[co-author: Ben Baek]*

On November 16, 2023, USPTO Director Kathi Vidal ordered a Delegated Rehearing Panel (“DRP”) to review whether the PTAB misapprehended or overlooked certain issues when denying challenger SynAffix B.V.’s petition for inter partes review. The Director’s order states the DPR is to make its decision whether to grant rehearing independently and without direction from her. This is only the second time Director Vidal has delegated director review proceedings to a DRP, the first time being on November 7 earlier this year.

SynAffix filed its challenge against Hanzhou DAC Biotech Co., Ltd. (“DAC”) in February, alleging that claims of DAC’s patent, which is directed to protein-drug conjugates for targeted delivery of drugs to specific cells, are invalid as obvious and anticipated. The two biotech companies are rivals in antibody-drug conjugates, therapeutic agents often used in cancer research and treatment to specifically target cancer tissue while limiting collateral damage to healthy tissue. In its decision denying institution of inter partes review, the PTAB panel found that SynAffix’s petition failed to establish a reasonable likelihood of success on the merits.

The option for the Director to delegate director review proceedings to a DRP began with the Revised Interim Director Review Process, enacted on July 24, 2023 after the Supreme Court’s United States v. Arthrex holding. The DRP may be selected from a pool of the Chief Judge, Deputy Chief Judge, Vice Chief Judges, and Senior Lead Judges, excluding the judges who served on the original PTAB panel for the case under review or otherwise have a conflict with the case. The DRP must make its decisions independently and without direction from the Director, unless that direction is specifically stated in a Director order. Consistent with Arthrex, the Director retains the authority to review any DRP decision on sua sponte Director Review, but the parties are not permitted to request Director Review of a DRP decision or remand to the PTAB.

While the ultimate outcome of this particular Institution Decision remains uncertain, the Director has now shown continued willingness to utilize the DRP process. This willingness coupled with the recent appointment of “director review executive” Thomas Krause may give parties greater opportunity to seek Director reconsideration of PTAB decisions.

*Law Clerk