In a recent submission to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech raised concerns regarding Moderna’s handling of prior art in relation to Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s mRNA vaccine technology patent. The brief highlighted what Pfizer perceives as inconsistencies between Moderna’s statements to the Food and Drug Administration (FDA) during the drug approval process and its dismissal of certain prior art in response to Pfizer’s petition.
During the FDA approval process for its COVID-19 vaccines, Pfizer asserts that Moderna acknowledged the relevance of prior studies supporting safety and efficacy, yet now, faced with potential invalidation of vaccine-related prior art, Moderna allegedly deems the same evidence irrelevant. Pfizer characterizes this shift as a “litigation-driven one-eighty,” suggesting a strategic change rather than a genuine assessment of the evidence’s significance. Pfizer contends that Moderna’s statements merit further examination by the PTAB to address the factual questions they raise.
Specifically, Pfizer points to Moderna’s treatment of International Patent App. Pub. No. WO 2012/006369 (“Geall”), which Pfizer presented in its IPR petition. Moderna allegedly argues that Geall’s vaccine examples pertain to “saRNA,” which it claims is substantially different from mRNA. However, Pfizer asserts that Moderna’s previous statements to the FDA acknowledged the involvement of mRNA vaccines in similar work, indicating inconsistency in Moderna’s position.
Regarding another reference referred to as “Yang,” which pertains to DNA vaccines, Pfizer alleges that Moderna attempted to dismiss its relevance by emphasizing the differences between DNA and mRNA vaccines. Yet, Pfizer claims that Moderna previously acknowledged the significance of prior DNA vaccine studies in anticipating immune responses to its COVID-19 vaccine candidate. Pfizer asserts that Moderna’s shifting stance on these matters warrants scrutiny by the PTAB.
Pfizer argues that it is essential for the PTAB not to permit Moderna to selectively embrace prior art when convenient, only to distance itself from the same evidence when challenged. Moderna, in response, has criticized Pfizer’s petition as an attempt to reassert the same insufficient evidence already presented in district court litigation between the companies. Moderna contends that the cited documents are not inconsistent and that Pfizer’s accusations are unfounded attempts to rectify deficiencies in its petition.
The issue of inconsistent statements to both the FDA and the USPTO has garnered attention from both agencies and Congress in recent years. Concerns over conflicting submissions prompted the USPTO to issue a notice clarifying disclosure duties for pharmaceutical patent applicants and PTAB parties, particularly in response to legislative urging aimed at addressing issues such as “drug patent thickets.” Senators have called on the USPTO to take steps to reduce conflicting statements in submissions to federal agencies, a plea likely influenced by recent legal cases.
Despite these efforts, some within the pharmaceutical community view such initiatives as unnecessary and potentially influenced by incomplete or inaccurate data provided by organizations like the Initiative for Medicines, Access, and Knowledge (I-MAK).
The patent in question in Pfizer’s IPR is U.S. Patent No. 10,933,127.