[1] See our previous post on this case for a description of the arguments made on either side of the issue. Recently, a unanimous Supreme Court issued its ruling in Amgen Inc. v. Sanofi, holding that Amgen’s challenged patents ran afoul of Section 112’s enablement requirement.[1] Writing for the Court, Justice Gorsuch focused on the […]
On Friday, February 10, 2023, the latest round of amicus briefs in Amgen Inc. v. Sanofi poured in. The case, set to be argued on March 27 before the U.S. Supreme Court, asks the Court to wrestle with the enablement requirement of Section 112 of the Patent Act. Specifically, the Court has been asked to […]
In a recently unsealed opinion from the District of Delaware, Judge Dyk of the Federal Circuit sitting by designation, held a patent in the “inherently unpredictable” field of antibodies invalid on summary judgment for failing to satisfy the enablement requirement. Baxalta Inc. v. Genentech Inc. Delaware Opinion, Case No. 17-cv-509-TBD (D. Del. Jan. 13, 2022). […]
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 […]
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 […]
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, […]
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 […]