PTAB

IPR2023-01359

BioNTech Se v. ModernaTX Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: mRNA Vaccines for Betacoronaviruses
  • Brief Description: The ’127 patent claims methods for inducing an immune response to a betacoronavirus in a subject. The methods comprise administering a messenger ribonucleic acid (mRNA) that encodes a betacoronavirus (BetaCoV) S protein, where the mRNA is formulated in a specific lipid nanoparticle (LNP) delivery system.

3. Grounds for Unpatentability

Ground 1: Anticipation by Schrum - Claims 1-3, 6-9, 11-13, 17-18, and 20 are anticipated under 35 U.S.C. §102 by Schrum.

  • Prior Art Relied Upon: Schrum (Application # US 2013/0266640).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Schrum, filed by the Patent Owner, discloses every element of the challenged claims. Schrum teaches administering a modified mRNA formulated in an LNP to induce an immune response. Crucially, Schrum expressly incorporates by reference the entire disclosure of Geall (WO 2012/006369), which teaches using an RNA vaccine to encode the spike (S) protein of SARS-CoV, a known betacoronavirus. Petitioner asserted this incorporation makes the disclosure of a BetaCoV S protein antigen explicit in Schrum. Furthermore, Schrum describes LNP formulations with specific lipid components (cationic lipid, neutral lipid, cholesterol, PEG-lipid) and molar ratios (50:10:38.5:1.5) that fall squarely within the ranges claimed in the ’127 patent. Schrum also explicitly discloses the other features of dependent claims, including intramuscular administration, 5' and 3' UTRs, a poly(A) tail, a 5' cap analog, and the use of 1-methylpseudouridine modification at levels of 100%.

Ground 2: Obviousness over Schrum and Geall - Claims 1-3, 6-9, 11-13, 17-18, and 20 are obvious under 35 U.S.C. §103 over Schrum in view of Geall.

  • Prior Art Relied Upon: Schrum (Application # US 2013/0266640) and Geall (WO 2012/006369).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that, even if Schrum’s incorporation of Geall were disregarded, the combination of the two references renders the claims obvious. Schrum discloses a broad platform for mRNA vaccines, including the specific LNP formulations and mRNA modifications (e.g., 1-methylpseudouridine) recited in the claims, for delivering an unspecified "immunogen" to elicit an immune response. Geall remedies this by explicitly teaching an RNA vaccine that encodes the S protein of SARS-CoV (a betacoronavirus) to induce a protective immune response.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to combine Schrum's advanced mRNA/LNP delivery platform with the specific, promising antigen disclosed in Geall. The references are in the same field of endeavor (nucleic acid vaccines), and combining a known effective delivery system with a known effective antigen was a well-understood pathway for vaccine development. The known success of the SARS-CoV S protein as a vaccine target would have provided a strong reason to select it as the "immunogen" for Schrum's platform.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success. Schrum demonstrated that its LNP-formulated, modified mRNA could effectively produce encoded proteins in vivo. Separately, the art, including Geall, established that the SARS-CoV S protein was a primary target for inducing neutralizing antibodies and protective immunity. Combining these known elements would predictably result in an effective vaccine.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combining Schrum with Yang (a 2004 journal article) or Altmeyer (WO 2005/118813). These grounds relied on similar reasoning, arguing Yang and Altmeyer also taught that the SARS-CoV S protein was a key, immunogenic target for nucleic acid vaccines, providing the same motivation to use it as the antigen in Schrum's mRNA vaccine platform.

4. Key Claim Construction Positions

  • Petitioner adopted, for the purposes of the petition, constructions advanced by the Patent Owner in parallel district court litigation:
    • betacoronavirus: "an enveloped, positive-sense, single stranded RNA virus of zoonotic origin that belongs to one of the four lineages of the betacoronavirus genus of the subfamily Coronavirinae (e.g., OC43, HKU1, MERS-CoV, and SARS-CoV)."
    • S protein: a "spike protein," which is "a structural protein forming a spike."
    • open reading frame: "in a DNA, a continuous stretch of DNA beginning with a start codon, and ending with a stop codon and encodes a polypeptide, or, in an mRNA, a corresponding stretch of mRNA."
    • subject: "a mammal."

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under either Fintiv or 35 U.S.C. §325(d) is inappropriate.
    • Fintiv: Denial was argued to be unjustified because the parallel district court case is in its early stages, with fact discovery ongoing and expert discovery not yet started.
    • §325(d): Denial was argued to be inappropriate because the primary prior art references were either not substantively considered by the Examiner or not before the Office at all. Schrum and Geall were cited in a large Information Disclosure Statement (IDS) with hundreds of other documents and were never used in a rejection. Yang and Altmeyer were never presented to the Examiner. Petitioner contended the Office therefore materially erred by allowing the claims over this highly relevant prior art.

6. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-3, 6-9, 11-13, 17-18, and 20 of the ’127 patent as unpatentable.