Hikma v. Amarin: Six Takeaways From the Pivotal Ruling

William Milliken, director and co-chair of Sterne Kessler’s appellate practice, shared his thoughts with Life Sciences IP Review on the recent unanimous Supreme Court decision in Hikma v. Amarin.

Milliken commented the decision resolves a deeper inconsistency in inducement law but cautions against viewing it as the final word, noting that the decision settles one important debate under Section 271(b), but “will it give rise to more?”.

He continued, “How clear is ‘clear’? What’s the line between a statement that is ‘designed to stimulate others’ and a statement ‘that could stimulate others’? What is the limit to the principle that ‘just complying with the law or with standard industry practice’ is not active inducement?”

Milliken also raised the question of how to address a scenario where a branded drug’s label itself includes language that clearly encourages infringing use, and a generic manufacturer has to replicate that. In that situation, Milliken noted, “the generic cannot avoid liability by saying ‘the FDA made us do it.’ We can expect ample litigation in coming years on these questions.”