Federal Circuit Affirms PTAB’s Decision Invalidating Genzyme Patents

Yesterday, the Federal Circuit issued a final decision in Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720 case affirming two PTAB IPR final decisions invalidating as obvious the claims of U.S. Patent Nos. 7,351,410 and 7,655,226, which are directed to the treatment of Pompe’s disease with injections of human acid α-glucosidase (GAA).

The PTAB had found that a prior art reference disclosed every claim limitation other than bi-weekly dosing, which the Board found would have been arrived at through routine optimization.  Although Genzyme argued that there would have been no reasonable expectation of success in the claimed dosing regimen, the Board found that as of the priority date, “all that remained to be achieved over the prior art was the determination that a specific dose within a previously suggested dose range, and its corresponding dosing schedule, would have been safe and effective for the treatment of human patients.”

On appeal, Genzyme challenged the PTAB decision on lack of notice grounds under the APA based on the Board’s citation of references not specifically cited among the prior art combinations that formed the basis for institution.  The Court rejected that challenge and held 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.”

Genzyme also challenged the PTAB decision on the grounds that the PTAB changed its construction of the “whereby” clauses between its institution decision and its final written decision and on the grounds that the clause should be construed to require reduction of glycogen in the skeletal system rather than elsewhere in the body.  The Court held that the Board’s construction did not substantially change and that the Board correctly construed the terms according to the broadest reasonable interpretation consistent with the specification.

Genzyme argued that the Board erred in not making an explicit finding of the level of skill of POSA in its obviousness analysis.  The Court held the failure to make the finding was not reversible error because the two parties asserted nearly identical standards with no meaningful differences.

Genzyme challenged the Board’s finding concerning likelihood of success was not supported by substantial evidence.  The Court found that Petitioner’s expert declaration provided sufficient evidence to support the Board’s finding based on the known half-life of GAA in the body and the known effect of GAA on glycogen levels.