Precedential US Federal Court Decision Hands SNIPR Biome a win in patent appeal over Rockefeller University for CRISPR-Cas microbial gene editing

Five contested patents held by SNIPR remain in place

Precedential ruling means that SNIPR's patent portfolio will not be subject to any further interference and will not be judged by the old first-to-invent standard

COPENHAGEN,Denmark,July 17,2023 -- SNIPR Biome ApS,the company pioneering CRISPR-based microbial gene therapy,announces today that the United States Court of Appeals for the Federal Circuit has issued a precedential ruling in favor of SNIPR in a patent interference case with Rockefeller University.

The patent interference case focused on one allowed patent application owned by Rockefeller University and five patents owned by SNIPR and was declared by the US Patent Trial and Appeal Board in 2021 in Rockefeller University's favor. This ruling has now been overturned in favor of SNIPR following a hearing by the United States Court of Appeals for the Federal Circuit in February 2023.

SNIPR's successful appeal was based on the argument that all of SNIPR's patents have been filed under the America Invents Act (AIA),in which interferences were removed as a feature of the statute. The AIA was a systematic change to US patent law that moved from a first-to-invent standard to a first-to-file system,in line with Europe and other parts of the world.

The Court held that "SNIPR appeals,contending that the Board never should have subjected its first-inventor-to-file patents to a vestige of the old first-to-invent system: an invention date contest against Rockefeller's first-to-invent application through an interference. 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."

This ruling determines that the five contested patents that SNIPR holds will remain in place,that none of SNIPR's patent portfolio can be subjected to an interference again,and that SNIPR's patents will not be judged by the old first-to-invent standard.

The ruling reinforces SNIPR's extensive intellectual property portfolio,comprising more than 60 granted patents worldwide supporting SNIPR Biome's technology platform,which enables editing of prokaryotes using CRISPR/Cas. SNIPR's patent filings were the first in the field to demonstrate selective killing of bacteria in a mixed species population (i.e. a microbiome),demonstrated by the European patent,EP3291679,titled 'Altering Microbial Populations & ModifyingMicrobiota'granted by the European Patent Office to SNIPR in 2021. This patent relates to the use of vectors carrying CRISPR/Cas systems for targeting species in mixed populations of bacteria. Use of any Cas is covered,as is the targeting of any species of bacteria and in any microbiome. Broad protection has similarly been granted by the US Patent Office (USPTO) and further examples of SNIPR's granted US patents can be found here.

This portfolio is licensed in many fields,including being exclusively licensed to SNIPR Biome for medical applications,from which sub-licenses are available.

Dr Christian Grøndahl,Co-founder and CEO of SNIPR Biome,commented,"We are pleased this interference case has been resolved,upholding protection in the US of the intellectual property acquired through the pioneering work of SNIPR's scientists. SNIPR was the first company to receive a patent for the use of CRISPR to target and modulate bacterial genomes,and we now have an extensive intellectual property portfolio,comprising more than 60 granted patents worldwide. The applications of CRISPR are continuing to expand,and we are applying our knowledge of CRISPR to develop innovative therapeutics that leverage our pioneering efforts in microbial gene editing,in order to address serious and difficult-to-treat diseases."

JasperClube,Co-founder and Chief Patent Counsel of SNIPR Biome,"SNIPR is delighted with this important decision of the Federal Circuit. We are also pleased that the Court recognized that the U.S. Patent Trial & Appeal Board (PTAB),has never determined whether Rockefeller's claims,which it copied from our issued patents,satisfy the patentability requirements."

Contact:

SNIPR Biome

Dr. Christian Grøndahl,Co-founder and CEO

E-mail: cg@sniprbiome.com

Mobile: +45 20202747

www.sniprbiome.com

Please follow us on LinkedIn & Twitter: @sniprbiome

Consilium Strategic Communications

Tracy Cheung,Chris Welsh,Davide Salvi

Tel: +44 (0) 203 709 5700

SNIPR@consilium-comms.com