Moderna COVID Vaccine Technology Banned by PTAB
“The companies told the PTAB in the petitions that Moderna’s patents include ‘unimaginably broad claims directed to a basic idea.'”
Patent Trial and Appeal Board (PTAB) docket entries indicate that the PTAB has invalidated all challenged claims of Moderna’s patents for its COVID-19 vaccine technology. The final written decisions are sealed.
U.S. Patent Nos. 10,933,127 (IPR2023-01359) and 10,702,600 (IPR2023-01358) are both titled “Betacoronavirus Mrna Vaccine.” Moderna competitors Pfizer and BioNTech filed two petitions for inter partes review (IPR) in August 2023 against certain claims of each of the patents, accusing Moderna of attempting “to coopt an entire field of mRNA technology.”
The companies told the PTAB in the petitions that Moderna’s patents include “unimaginably broad claims directed to a basic idea” and asked the Board to cancel all of the challenged claims of both patents. Moderna filed the IPRs after suing the companies in Massachusetts. They claimed that Pfizer’s COVID-19 Comirnaty (r) and BioNTech’s COVID-19 mRNA vaccine Spikevax (r) violated Moderna’s technology. The complaint claimed Pfizer and BioNTech “followed Moderna’s lead” in developing its COVID vaccine and knowingly copied Moderna’s patented technology.
But in the IPRs, Pfizer and BioNTech claimed that the idea behind the patents–i.e. “the use of mRNAs encoding any spike protein or spike protein subunit of any betacoronavirus, formulated in a broadly claimed lipid delivery system, to induce an immune response–was known long before the asserted priority date of 2015.” In fact, the petitions said, once “mRNA was first administered to induce protein production in vivo in 1990, ‘the concept of using mRNA as a basis for vaccines was pursued almost immediately.'”
The petitions claimed that both patents are anticipated by four key prior art references and combinations thereof.
In January 2024, Pfizer and BioNTech filed a brief in the IPRs alleging that Moderna’s dismissal of prior art listed in the petitions is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. The brief states that when Moderna sought approval for its COVID-19 vaccinations, it “honestly represented to FDA that prior studies of related vaccines…supported expectations of safety and efficacy.” But now, faced with invalidating vaccine prior art…Moderna wrongly casts the same vaccine prior art as irrelevant.” The brief referred to this as a “litigation-driven one-eighty.”
In October 2020, Moderna pledged not to enforce its COVID-19 related patents while the pandemic continued. Moderna updated its pledge in March 2022 when the fight against COVID-19 reached a new phase, and vaccine supply no longer was a barrier for access to many parts of the globe. In an email sent by Paul Hasting who represents BioNTech, he said that the docket indicated that all of these challenged claims were found to be unpatentable. The firm also stated that the decisions will impact the Massachusetts federal case which was stayed pending PTAB’s decision. Another related case is also set to begin next week in the Eastern District of Virginia.
IPWatchdog has reached out to counsel for Moderna for comment and will update with any response.
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Eileen McDermott
Eileen McDermott, Editor-in Chief of IPWatchdog.com is a veteran IP and legal journalist. Eileen McDermott is a veteran IP journalist and has held editorial and management positions at .
