This case may bring renewed hope to the skinny label practice.
In the recent opinion of Amarin Pharma v. Hikma Pharms. U.S. (No. 20-1630-RGA-JLH), the District Court of Delaware dismissed Amarin’s complaint against Hikma for induced infringement of three patents when Hikma used a skinny label to carve out a patented indication. However, the court held that Amarin sufficiently pled to proceed with the complaint against an insurer, Health Net, for induced infringement.
To prove induced infringement of a patent, a complaint must plead three elements: (1) existence of direct infringement, (2) a defendant’s knowingly inducing the infringement and (3) the defendant’s specific intent to encourage the infringement. In GlaxosmithKline LLC v. Teva Pharmaceuticals USA, Inc. (No. 2018-1976), the Federal Circuit overturned the District Court of Delaware’s ruling for Teva and twice confirmed that substantial evidence supported the jury’s findings of induced infringement when Teva used a skinny label to carve out a patented use, as discussed in a previous Alert.
This new case, which was filed in the same district court between the Federal Circuit’s two GSK decisions, arose from Amarin’s Vascepa icosapent ethyl drug, approved for treating severe hypertriglyceridemia (the SH indication) and cardiovascular risk reduction (the CV indication). Amarin’s three patents are directed to methods for using the drug for the CV indication. Hikma received FDA’s approval to sell a generic version for the SH indication only and carved out the patented use. Amarin sued Hikma for inducement infringement and argued that Hikma’s label and public statements instruct physicians to use the generic product for the patented indication.
Regarding Hikma’s label, Amarin argued that the label contains a notice regarding side effects for patients with cardiovascular disease and does not state that the generic version should not be used for the CV indication or “that the effect of icosapent ethyl on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined” (the CV limitation). The court sided with Hikma regarding the warning as to side effects and stated that this is “hardly instruction or encouragement.” The court noted that the Federal Circuit has previously rejected the argument that generic labels must contain a clear statement discouraging use of the patented indication. According to the court, the plaintiff must show the defendant’s affirmative act to induce, such as recommending, encouraging or promoting an infringing use, and the lack of a CV limitation on the skinny label does not plausibly teach cardiovascular risk reduction.
Regarding Hikma’s public statements, the court stated they did not support actual inducement. For Hikma's press releases stating that its product is the “generic equivalent to Vascepa,” the court noted that an advertisement about a generic equivalent “does not expose Hikma to liability” based on GSK. Amarin argued that Hikma’s press releases also cited the sales figures of Vascepa including the sales of the patented indication. The court stated that such a citation might be relevant to Hikma’s intent, but Amarin did not plead an affirmative inducing act. Amarin argued that Hikma’s website states that Hikma's generic is “AB rated” in the “Therapeutic Category: Hypertriglyceridemia,” which is broader than the indication (only severe hypertriglyceridemia) in the label and includes infringing uses. The court concluded that without instructions as to the infringing uses, this is not enough to induce infringement, and such a statement does not rise to the level of encouraging, recommending or promoting taking the generic drug for the patented uses.
In addition, the court ruled that Amarin’s complaint plausibly alleged that Health Net’s knowledge of the asserted patents and affirmative acts, such as the insurer’s formulary placement and prior authorization process, could plausibly show specific intent to induce another to infringe. According to the court, for example, the insurer’s prior authorization form listing the patented indication for the generic drug and placement of the generic drug on a preferred tier can be inferred as the insurer’s specific intent and encouragement for infringement.
This case may bring renewed hope to the skinny label practice. However, this case and the Federal Circuit’s GSK case still bring uncertainty and confusion. Case-specific, fact-based and detailed analysis is needed to determine whether a generic company’s skinny label fully carves out a patented use, and promotional materials need to be scrutinized to mitigate potential infringement risk. Additionally, the case serves as a reminder to health insurers, who should watch for potential risk when a generic drug has a skinny label.
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