Hikma Pharms USA Inc. v. Amarin Pharma, Inc., Appeal No. 24-889 (Sup. Ct. June 4, 2026)

In its first patent case of 2026, the Supreme Court addressed a question of induced infringement as applied to the pharmaceutical industry.  Specifically, the Court considered whether a “skinny label” can give rise to claims of induced infringement.  After a panel of the Federal Circuit unanimously held that it could, the Supreme Court unanimously reversed.

Amarin developed a drug called Vascepa, which contains the active ingredient icosapent ethyl.  In 2012, the FDA approved Vascepa for the treatment of severe hypertriglyceridemia (the “SH indication”).  Amarin also obtained a patent for the use of icosapent ethyl to treat SH.  Amarain also continued its research into the use of icosapent ethyl, and found that it was also effective at reducing cardiovascular risk in hypertriglyceridemia patients who already take statins (the “CV indication”).  In 2019, the FDA approved Vascepa for the CV indication, which is a much more common use.

In 2016, Hikma submitted an Abbreviated New Drug Application (ANDA) for approval of its generic icosapent ethyl medication.  An ANDA piggy backs on the premier drug manufacturer’s new drug application (NDA), demonstrating merely that the generic drug has the same active ingredients as, and is biologically equivalent to, the brand-name drug.  This allows the generic drug manufacturer to avoid the cost and time-consuming studies of seeking approval.  By statute, the label for the generic must be identical to the premier drug on which it relies, excepting only any carved-out uses.

Amarin sued Hikma for patent infringement arising from the filing of the ANDA.  A district court invalidated Amarin’s patents directed to the method of using icosapent ethyl in relation to the SH indication.  But Amarin later obtained patents directed to the CV indication.  This posed a problem for Hikma.  If it used the same label for its generic version of icosapent ethyl as Amarin, it would be liable for inducing patent infringement, because the label instructs users to take the medicine in relation to either the SH indication or the CV indication.

Hikma solved that problem by creating a “skinny label”: it copied Amarin’s label, but removed the CV indication, so that only the SH indication was listed on the label.  Because using icosapent ethyl in relation to the SH indication was not patented, simply removing any reference to the CV indication would avoid patent infringement.  Hikma started selling its medicine with its skinny label, advertising it as the generic version of Vascepa.

But that wasn’t sufficient according to Amarin.  That is because all doctors know that Vascepa is prescribed for the much more common CV indication.  Moreover, all states have laws either permitting or requiring medical professionals to prescribe generic drugs instead of the more expensive brand name drugs.  So advertising the product as a generic version of Vascepa is effectively inducing doctors to prescribe it in relation to that indication with a wink and a nod.

Amarin sued Hikma again, alleging induced infringement, relying on a series of statements made by Hikma, along with its skinny label.  The district court dismissed the case, but a panel of the Federal Circuit reversed.  Hikma appealed to the Supreme Court, which accepted cert.

The Supreme Court applied its three-part test for induced infringement claims.  “First, there must be direct infringement by a third party.”  “Second, the inducer must know that the induced acts constitute patent infringement.”  And “[t]hird, and most relevant here, the inducer must take active steps . . . to encourage direct infringement.”

In its 14-page unanimous opinion authored by Justice Jackson, the Court found that Hikma’s actions did not constitute “active steps” to encourage direct infringement.  Merely advertising a product as equivalent to another product does not constitute active steps to induce using it for a particular purpose.  “’Vague’ statements combined with speculation about how medical providers may act in response to those statements” do not give rise to induced infringement because they do not “plausibly constitute affirmative steps to bring about the desired result of infringement.”  Treating such statements as inducing infringement “would turn any statement extraneous to the unpatented method of use—even one warning people against the patented method of use—into active inducement of infringement.”

The opinion can be found here.

By Nika Aldrich

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Ollnova Techs. Ltd. v. ecobee Techs. ULC, Appeal Nos. 2025-1045, -1046 (Fed. Cir. June 4, 2026)

The Federal Circuit erased an $11.5 million infringement verdict against smart thermostat products sold by ecobee, finding error in the lower court’s jury instructions concerning infringement and patent ineligibility under 35 U.S.C. § 101.  However, the reviewing panel rejected ecobee’s arguments that it was entitled to dismissal or judgment as  a matter of law on any claim, and so remanded for a new trial on infringement and damages.

