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Merck Sharp & Dohme Corp. v. Wyeth LLC

United States Court of Appeals for the Federal Circuit

November 26, 2019, Decided

2018-2133, 2018-2134

Opinion

 [*814]  Dyk, Circuit Judge.

Merck Sharp & Dohme Corp. ("Merck") appeals decisions of the Patent Trial and Appeal Board ("Board") declining to find claim 18 of U.S. Patent No. 8,562,999 ("the '999 patent") unpatentable as obvious. We vacate and remand for further proceedings.

Background

The '999 patent, owned by Wyeth LLC ("Wyeth"), is directed to formulations for stabilizing polysaccharide-protein conjugate vaccines. These vaccines are derived from the capsular polysaccharides present on the surface of certain disease-causing bacteria. The human immune system can use these capsular [**2]  polysaccharides to detect and identify different serotypes (i.e., strains) of a species of bacteria. Polysaccharide vaccines can be monovalent (comprising a single serotype), or multivalent (comprising multiple serotypes). For example, a 13-valent vaccine would contain polysaccharides from 13 different serotypes. Because these polysaccharides typically have low immunogenicity (i.e., ability to provoke an immune response), it is desirable to enhance the effectiveness of these vaccines by conjugating (i.e., bonding) the polysaccharides to a carrier protein with high immunogenicity. However, as the '999 patent explains, polysaccharide-protein conjugate vaccines aggregate (i.e., clump together) when exposed to silicone oil, a  [*815]  common lubricant used in vaccine storage containers. The invention described in the '999 patent is a formulation that inhibits silicone-induced aggregation by suspending the polysaccharide-protein conjugate in a mixture of (1) a pH-buffered saline solution and (2) an aluminum salt. Claim 1, the sole independent claim of the '999 patent, recites a formulation comprising of: (1) a pH-buffered saline solution, (2) an aluminum salt, and (3) one or more polysaccharide-protein conjugates. Claim 18 recites [**3]  a specific 13-valent pneumococcal polysaccharide conjugate with CRM197 as the sole carrier protein for use with the formulation recited in claim 1.

On December 1, 2016, Merck filed two petitions for inter partes review with the Board, challenging claims 1-6, 10, 11, 14, and 17-20 of the '999 patent. The Board instituted review of all challenged claims in two parallel proceedings, IPR2017-00378 ("the 378 IPR") and IPR2017-00380 ("the 380 IPR"). In each proceeding, the Board found all the challenged claims except one—claim 18—to be unpatentable as obvious. Claim 18 covers a 13-valent pneumococcal conjugate vaccine. In both proceedings, the Board rejected Merck's argument that the formulation recited by claim 18 was obvious in light of the prior art. Merck appeals the Board's decisions as to claim 18. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).

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792 Fed. Appx. 813 *; 2019 U.S. App. LEXIS 35352 **; 2019 U.S.P.Q.2D (BNA) 454882; 2019 WL 6320454

MERCK SHARP & DOHME CORP., Appellant v. WYETH LLC, Appellee

Notice: THIS DECISION WAS ISSUED AS UNPUBLISHED OR NONPRECEDENTIAL AND MAY NOT BE CITED AS PRECEDENT. PLEASE REFER TO FEDERAL RULES OF APPELLATE PROCEDURE RULE 32.1 GOVERNING THE CITATION TO UNPUBLISHED OPINIONS.

Prior History:  [**1] Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2017-00378, IPR2017-00380.

Disposition: VACATED AND REMANDED.

CORE TERMS

conjugate, vaccine, serotypes, protein, carrier, skilled, polysaccharides, comprising, combine, recited, polysaccharide-protein, reasonable expectation, pneumococcal, prior art, immunogenicity, motivation, references, artisan, immune, proceedings

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Nonobviousness, Evidence, Fact & Law Issues, Standards of Review, Elements & Tests, Prior Art, Ordinary Skill Standard