PFIZER INC. v. SANOFI PASTEUR INC. , No. 19-1871 (Fed. Cir. 2024)
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This case involves an appeal by Pfizer Inc. from decisions made by the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the Board). The Board concluded that claims 1–45 of U.S. Patent 9,492,559, owned by Pfizer and related to immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens for use in pneumococcal vaccines, were unpatentable. The Board also denied Pfizer’s proposed amendments to the claims.
Pfizer's first challenge pertained to the Board’s conclusion regarding the molecular weight of the glycoconjugate in the patent, arguing that the Board incorrectly applied the "result-effective variable doctrine." The court disagreed, upholding the Board's decision that the molecular weight was a result-effective variable that a person of ordinary skill in the art would have been motivated to optimize.
Pfizer's second challenge related to the Board’s finding that the compositions of additional claims incorporating more specific glycoconjugates would have been obvious. The court disagreed with Pfizer's argument that without examples showing the claimed glycoconjugates would have each been immunogenic, there would have been no reasonable expectation of success.
Thirdly, Pfizer challenged the Board’s denial of its motions to amend the claims. The court affirmed the Board's decision on some of the proposed claims but vacated the decision on others, remanding them for further consideration due to the Board’s lack of clarity.
Lastly, Pfizer challenged the Patent and Trademark Office’s Director Review procedure, alleging it violated the Administrative Procedure Act (APA). The court rejected this argument, finding any potential APA violation was harmless as Pfizer had not demonstrated prejudice.
Therefore, the court affirmed the Board’s decisions in part, vacated them in part, and remanded the case back to the Board for further proceedings.
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