The US Court of Appeals for the Federal Circuit found that the US Patent and Trademark Office (PTO) erred in calculating a patent term adjustment (PTA) for a patent covering an oral osmotic form of an antihypertensive drug, stating that the PTO failed to properly consider whether the applicant reasonably engaged in efforts to conclude prosecution. Supernus Pharmaceuticals, Inc. v. Iancu, Case No. 17-1357 (Fed. Cir. Jan. 23, 2019) (Reyna, J).

Supernus Pharmaceuticals filed a US patent application and an international application under the Patent Cooperation Treaty. The international application ultimately resulted in a European patent (EP). In the US case, a final office action issued on August 20, 2010, and Supernus filed a reply with a request for continued examination (RCE) on February 22, 2011.

On August 21, 2012, the European Patent Office notified Supernus that Sandoz had filed an opposition against the EP. Documents related to the opposition were forwarded to Supernus on September 11, 2012, and Supernus submitted the documents to the PTO on November 29, 2012. On September 10, 2013, the PTO entered Sandoz’s opposition and issued a first office action against the RCE. The US application issued on June 10, 2014, and reflected a PTA of 1,260 days beyond the 20-year patent term.

In calculating the PTA, the PTO assessed 886 days of applicant delay, of which 646 days were attributed to the time between the filing of the RCE and the information disclosure statememt (IDS). Supernus requested reconsideration, asserting that the period between the RCE and the European Patent Office notice (546 days) could not have been attributed as its delay. The PTO rejected reconsideration, and Supernus appealed to the US district court. On appeal, the district court granted summary judgment in favor of the PTO, finding that the calculation was not erroneous and that the Federal Circuit’s 2015 decision in Gilead Sciences, Inc. v. Lee foreclosed Supernus’s argument that 37 CFR § 1.704(c)(8), which governs patent term adjustment based on the filing of a supplemental reply, is arbitrary, capricious and otherwise contrary to the PTA statute, as a matter of law. Supernus appealed to the Federal Circuit.

The Federal Circuit reversed, explaining that Gilead was not controlling as it involved different facts and a different legal question. Unlike Gilead, “there were no efforts in which [Supernus] could have engaged to conclude prosecution” of the RCE because the European opposition was not in existence during the entire period of the calculated delay.

Turning to the PTO’s interpretation of the PTA statute, the Court declined to give Chevron deference to the PTO, finding that the plain terms of 35 USC § 154(b)(2)(C)(i) directly addressed the question of whether the PTO may reduce PTA by a period that exceeds the time during which Supernus failed to engage in reasonable efforts to conclude prosecution. The Court found that the two limitations imposed by the statute were that (1) the delays attributable to Supernus must “be equal” to the time period in which it failed to reasonably engage in efforts to prosecute, and (2) the PTA reduction must be tied to the time period “during which” it failed to reasonably engage in prosecution. The Court found that the PTA reduction by the PTO was inconsistent with the plain meaning of the statute, and reversed and remanded the district court’s summary judgment order.