Pfizer/BioNTech Take COVID Vaccine Fight with Moderna to PTAB

Pfizer, Inc. and BioNTech SE on Monday hit back at competitor COVID-19 vaccine maker Moderna with inter partes review (IPR) petitions against two Moderna patents on mRNA vaccine technology at the Patent Trial and Appeal Board (PTAB). Pfizer/ BioNTech told the PTAB 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 U.S. patents being challenged are 10,933,127 (IPR2023-01359) and 10,702,600 (IPR2023-01358), which are two of the three patents asserted by Moderna against Pfizer and BioNTech in the District of Massachusetts last year. Moderna said in that complaint that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® infringes the patents covering 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 two IPRs filed yesterday, Pfizer and BioNTech claim that Moderna is attempting “to coopt an entire field of mRNA technology.” The petition said 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 say, 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 claim that both patents are anticipated by four key prior art references and combinations thereof. They also argue that discretionary denial under 35 U.S.C. § 325(d) is not appropriate because the petitions rely on art that was either presented to the Office but not substantively considered, or that was not previously before the Office, and because the examiners erred in allowing the patents to issue over the prior art.

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.

Williams & Connolly and Paul Hastings are representing Pfizer/BioNTech at the PTAB, and Wolf, Greenfield & Sacks is representing Moderna.