Intellia Therapeutics said it will respond to a lawsuit filed Monday in a Delaware federal court alleging it infringed on several of BlueAllele’s patents covering methods for targeted insertion of DNA into genes.
Intellia has made waves over the past year with its one-time CRISPR infusion, dubbed NTLA-2002, which lowered levels of an inflammation-promoting protein and reduced bouts of harmful swelling by 95% in patients with a rare disorder called hereditary angioedema. Then, this summer, more data from the same trial showed reduced swelling attacks by 98%.
The treatment works by making a small change to a patient’s DNA that prevents the liver from making an enzyme called kallikrein. If approved, it could mark the first in vivo CRISPR therapy in the US.
BlueAllele, which was founded to produce single-dose treatments to cure genetic diseases, claims in its suit that Intellia’s “experimenting, basic research, identification, optimizing, manufacturing, using, and making of bi-directional insertion templates” is infringing on BlueAllele’s patented method of making in vivo therapies. The company added that it received the patents in 2021 and 2022.
The private BlueAllele also specifically mentions NTLA-3001 in its complaint, which is Intellia’s in vivo gene insertion candidate for the treatment of alpha-1 antitrypsin deficiency, as well as its partnership with Regeneron. Intellia is collaborating with Regeneron on NTLA-2001, another CRISPR therapy for the treatment of ATTR amyloidosis that is in two Phase 3 trials.
Going after the Regeneron-Intellia agreement, BlueAllele claims that although Intellia has received more than $100 million as part of the 2016 agreement, the company “knows or should know that continuing its participation” is infringing BlueAllele’s patents.
BlueAllele is asking for a jury trial, an injunction from using the patented technology, as well as damages.
A spokesperson for Intellia told Endpoints News that the company is “aware of this legal filing and plan(s) to respond in due course.”