The U.S. Patent and Trademark Office (USPTO) released a report on innovations in COVID-19-related diagnostics as a case study of how innovation and intellectual property operate during times of crisis. The study utilized publicly available data from December 2019 through April 2023. Highlights that might be of interest to stakeholders in this space include trends in the volume of COVID-19 diagnostic patents filed, the entities filing them, and countries with the most identified patent families in this field. For example, the report found that most of the patents identified were filed by small companies and universities, and that U.S.-based applicants were responsible for the bulk of the filings at the USPTO. Taken as a whole, the report finds that U.S. innovators were highly responsive to the urgent demand for novel diagnostic methods at the outset of the COVID-19 pandemic.

The images in this article include excerpts from the USPTO’s report, which is available here.

The USPTO’s Search Strategy

The USPTO used keywords and classification queries to identify relevant patent filings for the study. It utilized a three-step approach: first, identifying a large group of publicly available patent filings related to COVID-19; second, searching within that group to identify filings relating to COVID-19 diagnostics; and finally, performing a manual evaluation to determine search performance. The USPTO created two search groupings. The first was COVID-19-specific in that it searched for keywords in abstracts and titles, while the second was COVID-19-related in that it included filings that included keywords in the full text of the documents. COVID-19 diagnostic patent filings were identified by selecting only applications classified in diagnostics classes.

The search only involved publicly available documents, such as published patent applications and granted patents (which may have been examined under an accelerated examination program).

Trends in Volume and Share of U.S. COVID-19 Diagnostic Public Patent Filings

The search identified 824 COVID-19 diagnostic-specific patent filings, while the more general search identified 1,209 COVID-19 diagnostic-related patent filings (including those uncovered in the specific search). These identified patent filings followed a wave-like surge present throughout 2021, and a subsequent drop beginning in 2022, with a peak of 167 now-public patent filings during the fourth quarter of 2021. The peak quarter included 20% of all published patent filings identified by the COVID-19 diagnostic-specific search, and corresponded to applications filed in April, May, and June of 2020.

The report compares the percentage of COVID-19 diagnostic-specific filings to all now-public COVID-19 filings and to all now-public COVID-19 diagnostic-related filings at the USPTO. It appears that although the percentage of COVID-19 diagnostic-specific filings peaked in the second quarter of 2021 as compared to all COVID-19 patent filings, the percentage of diagnostic-related filings remained relatively steady through the beginning of 2023, with about 30% of all now-public COVID-19 filings relating to COVID-19 diagnostics. Overall, however, COVID-19 diagnostic filings make up a very small percentage of all diagnostic patent filings, with a peak of 2.6% in the fourth quarter of 2021.

Trends in U.S. COVID-19 Patent Filings by Applicant Entity Types

According to the report, the largest share of now-public U.S. COVID-19 diagnostic filings in the period analyzed were generated by companies. Of the 824 patent filings identified in the specific search, companies generated over 58%, while universities, nongovernment research institutes, and hospitals generated around 27%, and individuals not obviously affiliated with a research institute were responsible for around 13%.

The report breaks down these shares further for each group by examining the fee discounts used by the filing entities. Around 71% of the patent filings were associated with small entities, with 64% of the companies and 82% of the universities, nongovernment research institutes, and hospitals receiving small entity discounts.

Data Concerning Federally Supported COVID-19 Diagnostic Patent Filings

Only a small fraction of the identified patent filings was assigned to U.S. government agencies. To further understand how government sponsorship supported innovation, the patent filings were examined to determine if a government support statement was included, which is mandatory under the Bayh-Dole Act if government funding was utilized to create the invention. The USPTO found 88 of the 824 identified patent filings included a government support statement, and 81% of these were filed by small or micro entities. The top three sponsoring agencies were the National Institutes of Health in the Department of Health and Human Services, the National Science Foundation, and the Department of Defense.

Top U.S. COVID-19 Diagnostic Patent Filers

The USPTO also analyzed the COVID-19 diagnostic patent filings to determine which entities were the top filers. The report identifies the top 21 filing entities. Seventeen of these are U.S.-based companies, which contrasts with the World Intellectual Property Organization’s (WIPO’s) finding that only one U.S.-based company was in the top 16 for COVID-19 therapeutic patent filings and only two were in the top 16 for COVID-19 vaccine patent filings worldwide.

Trends in the Number of COVID-19 Diagnostic Patent Filings by Assignee’s Citizenship

The USPTO also sorted the COVID-19 diagnostic patent filings by U.S. assignees and non-U.S. assignees, and charted the filings over the time period analyzed. Consistently, U.S. assignees outnumbered non-U.S. assignees. However, it is important to keep in mind that the data would not have captured all applications initially filed as international patent applications under the Patent Cooperation Treaty, which have up to 30 months to enter the U.S. national stage. (This may at least partly explain the discrepancy with the WIPO data.) Thus, it could be important to revisit this data once international applications filed in the peak filing period have entered the U.S. national stage.

Somewhat relatedly, the report also examined where COVID-19 diagnostic patent filings have been made globally, and found the most by far in China, with 2,643 now-public COVID-19 diagnostic patent families in China as of the first quarter of 2023, and 47% of all families identified through the COVID-19 diagnostic-specific search approach. Interestingly, it appears that only 102 of the patent families filed in China have also been filed with the USPTO. The report found 784 patent families, the second-largest number associated with a national intellectual property organization, have been made with the USPTO. Moreover, the report identified 1,970 PCT filings with WIPO, any number of which could enter the U.S. national stage as discussed above.

Thoughts on the Report

Overall, the data from the USPTO indicates that small companies and universities were responsible for the bulk of the U.S. patent filings relating to COVID-19 diagnostics during the period examined, and that most of the applicants were U.S.-based entities, as opposed to foreign entities.

While this data is interesting, the number of patent applications filed does not necessarily correlate with the number of patents that will be granted, let alone trends concerning commercial products. For example, the USPTO stated that it was unable to link many of the patent filings with diagnostic tests that received an emergency use authorization from the U.S. Food and Drug Administration (FDA) (and did not report which ones it was able to link), which makes it difficult to understand whether the patent filings correspond to any products that were developed and commercialized in this period. While patent filings present one mechanism of understanding innovation, also considering other relevant market information, such as products with FDA emergency use authorization, and other products in development, can provide a more complete picture.