What exactly is the standard for institution of an IPR? A recent institution decision shows the Board is not in agreement.
A recent decision by the PTAB denying institution of an IPR shows that disagreements exist within the PTAB over the precise standard that must be met for institution. The IPR (Case No. IPR2017-01166) filed by Pfizer challenged U.S. Patent No. 8,329,172 (“the ‘172 Patent”) owned by Biogen. Biogen’s Rituxan® (rituximab) is indicated for treating low-grade non-Hodgkin’s lymphoma. The ‘172 Patent is directed to a method of treating low grade non-Hodgkin’s lymphoma through CVP (cyclophosphamide, vincristine, and prednisone) chemotherapty in combination with rituximab maintenance therapy.
Pfizer relied an early version of the Rituxan® label as one of its primary prior-art references. The Board denied institution because it found that Pfizer failed to show in its petition that the Rituxan® law was prior art. Rather, the Board cited to earlier IPR precedent holding that a petitioner is required to make a threshold showing that a prior-art reference was publicly-accessible as a printed publication prior to the effective filing date. Among other deficiencies, the Board pointed out there was no affirmative evidence that the label was available prior to the critical date. Rather, Pfizer relied upon circumstantial evidence to suggest the label was probably publicly-available prior to the critical date. For instance, Pfizer showed that the FDA’s website today suggests the label was available prior to the critical date. Pfizer also showed that a webpage from before the critical date included nearly identical information as the label itself. Pfizer relied upon this, and other circumstantial evidence, to show that the Rituxan® label most likely preceded the critical date. The Board disagreed and denied the petition.
Yet, the decision denying institution included a dissent. Technically, the dissent did not disagree with the Board’s conclusions regarding the Pfizer’s deficient proof to affirmatively estalish the date the label was first publicly accessible. Yet, by the same token, the dissent pointed out that none of the evidence submitted by the patent owner, Biogen, indicated that the label was affirmatively dated after the patent’s filing date. Further, the dissent suggested that Biogen was likely in a unique position to know the actual date when the label was first publicly accessible. The dissent argued that the petitioner should have the opportunity to adduce that evidence at trial. The dissent concluded that the evidence, when viewed cumulatively, and as a whole, suggests that the standard for meeting institution was satisfied, namely, it is reasonably likely that Pfizer will be able to prove, by the end of the proceeding, that the prior-art Rituxan® label was publicly accessible prior to the patent’s filing date.
The back and forth between the majority and the dissent illustrate a clear tension over the standard for instituting an IPR. The majority emphasized that, under 35 U.S.C. § 314(a), the Board can only institute based upon information disclosed in the petition and any replies. Institution cannot be predicated upon information that the petitioner might be able to adduce later on at trial.
By contrast, the dissent essentially argued that where the cumulative evidence strongly indicates that it is more than likely that the label was publicly-accessible prior to the critical date, then that conclusion would be based upon evidence disclosed in the petition. This is especially so, where the patent owner, who is in a unique position to know the actual date, has failed provide evidence of a different date.
The question is a good one: while Biogen sufficiently attacked the Pfizer’s evidence purporting to establish the date when the Ritaxun® label was first publicly-accessible, Biogen did not affirmatively establish that the actual date was after the critical date. Surely, Biogen knows when the label was first publicly-accessible. While the date when a document is first publicly accessible should, in theory, itself be a matter of publicly-available information, is that always the case? What if Biogen does have non-public information that would resolve this factual inquiry? Should it be allowed to hide behind that information? Even if policy dictates that patent owners should not be allowed to hide behind information pertinent to patentability, which would presumably be the policy behind inequitable conduct, is that nonetheless consistent with § 314(a)?
These are interesting questions, and important ones, because they go right to the heart of the precise contours of a petitioner’s burden for instituting a petition for inter partes review. Indeed, this case illustrates that these questions, along with a more precise interpretation of § 314(a), would be ripe for resolution by appellate review. Yet, because the Patent Office previously argued, and the Supreme Court held, that a denied institution cannot be appealed, these questions will not necessarily be resolved any time soon. See Cuozzo Speed Techs. v. Lee, 136 S. Ct. 2131 (2016). Consequently, the public will not gain the benefit of developing that rigor of jurisprudence that typically sows up procedural ambiguities, such as these, and makes both the law and the outcome of litigious disputes more predictive.