PTAB

IPR2023-01358

Pfizer Inc v. ModernaTX Inc

Key Events

Petition

petition Intelligence

Title: Compositions of mRNA Encoding a Betacoronavirus Spike Protein Formulated in a Lipid Nanoparticle
Brief Description: The ’600 patent relates to pharmaceutical compositions comprising a messenger RNA (mRNA) that encodes a betacoronavirus (BetaCoV) spike (S) protein, where the mRNA is formulated in a lipid nanoparticle (LNP). The technology is directed to mRNA-based vaccines for betacoronaviruses.

Prior Art Relied Upon: Schrum (Application # 2013/0266640).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Schrum, a prior art application filed by the Patent Owner, discloses every element of the challenged claims. Schrum teaches a general platform for mRNA vaccines, including modified mRNA formulated in LNPs with specific lipid components and molar ratios (e.g., 50:10:38.5:1.5 for cationic lipid:DSPC:cholesterol:PEG) that fall squarely within the ranges claimed in the ’600 patent. Crucially, Schrum expressly “incorporates by reference in [its] entirety” Geall (WO 2012/006369). Geall discloses using the spike protein of SARS-CoV, a known betacoronavirus, as the specific immunogen for an RNA vaccine. Petitioner contended that through this incorporation, Schrum's disclosure is legally identical to one that explicitly names the betacoronavirus S protein as the encoded antigen, thereby anticipating all claims.

Prior Art Relied Upon: Schrum (Application # 2013/0266640) and Geall (WO 2012/006369).
Core Argument for this Ground:
- Prior Art Mapping: As an alternative to anticipation, Petitioner asserted this combination renders the claims obvious. Schrum provides the foundational mRNA vaccine platform, describing modified mRNA compositions and the exact LNP formulations later claimed. Geall explicitly teaches an RNA vaccine encoding the spike protein of SARS-CoV (a betacoronavirus) to elicit an immune response.
- Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Schrum’s delivery platform with Geall’s known and effective antigen. The motivation is strong because Schrum itself identifies Geall as relevant art, both references are in the same field of nucleic acid vaccines, and the SARS-CoV spike protein was well-established as a promising target for vaccine development. The combination represents applying a known vaccine platform to a known antigen to achieve a predictable result.
- Expectation of Success: Given that Schrum’s platform was designed to express encoded proteins and Geall’s antigen was known to be immunogenic, a POSITA would have had a reasonable expectation of success in creating a functional betacoronavirus mRNA vaccine.

Prior Art Relied Upon: Schrum (Application # 2013/0266640) and Yang (a 2004 journal article in Nature).
Core Argument for this Ground:
- Prior Art Mapping: Schrum again provides the core mRNA and LNP platform technology. Yang, which was not before the Examiner, teaches that a DNA vaccine encoding the SARS-CoV spike protein induces robust T cell and neutralizing antibody responses, as well as protective immunity, in animal models.
- Motivation to Combine: A POSITA would have been motivated to use the proven immunogenic spike protein from Yang in the more advanced mRNA vaccine platform of Schrum. Petitioner argued that by the patent’s priority date, mRNA vaccines were recognized as having significant advantages over DNA vaccines (e.g., safety, increased antigen production), providing a clear reason to adapt successful antigens from the DNA context to the superior mRNA platform.
- Expectation of Success: The demonstrated high efficacy of the SARS-CoV spike protein as an antigen in Yang's nucleic acid vaccine would provide a strong expectation that it would also be effective when delivered via Schrum's mRNA platform, which was a known and viable method for expressing antigens in vivo.
Additional Grounds: Petitioner asserted an additional obviousness challenge based on Schrum in view of Altmeyer (WO 2005/118813) but relied on similar design modification theories.

Petitioner adopted, for the purpose of the petition, claim constructions advanced by the Patent Owner in parallel district court litigation. Key constructions included:
- 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.’”

Petitioner argued that discretionary denial under either Fintiv (§314(a)) or §325(d) would be inappropriate.
- Fintiv Denial: Petitioner contended that denial is not warranted because the co-pending district court case is in its early stages, with no trial date set and expert discovery yet to begin. Furthermore, Petitioner argued the strong merits of the petition and the significant public interest in reviewing the validity of the patent weigh heavily in favor of institution.
- §325(d) Denial: Petitioner asserted that the primary prior art references were not substantively considered during prosecution. Schrum and Geall were cited only in an Information Disclosure Statement (IDS) containing hundreds of other references. Yang and Altmeyer were never before the Examiner. The prosecution history shows that the Examiner issued no prior art rejections, indicating a material error by the Patent Office in allowing the claims without considering this highly relevant art.

Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1, 2, 4-6, 8-12, 16-17, 20-21, and 26 of the ’600 patent as unpatentable.