Pfizer v. Sanofi Vaccines
Panel: Lourie, Prost, Stark
The Federal Circuit affirmed the Board's denial of Pfizer's motion to amend claims 48 and 49 of U.S. Patent 9,492,559, which covers pneumococcal vaccine compositions containing multiple serotypes of S. pneumoniae conjugated to a carrier protein. The case returned on remand after the court previously held that the Board had provided only conclusory statements regarding whether proposed substitute claims 48 and 49 would have been obvious, specifically as to a limitation requiring "more than a 2-log increase above baseline in serum IgG levels" across all serotypes. On remand, the Board found the claims obvious over prior art references including Hausdorff, Merck-086, and GSK-711.
The court's analysis focused on whether substantial evidence supported the Board's reasonable expectation of success finding for the 2-log increase limitation as applied to additional serotypes (15B, 33F, 12F, 10A, 11A, and 8) not specifically tested in the prior art. The Board relied on three pieces of evidence: Hausdorff's Table 3 showing the 2-log increase for thirteen of fourteen serotypes in a related composition, expert testimony that practitioners would seek to increase IgG levels to improve immunogenicity, and expert testimony that adding serotypes to CRM197 conjugates was possible without negatively affecting other vaccine components. The court emphasized that reasonable expectation of success does not require a guarantee or absolute certainty, and found this evidence adequate to support obviousness of composition claims reciting known serotypes despite the absence of specific immunogenicity data for each added serotype.