USPTO Issues Final Patent Term Adjustment Rules Under Novartis

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The USPTO has published final Patent Term Adjustment (PTA) rules addressing the treatment of Requests for Continued Examination (RCEs) under the Federal Circuit decision in Novartis v. Lee, which I discussed here. The final rules create a new type of deduction for “Applicant delay” that will apply to applications in which an RCE is filed on or after March 10, 2015.

The PTA/RCE Issue

In Novartis, the Federal Circuit determined that the USPTO had incorrectly interpreted 35 USC § 154(b)(1)(B)(i) as applied to applications in which an RCE was filed. That portion of the PTA statute provides for an award of PTA when the USPTO fails to issue a patent within three years, and reads as follows:

(B) GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY.- Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application in the United States, not including-
(i) any time consumed by continued examination of the application requested by the applicant under section 132(b)…

Under the USPTO’s original interpretation of the statute, once an RCE was filed, the application no longer accrued “B” delay, although it might still accrue “A” delay and/or “C” delay. (Please see my article on Exelixis I for a more detailed discussion of this issue and the PTA framework.) In Novartis, the Federal Circuit held:

We reject the PTO’s view that the time after allowance, until issuance, is “time consumed by continued examination” and so is excluded from adjustments given to the patentee. Such time from allowance to issuance undisputedly would count toward the PTO’s three-year allotment in a case not involving a continued examination. There is no basis for distinguishing a continued examination case.

The Final Rules

The final rules implement the Novartis decision by revising 37 CFR § 1.703(b)(1) to read as follows:

(b) The period of adjustment under § 1.702(b) is the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application and ending on the date a patent was issued, but not including the sum of the following periods:

(1) The number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 U.S.C. 132(b) was filed and ending on the date of mailing of a notice of allowance under 35 U.S.C. 151;

The USPTO rejected comments suggesting that the mailing date of the notice of allowance should not be included in the carve-out period, taking the position that “time consumed by continued examination” includes the day a post-RCE notice of allowance is mailed.

On the other hand, I am pleased to note that the USPTO did not implement its proposal to also exclude time consumed by examination if the USPTO sua sponte reopens prosecution after issuing a notice of allowance. (I pointed out the ultra vires nature of that proposal in this article here.)

The final rules also revise 37 CFR § 1.704(c) to create a new type of applicant delay:

(12) Submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed.

This means that filing an RCE after allowance not only will prevent the accrual of B delay until the application is allowed again, it also will result in a deduction from the total PTA award corresponding to the number of days between the (first) notice of allowance and the (subsequent) RCE. According to the Federal Register Notice, this rule will prevent applicants from “obtain[ing] multiple periods of adjustment… [after allowance] as a consequence of delaying issuance.. by filing [RCEs] after a notice of allowance.”

(This is the rule change that takes effect March 10, 2015, and applies to any application in which a post-allowance RCE is filed on or after that date.)

Exceptions for RCEs Filed to Support Information Disclosure Statements

The USPTO responded to comments regarding conflicts between charging “Applicant delay” for filing a post-allowance RCE and the IDS rules, which require an RCE to obtain consideration of an IDS after allowance, by revising § 1.704(d)(1) to read as follows:

(d)(1) A paper containing only an information disclosure statement in compliance with §§ 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under paragraphs (c)(6), (c)(8), (c)(9), or (c)(10) of this section, and a request for continued examination in compliance with § 1.114 with no submission other than an information disclosure statement in compliance with §§ 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under paragraph (c)(12) of this section, if the paper or request for continued examination is accompanied by a statement that each item of information contained in the information disclosure statement:

(i) Was first cited in any communication from a patent office in a counterpart foreign or international application or from the Office, and this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement; or

(ii) Is a communication that was issued by a patent office in a counterpart foreign or international application or by the Office, and this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement.

This means that post-allowance RCEs filed to obtain consideration of an IDS to cite references for which a thirty day certification is made will not result in a PTA deduction for “Applicant delay.”

Other Changes to the PTA Rules

The Federal Register Notice also sets forth 37 CFR 1.704(c)(13), which originally took effect October 21, 2013 as 37 CFR 1.704(c)(11). That rule provides for a deduction for “Applicant delay” when an application is not “in condition for examination” within eight months of its filing date under 35 USC § 111(a) or the date of commencement of the national stage under 35 USC § 371(b) or (f) in an international application, as I previously discussed in this article here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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