Knobbe Martens partner Jeremiah Helm shared his insights with Law360 and MLex on the key issues in the Supreme Court case Hikma v. Amarin ahead of oral arguments this week.
In the highly anticipated case, the court will clarify guidelines on the use of “skinny labels” to market generic drugs. Helm explained to Law360 and MLex how the Court’s decision will likely need to consider the complex interaction between patent law and the Hatch-Waxman Act, which allows generic drug manufacturers to use so-called skinny labels to market a product for only the uses of a brand-name drug that are no longer protected by patent. Expanding on this point with Law360, he said he expected the arguments to include “some probing into how much the skinny label statute expressed some intent by Congress, and what that intent was” as it relates to generic pharmaceutical marketing statements.
Helm also suggested that the Court could narrow its scope in deciding the case, focusing on particular issues associated with Hikma’s pharmaceutical marketing. In that instance, Helm said, the Court might offer guidance on how statements made to pharmaceutical company investors could have bearing on induced infringement claims.
Read Helm’s full comments in Law360 here and MLex here [subscriptions required].
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