Merck Sharp & Dohme Corp v. Wyeth LLC

1. Case Identification

• Case #: IPR2017-01211
• Patent #: 9,399,060
• Filed: March 30, 2017
• Petitioner(s): Merck Sharp & Dohme Corp.
• Patent Owner(s): Wyeth LLC
• Challenged Claims: 1-13

2. Patent Overview

• Title: Multivalent Pneumococcal Conjugate Vaccine
• Brief Description: The ’060 patent describes a multivalent immunogenic vaccine composition comprising polysaccharide-protein conjugates. The composition includes capsular polysaccharides from at least eight specific serotypes of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, 23F, and 3) conjugated to a CRM197 carrier protein.

3. Grounds for Unpatentability

Ground 1: Claims 1-13 are anticipated by the '380 Pub. under pre-AIA § 102(b).

• Prior Art Relied Upon: The '380 Pub. (Application # 2006/0228380).
• Core Argument for this Ground:
  • Petitioner’s anticipation argument is premised on challenging the challenged claims’ entitlement to their earliest priority date. Petitioner argued that claim 1 is open-ended, using the term "comprise" to cover any multivalent immunogenic composition containing the eight recited serotypes plus any number of "additional serotypes." This broad scope captures compositions with far more than the 13 serotypes specifically disclosed in the patent.
  • Petitioner contended that the ’060 patent’s parent applications fail to enable the full scope of these claims as required by 35 U.S.C. §112. The parent applications only disclose a 13-valent composition (13vPnC) and provide no guidance on how to create higher-valency immunogenic compositions, particularly when adding serotypes with unknown polysaccharide structures. Petitioner asserted that developing such vaccines is highly unpredictable and would require undue experimentation for each additional serotype to determine proper conjugation chemistry and confirm immunogenicity.
  • Because the parent applications allegedly do not enable the full scope of the claims, Petitioner argued that claims 1 and 4-13 are not entitled to a priority date earlier than January 22, 2009.
  • Consequently, the ’380 Pub., which was published on October 12, 2006, qualifies as prior art under pre-AIA §102(b).
  • Prior Art Mapping: Petitioner argued that the ’380 Pub., which shares the same specification as the ’060 patent, discloses every element of the challenged claims. The ’380 Pub. explicitly describes the 13-valent pneumococcal conjugate composition (13vPnC) that falls within the scope of the claims. This disclosure includes:
    • An immunogenic composition that elicits a functional antibody response against all vaccine serotypes.
    • The specific set of 13 polysaccharide serotypes recited in claims 2 and 3, which satisfies the requirements of claim 1.
    • The use of CRM197 as the carrier protein.
    • The use of an aluminum phosphate adjuvant, as required by dependent claims 4-7.
    • The inclusion of other antigens, as recited in claims 8-12.
    • The specific dosage formulation detailed in claim 13.
  • As the ’380 Pub. allegedly discloses a composition meeting every limitation of claims 1-13, Petitioner contended the claims are anticipated.

4. Key Claim Construction Positions

• "immunogenic": Petitioner argued this term, present in the preamble of 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 prosecution history, where the Patent Owner distinguished the invention from prior art by emphasizing its ability to produce a "robust immune response" for all serotypes, especially serotype 3, which a prior art vaccine allegedly failed to do. This argument made immunogenicity a limiting feature of the claims, not just a statement of intended use.
• "wherein the serotypes comprise...": Petitioner argued that this claim 1 language, using the open-ended term "comprise" and "at least one additional serotype," renders the claim open-ended regarding the number and identity of additional serotypes that can be included. This interpretation is central to the non-enablement argument, as it defines the broad scope that Petitioner alleges is not supported by the specification.

5. Key Technical Contentions (Beyond Claim Construction)

• Unpredictability of Vaccine Development: Petitioner’s central technical contention was that the field of multivalent conjugate vaccine development is highly unpredictable. It argued that a person of ordinary skill in the art (POSITA) would not be able to predict whether adding new serotypes to a known vaccine formulation would result in an immunogenic composition without undue experimentation. This is because conjugation chemistry must be tailored for each specific polysaccharide, and immunogenicity can be affected by "carrier induced epitopic suppression" or other interference effects.
• Enablement Requires More Than a Single Example: Petitioner contended that the disclosure of a single 13-valent embodiment is insufficient to enable the full, open-ended scope of claim 1, which covers potentially millions of combinations of additional serotypes. The lack of guidance on selecting additional serotypes, determining their unknown structures, and developing successful conjugation methods for them constitutes a failure to enable the full scope of the claims.

6. Relief Requested

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