U.S. Supreme Court Reverses Federal Circuit, Holding No Induced Infringement Plausibly Pled Based on Skinny Label and Related Statements

By  Jiazhong (Jason) Luo, Ph.D. and Frederick R. Ball

Recently, the Supreme Court of the United States unanimously reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., holding that Amarin failed to state a claim for active inducement of patent infringement under 35 U.S.C. § 271(b). The decision clarifies that the relevant inquiry is whether a defendant actively encouraged infringing use, not merely whether physicians could plausibly read the defendant’s statements related to a skinny label as instructions to infringe.

Read the full Alert on the Duane Morris LLP website.

Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey’s order to delist from the FDA Orange Book Teva’s five patents claiming just device components of a drug product without reciting any active ingredient.

Read the full Alert on the Duane Morris LLP website.

Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone did not, as a matter of law, recommend, encourage or promote any infringing use.

Read the full Alert on the Duane Morris LLP website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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