In a February 23, 2015 final written decision following an inter partes review, the PTAB determined that a claim relating to enzyme-replacement therapy for patients with Pompe disease was unpatentable. The challenged claim, which was the sole claim in the Genzyme Therapeutic Products patent, recited a method for treating Pompe disease comprising the intravenous administration of human GAA enzyme on a biweekly basis. The board found that the prior art disclosed intravenous administration of GAA for patients with Pompe disease, but did not expressly disclose the “biweekly” limitation. According to the board, the “key question” in the obviousness analysis was “whether the biweekly administration of GAA to a patient with Pompe disease was nothing more than the result of routine optimization that would have been obvious to one of ordinary skill in the art.” The board reasoned that the only thing that remained to be achieved over the prior art was calculating the biweekly dosing schedule for the administration of GAA. Because the execution of clinical trials to arrive at the appropriate dosage regimen would be “routine” to a person of ordinary skill in the art, the board determined that the claim was obvious, absent objective evidence of nonobviousness.

After reaching the same conclusion under a second, similar ground asserted by the petitioner, the board reviewed the patent owner’s objective evidence of nonobviousness, and concluded that it failed to show that the claim was not obvious. The board observed that, for such evidence to have merit, there must be a nexus between the objective evidence and a “novel element in the claim,” as opposed to something in the prior art. The only novel element of the challenged claim, according to the patent owner, was the biweekly dosing schedule. Because none of the objective evidence presented by the patent owner was tied to the dosing schedule, the board concluded that it failed to show that the challenged claim was not obvious.

BioMarin Pharm. Inc. v. Genzyme Therapeutic Prods. LP, Case IPR2013-00534 (PTAB Feb. 23, 2015).