USPTO Report on COVID-19 Diagnostics Shows Outsized Impact of Small Entities on R&D

Source: USPTO Report

On October 23, the U.S. Patent and Trademark Office’s (USPTO) Office of the Chief Economist (OCE) published a report detailing patent application filing trends at the USPTO related to COVID-19 diagnostics technologies. The OCE found that filing activity surged following the arrival of the novel coronavirus in early 2020, with much of that increase driven by small companies and research institutions. The report found further evidence suggesting that federal funding had a significant impact on driving innovation into COVID-19 diagnostics at small R&D entities.

Sixty-Four Percent of Corporate COVID-19 Diagnostics Filings from Small Entities

The fourth quarter of 2021 saw the publication of 167 U.S. patent applications covering COVID-19 diagnostics technologies, according to the OCE’s report. This represents 20% of the U.S. patent applications found by the OCE’s keyword search methodology, the peak quarter for publication of COVID-19 diagnostic patent applications since the pandemic began. While COVID-19 diagnostics only account for 1.4% of all patent application filings in medical diagnostics, COVID-19 diagnostics represented 30% of all COVID-19-related patenting activity.

Overall, the OCE’s report identified 824 U.S. patent applications covering COVID-19 diagnostics and filed between December 2019 and April 2023. Companies accounted for 58% of all filings, and of the total filings from corporate R&D applicants, 64% were filed by companies qualifying as small entities. Universities, research institutions and hospitals accounted for 27% of all COVID-19 diagnostic filings, and 82% of patent applications in this group were also filed by small entities. “Perhaps surprisingly,” the OCE’s report noted that unaffiliated individuals accounted for 13% of COVID-19 diagnostics patent applications identified in the survey.

The major contributions of small and micro entities to innovation in COVID-19 diagnostics also runs counter to larger trends, underscoring the importance of small businesses to research and development into COVID-19 diagnostics. The OCE’s report points out that only 24% of all U.S. patents issued during 2022 went to companies qualifying for small or micro entity discounts. Conversely, small entities filed the most COVID-19 diagnostics patent applications among every applicant group except for government agencies.

Federal Funding Helped to Spur Small Entity Patent Filings

While government agencies were only assigned 15 of the COVID-19 diagnostics filings identified by OCE, the report assessed government interest statements on patent applications showing that federal funding significantly contributed to developments in the sector. OCE found 88 patent applications, or 10.7% of all COVID-19 diagnostics filings, containing such a statement indicating federal funding contributions to the underlying invention. Small and micro entities accounted for 81% of the filings, indicating not only that federal funding mechanisms under Bayh-Dole were having a robust impact on COVID-19 R&D, but that small businesses were by far the top beneficiaries of Bayh-Dole’s impact on innovation during the pandemic.

Analyzing Cooperative Patent Classification (CPC) subclass codes, the OCE’s report found that nearly half of all COVID-19 diagnostics filings were classified as analyzing materials by chemical and physical properties. Aside from measuring enzymes, nucleic acids and microorganisms, no other CPC subclass was seen on more than 20% of COVID-19 diagnostics filings. The OCE’s report notes a higher than expected showing for health care informatics, a CPC subclass code appearing on 12.4% of COVID-19 diagnostics filings. The report indicates that this number reflects in part the impact of in-home diagnostics tests that became popular during the pandemic.

The OCE’s report also reflects the fact that COVID-19 diagnostics inventions are not always separate and distinct from COVID-19 vaccines and therapeutics. For example, 8.6% of public filings for COVID-19 diagnostics fell into the CPC subclass for specific therapeutic activity of chemical compounds or medicinal preparations.

Analyzing international patent filing data available through the Derwent World Patent Index, the OCE’s report found that the largest number of patent families related to COVID-19 diagnostics were filed at the China National Intellectual Property Administration (CNIPA). The CNIPA saw 2,643 patent families covering COVID-19 diagnostics during the pandemic, far more than the 784 such patent families filed at the second-place USPTO. Patent Cooperation Treaty (PCT) international filings accounted for 35% of the COVID-19 diagnostics filings tracked by the OCE’s survey, with that number expected to rise due to the 30-month national phase period under PCT for selecting additional countries for national filings.