Amarin Corp Plc (AMRN)

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Amarin-Hikma Appeal filings from FedCircuitBlog

A “brief” post
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See links for all filed briefs at https://fedcircuitblog.com/other-cases/amarin-pharma-inc-v-hikma-pharmaceuticals-usa-inc/

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

APPEAL NO. 23-1169
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?”

DATE/ SELECTED PROCEEDINGS AND ORDERS

March 21, 2023 Appellants' Opening Brief

May 31, 2023 Brief for Defendants-Appellees

June 7, 2023 Brief for the Association for Accessible Medicines as Amicus Curiae in Support of Defendant-Appellees and Affirmance

July 12, 2023 Appellants' Reply Brief