Federal Circuit Decision on Gilead Sciences, Inc. v. Lee

March 3, 2015

On February 26, 2015, in Gilead Sciences, Inc. v. Lee, the Federal Circuit upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute as permitting the USPTO to charge “Applicant Delay” when an Information Disclosure Statement (IDS) is filed after a response to a Restriction Requirement has been filed.

During prosecution, Gilead filed a response to a Restriction Requirement, and then filed an IDS. Thereafter, the Examiner issued a first Office Action on the merits.  The USPTO considered the IDS filed after the response to the Restriction as a “supplemental or other paper” under 37 C.F.R. § 1.704(c)(8), which created Applicant delay from the date the response was filed to the date the IDS was filed.  In this case, Applicant was charged with 57 days of delay.

Gilead argued that filing the IDS did not actually cause any delay in processing or examination, and that the rule violated the Administrative Procedure Act (APA).  However, the Federal Circuit found that the USPTO’s rule is acceptable.  The Federal Circuit held that “Congress intended to sanction not only applicant conduct or behavior that result[s] in actual delay, but also those having the potential to result in delay irrespective of whether such delay actually occurred.”  The court found that filing an IDS after a response to a Restriction Requirement has the potential of creating examination delays, such as, delaying the examination of other applications on the Examiner’s docket.  Therefore, the USPTO’s rule is not in violation of the APA.

Gilead Sciences, Inc. v. Lee is available at:  http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1159.Opinion.2-24-2015.1.PDF

The Federal Circuit’s decision is not surprising.  However, it is an important reminder for applicants to carefully consider when to file an IDS after a response has been filed in order to avoid Applicant delay.  For example, under 37 C.F.R. § 1.704(d), filing an IDS after a response has been filed will not be considered Applicant delay, if Applicant certifies that the IDS is being filed within 30 days of receipt of an Office Action in a counterpart foreign application or  copending U.S application.  Alternatively, in Gilead’s case, it might have been better to file the IDS with a response to the first Office Action on the merits, along with the payment of a $180 PTO fee.  However, delaying the IDS filing could have been problematic, because a Notice of Allowance could have issued as the first Office Action, and then Gilead would have been required to file the IDS with a request for continued examination (RCE). 

The 37 C.F.R. § 1.704(d) certification is available at:  http://www.uspto.gov/web/offices/pac/mpep/mpep-9020-appx-r.html#eff_20130401_d0e331597