PTAB

IPR2017-00378

Merck Sharp & Dohme Corp v. Wyeth LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Formulations for Polysaccharide-Protein Conjugate Vaccines
  • Brief Description: The ’999 patent is directed to immunogenic formulations containing polysaccharide-protein conjugates designed to inhibit protein aggregation induced by siliconized containers. The claimed formulation comprises a pH buffered saline solution, an aluminum salt, and one or more polysaccharide-protein conjugates.

3. Grounds for Unpatentability

Ground 1: Obviousness over Chiron, Smith, and Elan - Claims 1-6, 10-11, 14, and 17-20 are obvious over Chiron 2003 in view of Smith 1988 and Elan 2004.

  • Prior Art Relied Upon: Chiron 2003 (WO 03/009869), Smith 1988 (a technical report on siliconization), and Elan 2004 (WO 2004/071439).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Chiron 2003 taught an aluminum-adjuvanted vaccine formulation containing all the essential components recited in claim 1 of the ’999 patent: polysaccharide-protein conjugates, a pH buffer (histidine), a salt (sodium chloride), an aluminum salt adjuvant, and a surfactant (polysorbate 80). Smith 1988 established that siliconizing pharmaceutical containers (e.g., vials, stoppers, and syringes) with silicone oil was a standard, required industry practice to ensure proper function and machinability. Elan 2004 explicitly addressed the known problem of protein aggregation caused by silicone oil in containers and taught the solution: adding a surfactant, specifically polysorbate 80, to inhibit this aggregation. Petitioner contended that the combination of these references rendered the claims obvious. Dependent claims were argued to recite routine and obvious variations, such as specific antigens (pneumococcal, meningococcal), aluminum salts, and surfactants (polysorbate 80) that were all taught or suggested by Chiron.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine the teachings for predictable reasons. A POSITA starting with the vaccine formulation of Chiron would have been motivated by the teachings of Smith to package it in a standard, siliconized container to ensure proper delivery and storage. Upon doing so, the POSITA would confront the well-known problem of silicone-induced protein aggregation. Elan provided the explicit motivation and solution—using a surfactant like polysorbate 80 (which was already present in Chiron's formulation) to stabilize the formulation.
    • Expectation of Success: A POSITA would have had a high expectation of success. The problem of silicone-induced aggregation was well-known, and the use of surfactants as a solution was a widely applied and successful strategy. The fact that Chiron’s formulation already contained the exact surfactant (polysorbate 80) taught by Elan to solve the specific problem would have provided a strong basis to expect that the Chiron formulation, when placed in a siliconized container, would inherently inhibit aggregation.

Ground 2: Obviousness over Chiron, Smith, Elan, and Pena - Claims 17-18 are obvious over Chiron 2003, Smith 1988, and Elan 2004 in view of Pena 2004.

  • Prior Art Relied Upon: Chiron 2003, Smith 1988, Elan 2004, and Pena 2004 (a journal article translation).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground reinforced Ground 1 but added the Pena 2004 reference to specifically address the limitations of claims 17 and 18, which recite specific 7-valent and 13-valent pneumococcal conjugate combinations, respectively. Petitioner argued that the underlying formulation was rendered obvious by Chiron, Smith, and Elan. The Pena reference was introduced to demonstrate that the specific antigen combinations recited in claims 17 and 18 were not themselves inventive but were part of the general knowledge and represented a natural, predictable progression in vaccine development. Pena explicitly disclosed the 7-valent conjugates of claim 17 and described the development of vaccines up to the 13-valent version of claim 18.
    • Motivation to Combine: The motivation to combine Chiron, Smith, and Elan was the same as in Ground 1. A POSITA would have been motivated to apply this stable formulation to known, clinically relevant antigen combinations to create improved vaccines. Pena showed that the 7- and 13-valent combinations were well-known and the subject of active development, providing the motivation to use them in an improved, stable formulation.
    • Expectation of Success: The expectation of success was high for the same reasons as Ground 1. The addition of Pena confirmed that the specific antigen sets were not novel hurdles but were instead well-characterized components that a POSITA would expect to be compatible with the stabilized formulation.

4. Key Claim Construction Positions

  • Term: "the formulation ... inhibits aggregation induced by the siliconized container means"
    • Petitioner's Position: Petitioner argued this phrase should be construed as reciting a functional property of the formulation as a whole. It does not require that a specifically recited ingredient in the claim (e.g., the aluminum salt) be the sole or primary cause of the aggregation inhibition.
    • Importance: This construction was central to Petitioner's obviousness argument. It allowed Petitioner to contend that the claim limitation is met if the formulation inhibits aggregation for any reason, including the presence of an unrecited but obvious component like a surfactant. This prevents the Patent Owner from arguing that the prior art fails because it does not explicitly teach that the aluminum salt inhibits aggregation, thereby focusing the inquiry on the properties of the overall, obvious-to-combine formulation.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-6, 10-11, 14, and 17-20 of the ’999 patent as unpatentable under 35 U.S.C. §103.