Addressing subject matter eligibility in the life sciences context, the US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment ruling that certain claims directed to genetically engineered...more
On February 20, 2026, in REGENXBIO Inc. et al. v. Sarepta Therapeutics Inc., et al., No. 2024-1408, the Federal Circuit reversed a district court decision which held that claims covering a cultured host cell containing a...more
Lysosomal storage disorders are a group of inherited diseases that range from treatable (Fabray Disease and Gaucher disease) to fatal (Niemann-Pick disease and Tay-Sachs disease). Drug-induced phospholipidosis (DIP) is...more
The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for supporting §101...more
The evolution of subject matter eligibility after the Supreme Court's decisions in Prometheus v. Mayo, Alice v. CLS Bank, and Association for Molecular Pathology v. Myriad Genetics has resulted in a regime of predictable...more
Over the last 15 years, the discussion over the types of subject matter that are considered patent eligible under 35 U.S.C. § 101 has been mostly focused on the software and biological fields. Several years ago, the Federal...more
Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more
A consequence (predominantly negative) of the Supreme Court's recent foray into defining (however inadequately) the contours of patent-eligible subject matter is to give the district courts (and to a somewhat lesser extent,...more
This past Friday, a federal district court held that the mere fact of combining certain natural products – such as isolated, naturally occurring AAV sequences and a heterologous non-AAV sequence – and putting them into a...more
In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more
It's not often that we write about pharmaceutical patents on this blog, and even less often that we blog here about PTAB decisions. The former is a function of the Federal Circuit's decision in Vanda Pharmaceuticals Inc. v....more
Provisur Technologies, Inc. v. Weber, Inc., Appeal Nos. 2021-1942, -1975 (Fed. Cir. Sept. 27, 2022) - In this week’s Case of the Week, the Federal Circuit reviewed an IPR decision and addressed the Patent Trial and Appeal...more