Hikma v. Amarin SCOTUS Decision

Need to know

The Supreme Court held that inducement of patent infringement requires active, affirmative statements or actions encouraging infringement, not merely statements that could be read as encouraging infringement. 

The U.S. Supreme Court held in Hikma Pharmaceuticals, Inc. v. Amarin Pharma, Inc., that Amarin failed to show “more than a sheer possibility” that Hikma actively induced infringement of Amarin’s Vascepa^®.  The Court held that infringement under 35 U.S.C. § 271(b) requires more than the mere possibility that third parties might use a product in an infringing manner; rather, it requires the patentee show that the alleged infringer engaged in affirmative conduct designed to encourage infringement. The Court also noted that “affirmative conduct” does not have to be express; it can be achieved through “implicit encouragement” if it is clear to the relevant audience and affirmative in nature. 

Background

Amarin’s Vascepa^® is approved by the Food and Drug Administration (FDA) to treat severe hypertriglyceridemia (the SH indication) and to reduce cardiovascular risk (the CV indication). The dispute arose when Hikma filed an Abbreviated New Drug Application (ANDA) for its generic product with a Paragraph IV certification asserting that Amarin’s SH indication patents were invalid. After a district court invalidated the SH indication patents, Hikma supplemented its application with a section viii statement seeking approval of a skinny label that included only the SH indication and carved out the still-patented CV indication. FDA approved Hikma’s ANDA with the skinny label and assigned it an AB rating indicating therapeutic equivalence to Vascepa^®.

Procedural history

Amarin filed suit in the District of Delaware, alleging that Hikma induced infringement based on its statements on the skinny label, the patient information leaflet, its website, and its press releases. The district court granted Hikma’s motion to dismiss, finding that none of those statements constituted active steps to induce infringement. The Federal Circuit reversed, holding that it was at least plausible that physicians could read the statements as instructions or encouragement to infringe. 

The Court’s opinion

The Court framed the central question as whether Amarin had plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe. It explained that active steps to encourage infringement require “purposeful, culpable expression and conduct” — i.e., affirmative, as opposed to passive, actions to bring about the desired result of patent infringement. The Court noted that “active steps” excludes “ordinary acts incident to product distribution.” 

Given those standards, the Court found that Amarin had not shown that Hikma had actively encouraged infringing use. Amarin had argued that it need do no more than allege a “plausible chain of events through which [Hikma] could lead a healthcare provider…to prescribe or dispense Hikma’s drug [for the still-patented CV indication.” The Court rejected Amarin’s argument, explaining that “active steps” cannot be based on “vague” language “combined with speculation about how [others] may act.” Rather, the Court looks for affirmative statements or actions to induce liability. 

The Court found that Amarin could not show active inducement with “mere omissions, inactions, or nonfeasance” — such as the skinny label’s omission of a CV Limitation of Use or Hikma’s press release that failed to mention that its product’s approved use was limited to the SH indication. It also found that several statements that Amarin argued could be read as encouraging infringement have alternative explanations. For example, Hikma’s label retained information about a clinical study relevant to the CV indication, but the Court noted that Hikma’s label must be identical to Amarin’s except for the carved-out use. Further, the Court pointed out that truthfully describing a drug as the “generic equivalent” of a brand-name drug, as Hikma did, is a normal industry practice and thus declined to turn adherence to industry standards into a building block for unlawful conduct. 

Finding the rest of the Hikma statements that Amarin relied on too vague to support inducement liability, the Court reversed and remanded. 

Takeaways

• The Court emphasized that active, affirmative steps are required for inducement.
• Omissions, neutral statements, or ambiguous context are insufficient.
• Ordinary commercial behavior, such as truthful “generic equivalent” statements, the use of AB ratings, and broad therapeutic classification language is, without more, unlikely to support inducement liability.
• Inducement claims likely will be harder to plead and face more scrutiny following this decision.
• To avoid liability, a party should ensure that it does not take active, affirmative steps to encourage an infringing use of its products.