Pfizer Inc. v. Sanofi Pasteur Inc. et al. (Merck)

Docket No. 2019-1871, -1873, -1875-76, -2224 (IPR2017-02131-32, -02136, -02138, IPR2018-00187) (https://cafc.uscourts.gov/opinions-orders/19-1871.OPINION.3-5-2024_2280462.pdf)

LOURIE, BRYSON, STARK

March 5, 2024

Brief Summary:  Five IPR FWDs finding Pfizer’s S. pneumoniae vaccine claims unpatentable for obviousness affirmed.

Summary:   Pfizer appealed five IPR final written decisions (FWDs) concluding claims 1-45 of its US 9,492,559 directed to S. pneumoniae glyconjugates (pneumonia, febrile bacteremia, and meningitis vaccines) are unpatentable for obviousness.  Independent claim 1 relates to a composition comprising the S. pneumoniae serotype 22F glyoconjugate having “a molecular weight [MW] of between 1000 kDa and 12,500 kDa” and a carrier protein.  Dependent claims 3 and 4 add the 15B and 33F saccharides (claim 3), and the 12F, 10A, 11A, and 8 glyconjugates (claim 4).  Merck and Sanofi argued Pfizer’s claims would have been obvious in view of two patent applications (GSK-711 directed to a composition of “at least ten serotypes of S. pneumoniae” including 22F; and Merck-086 directed to “multivalent immunogenic composition[s] having 15 distinct polysaccharide-protein conjugates” including 22F).  The Board and Sanofi acknowleged that “neither GSK-711 nor Merck-086 discloses any [MW] for a S. pneumoniae serotype 22F glycoconjugate” but the Board concluded MW “is a result-effective variable that a person of ordinary skill in the art would have been motivated to optimize to provide a conjugate having improved stability and good immune response” and therefore obvious.  Pfizer argued the “‘result-effective variable doctrine’…is only appropriate in circumstances where there is actual overlap between a range in the prior art and a claimed range”, but the FC panel disagreed.  The FC panel explained that “result-effective variable is merely one aspect” of the basic obviousness analysis and that “it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller, CCPA 1955; E.I. DuPont, FC 2018).  And, “[i]n the context of numerical ranges”, as in this case, “an overlap between a claimed range and a prior art range creates a presumption of obviousness that can be rebutted with evidence that the given parameter was not recognized as result-effective” (“[t]hat does not mean, however, that the determination whether or not a variable is result-effective is only appropriate when there is such an overlap”; Genentech, FC 2020; In re Applied Materials, FC 2012).  It also explained that one must determine “whether a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to bridge any gaps in the prior art to arrive at a claimed invention” and if “that gap includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective” as “optimization of that parameter is ‘normally obvious’” (and “where optimization requires case-specific considerations, then the results must be unexpected”).  Based on these principles, the FC panel found the Board’s obviousness conclusion to be supported by substantial evidence, including expert testimony (e.g., “conjugation techniques and conditions were routine”; “a prior art reference is not limited to its specific working examples” (In re Mills, CCPA 1972); “expectation of success need only be reasonable, not absolute” (Pfizer, FC 2007)).  The FC panel also agreed with the Board’s denial of Pfizer’s request to amend the claims as those would still have been obvious (e.g., “the prior art here does not evidence ‘only failures to achieve that at which the inventors succeeded’” (Univ. Strathclyde, FC 2021).

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.