Amgen v. Sanofi – Federal Circuit Focuses on Functional Claim Elements in Affirming Invalidity of Antibody Patent Claims as Not Enabled

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware holding claims covering two Amgen-owned patents invalid for lack of enablement under 35 U.S.C. § 112.  Amgen Inc., v. Sanofi, 2021 U.S. App. LEXIS 3952 (Fed. Cir. 2021).  The patents at issue are directed to antibodies that bind […]

Breadth of Noven’s Claims to “Transdermal” Drug Delivery System Leads to Holding of Invalidity Under § 112

Judge Stark of the District of Delaware invalidated three Noven patents directed to its Minivelle estrogen therapy patch under § 112, finding that each claim failed to enable and provide written description support for the full scope of the claim.  Noven Pharms., Inc. v. Amneal Pharms. LLC, No. 18-699 (D. Del. 2020).  Noven’s Minivelle product, […]

Post-Priority-Date Evidence May Be Relevant to 35 U.S.C. § 112 Inquiry

Recently, the Federal Circuit reversed a jury decision upholding the validity of two Amgen patents directed to a large genus of antibodies that reduce LDL cholesterol. Amgen et al. v. Sanofi et al., No. 2017-1480.  Defendants argued that the patents failed to satisfy the written description and enablement requirements under 35 U.S.C. § 112.  The […]