Posted on 5/26/2020 5:26:05 PM By Todd Sheldon Parkhurst

Companies with COVID-19 technology may benefit from expedited patent examination if able to respond quickly to a fast new process providing issued patents in as little as six months.

On Saturday, May 16, 2020, The U.S. Food and Drug Administration (“FDA”) publicly announced that it

"has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc.[i] for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit."[ii]  

This at-home sample collection kit may qualify for U.S. patent protection.  On May 8, 2020, the United States Patent and Trademark Office (“USPTO”) announced the COVID-19 Prioritized Examination Pilot Program, permitting COVID-19-related patent applications filed by small and micro entities to be put on a fast track for examination.[iii] And on May 18, 2020, the USPTO launched a related webpage, where you can find additional resources and information pertinent to the program:

"As outlined in the official notice, up to 500 qualifying patent applications will be accepted for prioritized examination and exempted from prioritized examination fees. The USPTO will endeavor to reach final disposition of applications in this program within six months if applicants respond promptly to communications from the USPTO."[iv]

Historically, the U.S. patent system has long offered patent protection to a wide variety of products and processes related to some kinds of medical devices and procedures. Patent protection is offered not just to pharmaceuticals, but to instrumentation and kits.

To obtain patent protection, a patent application must be prepared and submitted to the USPTO. A cognizant Patent Examiner will then conduct what is known as a prior art search through the more than 10 million already-issued U.S. patents; through the millions of other patents issued by foreign nations; and through non-patent publicly available information. If the Examiner finds devices or kits similar to devices or kits described in the patent application, the Examiner will deny and reject the pending application on the grounds that the description and claims in the application are anticipated by, or are obvious to, one skilled in the art to which the application subject matter pertains. In that instance, the applicant will be given three months to amend the application and submit an argument urging the Examiner to issue the patent in view of the amended language. Appeals and other legal proceedings are available to the applicant.

These procedures can take time; it is not unusual for two, three, or more years to elapse between the time the patent application is filed and the patent is finally issued.

When the patent issues, the patent owner has the right to exclude any person or entity from making, using, selling or offering for sale the device, material or kit described in the claims appended to the issued patent.

In quickly moving technical development markets such as those involved in COVID-19 assessments, treatments or vaccines, these extensive delays can fundamentally affect — even vitally affect — related financing and business activity. A U.S. patent cannot be enforced until the patent application has been allowed and the patent has issued.

It is possible to prospectively license the patent which is expected to issue from a pending application, but significant risk may attach: will the patent application really mature as a patent? When? What will be the scope of the protection be if and when the patent issues?

To ameliorate these problems, the USPTO will attempt to examine COVID-19-related patent applications and issue the patents within six months of their filing dates.

For the USPTO, or the patent office of any other nation, to completely process a patent application in only six months is Star Trek warp speed.  Fire your thrusters, Mr. Spock.

For any questions regarding this or other IP-related COVID-19 concerns, please contact us.
 
 
 
[i] Letter Re: Everlywell COVID-19 Test Home Collection Kit (May 15, 2020), available at https://www.fda.gov/media/138144/download.
[ii] Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests (May 16, 2020), available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-standalone-home-sample-collection-kit-can-be-used.
[iii] USPTO announces COVID-19 Prioritized Examination Pilot Program for small and micro entities (May 8, 2020), available at https://www.uspto.gov/about-us/news-updates/uspto-announces-covid-19-prioritized-examination-pilot-program-small-and.
[iv] USPTO releases additional information on the COVID-19 Prioritized Examination Pilot Program (May 18, 2020, available at https://www.uspto.gov/about-us/news-updates/uspto-releases-additional-information-covid-19-prioritized-examination-pilot.