In a recent IAM article, Thompson Coburn partner Olga Berson was quoted extensively on the U.S. Supreme Court’s decision in Amarin v. Hikma, a landmark ruling that reshapes how courts evaluate induced infringement claims in the context of “skinny label” drugs.
Olga highlighted that the ruling gives generic companies “more breathing room for disciplined section viii launches.”
However, she emphasized that the decision does not give generics unlimited flexibility. “The safer path remains careful alignment among the skinny label, website content, press releases, sales training, payer communications, and other external statements,” she said. “The court’s opinion makes clear that ordinary product distribution and truthful generic-equivalence statements are not enough by themselves, but affirmative encouragement of the carved-out patented use remains the line to avoid.”
Olga also explored the legal-strategic implications of the ruling. “For branded companies and investors in branded drug assets,” she explained, “the lesson is that indication-specific patent diligence needs to be more granular. It may also be important to evaluate the strength of patent coverage across all indications and make strategic decisions about whether a smaller indication of patent coverage should be retained, de-emphasized, or abandoned if it creates a pathway for broader generic erosion.”
Looking ahead, Olga said the ruling is prompting both sides of the market to plan more carefully and strategically. “Overall, the decision should push both sides toward more rigorous pre-launch planning,” she said.
“Brands will need better evidence and monitoring if they want to plead inducement after skinny-label entry, while generics will need tighter controls over post-launch messaging,” said Olga.
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