USPTO to Tweak PTA Rules in View of Supernus

08 October 2019 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

In Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit held that the USPTO cannot charge a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.” The PTA deduction at issue was charged under 37 CFR § 1.703(c)(8) for an Information Disclosure Statement (IDS) filed after a Request for Continued Examination (RCE) had been filed, but the USPTO proposes to make changes to other PTA rules to comply with the court’s interpretation of  35 USC § 154(b)(2)(C).

Proposed Tweaks to PTA Rules

In the Federal Register Notice dated October 4, 2019, the USPTO interprets Supernus as holding “that a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” The USPTO admits that “[s]everal provisions in 37 CFR 1.704 specify a period of reduction corresponding to the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution,” rather than “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts,” as the court indicated in Supernus. Thus, the USPTO proposes to revise 37 CFR §§ 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10) to be consistent with Supernus.


PTA Rule Current Language  Proposed Language 
 

§ 1.704(c)(2)

Deferral of issuance of a patent under § 1.314

the period of adjustment … shall be reduced by the number of days .. beginning on the date a request for deferral of issuance … was filed and ending on the date the patent was issued the period of adjustment … shall be reduced by the number of days .. beginning on the date a request for deferral of issuance … was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued
 

§ 1.704(c)(3)

Abandonment of the application or late payment of the issue fee

 the period of adjustment … shall be reduced by the number of days … beginning on the date of abandonment or the date after the date the issue fee was due and ending on the earlier of:

(i) The date of mailing of the decision reviving the application or accepting late payment of the issue fee; or
(ii) The date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed

the period of adjustment … shall be reduced by the number of days …beginning on the date of abandonment or the date after the date the issue fee was due and ending on the date the grantable petition to revive … or accept late payment of the issue fee was filed

 § 1.704(c)(6)*

Submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance

 
 the period of adjustment … shall be reduced by the lesser of:
(i) The number of days …  beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance; or
(ii) Four months
the period of adjustment … shall be reduced by the number of days … beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed
 

 § 1.704(c)(9)

Submission of an amendment or other paper after a decision by the PTAB, other than a decision designated as containing a new ground of rejection … or statement under § 41.50, or a decision by a Federal court, less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or supplemental notice of allowance

 
the period of adjustment … shall be reduced by the lesser of:
(i) The number of days … beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance; or
(ii) Four months
the period of adjustment … shall be reduced by the number of days … beginning on the day after the date of the decision by the [PTAB] or …Federal court and ending on date the amendment or other paper was filed

 § 1.704(c)(10)


Submission of an amendment under § 1.312 or other paper, other than a RCE, after a notice of allowance has been given or mailed

 
the period of adjustment … shall be reduced by the lesser of:
(i) The number of days … beginning on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or
(ii) Four months
the period of adjustment … shall be reduced by the number of days …beginning on the day after the mailing date of the notice of allowance … and ending on the date the amendment under Sec.  1.312 or other paper was filed.

*With reference to the changes to § 1.704(c)(6), the Notice explains that an application is expected to be in condition for examination within 8 months of filing.

Review Your Applications

It is easy to see how these changes could have a significant impact on PTA calculations, especially in cases where the USPTO takes a while to act on a submission that incurs a PTA deduction under 37 CFR §§ 1.704(c)(2), (c)(3), (c)(6), (c)(9), or (c)(10). Although the proposed rules won’t go into effect until after a notice of final rulemaking is issued (likely sometime in 2020), applicants making submissions that fall under 37 CFR §§ 1.704(c)(2), (c)(3), (c)(6), (c)(9), or (c)(10) may want to flag those applications for PTA review once the patents are granted.

Provide Your Feedback

The USPTO will consider written comments received by December 3, 2019. As set forth in the Notice, comments should be sent by email to AD38.comments@uspto.gov.

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