Pfizer’s patent claimed immunogenic compositions for use in a pneumococcal vaccines. Claim 1 of the patent recited the presence of a streptococcus pneumoniae glycoconjugate of serotype 22F, having a molecular weight between 1000 and 12,500 kDa. Dependent claims 3 and 4 recited the inclusion of additional glycoconjugates.
Sanofi challenged all claims of the patent in five IPRs, principally asserting that a PCT application (GSK-711) and a U.S. patent application (Merk-086) rendered the claims obvious. The Board found all of the claims unpatentable as obvious and denied Pfizer’s contingent motions to amend the claims, determining that the substitute claims were unpatenable.
On appeal, Pfizer argued that the Board had erred in its obviousness finding by considering whether the molecular weight of glycoconjugates was a result-effective variable that one would have sought to optimize. According to Pfizer, application of the result-dependent-variable doctrine was solely applicable to rebutting a presumption of obviousness created where the prior-art ranges actually overlapped with the claimed range. Because it was undisputed that none of the prior art disclosed molecular-weight ranges that overlapped with the range claimed by the patent, Pfizer contended that there was no presumption of obviousness and, therefore, no reason to consider whether molecular weight was a result-effective variable.
The Federal Circuit rejected that argument. While the court recognized that application of the result-effective-variable doctrine was appropriately applied to rebut a presumption of obviousness arising from overlapping ranges, it concluded that the doctrine could be applied where the prior-art ranges did not overlap with the claimed range. The court reasoned that a routine-optimization analysis requires consideration whether there was a motivation, with a reasonable expectation of success, to “bridge any gaps in the prior art to arrive at the claimed invention.” In the court’s view, where such a gap includes a parameter not disclosed the by art, it is not error to consider whether that parameter was recognized as result-effective.
The court then determined that substantial evidence supported the Board’s obviousness findings. The evidence showed that GSK-711 disclosed the serotype 22F glycoconjugate—even if not of the claimed molecular weight—and also disclosed 14 other serotypes having weights in the claimed range. GSK-711 also disclosed that pneumococcal vaccines having a larger sized saccharide conjugate can have a good immune response. And GSK-711 and Merck-086 both teach that the polysaccharides can be sized to improve filterability of the conjugated product.
Pfizer also advanced substantial-evidence challenges to the Board’s obviousness findings as to dependent claims 3 and 4. Both claims recited that the conjugates were “immunogenic,” meaning that they “elicit functional antibody” according to the term’s construction. Pfizer argued that there was no substantial evidence of a reasonable expectation of success because the art did not disclose that the glycoconjugates were ever made or tested. The court rejected this argument, noting that GSK-711 described its compositions as “immunogenic,” which the Board accepted as eliciting a functional antibody. The Board’s conclusion was not unreasonable because the claimed serotypes had been formulated into a commercially available pneumococcal vaccine.
Pfizer also challenged the Board denial of three contingent motions to amend it had filed across the five IPRs. While the court affirmed the Board’s denial of substitute claims 46 and 47, it vacated as the Board’s denial of substitute claims 48 and 49 and remanded for further consideration. The court ruled that the Board not considered the limitation in those claims. Specifically, the Board found claims 48 and 49 unpatentable for the same reasons as claim 46, but claims 48 and 49 contained a limitation not recited by claim 46.
The court rejected Pfizer’s final argument that the standards for director review were not the lawful product of notice-and-comment rule making but were instead posted on a Q&A portion of the Office’s website and were changed multiple times. The court reasoned that, even if director review standards needed to be subject to notice and comment, Pfizer’s challenge failed because it had not shown any prejudice resulting from such an APA violation.
This article appeared in the 2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions report.
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