out litigation.  “Plausibility” pleading should be sufficient, this amicus argues, to “preserve[] the statutory balance between generic competition and innovation.”

The brief succinctly sets forth what should be done for Section viii pleadings:

[L]ower courts should review all well-pled facts in determining whether a claim for active induced infringement of a granted U.S. patent has been sufficiently pled under 35 U.S.C. § 271(b). In the context of a pharmaceutical patent, this would include all statements and information included in the FDA-approved drug label, as well as all statements made by the accused infringer in connection with the marketing of the alleged infringing drug product. Such an evaluation of the totality of the circumstances will turn on the particular facts plausibly pled in the complaint, as IPO contends it should.

“The crucial point here is that context matters.  Analyzing statements in isolation rather than in the total context of well-pled facts can lead to incorrect conclusions,” this amicus counsels.  But the brief cautions against instituting “bright line rules” which are not supported by either the Federal Food, Drug, and Cosmetic Act (“FFDCA”) or the Patent Act of 1952.  Such rules would enable “generic drugmakers to game the carefully balanced system set up by Congress, allowing generic drugmakers to receive FDA approval based on a Section viii carveout while, at the same time, promoting potentially infringing, off-label uses” (which is, of course, what Amarin and other branded drug makers are afraid is happening without application of inducement of infringement liability to prevent it).

Licensing Executives Society

This amicus argues the platitude that “reliable patent rights are essential for robust innovation and investment” as well as assessing the role of induced infringement in protecting patent rights.  Amicus argues that stable patent rights are promoted by “clear, flexible pleading requirements” and remind the Court that “FDA approval concerns equivalence—not patent law.”  And regardless of the conventionality of these sentiments, the brief argues that “[t]he outcome of this case will have significant practical implications for the American innovation ecosystem—in the pharmaceutical industry as well as all other industries that rely on patent protection to enable investment in innovative research and development” because “[w]hen the rights granted under a U.S. patent become unpredictable, investment in innovation declines, which in turn reduces research and development.”  The importance of having certainty is reflected in the costs of bringing pharmaceuticals to market, the brief citing Michael Schlander et al., “How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment”, 39 PharmacoEconomics 1243 (August 2021), regarding pre-launch capitalized costs ranging from $161 million to $4.5 billion in USD as of 2019, particularly in an industry where “[m]any of these products never reach the market,” citing Chi Heem Wong et al., “Estimation of clinical trial success rates and related parameters,” 20 Biostatistics 273 (April 2019) (probabilities of success in clinical trials ranging from 3.4% for oncology drugs to 33.4% for infectious disease vaccines).

The brief sets out the consequences of affirmance or reversal by the Court:

If the Court affirms, permitting enforcement of claims of induced infringement as presented here, patent rights will be seen as more reliable and predictable and, thus, stronger.  This will lead to increased investment in innovation, including the discovery of new drugs and new treatments.

Conversely, if the Court reverses and curtails enforcement of induced infringement claims such as are made here, entry of follow-on (generic) products during the patent term—in pharmaceutical markets and others—will be more likely to occur.  And it bears repeating that the outcome of this case will have implications for patent law generally and thus will reach far beyond the pharmaceutical sector.  As noted above, the pleading requirements for induced infringement will apply equally to all patents and all industries, from microchips to baseball mitts.

Gugliuzza and Sherkow

These academic amici make the argument that the Federal Circuit’s decision “improperly expands induced infringement liability beyond the proper bounds of § 271(b), “continu[ing] the trend of imposing inducement liability for regulated statements by generic drug companies” (citing GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.; United Therapeutics Corp. v. Liquidia Technologies, Inc.; and Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., in support of this assertion).  The Court’s error (or at least one of them) is that the Federal Circuit “improperly relied on Food and Drug Administration (FDA)-regulated drug labeling to expand inducement liability beyond its proper boundaries,” in these amici‘s opinion (i.e., the “bare textual reading of a drug label”) in combination with “anodyne public statements about generic equivalence.”  What is missing in the evidence relied upon by the Federal Circuit, according to the brief, is that labeling “reflects regulatory compliance rather than affirmative encouragement” and “cannot be inducement without evidence of causation” (which they have termed elsewhere “infringement by label,” see Sherkow & Gugliuzza, 2026, “Infringement by Drug Label,” 78 Stan. L. Rev. 131).  Skinny labels, on their own, should not raise inducing infringement liability amici contend; after all, “[g]enerics do not write their drugs’ labels” and thus labels alone should not raise inducing infringement liability.  The brief also emphasizes the restrictive nature of FDA label requirements, and (citing Judge Prost’s dissent in GSK v. Teva“) “the statutory design of the Hatch-Waxman Act makes it untenable to infer culpable intent from what the law mandates.”

The remedy is for the Court to reaffirm existing inducement law, these amici argue, particularly the requirement for volitional conduct by the generic drug maker that “encourages, recommends, or promotes infringement” and “actually [(presumably) imposing an evidentiary burden on plaintiffs)] influences physicians’ prescribing behavior” (emphasis in brief).  Under these circumstances, “in cases where there are plausible allegations and genuine, disputed evidence of inducement beyond the mere wording of a label, both brands and generics would retain their right to have those factual disputes resolved at trial.”