Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., et al.

The Director of the U.S. Patent and Trademark Office (acting through the Patent Trial and Appeals Board) has created a six-factor test known as the NHK-Fintiv Rule to determine whether to institute inter partes review in light of parallel infringement litigation pending in district court. Under NHKFintiv, the Board may deny a petition if it believes that the parallel litigation has may proceed too far for IPR to be of any efficient use. That is true even if the IPR petition is timely filed within one year of the petitioner being served with a patent-infringement complaint, 35 U.S.C. § 315(b), and otherwise complies with Congress’s express limitations related to co-pending litigation in other fora. The practical import of the NHK-Fintiv Rule is that it allows the Director to truncate the explicit time limit created by Congress. Indeed, the Board has wielded the NHK-Fintiv Rule to terminate scores of timely filed petitions since March 2020. Worse, this “rule” is not the product of a formal rulemaking, despite Congress’s command that the Director “prescribe regulations” setting forth the standards and rules governing the institution of IPR. 35 U.S.C. § 316(a). NHK-Fintiv is instead a creature of two precedential Board decisions from which it takes its name. It has never faced public comment, let alone judicial review. In this case, Petitioner appealed non-institution of its IPR petition under NHK-Fintiv because the rule exceeds the substantive and procedural limitations placed on the Director’s authority by Congress. Notwithstanding the general prohibition on appellate