Sorry Doc, no Patent Term Adjustment under the C-delay Provision!
| March 1, 2021
Steven C. Chudik vs., Andrew Hirshfeld (performing the functions & duties of the under Secretary of Commerce for IP and Director of the US.PTO).
February 8, 2021
Bryson, Hughes, and Taranto (author).
Summary:
i. Background:
Dr. Chudik filed his patent application before the USPTO on September 29, 2006.
After the issuance of a second rejection in 2010 “Dr. Chudik took a step that would turn out to have consequences for the patent term adjustment awarded under 35 U.S.C. § 154(b)” by requesting continued examination rather than “immediately taking an appeal to the Patent Trial and Appeal Board.”
Then in 2014, the Examiner again rejected the claims and Dr. Chudik appealed to the Board. As a result, the Examiner reopened prosecution and issued a subsequent office action rejecting the claims as unpatentable on a different ground.
Two more times Dr. Chudik appealed and each time the Examiner reopened prosecution and issued a new rejection.
In December 2017, while a fourth notice of appeal was pending, the Examiner withdrew several rejections; and after some claim amendments, the Examiner issued a Notice of Allowance in 2018. The application issued as a patent on May 15, 2018, eleven and a half years (11.5 yrs) after the patent application was originally filed.
Dr Chudick was given a patent term adjustment of 2,066 days under 35 U.S.C. § 154(b). The PTO rejected Dr. Chudik’s argument that “he was entitled to an additional 655 days, under 35 U.S.C. § 154(b)(1)(C)(iii) (C-delay), for the time his four notice of appeals were pending.
ii. Issues:
Is Dr. Chuick entitled to patent term adjustment under 35 U.S.C. § 154(b)(1)(C)(iii) (C-delay) for the time his four notice of appeals were pending, even though each time prosecution was reopened, and the case never proceeded to the Board?
iii. Holding
No, the CAFC agreed with the United States District Court for the Eastern District of Virginia in affirming that Dr. Chudick was not entitled to the additional PTA under the C-delay provision. Chudik v. Iancu, No. 1:19-cv-01163 (E.D. Va. March 25, 2020), ECF No. 33.
The C-delay provision covers delays due to “appellate review by the Patent Trial and Appeal Board or by a Federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability.” 35 U.S.C. § 154(b)(1)(C)(iii).
The District Court held and the CAFC affirmed that the provision does not apply here because the Examiner reopened prosecution after each Notice of Appeal and so (1) the Board did not review the patent at issue and thus “the Board’s jurisdiction over the appeal never attached,” and as a consequence “(2) there was no reversal of the rejection by the Board.”
Dr. Chudick “argued that [the] C-delay applies in situations of “appellate review,” which, he urged, refers to the entire process for review by the Board, beginning when a notice of appeal is filed.”
The District Court rejected this argument and the CAFC agreed holding that the statutory language for “appellate review” requires a “decision in the review reversing an adverse determination of patentability.” 35 U.S.C. § 154(b)(1)(C)(iii), and that language is both “reasonably” and “best interpreted” to require an actual “reversal decision made by the Board.” Consequently, the language excludes the “time spent on a path pursuing such a decision when, because of an examiner reopening of prosecution, no such decision is ever issued.”
The CAFC noted that “[W]hen adopting its 2012 regulations, the PTO explained that the limitations on C-delay adjustments… may be offset by an increased availability of B-delay adjustments.” However, for Dr. Chudik a B-delay increase fails to apply because rather than appealing his initial 2010 final rejection, a request for continued examination was filed and so the statutory exclusion was triggered. See 35 U.S.C. § 154(b)(1)(B)(i) (excluding “any time consumed by continued examination of the application requested by the applicant under [35 U.S.C. § 132(b)]”).
The CAFC concluded that “[T]he unavailability of B-delay for nearly two years (655 days) of delay in the PTO illustrates what applicants should understand when deciding whether to request a continued examination rather than take an immediate appeal. The potential benefit of immediate re-engagement with the examiner through such continued examination comes with a potential cost.”
Additional Note:
Congress set forth three broad categories of delay for which a patent may receive a patent term adjustment. See 35 U.S.C. § 154(b)(1)(A)–(C).
