In a recent Federal Circuit case, Supernus Pharmaceuticals, Inc. v. Iancu, No. 2017-1357 (Federal Circuit, January 23, 2019), the USPTO’s calculation of Applicant delay in the determination of Patent Term Adjustment was found to be inconsistent with statute.

In the 1990s, the patent term for United States utility patents was changed from 17 years from the date of patent issue to twenty years from the filing date, or the filing date of the earliest non-provisional application in the priority claim, for applications filed on or after June 8, 1995.  In order to account for delays during prosecution of the application, Congress also passed a statute, 35 U.S.C. § 154, providing for patent term adjustment for various delays by the United States Patent and Trademark Office (USPTO), but also allowing for reductions for Applicant delay.  The USPTO has promulgated regulations to implement the statute.

According to the Federal Circuit, the USPTO’s determination of Applicant delay for “late filing” of an Information Disclosure Statement is inconsistent with the statute.

The patent at issue was assigned to Supernus, who filed a Request for Continued Examination (RCE) on February 22, 2011.  About 18 months later, on August 21, 2012, the European Patent Office notified Supernus’s European counsel of the filing of an Opposition in the corresponding European application, and on September 11, 2012, Supernus received notice of the Opposition from European counsel.  Subsequently, on November 29, 2012, Supernus filed an Information Disclosure Statement (IDS) to notify the USPTO of the Opposition and the documents cited therein.  The next Office Action after the RCE was mailed on September 10, 2013.  Eventually, U.S. Patent No. 8,747,891 was granted and 1260 days of Patent Term Adjustment were awarded.

The Patent Term Adjustment was calculated as the number of days of delay attributed to the USPTO reduced by 886 days of Applicant delay.

Of these 886 days of Applicant delay, 646 days were due to the filing of the IDS on November 29, 2012.  According to regulations, specifically 37 C.F.R. § 1.704(c)(8), the filing of a supplemental reply or other paper after a reply has been filed, unless expressly requested by the Examiner, is Applicant delay.  The Applicant delay is calculated starting the day after the reply was filed and end on the day of filing the supplemental reply or other paper.  Therefore, the delay for filing the IDS was calculated from the day after the filing of the Request for Continued Examination, February 23, 2012, and to the day of filing the IDS on November 29, 2012.

Supernus requested reconsideration of the Patent Term Adjustment, and specifically, the USPTO’s calculation of Applicant delay, and appealed the decision in the U.S. District Court for the Eastern District of Virginia, which upheld the USPTO’s calculation.  The Federal Circuit found that the USPTO had exceeded its authority as provided by the statute, 35 § 154(b)(2)(C)(i).  The Federal Circuit noted that the plain language of 35 § 154(b)(2)(C)(i) states that in calculating the period of patent term adjustment, the time “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.”  35 § 154(b)(2)(C)(i) (emphasis added in the decision).  The Federal Circuit found that the time period from the filing of the RCE, February 22, 2011, up until the European Patent Office notified Supernus’s European counsel of the Opposition, August 21, 2012, was a time period in which Supernus could not have engaged in any efforts to conclude prosecution.  The Federal Circuit found that the “USPTO cannot count as applicant delay any period of time during which there were no efforts in which the applicant could have engaged to conclude prosecution of the patent.” (slip op. 16, citations omitted).  The Federal Circuit remanded the case.

The Federal Circuit distinguished the facts from an earlier case dealing with 37 C.F.R. § 1.704(c)(8), Gilead Sciences, Inc. v. Lee, 778 F. 3d 1341 (Fed. Cir. 2015).  Gilead had filed an IDS after filing a response to a restriction requirement and, upon issuance of the patent, challenged the USPTO’s determination of Applicant delay for late filing of the IDS.  Gilead argued that there was no actual delay in the prosecution.  However, the IDS cited two copending Gilead patent applications, and Gilead could have filed the IDS earlier.  The Federal Circuit upheld the application of 37 C.F.R. § 1.704(c)(8) in Gilead, but the Gilead case is distinguishable because it dealt with the delay in filing an IDS for references known at the time of filing the initial reply.

The USPTO does provide a “safe harbor” provision, 37 C.F.R. § 1.704(d), allowing one to file an IDS to cite a communication from a foreign patent office and/or references first cited in a communication from a foreign patent office in a counterpart foreign application.  The safe harbor provision of 37 C.F.R. § 1.704(d) was mentioned in the background of the Supernus decision, and the Court noted that Supernus did not utilize the procedure.  Nevertheless, the Federal Circuit found that the USPTO had exceeded the authority of the statute.

In summary, any delay attributed to the Applicant for the filing of an IDS should be reviewed to determine if the additional Patent Term Adjustment could be obtained.