by Dennis Crouch
Prior to 1995, the U.S. measured patent term very simply – a patent was in force for 17 years after issuance so long as the appropriate maintenance fees were paid. Now, the U.S. has transitioned to a base term of 20-years from the filing date. With an average application pendency of about three-years, that transition has been seen as largely term-neutral. However, Congress also created the patent term adjustment (PTA) system to increase the post-issuance term where USPTO delays have eaten-up too much of the 20-years. A major problem with the PTA statute is that it is poorly drafted – leading to major gaps and ambiguities.
For most patentees, an extra month added to a patent set to expire 15 years from now is relatively worthless. However, there exists a subset of patentees that have good reasons to believe that the extra month may be worth millions of dollars (typically pharma).
In Gilead v. Michelle Lee (Fed. Cir. 2015), the fight focused on whether a “late” submission of an information disclosure statement (IDS) should count against the applicant’s PTA. In its unanimous decision, the Federal Circuit affirmed the lower court holding that the PTO’s interpretation of the statute was reasonable and thus enforceable.
The relevant timeline in the case is as follows:
- February 22 2008: Gilead files its application.
- November 18 2009: USPTO mails a restriction requirement.
- February 18 2010: Gilead files a responsive election.
- April 16 2010: 57-days later, Gilead files a supplemental IDS.
- July 29 2011: USPTO mails its notice of allowance.
- April 3, 2012: Application issues as U.S. Patent No. 8,148,374.
The particular fight is whether that 57-days between its responsive-election and IDS filing should be counted against Gilead.
35 U.S.C. § 154(b)(2)(C) indicates 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 also gives the USPTO 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 an application.” Taking on that role, the USPTO created did establish a rule that such a failure includes the “submission of a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the examiner, after a reply has been filed.” 37 C.F.R. § 1.704(c)(8)
The IDS filing appears to squarely fall within the rule as written by the USPTO and Gilead’s challenge here is that the rule itself invalid as arbitrary and capricious. In particular, Gilead argues that there is no indication whatsoever that the IDS filing led to any delays in prosecution.
In rejecting Gilead’s appeal, the Federal Circuit found: (1) the statute does not particularly address the IDS question but does give the USPTO authority to fill-the-gaps; and (2) the USPTO’s approach of creating an across-the-board rule is reasonable and certainly not arbitrary-and-capricious even though an applicant’s action may not have caused delay in the particular case at issue. In this second-step of the analysis, the USPTO’s decision-making is given wide deference so that courts regularly affirm the applicability of rules that – in the view of the court – are sub-optimal.
Holding: Gilead does not get its extra 57 days of patent term.
Practice Tip: Before filing an office action (OA) response, take a few minutes to consider whether there are any supplemental IDS filings that should be included. Otherwise, you may lose patent term.
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I should note that I avoided the genuine complexity of the PTA statute in the post above. If you really want to understand the statute then you’ll need at least an hour and several pieces of scratch paper.