Introduction
Moderna has achieved a significant victory in its patent dispute with Pfizer and BioNTech over the Covid-19 vaccine. The European Patent Office (EPO) has upheld the validity of one of Moderna’s key patents, bolstering the company’s efforts to claim a share of the pandemic profits from its competitors. This decision is a critical step for Moderna in its broader legal battle across various courts in Europe and the United States.
Background of the Patent Dispute
The dispute centers around Moderna’s assertion that Pfizer and BioNTech’s Comirnaty vaccine infringes on two of its patents. These patents, filed in 2011 and 2016, cover innovative aspects of mRNA technology, which is pivotal to Moderna’s Covid-19 vaccine. Moderna’s EP949 patent, which the EPO decided to maintain, relates to modifying mRNA to reduce the immune response when introduced as a vaccine. This technology is essential not only for Moderna’s Covid-19 vaccine but also for potential future mRNA-based treatments.
Details of the EPO Decision
On Thursday, the EPO’s Opposition Division announced its oral verdict, which upheld the validity of Moderna’s EP949 patent. The written decision is expected to be published in the coming months. Moderna expressed satisfaction with the ruling, stating, “We are pleased to announce that the European Patent Office decided to maintain the validity of Moderna’s EP949 patent, one of the key patents currently asserted against Pfizer and BioNTech in various European national courts.”
Pfizer and BioNTech have two months to appeal the decision. Pfizer indicated that it might pursue an appeal, while BioNTech reiterated its position that the patent is invalid and vowed to continue defending its innovations against all allegations of patent infringement.
Legal Battles in Multiple Jurisdictions
Moderna is not only pursuing its claims in the EPO but also in national courts across Europe and the US. The company seeks a share of the profits generated by the Comirnaty vaccine, alleging patent infringement. Meanwhile, Pfizer and BioNTech have countersued, arguing that Moderna’s patents are invalid.
The dispute has significant financial implications. In 2022 alone, Moderna, Pfizer, and BioNTech collectively generated $73.2 billion in revenue from Covid-19 vaccines. However, as the pandemic has receded, the demand for vaccines has decreased, impacting the share prices of all three companies.
Implications of the 949 Patent
The 949 patent is crucial for Moderna as it pertains to the innovative way mRNA is engineered to lower the immune response. This feature is not only vital for the Covid-19 vaccine but also has potential applications for future mRNA-based treatments. The EPO’s decision to maintain this patent, even in an amended form, strengthens Moderna’s position in ongoing and future litigation.
Previous and Ongoing Challenges
Despite this victory, Moderna has faced setbacks in other patent disputes. Last year, the company lost a validity challenge over its 565 patent, which specifically targets the use of mRNA technology for preventing coronavirus and other respiratory diseases. Moderna is appealing this decision.
National courts will continue to assess the validity of Moderna’s patents and whether Pfizer and BioNTech infringed upon them. These courts will also decide on any penalties that might be imposed. The EPO’s ruling could influence these proceedings, especially in European courts.
Ongoing and Future Proceedings
The legal battles are far from over. Courts in London, the Netherlands, Belgium, Germany, and Ireland are among those evaluating the validity of the disputed patents. In December, a Dutch court declared the 949 patent invalid, but Moderna is appealing this ruling. The outcomes of these cases will significantly impact the legal landscape for mRNA technology and Covid-19 vaccine-related profits.
Moderna’s Stance on Vaccine Access
Throughout the litigation, Moderna has maintained that it does not seek to prevent the use of the Comirnaty vaccine. The company’s focus is on securing a share of the profits generated from its patented technology.
Pfizer, on the other hand, has committed to continuing the manufacture and supply of the BioNTech/Pfizer Covid-19 vaccine, regardless of the legal outcomes. The company stated, “Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the BioNTech/Pfizer Covid-19 vaccine in line with our agreements and established supply schedules, in support of public health.”
Conclusion
Moderna’s recent victory at the European Patent Office marks a pivotal moment in its ongoing legal battle with Pfizer and BioNTech. The decision to uphold the validity of the EP949 patent strengthens Moderna’s position as it seeks to claim a share of the pandemic profits from its rivals. While the legal proceedings are set to continue across various jurisdictions, this ruling provides a significant boost to Moderna’s case. The outcomes of these disputes will have far-reaching implications for the pharmaceutical industry and the future of mRNA technology.
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