The US Court of Appeals for the Federal Circuit has ruled in favour of biotech company SNIPR Biome holding the first-to-file standard, in the patent infringement case against Rockefeller University, New York, US.
In 2021, the US Patent Trial and Appeal Board ruled in favour of the University regarding one patent in question, which was owned by Rockefeller University, and five others owned by SNIPR.
The company argued that all its patents were filed under the America Invents Act (AIA), where the statute removes all interferences, and grants rights under the first-to-file system.
SNIPR released part of the court’s ruling, which stated: “Because the text, purpose, and history of the AIA make clear that first-inventor-to-file patents exclusively governed by the AIA cannot be subject to an interference (save for one exception not applicable here), we reverse."
The patents encompass SNIPR's technology platform, which allows for targeting and modifying specific DNA sequences using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR).
The company recently reported positive early safety data for SNIPR001 targeting Escherichia coli (E. coli) bacteria in healthy volunteers. The therapy is intended for transplant recipients and cancer patients, who are at a high risk for developing bacterial infections.
Other drugs in SNIPR’s pipeline include an anti-microbial resistance drug (SNIPR-IV), two oncology drugs that target gut bacteria, and gut-directed gene therapy drugs. All these drugs are in preclinical development, with an undisclosed gut-directed gene therapy for cardiometabolic disease in development with Novo Nordisk.
To date, there have been no approved CRISPR therapies anywhere in the world, however, Vertex Pharmaceuticals and CRISPR Therapeutics have filled biologics licence applications (BLAs) for exa-cel CRISPR therapy to the US Food and Drug Administration (FDA), in April 2023.
Exa-cel therapy is an ex vivo CRISPR/Cas9 gene-edited CD34+ autologous haematopoietic stem and progenitor cells. This single-dose therapy is for the treatment of sickle cell disease and transfusion-dependent beta-thalassemia.
