Recitation of Common Functional Groups for Genus Claims Fails Written Description Requirement

In an opinion issued on March 6, 2023, the Federal Circuit affirmed the PTAB’s holding of unpatentability because the applications from which the patent claimed priority from lacked sufficient written description under 35 U.S.C. § 112. Regents of University of MN v. Gilead Sciences, Inc., No. 2021-2168 (March 6, 2021). Because the patent could not […]

Laundry List of Formulations Fails to Satisfy § 112 for Broad Functional Claims

Judge Bryson, sitting in the District of Delaware invalidated four patents owned by Lipocine, Inc., finding that the patents did not meet the written description and enablement requirements of 35 U.S.C. § 112. Lipocine Inc. v. Clarus Therapeutics, Inc., No. 19-622 2021 (D. Del. 2021). Lipocine’s patents were directed to methods for treating men deficient […]

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, […]


In a recent decision, the Federal Circuit reversed the District of New Jersey’s final judgment that two patents directed to methods of administering NSAIDs were adequately described under § 112. Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 2019 U.S. App. LEXIS 14345 (Fed. Cir. 2019). Both of the asserted patents are […]

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 […]

Federal Circuit Finds Barr Does Not Infringe But Rejects Enablement and Written Description Defenses

The recent appeal of Alcon Research Ltd. v. Barr Labs., Inc., No. 2012-1340 (Fed. Cir. Mar. 18, 2014) touched on several of the patent-law issues you will encounter in ANDA cases: infringement, written description, and enablement. Barr sought to market a generic version of Alcon’s glaucoma and ocular hypertension drug Travatan Z®.  Alcon filed suit […]

Federal Circuit Finds Sufficient Written Description

The Federal Circuit recently affirmed the District of Delaware’s rejection of a lack of written description defense in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 2013-1593 (Fed. Cir. 2014).  GlaxoSmithKline sued several generic companies for infringement of U.S. Patent No. 5,565,467, which is listed in the Orange Book for Avodart (dutasteride), a treatment for enlarged […]