The Federal Circuit affirmed PTAB’s decisions in two IPR proceedings that found the claims of two patents to be invalid as being obvious.

Biomarin requested an IPR on Genzyme’s two patents, US 7,351,410 and 7,655,226, directed to methods for treating Pompe's disease on obviousness grounds. In its response, Genzyme argued that Biomarin failed to cite any reference that disclosed the results of in vivo tests in humans or animals. Biomarin then asserted two references that disclosed in vivo tests. Citing those two references in its final decision, the Board found the claims to be obvious and hence invalid. Genzyme appealed the Board’s decisions.

On appeal, the Federal Circuit rejected each of the four arguments put forth by Genzyme. First, the Federal Circuit rejected Genzyme’s procedural challenge that the Board violated the “requirements of notice and opportunity to respond found in the Administrative Procedure Act (“APA”) by relying on “facts and legal arguments” that were not present in the institution decisions. More specifically, Genzyme argued that the Board erred by citing references in its final decision that were not specifically included in the combinations of prior art that served as the basis for the institution decision. While the Federal Circuit acknowledged that the APA imposes certain procedural requirements in IPR proceedings, it held that there is “no requirement for the institution decision to anticipate and set forth every legal and factual issue that might arise in the course of the trial.”  The Federal Circuit reasoned that the development of evidence in the course of the proceeding is in keeping with the adversarial nature of the IPR proceeding,” and accordingly, “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.” The Federal Circuit noted that Genzyme could not argue that it lacked notice, considering that Genzyme itself raised the issue of in vivo tests, and did not seek to exclude Biomarin’s evidence related to in vivo tests.

Second, the Federal Circuit rejected Genzyme argument that the Board had changed its construction of the “whereby” clause between institution of the IPRs and the final decisions.  The court  found that the Board had construed the clause the same way throughout the proceedings.

Third, the Federal Circuit rejected Genzyme’s assertion that the Board erred by not making an explicit finding as to the level of skill of a person skilled in the art, as it ruled that the Board’s failure to do so was not reversible error.

Lastly, in light of Biomarin’s expert testimony, the Federal Circuit also rejected Genzyme’s fourth argument that the Board’s determination of a likelihood of success from the combination of the prior art references was not supported by substantial evidence.  

Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm. Inc., Case Nos. 2015-1720, -1721 (June 14, 2016); Opinion by: Bryson, joined by Moore and Reyna; Appealed From: United States Patent and Trademark Office, Patent Trial and Appeal Board.  Read the full opinion here.

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