Chakrabarty Redux: Are Genetically Engineered Host Cells Patent Eligible?

"Regenxbio is appealing a district court's decision invalidating, as patent ineligible, its patent for a novel, genetically engineered host cell. The Federal Circuit has an opportunity to course-correct in this appeal, which was argued on October 7, 2025. Here, we provide post-argument thoughts about the appeal and why it should largely be controlled by precedent. It goes without saying that reaching the correct outcome is important to maintain the incentives that facilitate advances in genetically engineered technology and medicines."

"Regenxbio's invention is a cultured host cell that contains a recombinant nucleic acid encoded for a specific AAV viral capsid protein and a heterologous non-AAV sequence. In other words, the claimed host cell (such as a bacterial or human cell, for example) is a man-made, genetically engineered cell that can produce plasmids encoding for the viral capsid protein or can produce an engineered capsid with a DNA payload."

Diamond v. Chakrabarty (1980) held that non-natural, man-made organisms are patent eligible, enabling substantial investment in the nascent biotech industry. Regenxbio v. Sarepta raises the patent eligibility question for a genetically engineered host cell capable of producing non-native viral plasmids and proteins used in gene-based medicines. A district court invalidated Regenxbio's patent under Section 101, and Regenxbio appealed to the Federal Circuit, which heard argument on October 7, 2025. The Federal Circuit's ruling may reaffirm or alter precedent and will affect incentives for investment and development in genetically engineered technologies and gene therapies.

Read at IPWatchdog.com | Patents & Intellectual Property Law