In a blow to Moderna’s COVID-19 vaccine patent war against Arbutus Biopharma, a federal judge on April 3 adopted the latter’s interpretation of key technical terms in the disputed patents.
Arbutus sued Moderna in February 2022, seeking damages tied to patents that Moderna allegedly infringed with the production and sale of its Spikevax vaccine. Spikevax is a messenger RNA, or mRNA vaccine, meaning that it carries mRNA molecules that can instruct the body’s cells to produce a protein from the COVID-19 virus to trigger an immune response.
Those patents pertain to the technology of making lipid nanoparticles (LNPs), which rely on fat-like molecules, called lipids, to encapsulate and protect nucleic acids such as mRNA from degradation in the human body. These various lipids exist in specified ratios, expressed in terms of the “mol percentage,” or the percentage of each type of lipid molecule counted by the number of molecules.
The use of LNPs has been crucial to all mRNA-based medicines, which have been difficult to develop because mRNA molecules, without an effective carrier, are susceptible to rapid degradation before they have time to enter the cell.
At the center of the April 3 ruling are three claim terms that appear across the patents-in-suit. Arbutus and Moderna have proposed different interpretations of those terms for a legal procedure called “claim construction,” through which the judge will decide how the claims should be understood.
For example, when it comes to the phrase “mol percentage of the total lipid present in the particle,” Arbutus said it should be read at literal face value, while Moderna insisted that the word “particle” means only “finished particles” that aren’t subject to further processing.
In his claim construction order, U.S. District Judge Mitchell Goldberg mostly adopted Arbutus’s proposed definitions of the disputed terms, handing a win to the Pennsylvania-headquartered firm.
It isn’t immediately clear whether the case will go to trial or be settled.
Shares of Moderna fell by 4.6 percent to $98.81, while Arbutus shares increased by 17.5 percent to $2.96 in afternoon trading on April 3.
Moderna and other companies are currently testing a number of new mRNA-based products, including influenza vaccines and cancer treatments.
Moderna COVID Shots Linked to Greater Risk of Chronic Hives: Study
A review of data from Denmark and the European Union by the Danish Medicines Agency identified a potential link between increased risk of chronic hives, or chronic urticaria, and Moderna’s Spikevax vaccine, the agency said on March 20.For their study, the researchers looked at 360 chronic hives cases reported in Europe following injection of the Moderna or Pfizer-BioNTech vaccine. Based on background rates of chronic hives, the researchers expected that 175 people who received the Pfizer vaccine would experience chronic hives and that 18 people who received the Moderna vaccine would experience the issue.
While the 105 reported cases after Pfizer vaccination came in under the expected number, the 55 reported cases following Moderna vaccination came in more than three times higher than the expected number. Most cases of chronic hives occurred between seven and 13 days following vaccination.
The results of the study are the validation of a safety signal, or a sign that a vaccine, or vaccines, causes a specific health issue, Danish authorities said in a document describing the results.
Moderna didn’t return a request for comment.
Two of the patients, they noted, went on to receive a Pfizer dose with no problem.
