Routine Optimization Does Not Necessarily Require A Disclosure Of Ranges Under The Results-Effective Variable Doctrine – Pfizer V. Sanofi, No. 19-1871 (Fed Cir 2024)

The results-effective variable doctrine is a caselaw principle where prior art disclosing the "general conditions of a claim" invokes a presumption of obviousness if the particular workable ranges are identifiable through routine experimentation. The presumption can be rebutted with evidence that the given parameter was not recognized as being result-effective. Sanofi Pasteur, Inc. and SK Chemicals Co initiated an IPR (inter partes review) to invalidate U.S. Patent No. 9,492,559 (the "'559 Patent") owned by Pfizer based on the routine optimization theory. The '559 Patent is directed to compositions comprising a Streptococcus pneumoniae serotype 22F glycoconjugate with a molecular weight between 1,000 kDa and 12,500 kDa. The IPR petitioners cited two references mentioning the S. pneumoniae 22F serotype, but neither reference disclosed any molecular weight of the claimed glycoconjugate. Notwithstanding the lack of a disclosure of a general range, the Board applied