New Reverse-Payment Decision Sheds Further Light on Plaintiffs’ Causation Burden
More recent cases have addressed the question of how a plaintiff can make that showing when lawful generic launch would be precluded by patents held by the brand manufacturer. In a recent blog post, we discussed a November 2017 decision in the Lidoderm litigation in which the court ruled that plaintiffs could survive a motion for summary judgment by presenting “some evidence” that the generic manufacturer “could have” prevailed in patent infringement litigation against the brand manufacturer.
Now a second court has followed the Lidoderm opinion and reached the same conclusion. On Jan. 25, 2018, Judge Denise Casper of the U.S. District Court for the District of Massachusetts denied motions for summary judgment and allowed antitrust claims concerning allegedly delayed entry of generic Solodyn to proceed to trial. Judge Casper confirmed that, where the brand manufacturer’s patents create “an independent regulatory bar” to generic entry, the plaintiff has to show that the generic manufacturer could have released its drug “lawfully” – without infringing a valid patent. As in the Lidoderm opinion, Judge Denise Casper determined that the plaintiff can defeat a motion for summary judgment on this causation question by producing “some evidence” that the generic manufacturer “could have” proved that the patents were either invalid or not infringed.
The Solodyn and Lidoderm decisions articulated a private plaintiff’s burden to resist summary judgment on the issue of causation. Neither expressly limited its application to only summary judgment, but the courts will presumably hold the plaintiffs to the usual preponderance of the evidence (more likely than not) standard at trial to show that the patent-litigation settlement, as opposed to a rightful exclusionary bar presented by valid and infringed patent claims, delayed the generic entry and caused the asserted injury.