Pfizer faces infringement suit over COVID-19 vaccine
Arbutus and Genevant claims Pfizer/BioNTech vaccine uses patented technology | Claim follows last year’s lawsuit against Moderna.
Arbutus Biopharma and Genevant want to be compensated for tens of billions of dollars-worth of COVID-19 vaccines sold by Pfizer and BioNTech, according to a patent infringement lawsuit filed on Tuesday, April 4.
In the complaint filed at the US District Court for the District of New Jersey, Arbutus claims that without its patented technology for messenger ribonucleic acid (mRNA) delivery, Pfizer’s COVID vaccine would never have existed.
It says that Pfizer and BioNTech failed to license the patents despite being given the opportunity, and is seeking damages. Canadian biopharma firm Arbutus invented solutions to deliver mRNA therapeutics to human cells, through microscopic particles built from fat-like molecules known as lipid nanoparticles (LNP). It licenses this technology to Swiss company Genevant, which specialises in nucleic acid drug delivery.
The patents-in-suit are US patent numbers: 9,504,651; 8,492,359; 11,141,378; 11,298,320 and 11,318,098, which include ‘Lipid Compositions for Nucleic Acid Delivery’ and ‘Liposomal Apparatus and Manufacturing Methods’.
COVID-19 vaccine
Arbutus alleges that Pfizer and BioNTech infringed these patents when producing their COVID-19 vaccine in 2020 at rapid speed in response to the pandemic. “The defendants could not have accomplished the feat of creating and manufacturing a vaccine at a speed unprecedented in the history of medicine but for their use of plaintiffs’ existing and proven LNP technologies,” the complaint states.
It also makes clear that Arbutus and Genentech did not want to impede Pfizer’s important efforts to manufacture and distribute the vaccine at the time, and do not want to interfere with its continued supply.
Arbutus and Genentech say they notified Pfizer and BioNTech that their vaccine may infringe the claims of the ‘651 and ‘359 patents in November 2020 and offered to discuss the terms of a licence or collaboration. Notice was made again in 2021 and 2022 that the vaccine could infringe other patents related to the technology but “defendants have refused to take a licence from, partner with, or otherwise compensate plaintiffs for their contribution to defendants’ vaccine”, the filing states.
Arbutus and Genentech are asking for an award of damages in the form of a reasonable royalty on all allegedly infringing sales of the vaccine. The complaint states that Pfizer asserted that it manufactured more than three billion doses of the vaccine in 2021.
Moderna suit
Arbutus and Genevant are also jointly suing Moderna over its COVID-19 vaccine, which they say uses their LNP delivery platform, in a suit filed in March last year.
In February this year, the US government waded into the dispute, asking a federal court to throw out the patent infringement claims as Moderna had its “authorisation and consent” to use inventions covered by US patents to produce a COVID-19 vaccine.
“Accordingly, to the extent that any liability exists for infringement of the patents-in-suit by the manufacture or use of vaccine procured under the -0100 Contract, the patentee is limited to pursuing a claim against the US in the Court of Federal Claims,” the government’s filing stated.
