Genzyme Therapeutic Products v. BioMarin Pharmaceutical – CAFC Affirms PTAB Decision Invalidating Claims in Two BioPharma Patents

BSKB is pleased to announce that on June 14, 2016, in a precedential decision, the Court of Appeals for the Federal Circuit (CAFC) affirmed two decisions by the Patent Trial and Appeal Board (PTAB), which held that all challenged claims in two biopharma patents were obvious over the prior art. BSKB attorneys Gerald M. Murphy, Jr., MaryAnne Armstrong, Ph.D., Eugene Perez and Lynde Herzbach represented BioMarin before the PTAB and at the CAFC.

One of the important issues addressed by the CAFC was the type of evidence that the PTAB can rely on in a Final Written Decision. Genzyme (the patent owner) argued that the PTAB could only rely on references that were actually discussed in the Institution Decision as being relevant to an instituted ground and the PTAB could not rely on other references, discussed in the Petition, that were part of non-adopted “redundant” grounds. Genzyme argued that it did not have notice that certain references might be relied on in the Final Written Decision and, therefore, was deprived of due process. Relying heavily on the Administrative Procedure Act (APA), the court noted that the PTAB did not change theories mid-stream and that at the stage of the Institution Decision, the “Board cannot predict all the legal or factual questions that the parties may raise during the litigation”. Thus, in a Final Written Decision, the PTAB can rely on various references, including “redundant” references, to explain the state of the art and to support its decision.

A link to the decision can be found here.