Pfizer Alleges Inconsistencies in Moderna’s Statements to FDA and PTAB

“The Board should not allow Moderna to opportunistically embrace prior art before the FDA but now distance itself from the same prior art here.” – Pfizer’s brief to PTAB

FDAIn a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology 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.”

Moderna’s statements at a minimum warrant institution to resolve the factual questions they raise, said Pfizer.

Specifically, the brief explains, Moderna’s statements about International Patent App. Pub. No. WO 2012/006369 (“Geall”), which Pfizer presented in its IPR petition, claim that Geall’s vaccine examples have to do with “saRNA,” which is “materially different” from mRNA, according to Moderna’s patent owner preliminary response. But this suggests that the Board can ignore Geall’s teachings, which “is inconsistent with Moderna’s statements to the FDA that this same work did involve mRNA vaccines.”

With respect to another reference, dubbed “Yang,” which has to do with DNA vaccines, Pfizer said that Moderna attempted to argue “that DNA is so different from mRNA that a [person of skill in the art ] would discard all prior art teachings about DNA vaccines as irrelevant” but then told the FDA that “prior DNA vaccine studies allowed it to ‘anticipate[] that mRNA-1273 [Moderna’s COVID-19 vaccine candidate] will generate robust immune responses to the 2019-n-CoV S protein.”

“The Board should not allow Moderna to opportunistically embrace prior art before the FDA but now distance itself from the same prior art here,” said Pfizer’s latest brief.

For its part, Moderna has called Pfizer’s petition an attempt to “ask this Board to give them two bites at the invalidity apple” by “asserting the same insufficient, disparate art” that they are asserting in the district court litigation between the companies. In its preliminary statement, Moderna also said the cited documents “are clearly not inconsistent” because each document post-dates the priority date and that “Petitioner’s attempts to remedy the Petition’s deficiencies through such accusations are misplaced.”

The United States Patent and Trademark Office (USPTO) and Congress have been concerned about inconsistent statements to the FDA and USPTO in recent years. In August 2022, USPTO Director Kathi Vidal announced in a blog post that the agency had issued a notice in the Federal Register in late July clarifying the duties of disclosure and reasonable inquiry for pharmaceutical patent applicants, as well as parties to Patent Trial and Appeal Board (PTAB) proceedings. The notice was specifically targeted to parties proceeding before both the USPTO and FDA and was issued in response to urging by Senators to establish interagency communications aimed in part at eliminating so-called drug patent thickets.

On September 9, 2021, then-Senator Patrick Leahy (D-VT) and Senator Thom Tillis (R-NC) sent a letter to Andrew Hirshfeld, then Acting USPTO Director, noting that “[w]e are now requesting the PTO to take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the PTO and other federal agencies.”  The letter was likely motivated by the case of Belcher Pharmaceuticals, LLC v. Hospira (Fed. Cir Sept 1, 2021).

Some in the pharmaceutical community have cast such efforts as being unnecessary and motivated by inaccurate data provided by the Initiative for Medicines, Access and Knowledge (I-MAK).

The patent at issue in the Pfizer IPR is U.S. Patent No. 10,933,127.

Image Source: Deposit Photos
Author: iqoncept
Image ID: 59574913 


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Join the Discussion

3 comments so far.

  • [Avatar for Anon]
    February 1, 2024 06:29 pm

    Anon too,

    Interesting question – and Rule 56 applies to any and all representations before the patent office – and that does include everything in front of the PTAB.

    While NOT technically “examination,” or “before an examiner,” the claw back that occurs (and concurrent loss of sticks from the bundle or property rights of a granted patent) AT the time of institution.

    Once back in the office, BOTH the presence and level of the presumption of validity has been taken, AND the duty under Rule 56 reinstituted.

  • [Avatar for Anon too]
    Anon too
    February 1, 2024 03:32 pm

    Does Rule 56 apply to statements and representations made in the PTAB? Or does it perhaps only come into play when one presents substitute claims?

  • [Avatar for Anon]
    February 1, 2024 03:17 pm

    The words “admissions against interest” scream out to me.

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