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Generic Drugs The United States Food and Drug Administration Classen Immunotherapies

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., Case No. RDB-04-3521, 2016 U.S. Dist. LEXIS 131964 (D. Md. Sept. 27, 2016) - Drug Product and Patent(s)-in-Suit: Skelaxin® (metaxalone); U.S. Patent No. 6,...more

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

by Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

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