In a significant decision for the biotechnology sector, the Federal Circuit provided much needed clarity on the patent eligibility of genetically engineered compositions. The Federal Circuit held that the genetically...more
In REGENXBIO v. Sarepta Therapeutics, the Federal Circuit recently held that a cell containing a non-naturally occurring recombinant nucleic acid molecule is not a product of nature and is patent‑eligible under 35 U.S.C. §...more
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of...more
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
Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear...more
The use of artificial intelligence (AI) to advance stem cell therapy has produced exciting results, with a key role in driving recent growth and innovation. Separated into three parts, this article provides an overview the...more
The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require...more