Patent Term Adjustment Is Limited By Late Information Disclosure Statement (“IDS”)

In Gilead v. Michelle Lee (Fed. Cir. 2015), the Court affirmed that the United States Patent and Trademark Office (“USPTO”) has authority to fill gaps in rules regarding the patent term adjustment (“PTA”) system. Congress created the PTA system to increase the post-issuance term of a patent if the USPTO has delayed the patent protection for the 20-year term from the filing date.

Many scholars and patent applicants, along with Gilead, have voiced their opinion that the PTA statute is poorly drafted. However, the Federal Circuit reiterated courts’ wide deference of the USPTO’s decisions regardless if, in the view of the courts, the applicability of the rules is sub-optimal.

In Gilead, the applicant filed its information disclosure statement (“IDS”) 57 days after its responsive election and the issue was whether those 57 days should be counted against Gilead. 35 U.S.C. § 154(b)(2)(C) stated that “the period of adjustment … 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.” 

The statute gives the UPSTO authority to “prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of applications.

One of the rules that the USPTO created was a failure to submit “a supplemental reply or other papers, other than a supplemental reply or other paper requested by the examiner, after a reply has been filed.” 36 C.F.R. § 1.704(c)(8). The late IDS filing fell squarely within the rules. However, Gilead argued that the late filing did not lead to any delays in prosecution and therefore Gilead should still get the extra 57 days.

The Federal Circuit found that (i) the statute does not particularly address Gilead’s issue at hand but does give the USPTO authority to fill the gaps, and (ii) the no-exception rule by the USPTO was reasonable even though there was no delay in this particular case. 

Therefore, as a practice tip, practitioner and applicants need to consider supplemental IDS filings before filing an Office Action response in order to avoid losing patent term.