Supreme Court Decision Provides Ammo for Use Against Indirect Patent Infringement Claims

The Supreme Court issued its decision today in Hikma Pharmaceuticals v. Amarin Pharma, addressing what it takes to successfully plead a claim for indirect patent infringement.  The dispute focuses on the pharmaceutical industry and so-called “skinny labels,” which are important for generic drug manufacturers, but the Supreme Court's decision is not limited to drug disputes or to the particular FDA regulations raised by the parties. Instead, the Court's standard requires a plaintiff to allege “affirmative” steps to cause infringement—and found it lacking in this case.  It's not hard to see how defendants in any industry that are accused of infringement will use this new decision to kill indirect patent infringement claims.

In a unanimous opinion authored by Justice Ketanji Brown Jackson, the high court reversed a 2024 Federal Circuit decision that Hikma's marketing statements about its version of Amarin's Vascepa were sufficient to let the induced infringement case proceed.

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