First, under § 154(b)(1)(A), a patent owner may seek an adjustment where the PTO fails to meet certain prescribed deadlines for its actions during prosecution.
Second, under § 154(b)(1)(B), adjustment is generally authorized for each day that the patent application’s pendency extends beyond three years (B-delay), subject to certain exclusions, such as for “time consumed by continued examination of the application requested by the applicant under section 132(b).”
Third, under § 154(b)(1)(C), a patent owner may seek an adjustment for “delays due to derivation proceedings, secrecy orders, and appeals,” including “appellate review by the [Board] . . . in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability” (C-delay).
Take-away:
- Where no new amendments and/or evidence is to be presented, carefully consider the balance between “[T]he potential benefit of immediate re-engagement with the examiner through such continued examination” and the “potential cost” thereof with respect to lost PTA under the B-delay exclusion.
- C-delay provision only applies when “the Board’s jurisdiction over the appeal” attaches and there is a reversal of the Examiner’s rejection.
Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices
| February 4, 2019
Supernus Pharmaceuticals, Inc. et al. v. Iancu
January 23, 2019
Before Reyna, Dyk, and Schall. Opinion by Reyna.
Summary:
The Federal Circuit held that the PTO’s reduction of the patent term for a Supernus patent due to applicant delay (of filing an information disclosure statement after filing an RCE) is not correct because there is nothing Supernus could have done during the period of time from the filing of an RCE and the receiving of a communication from a foreign patent office to conclude the prosecution of the application.
Details:
Patent Term Adjustment (PTA) statute of 1999: 35 U.S.C. §154(b)
- §154(b)(1)(A)-(C): delays caused by the PTO
- Type A delay: the PTO fails to provide a notification under 35 U.S.C. §132 or a Notice of Allowance within 14 months of filing date.
- Type B delay: the PTO fails to issue a patent after 3 years have passed between the filing date and the date of allowance.
- Type C delay: for delays that are excluded from Type B delay due to derivation proceedings, secrecy orders, or successful appeals.
- §154(b)(2): delays caused by applicants
Supernus Pharmaceuticals, Inc. is the owner and assignee of U.S. Patent 8,747,897 (“the ’897 patent”), and United Therapeutics Corp. is the exclusive licensee of the ’897 patent.
Relevant timelines:
- 4/27/06: Supernus filed U.S. application and international application claiming priority from the U.S. application (international application gave rise to EP application).
- 8/20/10: the PTO issued a final OA.
- 2/22/11: Supernus filed an RCE.
- 10/13/11: the EPO issued the EP application as EP patent.
- 8/21/12: the EPO notified Supernus’s European patent counsel that a Notice of Opposition was filed by Sandoz to the EP patent.
- 9/11/12: Supernus received a letter from its European patent counsel regarding the EPO notification.
- 11/29/12 (79 days later from 9/11/12 and 100 days from 8/21/12): Supernus filed a supplemental IDS citing the EPO notification.
- 9/10/13: the PTO issued a first OA responding to Supernus’s RCE.
- 1/10/14: Supernus filed a response.
- 2/4/14: the PTO issued a Notice of Allowance.
- 6/10/14: the U.S. application issued as the ’897 patent (PTA of 1,260 days).
PTO
The PTO attributed 2,321 days to the PTO delay (1,656 days for Type A delay and 665 days for Type B delay). The PTO reduced 2,321 days by 175 days to account for overlapping Type A and Type B delays and 886 days for applicant delay. Out of 886 days, 646 days were assessed for the 2/22/11 filing of the RCE and the 11/29/12 filing of the IDS.
PTA of 1,260 days = 2,321 days – 175 days – 886 days.
Supernus filed a request for Reconsideration of PTA because the deduction of 646 days was improper. The PTO rejected the request because citing Gilead, filing the IDS after filing of the RCE “interferes” with the PTO’s ability to process an application.
District Court
Supernus appealed to the U.S. District Court for the Eastern District of Virginia. The district court granted summary judgment in favor of the PTO because the PTO did not err in the PTA calculation for the ’897 patent.
