In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the Supreme Court held that allegations based on a generic manufacturer’s skinny label, website statements, patient leaflet and press releases did not plausibly state a claim for induced infringement under 35 U.S.C. §271(b). The Supreme Court emphasized that it is not enough to allege physicians could plausibly read a generic manufacturer’s statements as encouraging an infringing use; instead, a plaintiff must plausibly allege affirmative, culpable steps taken to bring about infringement.
This decision is particularly important for generic pharmaceutical companies because it reduces the risk of liability based solely on marketing a lawfully approved generic product that may have substantial off-label or substituted use, and it makes inducement claims more difficult to plead when the alleged conduct consists of ordinary labeling, industry-standard descriptions, vague statements or, in particular, omissions regarding limits on use from the skinny label or marketing materials. Not only will it now be more difficult for brand manufacturers to allege induced infringement, but it will also make it more difficult for them to prove induced infringement at trial based on a label that includes a “section viii” carve-out. 21 U.S.C §355(j)(2)A)(viii). Moreover, many prior district court rulings finding induced infringement based on skinny labels will no longer be citable in support of an inducement claim due to their faulty induced infringement analysis.
Amarin, the maker of Vascepa®, alleged that Hikma induced infringement of Amarin’s patented cardiovascular-risk-reduction method of use for icosapent ethyl. Amarin’s complaint alleged that, although Hikma obtained FDA approval only for a carved-out “skinny label” covering the older severe hypertriglyceridemia indication, Hikma’s overall messaging still encouraged the patented cardiovascular use. Amarin’s complaint pointed to several categories of statements: the skinny label’s omission of the prior cardiovascular limitation of use and retention of clinical-study information involving statin users; a patient information leaflet referring to side effects in people with cardiovascular disease and noting medicines are sometimes prescribed for uses other than those listed; Hikma’s website describing the product as “AB” rated and identifying its therapeutic category broadly as hypertriglyceridemia; and pre-launch press releases referring to the product as generic Vascepa and citing sales figures that reflected both patented and unpatented uses.
The Supreme Court unanimously rejected those allegations as insufficient. An induced infringement claim under 35 U.S.C. §271(b) generally has three elements: (1) direct infringement by a third party; (2) knowledge that the induced acts constitute infringement; and (3) active steps to encourage or cause the infringement. Writing for the Court, Justice Jackson addressed the element of “active steps … to encourage direct infringement,” and explained that §271(b) requires more than a plausible inference that a doctor might interpret certain statements as encouragement to infringe; it requires plausible allegations the defendant took affirmative steps to encourage the infringing use. The Court reasoned that several of Hikma’s statements had obvious lawful explanations, including compliance with the FDA’s duty of sameness and ordinary industry practice in describing a product as the generic equivalent of a brand drug. The Court also held that omissions, such as failing to highlight that approval was limited to the severe hypertriglyceridemia indication, cannot themselves amount to active inducement, and the remaining statements were too vague and attenuated to plausibly show purposeful encouragement of infringement. The Court stated that inducement cannot be based only on “vague” language “combined with speculation about how [others] may act.”
The case arose after Hikma filed an abbreviated new drug application for generic icosapent ethyl and, following developments in Amarin’s patent portfolio, supplemented the application with a section viii statement seeking approval for a skinny label that carved out Amarin’s still-patented cardiovascular indication. After the FDA approved Hikma’s product in 2020, Amarin sued in the District of Delaware for induced infringement. The district court granted Hikma’s Rule 12(b)(6) motion to dismiss, concluding the alleged statements did not constitute active steps to encourage infringement. The Federal Circuit reversed, holding it was at least plausible that a physician could read Hikma’s statements as instruction or encouragement to prescribe the drug for infringing uses. The Supreme Court then granted certiorari, reversed the Federal Circuit, and remanded, holding that the complaint failed to plausibly allege the kind of affirmative encouragement required to state an inducement claim. Because the Court was addressing the merits of Amarin’s allegations in the complaint, not evidence that was, or could be, developed during the litigation, the holding in this case telegraphs what type of conduct the court will find insufficient to allege induced infringement as a matter of law.
Our Intellectual Property Practice Group tracks significant court decisions in the IP field to ensure it is in the best position to advise clients. If you need assistance with these matters, please reach out to attorney Richard J. Basile at (203) 653-5412 and rbasile@harrisbeachmurtha.com; attorney Laura W. Smalley at (585) 419-8736 and lsmalley@harrisbeachmurtha.com; or the Harris Beach Murtha attorney with whom you most frequently work.
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