On June 4, the Supreme Court in Hikma Pharmaceuticals v. Amarin Pharma addressed the standard for induced patent infringement by generic drugmakers.
Hikma manufactured generic icosapent ethyl, a drug pioneered by Amarin under the name Vascepa and approved by the FDA for the limited purpose of treating very high blood triglyceride levels, or severe hypertriglyceridemia (the “SH indication”). Amarin owned method-of-use patents for the SH indication use of the drug, and sued Hikma for infringement. Hikma challenged the validity of those patents, and the district court held the SH indication patents invalid.
Before the invalidity decision, the FDA approved Amarin’s drug for another indicated use: reducing cardiovascular risk for hypertriglyceridemia patients already on statins (the “CV indication”). Amarin modified the label on its drug such that it continued to reference the SH indication, but removed previous restrictions on the CV indication. Amarin also obtained new method-of-use patents for the CV indication.
The law generally requires that a generic’s label be the “same” as the brand-name drug, so Hikma changed its label to mirror Amarin’s, namely, to reference the SH indication with no mention or restriction on the CV indication. Hikma also distributed literature identifying its offering as the “generic” alternative to the brand-name drug, and suggesting that the generic was in a therapeutic category broader than the SH indication.
Amarin then brought an infringement suit on the CV-indication method-of-use patents, accusing Hikma of knowingly and actively inducing others—namely, physicians—to infringe the patent. The district court dismissed the case as failing to state a claim, finding that none of Hikma’s statements or actions constituted active steps to encourage infringement of the CV-indication patents. But the Federal Circuit reversed, finding it “at least plausible” that the generic’s modified label and accompanying literature and other marketing materials could be viewed by physicians as an “instruction or encouragement” to prescribe the generic for any of the approved uses of the brand-name drug, including those protected by the CV-indication patents.
The Supreme Court unanimously reversed the Federal Circuit, with Justice Jackson writing the opinion finding that Amarin failed to state a claim. It noted that the law required Hikma to mirror the brand-name’s label, which set no restriction on the CV indication. The Court also found it was normal industry practice to refer to a generic as the “generic equivalent” of a brand name. The statements on Hikma’s website and other marketing materials, while broad enough to encompass the CV indication, were not specific enough to the CV indication to induce infringement.
The Supreme Court thus agreed with the district court that Amarin failed to state a claim for induced infringement, which requires “actively encourag[ing] infringing uses.” The fact that some doctors could “plausibly” read Hikma’s statements as encouragement was not enough. The Court remanded the case to the lower court for further proceedings.
This IP Advisory was prepared by Lando & Anastasi, LLP. The information provided in this Advisory does not, and is not intended to, constitute legal advice; instead, all information, content, and materials are for general informational purposes only. Readers should contact an attorney to obtain legal advice with respect to any particular legal matter.
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