We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation.  The reason is simple − our clients (and target audience) can be found on either side of the “v.”  So, it’s best that we leave the offering of opinions on patent/IP issues to others.

That certainly wasn’t a problem with the recent Hikma “skinny label” patent decision, Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391 (U.S. 2026).  Hikma touched off a torrent of patent-related commentary – see, e.g., here, here, here, here, here, here, here, here, and here.  We wouldn’t have been able to match that, since we’re product liability, not patent, lawyers.

But we do think that Hikma has implications for product liability litigation as well.  For one thing, it has off-label use issues throughout, even though that phrase is not directly mentioned (the decision uses “off-patent” as the equivalent).  Hikma involved the drug Vascepa, manufactured by the plaintiff/respondent Amarin Pharma.  That’s a tip off right there.  The same drug, and the same manufacturer, produced the landmark off-label use decision, Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), that we named our sixth best case of 2015.  Amarin beat the FDA on First Amendment grounds after the agency threatened to take enforcement action against the company for truthful off-label speech:

Plaintiff  . . . Amarin[] manufactures . . . Vascepa.  The FDA has approved Vascepa for one use, but doctors have widely, and lawfully, prescribed it for another.  Amarin wishes to make truthful statements to doctors relating to Vascepa’s off-label use. . . .  [that] the FDA largely but not wholly concedes . . . are truthful and non-misleading.  However, the FDA, recognizing that Amarin’s purpose . . . would be to promote an unapproved use of Vascepa, has threatened to bring misbranding charges against Amarin (and, presumably, its employees) if it does so.

119 F. Supp.3d at 198.  The initial, limited, FDA approval for Vascepa – that also made off-label use possible − occurred in 2012.  Id. at 209.

Fast forward ten years.  As Hikma discussed, “[i]n 2019, . . . the FDA approved Vascepa for a second, much more common use.”  146 S. Ct. at 1398.  The use approved in 2019 was the same use that was off-label in 2015 and was the subject of Amarin’s win over the FDA.  The more limited Vascepa use originally approved in 2012 was the same one allowed by the “skinny label” for the generic competitor in Hikma, since Amarin’s original patent for that use − but not for the more lucrative use ultimately approved in 2019 – had expired.  Id. (“Hikma [the generic defendant] now sought approval of a skinny label that included only the [more limited use that was] no longer protected by [the relevant] patent”).

Thus, the same off-label use issue existed between the parties in Hikma that had been litigated between the FDA and Amarin in 2015 – only the interested parties were different.  The FDA had been defanged and took no action against any off-label generic promotion of the same, broader use.  Instead, Amarin, the branded manufacturer, sued the generic (Hikma) on a patent-based theory that paralleled the FDA’s threatened enforcement action from 2015:

Soon after [the generic defendant] began marketing its generic drug, Amarin filed suit . . ., alleging that [defendant] had actively induced others to infringe Amarin’s patent for the [more lucrative] method of use.  Amarin alleged that the totality of [defendant’s] statements across several documents encouraged infringing uses.

Id.  Since, as Buckman has taught us, private parties cannot enforce the FDCA, the patent claim in Hikma was phrased differently – as “induced infringement” – but functionally it involves “encouragement” via speech, which is closely parallel to the FDA’s concept of “off-label promotion.”  Indeed, given the “skinny label,” the use that the generic defendant allegedly sought to induce was necessarily also off-label, since the omission of “the carved-out use” is what made the generic defendant’s label “skinny” in the first place.  Id. at 1401.

Which leads us to what the Supreme Court found lacking about the induced infringement that was pleaded in Himka.  It is not enough under Rules 8 and 12 simply to “allege a plausible chain of events through which statements made by [the defendant] could lead a healthcare provider to prescribe or dispense [defendant’s] drug” for an off-label/off-patent use.  146 S. Ct. at 1400 (quotation marks omitted).  Instead:

• A defendant must take “affirmative steps to encourage infringement.”  Id. at 1401.
• Statements that “comply[] with the law or with standard industry practice” are insufficient to create inducement liability.  “[A]dherence to the law and industry standards” are not “building blocks for illegal conduct.”  Id.
• Plaintiffs “may not rely on mere omissions, inactions, or nonfeasance” to allege active inducement.”  Id. at 1402 (citation and quotation marks omitted).
• “[W]e look for affirmative statements or actions . . . to avoid trenching on regular commerce based on such a contingent chain of events.  Otherwise, ordinary merchants could become liable for any misuse of their goods and services [by their customers], no matter how attenuated their relationship with the wrongdoer.”  Id.
• “[V]ague statements combined with speculation about how medical providers may act in response to those statements” “come[] up short” as pleadings.  Id. (citation and quotation marks omitted).
• Since the relevant statute “requires active not passive, inducement . . ., the question is not merely whether the statements could be plausibly understood to induce infringement, but whether they plausibly constitute affirmative steps to bring about the desired result of infringement.”  Id. (citation and quotation marks omitted).
• Statements such as “a warning and a disclaimer” cannot be “active inducement of infringement” because they “are implausibly roundabout ways to induce medical providers to infringe” by engaging in off-label use.  Id.

