1. “Did the district court err by failing to consider the combined weight and effect of evidence demonstrating Hikma’s repeated extra-label encouragement of using their generic version of Amarin’s patented drug for both the approved skinny-label use of treating severe hypertriglyceridemia and the non-approved and infringing use of reducing cardiovascular risk in patients who do not suffer from severe hypertriglyceridemia when it dismissed Amarin’s complaint for failure to state a claim?”
2. “Did the district court err by implicitly making a factual finding on the pleadings regarding what Hikma’s conduct communicated to prescribing physicians, a key element of induced infringement?”
3. “Did the district court improperly analogize Amarin’s allegations to Grunenthal, a label-only case where the asserted patent covered a use narrower than the generic label instructed, whereas Amarin alleged extra-label inducement activity by Hikma in the context of Amarin’s patents, which are directed to a use broader than Hikma’s approved use?”
1. “Hikma’s press releases, at least prior to November 2020, consistently referred to Hikma’s product as a ‘generic equivalent to Vascepa®.’ . . . Those allegations, taken together with those relating to Hikma’s label, at least plausibly state a claim for induced infringement.”
2. “As Amarin notes, and the magistrate judge observed, many of the allegations depend on what Hikma’s label and public statements would communicate to physicians and the marketplace. As we observed in GSK, that is a question of fact—not law—and is therefore not proper for resolution on a motion to dismiss.
3. “[T]he allegations of the complaint transform this case from a pre-approval, label only induced infringement claim to one where the alleged infringement is based on the generic manufacturer’s skinny label as well as its public statements and marketing of its already-approved generic product.”
