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“The Board shouldn’t enable Moderna to opportunistically embrace prior artwork earlier than the FDA however now distance itself from the identical prior artwork right here.” – Pfizer’s transient to PTAB
In a recent brief to the Patent Trial and Enchantment Board (PTAB), Pfizer and BioNTech (Pfizer) informed PTAB judges that Moderna’s dismissal of prior artwork listed in Pfizer’s August 2023 petition for inter partes evaluate (IPR) of Moderna’s patent on mRNA vaccine expertise is inconsistent with its declarations to the Meals and Drug Administration (FDA) through the drug approval course of.
In keeping with the transient, when Moderna was searching for approval for its COVID-19 vaccines, the corporate “candidly represented to the FDA that prior research for associated vaccines…supported an expectation of security and efficacy. However now, confronted with invalidating vaccine prior artwork…Moderna wrongly casts the identical vaccine prior artwork as irrelevant.” The transient referred to this as a “litigation-driven one-eighty.”
Moderna’s statements at a minimal warrant establishment to resolve the factual questions they elevate, mentioned Pfizer.
Particularly, the transient explains, Moderna’s statements about Worldwide Patent App. Pub. No. WO 2012/006369 (“Geall”), which Pfizer offered in its IPR petition, declare that Geall’s vaccine examples should do with “saRNA,” which is “materially totally different” from mRNA, in line with Moderna’s patent owner preliminary response. However this means that the Board can ignore Geall’s teachings, which “is inconsistent with Moderna’s statements to the FDA that this similar work did contain mRNA vaccines.”
With respect to a different reference, dubbed “Yang,” which has to do with DNA vaccines, Pfizer mentioned that Moderna tried to argue “that DNA is so totally different from mRNA {that a} [person of skill in the art ] would discard all prior artwork teachings about DNA vaccines as irrelevant” however then informed the FDA that “prior DNA vaccine research allowed it to ‘anticipate[] that mRNA-1273 [Moderna’s COVID-19 vaccine candidate] will generate strong immune responses to the 2019-n-CoV S protein.”
“The Board shouldn’t enable Moderna to opportunistically embrace prior artwork earlier than the FDA however now distance itself from the identical prior artwork right here,” mentioned Pfizer’s newest transient.
For its half, Moderna has called Pfizer’s petition an try to “ask this Board to offer them two bites on the invalidity apple” by “asserting the identical inadequate, disparate artwork” that they’re asserting within the district courtroom litigation between the businesses. In its preliminary statement, Moderna additionally mentioned the cited paperwork “are clearly not inconsistent” as a result of every doc post-dates the precedence date and that “Petitioner’s makes an attempt to treatment the Petition’s deficiencies by means of such accusations are misplaced.”
The USA Patent and Trademark Workplace (USPTO) and Congress have been involved about inconsistent statements to the FDA and USPTO lately. In August 2022, USPTO Director Kathi Vidal announced in a blog post that the company had issued a notice within the Federal Register in late July clarifying the duties of disclosure and cheap inquiry for pharmaceutical patent candidates, in addition to events to Patent Trial and Enchantment Board (PTAB) proceedings. The discover was particularly focused to events continuing earlier than each the USPTO and FDA and was issued in response to urging by Senators to determine interagency communications aimed partly at eliminating so-called drug patent thickets.
On September 9, 2021, then-Senator Patrick Leahy (D-VT) and Senator Thom Tillis (R-NC) despatched a letter to Andrew Hirshfeld, then Performing USPTO Director, noting that “[w]e are actually requesting the PTO to take steps to cut back patent candidates’ making inappropriate conflicting statements in submissions to the PTO and different federal companies.” The letter was doubtless motivated by the case of Belcher Pharmaceuticals, LLC v. Hospira (Fed. Cir Sept 1, 2021).
Some within the pharmaceutical neighborhood have solid such efforts as being unnecessary and motivated by inaccurate data supplied by the Initiative for Medicines, Entry and Information (I-MAK).
The patent at difficulty within the Pfizer IPR is U.S. Patent No. 10,933,127.
Picture Supply: Deposit Pictures
Creator: iqoncept
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