Moderna COVID Vaccine Technology Struck Down by PTAB

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 remain 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. The IPRs came after Moderna sued the companies in the District of Massachusetts, arguing in their complaint that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® infringed Moderna’s mRNA technology, which was critical to the development of its own mRNA COVID-19 vaccine, Spikevax®. 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. According to the brief, when Moderna was seeking approval for its COVID-19 vaccines, the company “candidly represented to the FDA that prior studies for related vaccines…supported an expectation 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. In March 2022, when the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge. It explained that while it would not enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets.

In an email sent by Paul Hasting, which is representing BioNTech, the firm said the docket indicates that all of the challenged claims were found unpatentable and that the decisions are expected to impact the Massachusetts federal court case, which was stayed pending the PTAB 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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