Celgene Corp. v. Laura A. Peter (USPTO)
Docket No. 2018-1167, -1168, -1169, -1171 (IPR2015-01096, -01102, -01103, -01092)
TARANTO, MAYER, CHEN
July 30, 2019
Brief Summary: Board obviousness determinations of Celgene’s thalidomide administration-related claims affirmed; arguments that IPRs are unconstitutional for pre-AIA patents rejected.
Summary: Celgene appealed Board IPR decisions finding its thalidomide administration-related claims (e.g., “method for delivering a teratogenic drug…while avoiding the delivery of said drug to a [fetus]”; US 6,045,501 and US 6,315,720) invalid for obviousness, but also regarding the constitutionality of “the retroactive application of IPR proceedings to pre-AIA patents”. The Coalition for Affordable Drugs filed the IPRs. The FC panel reviewed the Board’s claim construction under the broadest reasonable interpretation de novo (BRI; note the new Phillips standard came into effect on Nov. 13, 2018, after these IPR petitions were filed). Celgene argued that its ‘501 claims require “a centralized computer readable storage medium” but the Board disagreed, as did the FC panel (e.g., “Neither the claims themselves, the specification, nor the prosecution history necessitate…a departure” from “the general rule that ‘a’ or ‘an’ means more than one” (“the use of ‘a’ or ‘an’ in an open-ended ‘comprising claim connotes ‘one or more’”); “the Board was correct to not allow the extrinsic evidence, including expert testimony, to ‘trump the persuasiveness intrinsic evidence in this case’”). The FC panel also agreed with the Board’s conclusion of obviousness of the ‘501 claims (e.g., “it would have been obvious in light of the prior art to counsel male patients about the risks of fetal exposure”) and that the secondary consideration evidence “do not outweigh the showing of obviousness” (e.g., no “long-felt but unsolved need” since “Celgene failed to establish…that the prior art methods of controlling…distribution…were insufficient”; In re NTP (FC 2011) (“[t]his court does not reweigh evidence [fact findings] on appeal”, “substantial evidence”); “no conflict between finding a motivation to improve the safety of existing systems even though the existing systems were mostly successful” (Spectrum, FC 2015)). The FC panel also agreed with the Board’s determination that the ‘720 claims were invalid for obviousness (e.g., “The desire to decrease the risks…is a specific motivation to improve the prior art.” (Tokai, FC 2011; Hologic, FC 2019)).
Regarding the constitutional issue, the FC panel found that “the retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment”, based in large part on the “significant similarities between IPRs and their reexamination predecessors” (e.g., “IPRs do not differ sufficiently from the PTO reconsideration avenues available when the patents here were issued” and “serve essentially the same purpose”; In re Baxter, FC 2012 (“In PTO reexaminations, ‘the standard of proof [is] a preponderance of the evidence.”); In re CSB-Sys., FC 2016 (“During reexamination proceedings of unexpired patents…the Board uses the” BRI (applied in this case due to the timing of the filings)); Return Mail, US 2019 (“ex parte reexaminations and IPRs as different forms of the same thing-reeexamination”); Patlex, FC 1985 (“section  presumption [of validity]” not “a property right subject to protection of the Constitution”)). Thus, Celgene’s constitutional challenge was rejected.