Ollnova asserted four patents directed to wireless communication techniques in building automation systems, all of which ecobee challenged on the pleadings as being impermissibly directed to abstract ideas.  At step one of the Alice eligibility inquiry, the district court found U.S. Patent No. 7,860,495 to be directed to the abstract idea of “controlling generic ‘components’ using information from two separate sources,” but that issues of fact precluded determining whether the claims disclosed an inventive concept under Alice step two.  The district court rejected ecobee’s dismissal arguments on the remaining patents, and Ollnova’s claims on all four patents proceeded to trial.

At trial, to ascertain infringement, the district court charged the jury only with determining whether ecobee “infringed ANY of the Asserted Claims of the Asserted Patents.”  (Emphasis in opinion.)  Based on its recent decision in Optis Cellular Tech. LLC v. Apple Inc., 139 F.4th 1363 (Fed. Cir. 2025), the Federal Circuit found this to be reversible error, because it permitted the jury to find infringement without a unanimous decision that any one patent claim was infringed.  As to the eligibility question on the ’495 patent, the lower court asked the jury to determine only whether the claims were directed to “well-understood, routine, and conventional” technology under Alice step two, without informing the jury that it had found the claims directed to an abstract idea, or what that abstract idea was.  The reviewing panel also found this to be error.  By failing to instruct the jury what abstract idea the claims were directed to, the court’s instructions permitted the jury to use that abstract idea itself to supply an “inventive concept,” contrary to controlling eligibility jurisprudence.

The reviewing panel found that the erroneous instructions required vacatur of the infringement judgment and associated damages award, but also rejected ecobee’s arguments that it was entitled to dismissal or JMOL on any claim.  Accordingly, the panel remanded the case for a new trial on infringement and damages, and did not reach the parties’ arguments concerning evidentiary and legal issues with the damages award.

The opinion can be found here.

By Jason Wrubleski

AGI Suretrack LLC v. Farmers Edge Inc., Farmers Edge (US) Inc., Appeal Nos. 2024-1730, 2024-1830

The Federal Circuit affirmed the District of Nebraska’s holding that AGI’s asserted claims were patent ineligible, but vacated the holding that the case was not “exceptional”, due to the District Court’s failure to explain its reasoning on that point.

The Federal Circuit quickly affirmed the asserted claims’ patent ineligibility under § 101, because the claims were directed to merely an abstract idea. Turning to the District Court’s exceptionality holding, the Federal Circuit explained that while District Courts were not always required to explain their reasoning in detail (for example, where the record spoke for itself), under most circumstances the District Court needs to provide enough material to allow for meaningful review of its holding. In this case, there was nothing in the District Court’s holding, or the record, that allowed the Federal Circuit to review whether the District Court abused its discretion in holding that the case was not exceptional.  Without anything allowing the Federal Circuit to review the District Court’s decision, the Federal Circuit was forced to vacate and remand the non-exceptionality holding, with instructions to the District Court to allow each party to present arguments on exceptionality and attorneys’ fees.

The opinion can be found here.

By Tyler Hall

Hafeman v. Google LLC et al., Appeal Nos. 2024-1600 through -1605 (Fed. Cir. June 5, 2026

In an appeal from a final decision of non-obviousness by the US patent office in an inter parties review (IPR), the Federal Circuit dismissed a portion of the appeal on the grounds that 35 U.S.C. § 315(d) bars judicial review of institution-related determinations by the US patent office.  Appellant argued that the Board abused its discretion by failing to address Sotera-related arguments in its final written decision, and attempted to frame such arguments as directed to how the IPR proceeded after institution of the IPR.  The Court disagreed, pointing out that an argument that the Sotera stipulation was “consideration” for institution is an institution-related argument, and thus barred from the Court’s review by 35 U.S.C. § 315(d).

Appellant’s remaining arguments, concerning the Board’s claim interpretation, as well as the Board’s analysis of secondary considerations of non-obviousness, did not fare any better.  The Court affirmed the Board’s construction of the relevant claim limitation, and additionally affirmed the Board’s findings regarding secondary considerations (as being supported by substantial evidence).

The opinion can be found here.

By Michael Cofield

This article summarizes aspects of the law and does not constitute legal advice. For legal advice with regard to your situation, you should contact an attorney.