Deferred-fee provisional patent application pilot program and collaboration database to encourage inventions related to COVID-19

The pilot is effective or starts on September 17, 2020, the date of publication of the notice in the Federal Register.

The pilot will last for one year from September 17, 2020.  The USPTO no longer accepts applications for this pilot effective at midnight September 17, 2021.

No, the request can only be made with the filing of a provisional application.

Participation is requested by filing a technical disclosure in legible DOCX format as well as a provisional application cover sheet and a certification and request to participate in the program (form PTO/SB/452, titled “Certification and Request for COVID-19 Provisional Patent Application Program,” available at https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012).  The filing fee for a provisional application does not need to be paid at the time of filing.  A submission that fails to include a legible specification in DOCX format will not be treated as a program submission, even if it is accompanied by form PTO/SB/452. The submission will be handled as a provisional application, and a notice will be sent pursuant to 37 CFR 1.53(g), including a requirement for payment of the basic filing fee ordinarily within two months of the date of the notice. See MPEP 601.01(b).

U.S. Food and Drug Administration (FDA) approvals may include, but are not limited to, an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA). Information on these approvals are available at www.fda.gov.  To qualify for the pilot, the subject matter disclosed in the provisional application must concern a product or process related to COVID-19, and such product or process must be subject to an applicable FDA approval for COVID-19 use.  The requirement is broadly drafted to include any sort of FDA premarket regulatory review procedure. You can apply to the pilot when the FDA approval has been obtained, is pending, or will be sought prior to marketing such product or process for COVID-19.

No, the pilot is limited to provisional applications that disclose subject matter that is subject to an applicable FDA approval for COVID-19 use.  Applicants are required to make a certification to this effect when applying to the pilot program.

Any patent applicant, including a non-discounted entity (e.g., an applicant not subject to any filing discounts), may file a request under the pilot.

There is no provision for withdrawal from the program.

Yes, if the provisional application basic filing fee was not paid, a reminder will be sent 10 months after the provisional application filing date indicating that the basic filing fee must be paid not later than 12 months after the provisional application filing date.

The fee due is the fee in effect when the fee is paid.  Thus, if the filing fee increases after the filing date but prior to payment, the higher fee would be due.  See MPEP 509.

A later-filed international, foreign or U.S (domestic) nonprovisional application may be entitled to claim benefit or priority of the filing date of a provisional application. The later-filed nonprovisional, international or foreign application should be filed not later than 12 months after the date on which the provisional application was filed if a benefit or priority claim to the provisional application is to be made. Domestic benefit under 35 U.S.C. 119(e)(1) and 37 CFR 1.78 requires that the provisional application be entitled to a filing date, and name the inventor or a joint inventor also named in the later-filed nonprovisional application. Furthermore, the basic filing fee set forth in 37 CFR 1.16(d) must be paid in order to rely on the provisional application in a later-filed nonprovisional application.

It may be possible to still claim benefit by filing a petition under 37 CFR 1.78(b) in the nonprovisional application if the nonprovisional application was filed within 14 months of the provisional application.  See MPEP 211.01(a), II.

No, the surcharge set forth in 37 CFR 1.16(g) is not owed because the pilot program allows the filing fee to be deferred.

The Office will notify the applicant and explain the reason(s) the request fails to meet the requirements of the program. The Office may issue a requirement for information to the applicant before making this determination.  Where a submission fails to meet the requirements of the program the Office may refuse to include the technical disclosure in the database and may issue a requirement to pay the filing fee and surcharge.

If a program submission is otherwise complete but does not include a cover sheet as required for a provisional application by 37 CFR 1.51(c)(1), or any necessary application size fee as required by 37 CFR 1.51(c)(4), the applicant will be notified and given an extendable two-month time period from the date of the notice to submit the missing items in accordance with 37 CFR 1.53(g). However, the applicant may continue to defer payment of the basic filing fee until a nonprovisional application claiming benefit of the provisional application is filed. Even if the notice sets a due date for the basic filing fee that is earlier than 12 months after the date the provisional application was filed, the fee will be considered timely if paid not later than the date on which a nonprovisional application that is entitled to claim benefit of the provisional application is filed. A reply to an Office notice that purports to require payment of the basic filing fee earlier than 12 months after the date the provisional application was filed will be considered complete, as to the fee payment issue, if it refers to the Federal Register notice as the basis for deferring payment or includes a copy of the notice. Failure to draw the Office’s attention to the Federal Register notice will result in the application being processed as if the fee were due in response to the Office notice, and substantial processing delays may occur.

Examples Showing Prior Art Implications of Submissions Under the Program

These facts apply to all four scenarios below: Tom and Jane work together to invent a new drug for treating COVID-19. They prepare a provisional patent application, including a cover sheet that names themselves as joint inventors. The technical disclosure of the provisional patent application complies with 35 U.S.C. 112(a), describing and enabling a two-component drug AB, as well as a method of using drug AB to treat COVID-19. Tom and Jane use form PTO/SB/452 to submit the application to the program via EFS-Web on September 17, 2020. The Office assigns a provisional application number to the papers filed as a provisional application and informs Tom and Jane that the filing date of their provisional application is September 17, 2020. The technical disclosure of the application becomes available to the public when it is posted to the program database on October 7, 2020. 

