June 22, 2016

Federal Circuit Weighs in on Propriety of New Evidence Adduced During IPR Trial

By Gregory S. DeLassus, Associate

In Genzyme Therapeutics v. Biomarin Pharma., the Federal Circuit considered what sort of notice and opportunity to be heard in an IPR will satisfy the Administrative Procedure Act (“APA,” 5 U.S.C. § 554(b) & (c)). Genzyme owns US 7,351,410 and US 7,655,226, which both concern methods of treating Pompe’s disease. When Biomarin petitioned for IPR of these two patents, Genzyme submitted a patent-owner statement arguing that the in vitro data in Biomarin’s petition were not sufficient to establish a reasonable expectation of success for the claimed methods, and therefore could not show that the challenged claims were more likely than not to be obvious.

The Board instituted IPR on both patents, despite Genzyme’s arguments about the insufficiency of in vitro data. In its petitioner response, Biomarin responded to Genzyme’s arguments about in vitro data by citing additional references that included in vivo data. Instead of arguing that these additional references do not establish a reasonable expectation of success, Genzyme pressed a procedural point, arguing that it was improper for the Board to consider references that were not included in the grounds of institution for each IPR trial. When the Board disagreed with Genzyme’s argument and relied on two of the in vivo references in its final written decision of unpatentability, Genzyme appealed this point to the Federal Circuit.

Judge Bryson wrote for a unanimous panel that also included Judges Moore and Reyna. The court disagreed with Genzyme’s argument in the strongest possible terms. The Federal Circuit noted that IPRs are trials, and that it is expected that additional evidence will come to light during the course of a trial. The Federal Circuit strongly disagreed with the idea that the Board is constrained to consider only those references that are cited in the institution decision. Indeed, the court noted that it had previously reversed the PTAB for refusing to consider a reference on the same grounds that Genzyme was urging here. Ariosa Diagnostics v. Verinata Health, 805 F.3d 1359, 1365 (Fed. Cir. 2015).

Rather, drawing on D.C. Circuit precedents, the court held that the APA is satisfied so long as the patentee has reasonable notice of the argument being advanced for unpatentability, and an adequate chance to respond. Here Genzyme was on notice of Biomarin’s reliance on the in vivo data from at least the point of Biomarin’s response brief. Also, during oral argument the PTAB questioned Genzyme extensively about several of the in vivo references. Genzyme could have moved under 37 C.F.R. § 42.64(c) to exclude the challenged references, but it did not. Therefore, the Federal Circuit held that Genzyme had been afforded adequate notice and opportunity to respond under the APA.

The Federal Circuit affirmed the PTAB’s holding of unpatentability for the challenged claims.