Federal Judge Rules Against Moderna in Patent Dispute Over mRNA Vaccine
In a recent legal battle between Moderna and Arbutus Biopharma, a federal judge has ruled in favor of Arbutus, marking a setback for Moderna in its COVID-19 vaccine patent war. The dispute revolves around patents that Arbutus claims Moderna infringed upon with its Spikevax vaccine, an mRNA vaccine that utilizes lipid nano-particle (LNP) technology. LNPs are vital in mRNA-based medicines as they protect the mRNA molecules from degradation in the human body. However, the interpretation of key technical terms in the disputed patents has been a point of contention.
Arbutus sued Moderna in February 2022, seeking damages for patent infringement. The judge’s decision will largely hinge on the interpretation of three claim terms present in the patents. Arbutus and Moderna have proposed different interpretations, known as “claim construction,” which will determine how the claims should be understood.
One of the disputed terms is the phrase “mol percentage of the total lipid present in the particle.” Arbutus argues that it should be taken literally, while Moderna claims that the word “particle” refers only to finished particles that are not subject to further processing. In his claim construction order, U.S. District Judge Mitchell Goldberg mostly sided with Arbutus, adopting their proposed definitions of the disputed terms.
The ruling has had immediate effects on the stock market, with Moderna’s shares falling 4.6 percent to $98.81 and Arbutus’s shares surging 17.5 percent to $2.96 in afternoon trading. The outcome of this case is still uncertain, as it remains unclear whether it will go to trial or be settled outside of court.
Moderna and other companies are currently developing various mRNA-based products, including influenza vaccines and cancer treatments. Moderna’s CEO, Stephane Bancel, expressed optimism for the future, stating that the company has an exciting pipeline with up to 15 launches planned in the next five years.
Moderna COVID Shots Linked to Greater Risk of Chronic Hives: Study
In addition to the patent dispute, Moderna faces another challenge as a recent study suggests a potential link between its Spikevax vaccine and chronic hives, or chronic urticaria. The Danish Medicines Agency conducted a review of data from Denmark and the European Union, which identified an increased risk of chronic hives associated with Moderna’s vaccine.
The researchers analyzed 360 cases of chronic hives reported in Europe following vaccination with either Moderna’s Spikevax or Pfizer-BioNTech’s vaccine. Based on the expected background rates of chronic hives, they anticipated that 175 individuals who received Pfizer’s shot would experience the condition, and only 18 individuals who received Moderna’s shot would be affected. However, the reported cases following Moderna vaccination were over three times higher than expected, with 55 cases recorded.
Most cases of chronic hives occurred between 7 to 13 days after vaccination. Danish authorities consider these results as a validation of a safety signal, indicating a potential correlation between Moderna’s vaccine and the development of chronic hives.
In January, American researchers also reported a case series involving seven patients who developed chronic urticaria within weeks of receiving the Moderna vaccine. Interestingly, two of these patients subsequently received the Pfizer vaccine without experiencing any issues.
Moderna has not yet commented on the study findings, and it remains to be seen how these reports will impact the ongoing discussions surrounding the safety of mRNA vaccines.
Conclusion
The recent ruling against Moderna in its patent dispute with Arbutus Biopharma has dealt a blow to the company’s efforts to protect its Spikevax vaccine. The judge’s adoption of Arbutus’s interpretation of key technical terms may have significant implications for Moderna’s future legal battles and the broader mRNA-based medicine industry.
Additionally, a study indicating a potential link between Moderna’s vaccine and chronic hives raises concerns about the safety of mRNA vaccines. While further research is needed to fully understand this correlation, it highlights the importance of continued monitoring and evaluation of vaccine safety.
As Moderna continues to navigate these challenges, its CEO remains optimistic about the company’s pipeline and potential for future launches. However, the outcome of the patent dispute and the impact of safety concerns on public perception will undoubtedly shape Moderna’s trajectory in the coming months.
