On May 8, 2020, the United States Patent and Trademark Office (USPTO) began a Pilot Program to provide prioritized examination of patent applications of a product or process related to COVID-19 diagnosis or treatment. Examples of such patents include: 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).
Aimed at applicants claiming small or micro entity status, the overall goal of the prioritized examination is to expedite patent prosecution to within 12 months for one of the following final dispositions: a notice of allowance; a Final Office Action; a filing of an RCE; an abandonment of the application; or filing of a Notice of Appeal. Additionally, if an Applicant provides timely responses to USPTO notices and actions, the USPTO hopes a final decision will be arrived at within six months.
According to a statement by the Director of the USPTO, Andei Iancu, the program is being established to help “independent inventors and small businesses” who are “often the difference makers when it come to cutting-edge innovation and the growth of our economy.” He explained that “[a]ccelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly.”
While new patent applications are normally taken up for examination in the order of their U.S. filing dates, in extraordinary situations, 37 C.F.R. §1.183 permits the USPTO to suspend or waive any requirement of its regulations not required by statute. Clearly, the COVID-19 pandemic is an “extraordinary situation.” The Pilot Program will accept requests for prioritized examination until such time as the USPTO has accepted a total of 500 requests. The USPTO indicated a willingness to extend the pilot program, depending on the workload of the Examiners and the effectiveness of the program.
Under the new program, an applicant does have to pay the prioritized examination fee and a processing fee at the time of filing. However, the fees will be waived if the requirements are met. Any remaining fees listed in 37 C.F.R. §1.102(e) and MPEP § 708.02(b) must be paid by all applicants at the time the request for prioritized examination is made. A request for prioritized examination under the new program can be made if all of the following requirements are met:
- Filing of a non-continuing original utility or plant nonprovisional application.
- Filing of a request for continued examination (RCE) of such plant or utility application or of a national stage of an international application.
- Certification that at least one of the pending claims covers a product or process related to COVID-19 and is subject to FDA approval for COVID-19 use.
- Applicant must certify either small or micro entity status.
- The request must include an executed application data sheet.
- No more than four independent claims, no multiple dependent claims, and no more than 30 total claims.
- Payment of required fees (examples: basic filing fee, search fee, and examination fee).
In order to expedite prosecution, extensions of time in response to an office action will terminate the prioritized examination. Upon termination of prioritized examination, the application will be removed from the examiner’s special docket and placed on the examiner’s regular docket. Also, Applications accepted into the First Action Interview (FAI Pilot Program) are not eligible for this pilot program. However, standard interview practices and procedures applicable to regular ex parte prosecution will still be available.
It is unclear how the COVID-19 Prioritized Examination Pilot Program will be perceived by those who have critiqued the role that patents play in addressing the pandemic, as discussed in our blog post here. It is, however, another tool that the USPTO has offered that may encourage the participation of more, and more diverse, innovators in the patent process.