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 Feb. 20, 2026, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a thoughtful analysis of biotechnology subject-matter eligibility in REGENXBIO, Inc. v. Sarepta Therapeutics, Inc., No....more
On February 20, 2026, the US Court of Appeals for the Federal Circuit issued a precedential decision in REGENXBIO Inc. v. Sarepta Therapeutics, Inc., holding that claims directed at an “undisputedly human made” host cell...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
On February 20, 2026, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a closely watched decision in REGENXBIO, Inc. v. Sarepta Therapeutics, Inc., No. 24-01408 (Fed. Cir. 2026),...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
In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was...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