PTAB

IPR2026-00189

Pfizer Inc v. Pogona LLC

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Streptococcus Pneumoniae Vaccine
  • Brief Description: The ’757 patent relates to pneumococcal conjugate vaccines (PCVs). The invention is a pharmaceutical composition comprising a plurality of at least two unique immunogenic saccharide-polypeptide conjugates, where the capsular polysaccharides are from Streptococcus pneumoniae serotypes selected from a group consisting of 23A, 23B, and 35B.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-2, 4-8, 11, and 15-19 by Alexander

  • Prior Art Relied Upon: Alexander (International Publication No. WO 2005/120563).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Alexander anticipates all limitations of the challenged claims. Independent claim 1 requires a pharmaceutical composition with at least two unique saccharide-polypeptide conjugates from S. pneumoniae serotypes selected from 23A, 23B, and 35B. Alexander allegedly discloses compositions comprising a mixture of conjugates from two or more serotypes drawn from a list of 53 serotypes that expressly includes "23A," "23B," and "35." Petitioner contended that because Alexander directs a person of ordinary skill in the art (POSA) to select any two or more serotypes from this list, it explicitly discloses a composition containing conjugates of serotypes 23A and 23B. Alexander also allegedly discloses the limitations of the dependent claims, including mixtures of polypeptides (claim 2), various excipients like adjuvants (claim 4), standard administration routes like intramuscular injection (claim 5), and methods of making and administering the vaccine (claims 11, 15-19).

Ground 2: Anticipation of Claims 1, 3-6, 9, 11-12, 15, and 18-19 by Gu

  • Prior Art Relied Upon: Gu (International Publication No. WO 2015/121783).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Gu, which was not before the Examiner, anticipates the claims. Gu allegedly discloses immunogenic compositions (vaccines) comprising a plurality of glycoconjugates, including those with capsular polysaccharides from S. pneumoniae. Critically, Petitioner argued that Gu discloses an embodiment where the capsular polysaccharide is selected from a short list of just eight preferred serotypes: "2, 9N, 15A, 17F, 20, 23A, 23B, and 35B." Petitioner contended that this disclosure of a small, preferred group containing all three serotypes recited in claim 1 anticipates the claimed composition. Gu also allegedly discloses using known carrier proteins like CRM197 (claim 3), eliciting an opsonophagocytic response (claim 6), and using toxoids with mitigated toxicity (claim 9).

Ground 3: Obviousness of Claims 1-9 and 11-19 over Alexander or Gu in view of Serotype Prevalence and Vaccine Recommendation References

  • Prior Art Relied Upon: Alexander or Gu in view of the Serotype Prevalence References (Kaplan, Pilishvili, Waight, ECDC, and/or PHAC) and/or the Vaccine Recommendation References (Porro, Al-Sherikh, Richter, and/or Wagenvoort).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that even if Alexander or Gu do not anticipate claim 1, the claim is obvious when combining either reference with the wealth of publicly available epidemiological data and expert recommendations. Alexander and Gu provide the foundational teaching of multivalent PCV compositions. The secondary references, which survey the prevalence of S. pneumoniae serotypes after the introduction of existing PCVs (like PCV7 and PCV13), consistently identified serotypes 23A, 23B, and 35B as among the most common, emerging, and clinically important serotypes not covered by those vaccines.
    • Motivation to Combine: A POSA seeking to design a next-generation PCV with broader coverage would have been motivated to consult the exact type of data provided in the secondary references to identify emerging serotypes of concern. These references not only identified 23A, 23B, and 35B as highly prevalent but, in several cases, expressly recommended their inclusion in future vaccine formulations to improve efficacy. The motivation was to address the "serotype replacement" phenomenon, a well-known problem where vaccination against certain serotypes leads to an increase in disease caused by non-vaccine serotypes.
    • Expectation of Success: The long and successful history of developing multivalent PCVs by adding new serotypes to existing platforms (e.g., the development of PCV13 from PCV7) would have provided a POSA with a strong and reasonable expectation of success in incorporating the well-characterized serotypes 23A, 23B, and 35B into a vaccine composition like that disclosed by Alexander or Gu.
  • Additional Grounds: Petitioner asserted additional challenges, including that claims 1-9, 11-12, and 15-19 are obvious over Alexander alone (Ground II) and that claims 1, 3-6, 9, 11-12, 15, and 18-19 are obvious over Gu alone (Ground IV), as anticipation is the epitome of obviousness. Further grounds combined Alexander or Gu with other references like Lee, Anttila, PFL, and Vesikari to argue the obviousness of specific dependent claims related to opsonophagocytic response (claim 6), conjugate concentration (claims 7 and 10), and the use of mixed carrier proteins or booster shots (claims 2, 16-17).

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-19 of the ’757 patent as unpatentable.