Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.

 
APPEAL NO.
23-1169
OP. BELOW
DCT
OPINION
TBD
SUBJECT
Patent
AUTHOR
TBD

Issue(s) Presented

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?”