Regarding the procedures, the Federal Circuit noted that this appeal is neither a traditional Hatch-Waxman case arising from a submission of an abbreviated new drug application, nor a case arising solely from a skinny label for induced infringement.

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone did not, as a matter of law, recommend, encourage or promote any infringing use.

The case arose from Amarin’s Vascepa icosapent ethyl, approved for treating severe hypertriglyceridemia (SH indication) with a blood triglyceride at least 500 mg/dL and cardiovascular risk reduction (CV indication) for a patient having a blood triglyceride at least 150 mg/dL. Hikma carved out the CV indication covered by two of Amarin’s patents and received FDA’s approval to sell a generic version for the SH indication only. Amarin sued Hikma for induced infringement and argued that Hikma’s label and public statements instructed physicians to use the generic product for the patented indication. In 2021, the District Court dismissed Amarin’s complaint against Hikma, despite a magistrate judge’s opposite recommendation. Amarin appealed.

Based on the pleading standard adopted by the Third Circuit, a complaint needs to be plausible to proceed, if a court accepts all well-pled factual allegations as true and draws all reasonable inferences from such allegations in the complaint’s favor. Based on patent laws, to state an induced infringement, a complaint must plead (1) existence of direct infringement of a patent by a third party and (2) an alleged infringer’s affirmative act to induce the infringement with knowledge that the induced acts constituted patent infringement.

Regarding the procedures, the Federal Circuit noted that this appeal is neither a traditional Hatch-Waxman case arising from a submission of an abbreviated new drug application, nor a case arising solely from a skinny label for induced infringement. Amarin appealed only after case dismissal other than from a post-trial motion. Citing its GSK precedent on skinny labels, the Federal Circuit noted that it needs to review the totality of allegation of inducement, take the allegations as true and determine whether Amarin has plausibly pled that Hikma induced the infringement.

Regarding plausibility, the court stated that it is undisputed that Amarin’s complaint sufficiently alleges (a) physicians’ direct infringement by prescribing Hikma’s generic drug for the off-label CV indication and (b) Hikma’s intent and knowledge to induce that infringement, while only citing the district court’s statement that “Hikma’s press releases might be relevant to intent.” Therefore, the Federal Circuit narrowly focused on whether Amarin’s complaint plausibly pleads that Hikma actively induced—namely, encouraged, recommended or promoted—the physicians’ infringement.

Regarding Hikma’s label including the notice on side effects for patients with CV disease, the Federal Circuit concluded it may side with Hikma and the district court and agree that Hikma’s skinny label alone did not recommend, encourage or promote an infringing use. The court then turned its attention to Hikma’s public statements and the marketing materials. For example, after the FDA’s approval, Hikma’s website promoted the generic product as “AB-rated” in the category of “hypertriglyceridemia,” which is broad enough to encompass both infringing and noninfringing uses according to the court. The court also pointed out that prior to the FDA’s approval, Hikma had press releases referred to its generic product as “generic equivalent to Vascepa®,” “generic Vascepa®,” “Hikma’s generic version of Vascepa®,” without indicating that its product being AB-rated to the SH indication only. The court also pointed out the complaint alleged Hikma touted the overall sales figures for Vascepa including 75 percent from the patented CV indication. The court concluded that those allegations, together with those related to Hikma’s label, at least plausibly stated a claim for induced infringement, and such a claim is a question of fact, not law, and should not be resolved on a motion to dismiss.

The court stated that this reversal does not run afoul of the GSK case, clarified GSK’s holding and distinguished this case from GSK. The Federal Circuit in GSK overturned the District Court of Delaware’s ruling for Teva and confirmed that Teva’s skinny label, which unsuccessfully carved out the patented indication, in combination with marketing materials and press releases provided substantial evidence to support the jury’s findings of induced infringement.

However, it is not clear whether marketing materials, press releases and any other public statements alone may make a generic pharma liable for induced infringement when a skinny label is skinny enough to carve out a patented indication. For at least this reason, it is worthwhile to track this case. The Federal Circuit’s ruling in this case and the GSK case may diminish hope and add uncertainty to the statutory skinny label practices. Technical and legal analyses are needed to determine whether a skinny label fully carves out a patented use. Further, generic manufacturers need to securitize their websites, press releases and any other public statements or promotional materials to mitigate risk for potential induced infringement suits.

For More Information

If you have any questions about this Alert, please contact Jiazhong (Jason) Luo, Ph.D., Frederick R. Ball, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Intellectual Property Practice Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.