The USPTO has issued proposed rules to make permanent a Covid-19-related change in the manner in which applications for patent term extension under 35 USC § 156 are to be filed. While the Covid-19-related changes permitted electronic or paper filing, the proposed rule changes would require electronic filing.

PTE Under 35 USC § 156

Patent term extension (PTE) is part of the Hatch-Waxman scheme that provides for extension of patent term when the patented subject matter required FDA approval prior to marketing and the FDA approval process was not completed until after the patent granted. The basic PTE provision is set forth in § 156(a), which provides: 

(a)The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b), if— …

(4) the product has been subject to a regulatory review period before its commercial marketing or use ….

35 USC § 156(d) requires patent holders seeking PTE to file an application with the USPTO.

Prior to the COVID-19 pandemic, the USPTO required PTE applications to be filed in paper, in triplicate. During the COVID-19 pandemic, the USPTO started permitting electronic filing of PTE application documents. Now, the USPTO proposes to make that change permanent and take it one step further by requiring electronic filing.

Specific Rule Changes

The USPTO rules pertaining to PTE applications are set forth in 37 CFR § 1.740 et seq. The Federal Register Notice highlights the following specific proposed rule changes:

• Rule 740(a)(15) would be amended to require an email address of the person to whom inquiries and correspondence related to the PTE application are to be directed.

• Rule 740(b) would be amended to require electronic filing of PTE applications and related submissions, and to remove the requirement for filing in triplicate.

• Rule 741 would be amended to provide that the filing date of a PTE application is the date on which a complete PTE application is either received in the USPTO via the USPTO patent electronic filing system or filed pursuant to the procedure set forth in Rules 1.8(a)(1)(i)(C) and (a)(1)(ii) (pertaining to physical mailing and facsimile transmission procedures).

• Rule 770 would be amended to remove the requirement to file duplicates of express declarations of withdrawal of PTE applications.

• Rule 790 would be restructured, and Rules 790(c) and 790(d) would require electronic filing of interim PTE applications and related submissions, with no requirement for filing in triplicate.

It is not clear why a filing date would be accorded based on physical mailing or facsimile transmission if electronic filing is required, but perhaps that provision would be relied upon when electronic filing is not possible.

New Requirement For Interim PTE Applications

The proposed rule changes also would impose a new requirement for interim PTE applications (filed when the FDA review process still is ongoing when the patent’s un-extended expiration date is approaching). In particular, new Rules 790(c)(3) and 790(d)(3) would require an express statement that the applicable regulatory review period has begun for the product, and an identification of the application, petition, or notice that caused the applicable regulatory review period to begin (such as the NDA number).

Streamlining The PTE Application Process

As noted in the Federal Register Notice, these proposed rule changes would reduce the administrative burden on PTE applicants and support the USPTO’s efforts to “achieve complete beginning-to-end electronic processing of patent-related submissions.” I expect most PTE applicants will welcome these changes, but it will be interesting to see if the USPTO receives any negative feedback.