Pharmaceutical Business review

Alnylam, Silence Therapeutics settle patent dispute

Image: Silence will secure a low royalty on annual net sales of Onpattro in the EU. Photo: courtesy of Business Wire.

The agreement allows both firms to resolve all litigation across the world. It will enable Alnylam to reduce the costs and distraction linked with continued litigation in various countries.

As per terms of the global settlement, Silence will secure a low royalty on annual net sales of Onpattro (patisiran) in the EU, as well as tiered royalties of 0.33% to 1% through 2023.

In October this year, Silence started a new cross-border interim injunction application in the Netherlands against Alnylam’s Onpattro.

The injection application has been filed to prohibit Alnylam from commercializing Onpattro across Europe.

Onpattro is claimed to be the first-of-its-kind RNAi therapeutic and only FDA-approved treatment for this indication.

Additional terms of the deal include the grant of a non-exclusive, global irrevocable, license to all relevant patents from Silence to Alnylam, as well as all current and future Alnylam products that are commercialized by Alnylam or a collaborator or licensee.

The products comprise of Onpattro, vutrisiran, givosiran, lumasiran, inclisiran, fitusiran, cemdisiran, ALN-HBV02, ALN-AAT02, and all other investigational therapeutics in Alnylam’s current and future pipeline.

All current court proceedings will be dismissed and each party will bear its own attorney fees and costs incurred in the global proceedings.

Both firms have not disclosed the terms of the settlement, including no admissions by any party.

Silence Therapeutics CEO David Horn Solomon said: “We are excited for the potential of Onpattro  to treat patients with hereditary ATTR amyloidosis polyneuropathy as the first RNAi medicine and are looking forward to following Alnylam’s achievements.

“At Silence Therapeutics we now look forward to focusing on advancing a pipeline of competitive and differentiated medicines that will benefit patients and caregivers.”

Silence Therapeutics has developed an advanced technology that can selectively inhibit any gene in the genome, specifically silencing the production of disease-causing proteins.