Briefs from the USPTO – September 2022 | McDonnell Boehnen Hulbert & Berghoff LLP

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USPTO launches webpage on PTE applications and extended patent terms under 35 USC § 156

In a patent alert email distributed to stakeholders last week, the U.S. Patent and Trademark Office announced the launch of a new Web page provide information on patent term extension (PTE) applications that have been filed in the past five years and patent terms that have been extended under 35 USC § 156. For PTE applications, the new web page provides access to a spreadsheet listing the application number, patent number and trade name identified in the PTE application, and provides a link to the electronic file containing the PTE documents. The USPTO alert says the new webpage was launched in response to feedback from stakeholders requesting readily available information about PTE applications. The USPTO plans to update the information on the webpage on a quarterly basis.

USPTO Announces Fourth Expansion of Modified COVID-19 Priority Review Pilot Program

In a notice published in the Federal Register (87 Fed. Reg. 38714) in June, the U.S. Patent and Trademark Office announced that it was extending the Modified COVID-19 Priority Review Pilot Program and that pilot program applications would be accepted through December 31, 2022. The program pilot, which was implemented in May 2020 and has been extended three times previously, allows applicants who qualify for small or micro-entity status to apply for priority review without paying the fees typically associated with such priority review (seeUSPTO Announces COVID-19 Priority Review Pilot Program“).

In addition to the requirement that applicants are eligible for small or micro-entity status, claims in an application must cover a product or process related to COVID-19, and that product or process must be subject to applicable FDA approval for COVID-19 use. These approvals may include, for example, an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), pre-market release (PMA) or an Emergency Use Authorization (EUA). Other requirements to participate in the pilot program include submitting the application at the time of filing an original non-continuing factory or service non-provisional application; at the time of filing an original nonprovisional utility or factory application claiming the benefit of an earlier filing date under 35 U.S.C §§ 120, 121, or 365(c) of an earlier nonprovisional application or an earlier international application designating the United States; or at the time of filing or after the filing of a request for further examination of a plant or utility application or a national step of an international application. However, any application that claims the benefit of the filing date of two or more previously filed nonprovisional United States applications or international applications designating the United States under 35 USC §§ 120, 121, or 365(c) is not eligible to participate in the pilot project. program. In addition, applications for participation in the pilot program must include an application data sheet, be made through the Office’s electronic patent filing systems (EFS-Web or Patent Center), and eligible applications cannot submit more than four independent claims, more than 30 claims in total, or any multiple dependent claims.

In announcing the extension of the pilot programme, the Office noted that as of 16 May 2022, 261 patents had been granted from applications which had been accepted under the pilot programme, and that the average total duration, from the date from filing to date of issuance, for those requests was 280 days.

As we reported earlier this year in our “Top Patent Law Stories of 2021” webinar, of the 149 patents that mention “COVID-19” or “SARS-CoV-2” in the claims (as of January 2022), 89 issued per applications that had been accepted under the pilot program, and the average total time for these applications was 280 days. This compares favorably to the 41 patents that mention “COVID-19” or “SARS-CoV-2” in the claims where review was expedited under the Track One priority review program, and where the average total time waiting period was 259 days.

USPTO Announces Continuation of PPH Pilot Program with IMPI

In a notice published in the Official Journal (1499 GB 496) in June, the United States Patent and Trademark Office announced that the Mexican Institute of Industrial Property (IMPI) and the USPTO had agreed to expand the Patent Prosecution Highway (PPH) pilot program between the two offices. Under the PPH Pilot Program, which has been extended through June 30, 2027, the USPTO will timely process any PPH request based on an IMPI work product filed with the USPTO on or before June 30, 2027.

USPTO makes electronic filing of PTE applications permanent

In May 2020, the United States Patent and Trademark Office announced that, because it considered the effects of the COVID-19 pandemic to be an “extraordinary circumstance” within the meaning of 37 CFR § 1.183, the Office would allow patentees to file an initial request for patent term extension requests meeting certain criteria via EFS-Web or Patent Center (seeBriefs from the USPTO, June 2, 2020). At the time, the Office noted that while the waiver would be “effective only until further notice from the USPTO”, it was working to allow electronic filing of PTE applications on a permanent basis.

In a notice of proposed rulemaking published in the Federal Register (87 Fed. Reg. 27043) in May, the U.S. Patent and Trademark Office announced a proposal to amend the Rules of Practice in Patent Cases to require that patent term extension (PTE) requests, draft PTEs and any related submissions to the USPTO be submitted electronically through the USPTO’s electronic patent filing system (EFS-Web or Patent Center). According to the Agency, the proposed changes to the rules would reduce the administrative burden on PTE applicants, while improving administrative efficiency by facilitating electronic case management, optimizing workflow processes and reducing processing errors. The Bureau noted that it had received informal comments regarding the processing of electronic TEP applications under the COVID-19 pandemic waiver, and that stakeholders had communicated unanimous support for electronic filing of submissions. initials of PTE. The Office also noted that the USPTO and its partner agencies had successfully implemented a system whereby the USPTO electronically transmits a copy of any initial PTE submission to the relevant agency, and that the new system had no caused no processing error.

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