Supreme Court sides with Hikma in 'skinny label' case

Supreme Court backs generic drugmakers in patent case over “skinny labeling” for generic drugs.

The justices unanimously ruled that Hikma Pharmaceuticals USA did not infringe patents held by Amarin Pharma in a case that makes generic drugmakers less vulnerable to lawsuits over so-called skinny labels.

The Supreme Court unanimously reversed the Federal Circuit and held that Amarin’s lawsuit against the generic manufacturer Hikma could not survive a motion to dismiss.

The heart of the opinion is a distinction that sounds technical but does real work:
the question is whether Hikma actively encouraged infringement, not whether a doctor could read Hikma’s statements as encouragement.

The Court rejected Amarin’s expansive “could be read as encouragement” approach, but it also rejected Hikma’s position that inducement must be express; implicit encouragement can qualify, so long as it is clear and affirmative.

The Court held that Hikma’s skinny label, standing alone, did not induce infringement and that omissions and silence, including the absence of a cardiovascular limitation of use, cannot carry an active-inducement claim.

The decision is a decisive win for the generic industry that affirms skinny labeling as a shield against method-of-use liability and will generally shield generic companies that properly carve out a patented indication from induced-infringement liability.

The broader effect is to preserve the skinny-label pathway as a reliable route to generic entry, which expedites the arrival of cheaper drugs to patients.