The Federal Circuit recently provided guidance on the role of institution decisions and differences in the scope of institution decisions and final written decisions. Genzyme Therapeutic Products Limited Partnership v. Biomarin Pharmaceutical Inc., Appeal Nos. 2015-1720 and 2015-1721 (Fed. Cir. June 14, 2016).
The Patent Trial and Appeal Board found that various claims of U.S. Patent Nos. 7,351,410 ("the '410 patent") and 7,655,226 ("the '226 patent") are unpatentable on the ground of obviousness in inter partes review proceedings. IPR2013-00534 and IPR2013-00537. Patent Owner, Genzyme, appealed the Board's decisions.
Before the Federal Circuit, Patent Owner argued that in rendering the final written decisions, the Board relied on "facts and legal arguments" that were not set forth in the institution decisions. Therefore, Patent Owner argued that the Board violated the requirements of notice and an opportunity to respond found in the Administrative Procedure Act ("APA"). The Federal Circuit disagreed with the Patent Owner's arguments because the Board's final written decisions were based on the same combinations of references that were set forth in its institution decisions.
The Federal Circuit noted that the principal thrust of Patent Owner's APA challenge is the Board's reliance on references in the final written decisions that were not specifically included in the combinations of prior art in the Board's institution decisions. In response to Patent Owner's arguments that clinical trials could not have been conducted with a reasonable likelihood of success at the time of the priority date of the patents in suit, the Board relied on two references as support for its findings as to the state of the art regarding the in vivo studies. Patent Owner particularly objected to the Board's citations in the final written decisions of these two references as these references were not included in the grounds of rejection presented by Petitioner and adopted by the Board in the institution decision. However, the two references were discussed in an inter partes review petition filed by Petitioner, Patent Owner's response, Petitioner's reply and at the oral hearing.
The Federal Circuit noted that "the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings and, as long as the opposing party is given notice of the evidence and an opportunity to respond to it, the introduction of such evidence is perfectly permissible under the APA." The Federal Circuit observed that "[t]his court has made clear that the Board may consider a prior art reference to show the state of the art at the time of the invention, regardless of whether that reference was cited in the Board's institution decision" (citing Ariosa Diagnosticis v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015)). Then, the Federal Circuit clarified the role of the institution decision in inter partes review proceedings before the Board. The Federal Circuit held that "[t]here is no requirement, either in the Board's regulations, in the APA, or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise in the course of the trial." The Federal Circuit further noted that "it is hardly surprising that the Board cannot predict all the legal or factual questions that the parties may raise during the litigation."
Then, the Federal Circuit considered whether Patent Owner received "adequate notice of the issues that would be considered, and ultimately resolved, at that hearing." The Federal Circuit found that from the record as a whole, Patent Owner had actual notice of the issues and an opportunity to respond to them as Patent Owner took advantage of the opportunity by arguing that those references could be used only for limited purposes.
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