Supreme Court Rejects “Possibility” Standard for Induced-Infringement Claims Against Skinny-Label Generics

Supreme Court Rejects “Possibility” Standard for Induced-Infringement Claims Against Skinny-Label Generics

The Supreme Court issued a unanimous decision for Hikma in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. It reversed the Federal Circuit and held that Amarin failed to state a claim that Hikma induced infringement through its skinny-labeled generic icosapent ethyl product.

Key Takeaway

The decision reinforces the viability of the Hatch-Waxman “skinny label” / “section viii carveout” pathway, under which a generic manufacturer may seek approval for unpatented uses while omitting patented indications from its proposed labeling.

A generic manufacturer does not face induced-infringement liability merely because it markets a skinny-labeled product as the generic equivalent of a branded drug, uses standard regulatory terminology, or includes labeling language that federal law requires it to copy from the brand product. A plaintiff must plausibly allege that the generic manufacturer took affirmative steps to encourage infringement.

The Decision Turns on “Active Steps” to Encourage the Patented Use

Amarin markets icosapent ethyl as Vascepa®, which has two FDA-approved indications: (1) treating severe hypertriglyceridemia (“SH indication”); and (2) reducing cardiovascular risk in certain statin-treated patients (“CV indication”). Hikma’s proposed generic label omitted the patented CV indication and sought approval only for the unpatented SH indication.

Amarin nevertheless asserted induced infringement. It argued, and the Federal Circuit agreed, that Hikma’s label, patient information leaflet, website, and press releases encouraged physicians to prescribe the product for the patented CV use.

The Supreme Court held that these allegations were insufficient. Induced infringement requires, among other things, affirmative conduct that encourages another party to perform the patented method. The relevant question is not whether physicians could interpret a generic manufacturer’s statements as supporting the patented use, but whether the manufacturer itself actively encouraged infringement.

FDA-Required Labeling and Routine Generic-Equivalence Language Do Not Supply Inducement

A significant aspect of the Court’s analysis was its treatment of labeling language that Hikma copied from the Vascepa® label.

Amarin argued that Hikma’s label supported an inducement claim because it retained information regarding a clinical study involving statin-treated patients. The Court rejected that theory: generic manufacturers generally must maintain labeling that is the same as the branded product’s labeling except for the carved-out patented use. Because Hikma’s challenged labeling language reflected compliance with that statutory “duty of sameness,” it could not plausibly support an inference that Hikma was encouraging infringement.

The Court also concluded that Hikma’s remaining statements reflected ordinary regulatory compliance and standard industry practice rather than affirmative encouragement of infringement. In particular, descriptions of an ANDA product as a “generic equivalent,” an AB-rated product, or a generic version of the branded drug do not, without more, amount to induced infringement. Likewise, standard patient-information disclosures and investor-focused sales information were too attenuated and speculative to constitute affirmative encouragement of infringement.

As the Court put it, “We decline to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.”

Implications for Hatch-Waxman Litigation

The decision affirms the skinny-label framework. Going forward, brand companies will likely need to identify specific promotional conduct or other affirmative acts directed at the patented use, rather than relying on standard generic marketing language, FDA-required labeling language, regulatory terminology, or the possibility that physicians may prescribe a skinny-labeled generic for a patented indication.

At the same time, the Court stopped short of holding that inducement must be express. The opinion recognizes that inducement may arise from implicit as well as explicit encouragement, provided the alleged conduct clearly and affirmatively promotes the patented use.

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin