Pfizer Inc. v. Sanofi Vaccines US Inc.

Pfizer Inc. v. Sanofi Vaccines US Inc. The Federal Circuit affirmed the Board's denial of Pfizer's motion to amend because substantial evidence supported the Board's finding that proposed substitute claims 48 and 49 would have been obvious. The court held that the lack of prior-art immunogenicity data for every added serotype did not defeat obviousness because reasonable expectation of success need not be absolute. The decision reinforces that, in PTAB motion-to-amend practice, obviousness of amended composition claims can rest on reasonable-expectation evidence from related components and expert testimony even without data for every claimed species. Affirmed. The substitute claims concerned pneumococcal vaccine compositions adding serotypes and requiring more than a 2-log increase above baseline serum IgG levels in New Zealand White Rabbits across all serotypes. On a prior appeal, the Federal Circuit affirmed obviousness of proposed claim 46 but remanded because the Board had not adequately explained obviousness for proposed claims 48 and 49. On remand, the Board relied on Hausdorff's immunogenicity data, expert testimony on motivation to increase IgG levels, and testimony that additional CRM197-conjugated serotypes could be added without negatively affecting existing vaccine components. The Federal Circuit held that substantial evidence supported a reasonable expectation of success for the added known serotypes, despite the absence of direct immunogenicity data for each of them. The Board therefore did not abuse its discretion in denying Pfizer's motion to amend. § 103 remand non-precedential § 103 remand non-precedential § 103 non-precedential