IPR2017-00378, IPR00380, IPR2017-00390
U.S. Pat. No. 8,562,999 B2
June 13, 2017
Decision to Insitute IPR
Brief Summary: Board decision to institute IPRs against Wyeth’s (Pfizer’s) US 8,562,999 B2 relating to the vaccine Prevenar®.
Summary: Each of the ‘378, ‘380 and ‘390 IPRs relate to Wyeth’s (Pfizer’s) US 8,562,999 B2 relating to the vaccine Prevenar®, and each was instituted. The ‘380 IPR was granted on the basis of obviousness in view of “Chiron”, “Smith” and “Elan” (claims 1-6, 10-11, 14 and 17-20) and Chiron, Smith, Elan, and “Peña” (claims 17-18). The ‘380 IPR was also granted on the basis of obviousness in view of “Prevenar” and Chiron (claims 1-6, 10-11, 14 and 17-20) or Prevenar, Chiron and Peña (claim 18). The ‘390 IPR was granted on the basis of obviousness in view of Chiron, Smith, and Elan or Prevenar and Chiron (claims 7-9, 12, 13, 15, 16, 21 and 22). Claim 1 is presented in each decision as illustrative and claims “[a] formulation comprising (i) a pH buffered saline solution” (pKa “about 3.5 to about 7.5”), “an aluminum salt and (iii) one or more polysaccharide-protein conjugates, wherein the formulation is comprised in a siliconized container means and inhibits aggregation induced by the siliconized container means.” The terms “polysaccharide” and “polysaccharide-protein conjugates” were construed under the broadest reasonable construction (“BRC”; 37 CFR § 42.100(b); Cuozzo, US 2016). “[P]olysaccharide” was found to be “set forth with reasonable clarity, deliberateness, and precision” by the specification as “any antigenic saccharide element commonly used in the immunological and bacterial vaccine arts”. “[P]olysaccharide-protein conjugates” was found to be “generally describe[d]…in a manner that is consistent with the plain and ordinary meaning of the phrase” (“the resulting product of reacting” a polysaccharide as defined above “with a carrier protein that is amenable to standard conjunction procedures”). The Board also found the claims did not “require the formulation to provide any particular ‘level of immunogenicity’”. The inhibition of “aggregation induced by the siliconized container means” was determined to allow for additional ingredients that “may contribute the required aggregation inhibition” (In re Baxter, CCPA 1981 (“’comprising’ in a preamble”); CIAS, FC 2007 (“comprising”)) and not to “require maintaining any particular level of antigenicity”. The Board also adopted Wyeth’s description of one of ordinary skill in the art (Ph.D. or Masters degree and “familiarity or experience with the general components and formulation of bacterial vaccines” (Okajima, FC 2001)). In its ‘378 IPR obviousness analysis, the Board explained that, e.g., while “Chiron does not expressly teach that its formulations are comprised in a siliconized container means” but that that would have been obvious since, e.g., “standard pharmaceutical vial stoppers…were siliconized.” The Decision also “focuse[d] on the deficiencies in Patent Owner’s arguments in its Preliminary Response”, e.g., its dependence on “claim constructions that we have not adopted at this stage in the proceeding” (e.g., no requirement for “achieving or preserving some particular level of immunogenicity”). The Board also disagreed that certain references were not “pertinent prior art” because “they do not concern vaccine formulation” since, e.g., the same were “relied upon to show the standard practice of lubricating pharmaceutical container means”. It also found Merck’s expert testimony “to be reasonable and based on the knowledge of a person of ordinary skill in the art.” The Board did not agree with Wyeth that “Examples 3 and 4 of the Specification” shows “that the results…were unexpected compared to  the closest prior art.” It also did not find a teaching away in the cited art (no explanation or evidence “that the referenced lyophilized formulation was not simply a preferred formulation, as opposed to a necessary one” (In re Fulton, FC 2004). The Board’s conclusions were reached as appropriate “[a]t this stage in the proceeding”. The decision to institute the ‘380 and ‘390 IPRs were based on similar reasoning.