On October 23, 2023, the Office of the Chief Economist (OCE) of the United States Patent and Trademark Office (USPTO) released a report detailing trends in USPTO patent filings related to COVID-19 diagnostic technologies. The OCE found a surge in patent-filing activity following the emergence of the virus in early 2020, with much of the increase driven by small businesses and research institutions. The report finds further evidence that federal funding has had a significant impact on driving innovation in COVID-19 diagnostics among small R&D entities.

64% of corporate applications for COVID-19 diagnosis came from small entities

According to the OCE report, a total of 167 US patent applications involving COVID-19 diagnostic technologies were published in the fourth quarter of 2021. This accounted for 20% of the US patent applications identified by OCE's keyword search method, and it was also the peak quarter for the publication of patent applications for COVID-19 diagnosis since the start of the pandemic. While COVID-19 diagnostic patent applications accounted for only 1.4% of all patent applications in the medical diagnostics field, they accounted for 30% of all COVID-19 related patent application activity.

Overall, the OCE report identified 824 US patent applications covering COVID-19 diagnosis, filed between December 2019 and April 2023. Business applications accounted for 58 percent of all applications, and 64 percent of all applications filed by business R&D applicants were filed by businesses that qualified as small entities. Applications related to universities, research institutions and hospitals accounted for 27% of all COVID-19 diagnostic applications, and 82% of patent applications in this group were also filed by small entities. The OCE report noted that "perhaps surprisingly" 13 per cent of COVID-19 diagnostic patent applications identified in the survey came from independent individuals.

The major contribution of small and micro entities to COVID-19 diagnostic innovation also "runs counter" to the larger trend, but it also highlights the importance of small businesses to COVID-19 diagnostic research and development. The OCE report notes that only 24 percent of all U.S. patents issued in 2022 belonged to businesses eligible for the small or micro entity discount conditions. In contrast, small entities filed the most COVID-19 diagnostic patent applications of any applicant group except government agencies.

Federal funding has helped promote small entity patent applications

While government agencies accounted for only 15 of the COVID-19 diagnostic applications identified by the OCE, the report evaluated government interest statements for patent applications, showing that federal funding has made a significant contribution to the development of the field. The OCE found that 88 patent applications, or 10.7 percent of all COVID-19 diagnostic applications, included such statements indicating the contribution of federal funds to the underlying invention. Small and micro entities accounted for 81% of the total number of applications, demonstrating not only that the federal funding mechanism under the Baidu Act has had a huge impact on COVID-19 R&D, but also that small businesses have so far been the biggest beneficiaries of the Baidu Act's impact on innovation during the COVID-19 pandemic.

Analyzing the Cooperative Patent Classification (CPC) subclass code, the OCE report found that nearly half of all COVID-19 diagnostic applications were classified as analyzing materials by chemical and physical properties. In addition to measuring enzymes, nucleic acids, and microorganisms, more than 20% of patent applications related to COVID-19 diagnostics have no CPC subclass code present. The OCE report noted that healthcare informatics performed better than expected, with the CPC subcode appearing in 12.4% of COVID-19 diagnostic requests. The data partly reflects the impact of home-based diagnostic tests that have become popular during the coronavirus pandemic, the report said.

The OCE report also reflects the fact that COVID-19 diagnostic inventions are not always separate and distinct from COVID-19 vaccines and treatments. For example, 8.6% of public applications for COVID-19 diagnoses fall under the subcategory of CPC compounds or drug formulations with specific therapeutic activity.

Analyzing international Patent application data from the Derwent World Patent Index, the OCE report found that the largest number of patents related to COVID-19 diagnosis were filed with China's State Intellectual Property Office (CNIPA). During the COVID-19 pandemic, the CNIPA has 2,643 patents related to COVID-19 diagnostics, far surpassing the 784 such patents filed with the United States Patent and Trademark Office (USPTO), which ranks second. International applications filed under the Patent Cooperation Treaty (PCT) account for 35% of COVID-19 diagnostic applications tracked by the OCE survey, and this number is expected to continue to rise as the PCT provides for a national phase within 30 months from the priority date, during which applicants can choose more countries to file. (Compiled from http://ipwatchdog.com)