PTAB

IPR2017-01215

Merck Sharp & Dohme Corp v. Wyeth LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Multivalent Pneumococcal Conjugate Vaccine
  • Brief Description: The ’060 patent relates to multivalent immunogenic compositions for vaccines against Streptococcus pneumoniae. The claims are directed to a composition comprising polysaccharide-protein conjugates for at least eight specified serotypes (the seven from the commercial Prevnar® vaccine plus serotype 3), using CRM197 as the carrier protein.

3. Grounds for Unpatentability

Ground 1: Obviousness over Prevnar/Sigurdardottir - Claims 1, 4-7, and 13 are obvious over Prevnar 2001 in view of Sigurdardottir 2002.

  • Prior Art Relied Upon: Prevnar 2001 (a 2001 Physicians' Desk Reference entry) and Sigurdardottir 2002 (a 2002 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Prevnar 2001 disclosed an immunogenic 7-valent pneumococcal vaccine (Prevnar®) containing serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, each individually conjugated to the CRM197 carrier protein. Sigurdardottir 2002 taught the safety and immunogenicity of two 8-valent vaccines that included these same seven serotypes plus the claimed serotype 3. Although Sigurdardottir used different single-carrier proteins (diphtheria or tetanus toxoid), it demonstrated that an 8-valent vaccine including serotype 3 was immunogenic for all serotypes. The dependent claims reciting an aluminum phosphate adjuvant and specific dosages (claims 4-7, 13) were argued to be obvious modifications, as these exact features were disclosed as part of the standard formulation for the base 7-valent vaccine in Prevnar 2001.
    • Motivation to Combine: A POSITA would combine the teachings to improve the coverage of the commercially successful Prevnar® vaccine. Serotype 3 was well-known to be prevalent and cause serious disease, providing a strong incentive for its inclusion. Sigurdardottir showed that adding serotype 3 to the Prevnar-7 serotypes was feasible and resulted in an immunogenic vaccine. A POSITA would be motivated to use the proven CRM197 carrier protein from Prevnar rather than the carriers in Sigurdardottir, as this represented a minor and predictable modification to an established platform.
    • Expectation of Success: Petitioner asserted a POSITA would have a high expectation of success. The proposed modification was an incremental addition of one known, important serotype to a proven 7-valent vaccine platform. The immunogenicity of an 8-valent composition including serotype 3 was already demonstrated by Sigurdardottir, and substituting the well-characterized CRM197 carrier protein would be seen as a predictable and safe choice.

Ground 2: Obviousness over Huebner/Hausdorff - Claims 1-3 are obvious over Huebner 2004 in view of Hausdorff 2002.

  • Prior Art Relied Upon: Huebner 2004 (a 2004 journal article) and Hausdorff 2002 (a 2002 journal article).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground specifically addressed the 13-valent composition of claims 2 and 3. Petitioner argued that Huebner 2004 disclosed the next step in the art: an immunogenic 9-valent vaccine using the CRM197 carrier, which added serotypes 1 and 5 to the original Prevnar-7. Hausdorff 2002 then provided a clear roadmap for further expansion, identifying an 11-valent formulation (the 9-valent vaccine plus serotypes 3 and 7F) and explicitly stating that adding serotypes 6A and 19A to this 11-valent vaccine would "comprise all major serotypes." This combination of references disclosed all 13 claimed serotypes as the logical next step in vaccine development.
    • Motivation to Combine: The motivation was the natural and well-established progression of multivalent vaccine design: to expand coverage by incorporating additional, clinically relevant serotypes. Hausdorff explicitly identified the remaining serotypes (3, 7F, 6A, 19A) needed to achieve comprehensive coverage, providing a direct motivation for a POSITA to expand the 9-valent vaccine in Huebner to the claimed 13-valent composition.
    • Expectation of Success: A POSITA would have a reasonable expectation that expanding the proven 9-valent CRM197 platform by adding four more well-known, high-priority serotypes would result in an immunogenic 13-valent vaccine. Petitioner argued that a POSITA would not have been deterred by potential "carrier induced epitopic suppression" (CIES), as the literature showed CIES was not always observed, was often not clinically relevant, and successful 9-valent CRM197-conjugate vaccines already existed.

  • Additional Grounds: Petitioner asserted additional obviousness challenges for claims 8-12 over the combination of Prevnar 2001 and Sigurdardottir 2002, further in view of Chiron 2003 or Wyeth 2002, which taught adding other specified bacterial antigens or proteins to pneumococcal conjugate vaccines.

4. Key Claim Construction Positions

  • "immunogenic": Petitioner argued this term is a critical limitation that must be construed as "elicits immunologic memory and/or functional antibody with respect to each serotype of the vaccine, including serotype 3." This proposed construction was based on the Patent Owner's arguments during prosecution. Petitioner emphasized that the Patent Owner repeatedly distinguished a GSK prior art vaccine by arguing it failed to show sufficient immunologic memory or functional antibody for serotype 3. Therefore, to secure the patent, the Patent Owner implicitly defined "immunogenic" to include these specific, heightened criteria and should be held to that definition.
  • Scope of Serotype Limitations: Petitioner argued that in claim 1, the open-ended term "comprise" means the composition must include at least the eight specified serotypes (the Prevnar-7 plus serotype 3) but could include others. In contrast, Petitioner contended that the language in claim 2 ("consist of") and claim 3 ("consist essentially of") limited those claims to compositions containing exactly the 13 specified serotypes.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-13 of the ’060 patent as unpatentable.