Genentech’s antibody purification claims correctly found anticipated or obviousness in IPR, Fed. Cir. decides

Genentech, Inc. v. Hospira, Inc. (United States, Intervenor)

Docket Nos. 2018-1933 (IPR2016-01837)
January 10, 2020

Brief Summary: Board’s IPR anticipation and obviousness findings affirmed.

Summary: Genentech appealed PTAB (“Board”) IPR final written decision (FWD) finding certain claims of US 7,807,799 directed to methods of purifying antibodies (“a protein which comprises CH2/CH3 region”) using “protein A affinity chromatography at a temperature in the range of from about 10oC to about 18oC” unpatentable as anticipated or obvious. The FC panel explained that prior art WO ‘389 (an alleged anticipatory reference) teaches use of temperature range of “room temperature (18-25oC)”, which “overlaps with the claimed range…regardless of the construction of ‘about 18oC’”, and that “[a] prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range” (Ineos, FC 2015). Once an overlapping range has been established, the FC panel wrote, the patentee must “establish[] that the claimed range is critical to the operability of the claimed invention” to overcome anticipation (Ineos; DuPont, FC 2018; Galderma, FC 2013), but Genentech did not argue this point. Genentech argued WO ‘389 “refers only to the temperature of the laboratory where each step was performed, and not to the temperature of the [cell culture] composition applied to the chromatography column” (e.g., “WO ‘389 discloses some ‘steps’ being carried out where the composition was cold or frozen”, expert testimony regarding cell culture being carried out at 37oC and no instructions in WO ‘389 to allow it to cool to RT). The FC concluded that substantial evidence supports the Board’s conclusion that WO ‘389 properly discloses the claimed temperature range (Board can “give more credibility to [one expert’s] testimony over [another’s]” (Yorkey, FC 2010); “missing limitation” reasonably understood or inferred (CRFD, FC 2017; Akamai, FC 2003; Genetech cited Nidec Motor, FC 2017 (Board cannot “fill in missing limitations simply because a skilled artisan would immediately envision them”)). On obviousness, the FC panel explained that “even a slight overlap in range establishes a prima facie case of obviousness…which the patentee may rebut…by showing ‘that there is something special or critical about the claimed range” (In re Peterson, FC 2003) or “by showing that a process parameter…was not recognized as ‘result-effective’” (DuPont, FC 2018; In re Antonie, CCPA 1977 (show “evidence…that the prior art recognized that [that] particular parameter affected the result”); In re Applied Materials, FC 2012 (“not inventive to discover the optimum or workable ranges by routine experimentation”)). Genentech’s arguments related to use of the claimed methods in “large-scale, industrial processes” but the Board was unpersuaded, and the FC panel found the Board’s conclusions to be supported by substantial evidence (e.g., “routine experimentation to explore the temperature dependence of protein A leaching”, “no evidence” a “presentation was selected due to the claimed method”). The FC panel also rejected Genetech’s “constitutional challenge” since the IPR was carried out “on grounds that were available…when the patent was issued and under the same burden of proof”. Judge Newman’s dissent argued the decision was based on hindsight (e.g., “experts on both sides agreed that the solution presented in the ‘799 patent was new to them”; Nidec, FC 2017; King, FC 2010 (anticipation only where “expressly or inherently” disclosed)).

This entry was posted in Anticipation (35 USC 102), Inherency, Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations), Uncategorized. Bookmark the permalink.

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