Merck Sharp & Dohme Corp v. Wyeth LLC

1. Case Identification

• Case #: IPR2017-01194
• Patent #: 8,895,024
• Filed: March 29, 2017
• Petitioner(s): Merck Sharp & Dohme Corp.
• Patent Owner(s): Wyeth LLC
• Challenged Claims: 1-11

2. Patent Overview

• Title: Immunogenic Compositions Comprising 13-Valent Pneumococcal Conjugates
• Brief Description: The ’024 patent discloses a multivalent immunogenic composition for a vaccine against Streptococcus pneumoniae. The composition comprises 13 distinct polysaccharide-protein conjugates, where each polysaccharide corresponds to a specific pneumococcal serotype, and each is conjugated to a CRM197 carrier protein.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-5 by the ’380 Pub.

• Prior Art Relied Upon: ’380 Pub. (Application # 2006/0228380).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the effective filing date for claims 1-5 is January 22, 2009, not the earlier claimed priority date of April 8, 2005. This argument was based on a lack of enablement in the parent applications for the full scope of open-ended claim 1, which "consist[s] essentially of" the 13 serotypes, thereby potentially including additional, undisclosed serotypes. Petitioner contended this lack of enablement invalidates the priority claim. Consequently, the ’380 Pub., published in 2006 as part of the patent’s own family, qualifies as prior art under pre-AIA §102(b). The ’380 Pub. shares the same specification as the ’024 patent and allegedly discloses every limitation of claims 1-5, including the 13-valent immunogenic composition (claim 1) and the use of an aluminum phosphate adjuvant (claims 2-5).

Ground 2: Claims 1, 6, and 11 are obvious over Huebner 2004 in view of Hausdorff 2002.

• Prior Art Relied Upon: Huebner 2004 (a 2004 article in Vaccine on a 9-valent vaccine) and Hausdorff 2002 (a 2002 article in Pediatr. Infect. Dis. J. on pneumococcal serotypes).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Huebner 2004 described an immunogenic 9-valent pneumococcal vaccine using the same CRM197 carrier protein and containing 9 of the 13 claimed serotypes. Hausdorff 2002 was a study identifying the most prevalent pneumococcal serotypes causing disease, which explicitly listed the serotypes in the 9-valent vaccine, disclosed a known progression to an 11-valent vaccine (adding serotypes 3 and 7F), and identified the final two serotypes of the ’024 patent (6A and 19A) as the next most important "major serotypes" needed to provide comprehensive coverage. Together, these references allegedly taught a 13-valent composition with all claimed serotypes conjugated to CRM197. Claim 11, which recites an "opsonophagocytic antibody response," was argued to be an inherent and expected result of creating an immunogenic vaccine.
  • Motivation to Combine: A POSITA would combine these references following the well-established and predictable path of multivalent vaccine development, which involves progressively adding the most epidemiologically significant serotypes to an existing vaccine platform to broaden coverage. Hausdorff 2002 provided the clear roadmap for which serotypes to add to the 9-valent vaccine disclosed in Huebner 2004.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because expanding a proven vaccine platform (the 9-valent CRM197 conjugate vaccine) by adding four well-known, prevalent serotypes was a routine and predictable step. The strong immunogenicity of the 9-valent vaccine in Huebner 2004 would suggest that a 13-valent version would also be successful.

Ground 3: Claims 2-5 and 7-10 are obvious over Huebner 2004, Hausdorff 2002, and Prevnar 2001.

• Prior Art Relied Upon: Huebner 2004, Hausdorff 2002, and Prevnar 2001 (a 2001 entry in the Physicians' Desk Reference).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground extended the reasoning of Ground 2 to the dependent claims reciting an adjuvant. Petitioner argued that after arriving at the obvious 13-valent composition from Huebner 2004 and Hausdorff 2002, it would have been obvious to include an adjuvant to boost immunogenicity. Prevnar 2001, which described the commercially successful 7-valent Prevnar® vaccine (the predecessor to the 9-valent vaccine in Huebner 2004), explicitly disclosed its formulation with an aluminum phosphate adjuvant.
  • Motivation to Combine: A POSITA would be motivated to add an aluminum phosphate adjuvant, a standard and commonly used adjuvant in conjugate vaccines, to enhance the immune response of the 13-valent composition. The success and safety profile of the adjuvanted 7-valent Prevnar® vaccine provided a strong reason to use the same adjuvant in its next-generation, 13-valent version.
  • Expectation of Success: Given that aluminum phosphate was a well-known and effective adjuvant used in the prior art 7-valent vaccine, a POSITA would have a high expectation of success in using it to boost the immunogenicity of the obvious 13-valent composition.

4. Key Claim Construction Positions

• "immunogenic": Petitioner argued this term, recited in every claim, should be construed as "elicits immunologic memory and/or functional antibody with respect to each serotype of the vaccine, including serotype 3." This construction was based on the Patent Owner's arguments during prosecution, where it distinguished a prior art 11-valent vaccine by arguing it failed to elicit a sufficient functional antibody response for serotype 3, a deficiency the ’024 patent allegedly solved.
• "comprising 13 distinct ... conjugates ... wherein the serotypes consist essentially of...": For claim 1, Petitioner argued the broadest reasonable interpretation allows for unspecified additional serotypes, so long as they are also immunogenic and do not materially affect the immunogenicity of the 13 recited serotypes. This broad interpretation was central to Petitioner's enablement challenge.

5. Key Technical Contentions (Beyond Claim Construction)

• Lack of Enablement Invalidates Priority Claim: Petitioner’s primary contention for Ground 1 was that the ’024 patent’s parent applications failed to enable the full scope of claim 1. The claim is open-ended due to the "consist essentially of" language, potentially covering compositions with more than 13 serotypes. However, the specification only described the 13-valent composition (13vPnC) and provided no guidance for making and using higher-valency compositions, particularly with serotypes whose polysaccharide structures were unknown at the time. Petitioner argued that developing these additional conjugates would require undue experimentation, rendering the claim not enabled by the parent applications and thus breaking the chain of priority.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-11 of the ’024 patent as unpatentable.