Director Paul Ainsworth shared his thoughts with IP Watchdog on the Supreme Court ruling in Hikma v. Amarin to protect skinny drug labels and what it means for the pharmaceutical industry.
Ainsworth stated, “The Supreme Court decision in Hikma v. Amarin will likely be celebrated as a win for generic drug manufacturers as it will be viewed by some as providing greater certainty to the law regarding skinny drug labels. However, I think the decision may cast greater uncertainty over what constitutes a proper skinny label. In particular, I think we are likely to see lower courts grappling with more questions regarding whether FDA-mandated statements on a drug label are actively inducing infringement.”
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