In what these days appears to be highly unusual, a 9-0 ruling by the justices of the Supreme Court “overturned a lower court’s decision in favor of Amarin. Generic drugmakers argued that a ruling in favor of Amarin in the case would have discouraged them from making and selling their lower-cost drugs and increased U.S. drug prices” (here). This case is extremely important in helping define the bounds of the so-called “skinny label” under a so-called “little viii statement” that a product is not including a patent- or exclusivity-protected use in its label (i.e., a label that has fewer indications than the RLD used as the basis of submission and carves out the information that may be protected by patent or exclusivity). However, this recent decision does not mean that inducement to infringe could not result from a generic sponsor’s behavior and actions. It does mean that future cases will likely be fact-specific, but at least the current decision means that the guardrails of “skinny label” protection are clearer.
This case has been going on for quite some time, and we have written about it and other relevant cases and issues related to the “skinny label” extensively here, here, and here (the last link cites eleven of our other blogs dealing with the “skinny label” issue). The Supreme Court decision yesterday is a big win for “skinny label” generic manufacturers and especially patients who will benefit from availability of lower-cost, high-quality generic products that would otherwise be blocked from the U.S. market for years by patent or exclusivity protection.