The FDA’s intended use regulations, 21 C.F.R. §§201.128 (drugs), 801.4 (medical devices), as amended in 2021 (see our post here) contain similar language.  They rely on “objective” intent as “shown by labeling claims, advertising matter, or oral or written statements.”  Id.  Specifically, “intent” cannot exist “based solely on [a regulated entity’s] knowledge that such drug [or device] was being prescribed or used by health care providers for such use.”  Id.  Thus, we think that the pleading requirements for induced infringement” through encouragement of off-label use that the Court imposed in Hikma should be equally applicable to allegations that off-label speech affects a product’s “intended use” under these regulations.  It’s the same speech, subject to an equivalent affirmative intent legal element, concerning identical conduct – alleged encouragement of physician off-label use.

In addition, we think that the requirement of “active” inducement enforced in Hikma means that the latest ridiculously pro-plaintiff law review article that we’ve read, D. Simon, “Off-Label Inducement,” 111 Iowa L. Rev. 1181 (2026), is dead on arrival.  The entire premise of that article is application of “intellectual property” inducement concepts to tort law in order to create “a new theory of liability” − off-label inducement − that would hold a manufacturer liable if its speech “induces a provider to negligently prescribe, administer, or use its drug or device off-label.”  Id. (at abstract).  The article would allow liability on “evidence of a general awareness of a role in an improper activity.”  Id. at 1196.  Its “negligence” standard would not require “that the manufacturer actually knew that the promoted use was malpractice” – only that it was “foreseeable . . . regardless of the manufacturer’s intent.”  Id. at 1198.  Specifically relying on cases (including the decision reversed in Hikma), the article proposes:

[P]romotional activities can be a legal cause of the underlying tort, even if the promotion is not explicit about what it wants the infringer to do. . . .  [W]hat is problematic is the underlying behavior the speech encourages, rather than the speech itself[ such as] truthful commercial speech [that] accurately described the generic as “therapeutically equivalent to the brand product.”  But . . . in so doing, it implied that physicians should prescribe it for all uses, including the patented ones.  Even though it was truthful, the advertising could be prohibited because it encouraged tortious behavior.

Id. at 1208-09 (footnotes omitted).  But that is exactly what Hikma held was insufficient – right down to “therapeutically equivalent” claim.  See Hikma, 146 S. Ct. at 1401 (“it is normal industry practice to truthfully describe a generic drug as ‘equivalent’ to the brand-name comparator.”) (citation omitted).

Initially, we thought the “Off-Label Inducement” article was so far off the wall we weren’t going to bother with it – until Hikma obliterated the article’s core proposition less than three months after the article was published.  That’s a mercifully quick interment of a bizarre and unprecedented theory of liability.

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However, there is a second, and broader way that we think Hikma is important to our sandbox.  It’s a Supreme Court application of TwIqbal’s “well-established federal pleading standard” specifically in the pharmaceutical context.  146 S. Ct. at 1399.  

[TwIqbal’s] plausibility standard asks for more than a sheer possibility that a defendant has acted unlawfully.  If the complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.  Instead, to nudge a claim across the line from conceivable to plausible, a plaintiff must plead facts that, if true, allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged, and to rule out obvious alternative explanations for the defendant’s conduct.

This case requires us to apply these familiar pleading standards to the third element of an induced-infringement claim: that the inducer took active steps to encourage direct infringement.

Id. (numerous TwIqbal citations and accompanying quotation marks omitted).  So, maybe “TwIqbal” should become “Twiqbalma.”

Nah.

But this standard does apply to all pleadings.  Hikma should mean, for example, that for any liability theory premised on “affirmative, as opposed to passive, steps,” Rules 8 and 12 cannot be satisfied by allegations of “mere omissions, inactions, or nonfeasance.”  146 S. Ct. 1400, 1402.  Hikma should apply to the pleading of any claim (such as providing information or aiding and abetting) that seeks to impose liability on a defendant for conduct that purportedly encourages others to engage in supposedly tortious conduct.  For one thing, the pleading standards listed above should apply to motions to dismiss allegations involving sales representatives, which are a common preemption dodge in prescription medical product liability litigation.

Thus, for all these reasons, we think that Hikma should have significant impact on litigation not involving patents or intellectual property – and its toughened pleading standards are particularly applicable to prescription medical product liability litigation.