Scenario 1: Twelve months after the filing date of their provisional application, on September 17, 2021, Tom and Jane pay the basic filing fee for their provisional application and file a nonprovisional application naming themselves as joint inventors and claiming the benefit of the provisional application under 35 U.S.C. 119(e). The nonprovisional application includes one claim drawn to drug AB and another claim drawn to a method of using drug AB to treat COVID-19.  Both claims are supported by the provisional application. The technical disclosure is not prior art to the claims in the nonprovisional application because the effective filing date of the claimed inventions, which is the provisional application filing date of September 17, 2020, is prior to the date (October 7, 2020) the technical disclosure was made public. 

Scenario 2: Tom and Jane pay the basic filing fee for their provisional application not later than September 17, 2021. On September 27, 2021, Tom and Jane file a nonprovisional application that names themselves as joint inventors and includes one claim drawn to drug AB and another claim drawn to a method of using drug AB to treat COVID-19.  Both claims are supported by the provisional application. They attempt to claim benefit of the provisional application under 35 U.S.C. 119(e). The benefit claim is not effective because the nonprovisional application was not filed within 12 months of the provisional application. Tom and Jane have not sought to restore the right to claim benefit of the provisional application with a petition under 37 CFR 1.78(b). Thus, the effective filing date of all claimed inventions is September 27, 2021. Even though the benefit claim is not effective, the technical disclosure, published on October 7, 2020, is not prior art to the claims in the nonprovisional application. The prior art exception of 35 U.S.C. 102(b)(1)(A) applies because the technical disclosure was made by the inventor (Tom and Jane), and was made within the one-year grace period preceding the effective filing date of the claimed inventions. 

Scenario 3: Matt sees Tom and Jane’s technical disclosure in the program database and collaborates with them to invent drug ABC as well as a method of using it for the treatment of COVID-19. Drug ABC is a variant of Tom and Jane’s drug AB. On September 17, 2021, which is 12 months after the filing date of Tom and Jane’s provisional application, Tom and Jane pay the basic filing fee for their provisional application. Also on September 17, 2021, Tom, Jane, and Matt file a nonprovisional application naming themselves as joint inventors and claiming benefit of Tom and Jane’s provisional application under 35 U.S.C. 119(e). The nonprovisional application includes separate claims drawn to drug AB and to drug ABC, as well as separate claims drawn to methods of using drug AB and drug ABC to treat COVID-19. The two claims concerning drug AB have an effective filing date of September 17, 2020 because the claims are supported by the provisional application. The two claims concerning drug ABC have an effective filing date of September 17, 2021 because they claim subject matter that was newly added in the nonprovisional application. The technical disclosure, published on October 7, 2020, is not prior art to the claims concerning drug AB because the publication date is not prior to the effective filing date of those claimed inventions, which is the provisional application filing date of September 17, 2020. The technical disclosure is also not prior art to the claims concerning drug ABC. The prior art exception of 35 U.S.C. 102(b)(1)(A) applies because the technical disclosure was made by “the inventor or joint inventor” of the claimed inventions. In accordance with 35 U.S.C. 100(f), the term “inventor” in 35 U.S.C. 102(b)(1)(A) means the inventive entity which is all named joint inventors (Matt, Tom, and Jane). In this example, the technical disclosure was made by Tom and Jane within the one-year grace period preceding the effective filing date of the claimed inventions concerning drug ABC. Tom and Jane are joint inventors of the claims concerning drug ABC along with Matt. Although Matt is not named as a joint inventor of the technical disclosure, the prior art exception applies because the October 7, 2020 publication is a disclosure made by joint inventors Tom and Jane of subject matter that they invented. 

Scenario 4: Tom and Jane pay the basic filing fee for their provisional application not later than September 17, 2021. Acting independently with no input from Tom, Jane invents drug ABD as well as a method of using it for the treatment of COVID-19. Drug ABD is a variant of Tom and Jane’s drug AB. On September 17, 2021, Jane files a nonprovisional application naming herself as inventor and claiming benefit of the earlier filed provisional application under 35 U.S.C. 119(e). The nonprovisional application includes claims drawn to drug ABD and to a method of using drug ABD to treat COVID-19. Jane’s claims concerning drug ABD have an effective filing date of September 17, 2021, because those claims contain subject matter that is not supported by Tom and Jane’s provisional application. The technical disclosure regarding drug AB that was published on October 7, 2020, qualifies as prior art against Jane’s claims concerning drug ABD and could be cited in an obviousness rejection under 35 U.S.C. 103. The prior art exception of 35 U.S.C. 102(b)(1)(A) does not apply because the technical disclosure was not made by “the inventor or joint inventor” of the claimed inventions, which is required by 35 U.S.C. 102(b)(1)(A). In other words, Jane alone is “the inventor or joint inventor” of the claimed inventions; Tom is not a joint inventor of those claimed inventions but is named as a joint inventor in the technical disclosure. The technical disclosure was not made by the inventor (Jane) of the claimed inventions because the technical disclosure is not solely attributable to her.