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
The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by...more
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
In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more
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
The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more
Case Name: Classen Immunotherapies, Inc. v. Shionogi, Inc., Civ. No. 13-921-RWT, 2014 U.S. Dist. LEXIS 10642 (D. Md. Jan. 29, 2014) (Titus, J.) - Drug Product and Patent(s)-in-Suit: Computer algorithm and method of...more