Federal Circuit
First of all, the Federal Circuit held that Gilead did not apply in this case. In Gilead, the patent owner brought an action challenging the PTO’s assessment of a 57-day applicant delay in calculating PTA reduction based on Gilead’s delay during examination between its reply to a restriction requirement and its submission of a supplemental IDS (disclosing other co-pending Gilead patent applications). However, the Federal Circuit held that the issue in this case is whether the PTO may reduce PTA by a period that exceeds the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” (35 U.S.C. §154(b)(2)(C)(i)). The Federal Circuit held that Gilead did not answer this issue.
Supernus conceded that it failed to engage in “reasonable efforts” for the last 100 days of the 646-day period. However, Supernus argued that there was nothing Supernus could have done during the 2/22/11 filing of the RCE and the 8/21/12 receiving of the EPO communication.
The Federal Circuit agreed with Supernus’s arguments. The Federal Circuit held that there was no action Supernus could have done to advance prosecution of the patent during the 546-day period because the EPO communication did not exist yet. The Federal Circuit held that the PTO’s interpretation of the statute “would unfairly penalize applicants, fail to incentive applicants not to delay, and fail to protect applicants’ full patent terms.”
Finally, the Federal Circuit held that the PTO’s additional 546-day assessment is contrary to the plain meaning of the statute because “the 646-day total reduction is not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude the prosecution of the ’897 patent (35 U.S.C. §154(b)(2)(C)(i)). In addition, the Federal Circuit held that the PTO’s decision is not consistent with the intent of Congress because Congress intended that the PTA statute not adversely impact applicants who could have done nothing to advance the prosecution.
Therefore, the Federal Circuit held that the district court erred in granting summary judgment in favor of the PTO.
Takeaway:
Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices and submitted IDSs to the PTO citing communications from foreign patent offices.
Applicant should advise foreign patent counsels to forward the communications from foreign patent offices as soon as possible for a timely filing of IDSs.
Tags: information disclosure statement (IDS) > patent term > Patent Term Adjustment (PTA) > PTA reduction > Type A delay > Type B delay > Type C delay
Threshold of notice requirement for “A-delay” in PTA determination
| February 3, 2016
Pfizer Inc. v. Lee
January 22, 2016
Before: Newman, DYK and O’Malley. Opinion by O’Malley. Dissenting opinion by Newman.
Summary
Appellants (Pfizer) challenged the district court’s decision that denied their motion for acquiring additional part of A-delay by excluding a withdrawn office action as non-event for the A-delay. CAFC affirmed the district court’s decision.
35 U.S.C. § 154(b)は出願後14カ月以内に「at least one of the notifications under section 132」（いわゆるオフィスアクション）が出願人に通知されない場合は、その遅れた分の特許期間延長を認める（PTAのA-delayと呼ばれる）。本件では、最初のオフィスアクションとしてリストリクション要求（クレームに複数の発明が記載されていると認定すると審査官は特定の発明を出願人に選択させる要求）が審査官から出された。ところが、発明分類から漏れた従属クレームがあったため、審査官は最初のリストリクション要求を取り下げて、訂正したリストリクション要求を出し直した。特許庁は、初回と訂正の2つのリストリクション要求の間の197日をPTAのA-delayとして加えることなく、最初のリストリクション要求の送達日に基づいてPTAの計算を行った。連坊地裁において、特許権者は訂正リストリクション要求の日を基準にPTAを計算するべきであり、197日の追加を主張した。連邦地裁は197日を認めない判決を出した。
CAFCは地裁の判断を支持した。CAFCの多数意見は、35 U.S.C. § 154(b)の要件を緩く解釈し、「at least one of the notifications under section 132」の内容が広い意味での拒絶原因（“the broad statutory basis for the rejection”）と、出願人が応答可能な程度の情報量（sufficient information）を提示している場合に該当するので、本件の最初のリストリクション要求は、35 U.S.C. § 154(b)が要求する「通知」であると判断した。従属クレームの欠落程度は、出願人が応答できないほどの不備ではなく、審査官とのやり取りの結果リストリクション要求が出し直されたが、これは審査での通常のやり取りの範囲内であり、最初のリストリクションが取り下げられたという事実だけをもってして、特許期間の延長を認めないという判断である。これに対して、Newman判事はオフィスアクションの不備は出願人の責任ではなく、あきらかに特許庁の責任であり、特許期間の延長を認めるべきとの反対意見を述べた。
