Thought Leadership

COVID-19 USPTO Resources for IP Protection and Licensing

Client Updates
The COVID-19 pandemic has significantly impacted the licensing and procurement of life science-related intellectual property. The immediate and crucial need for vaccines and other therapeutics for the treatment and prevention of COVID-19 has driven innovation leading to new IP protection and licensing strategies with respect to COVID-19 related technologies. For example, as vaccines have been developed and are being produced for distribution, a number of companies have implemented entirely new and much more flexible licensing strategies for the duration of the pandemic. For companies navigating this complex period, it is imperative to assess IP portfolios to identify subject matter for potential pursuit of protection or licensing, especially in view of recent tools and programs implemented by the United States Patent and Trademark Office (USPTO) for COVID-19 related technologies.

In response to the pandemic, the USPTO has created an online USPTO COVID-19 Response Resource Center1 along with several pilot programs and platforms to promote licensing as well as patent and trademark filings. With respect to patent licensing, the USPTO launched a web-based IP marketplace platform, Patents for Partnerships (P4P), for COVID-19 related technologies including, for example, personal protective equipment, disinfectants, ventilators, and testing equipment.2 In the future, the platform may be extended to include other technological areas. The platform provides a searchable and centralized database of patents and published patent applications currently available for licensing. Patent owners can benefit from the platform because it provides a channel to monetize patents which may be underutilized in their portfolios. A potential licensee can also utilize the platform to locate patents and published patent applications in areas of interest which align with current business plans and are immediately available for license. Overall, the platform is intended as a source of information to facilitate contact between potential licensors and licensees. As of early December, 892 patents and published patent applications were listed in the database and available for license.    

Aside from licensing, IP protection and procurement remains vital to expand and diversify current portfolios to include advancements in COVID-19 related technologies. IP protection also remains a valuable asset to incentivize investment, for example, in drug and vaccine development, which can be unpredictable and costly. Lastly, IP application filings can provide protection in new and uncharted areas of technology, which can be important to pursue especially during a period of rapid scientific research and development.

In this regard, the USPTO has also provided pilot programs to incentivize patent application filings, such as the COVID-19 Prioritized Examination Pilot Program.3 New patent applications are normally taken up for examination in the order of their U.S. filing dates. See Manual of Patent Examining Procedure (M.P.E.P.) § 708. However, in the program, the USPTO advances COVID-19 related patent applications out of turn for prioritized examination without payment of certain fees associated with the same. The program is available from July 13, 2020 up until the USPTO has accepted and approved a total of five hundred (500) requests. To be eligible, the application must contain one or more claims directed to a product or process related to COVID-19 and subject to an applicable U.S. Food and Drug Administration (FDA) approval. Such approvals can include, for example, 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). The Request (Pilot Program Form PTO/SB/450) must include certification of small or micro entity status and an executed Application Data Sheet (ADS). Large entities, on the other hand, can request prioritized examination under 37 C.F.R. § 1.102(e). With respect to application type, the pilot program is available (i) with the filing of a non-continuing original utility or plant nonprovisional application; (ii) with the filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 U.S.C. §§ 120, 121 or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or (iii) with or after the filing of a Request for Continued Examination (RCE) of such plant or utility application or of a national stage of an international application. Consistent with 37 C.F.R. § 1.102(e)(2), only a single request for prioritized examination filed with or after filing an RCE may be granted in an application. After prioritized status is granted, the USPTO aims to provide a final disposition on the application in one (1) year or less. As of November 30, 2020, the USPTO reported four hundred thirteen (413) Requests were filed, of which two hundred thirty-three (233) were granted. The USPTO has implemented other pilot programs related to COVID-19 technologies including The Deferred-Fee Provisional Patent Application Pilot Program and Collaboration Database 4, which requires immediate disclosure of patent specifications in exchange for deferment of the filing fee until the filing of a corresponding nonprovisional application.

The USPTO has similarly incentivized trademark application filings to help speed to market medical products and services to combat COVID-19. Since June 15, 2020, the COVID-19 Prioritized Examination Pilot Program5 accepts petitions to advance the initial examination of trademark applications for marks directed to COVID-19 related qualifying medical products and services without a petition fee. To be eligible, the trademark application must seek registration for certain medical goods or services related to COVID-19, including “pharmaceutical products or medical devices such as diagnostic tests, ventilators, and personal protective equipment, including surgical masks, face shields, gowns, and gloves, that prevent, diagnose, treat, or cure COVID-19” and are subject to approval by the FDA and “medical services or medical research services for the prevention, diagnosis, treatment of, or cure for COVID-19”.6 The application can include additional related goods or services. To participate, the Applicant must file a Petition to the Director under 37 CFR § 2.146(a)(3) seeking to have the Director exercise supervisory authority to advance the initial examination of the application out of its regular order. See Trademark Manual of Examining Procedure (T.M.E.P.) § 1710 et seq. If the petition is granted, the application will immediately be assigned to an examining attorney for review, which will expedite examination by approximately two months.

In the new year, assessment of IP portfolios in view of the above-referenced USPTO pilot programs, platforms and initiatives is essential to maximize IP procurement and utilization of current IP assets. For example, licensing opportunities for COVID-19 related technologies can be capitalized on by both licensors and licensees. The USPTO’s Patents for Partnerships (P4P) program can facilitate derivation of  profits for licensors from underutilized IP and simultaneously provide opportunities for licensees that align with current business initiatives. Further, with respect to IP procurement, Applicants seeking patent and trademark protection for COVID-19 related technologies can take advantage of the several USPTO initiatives for prioritized and expedited examination. In this regard, companies with COVID-19 related technologies can initiate the following action items in 2021:

  • Perform an IP audit for COVID-19 related inventions not yet applied for;
  • Apply for these patents and trademarks and request expedited examination procedures as available; and
  • Seek out licensing opportunities as needed.

Finally, in view of the changing landscape of IP procurement and licensing during the COVID-19 pandemic, periodic monitoring of available USPTO programs and platforms would also be beneficial in order to ensure optimal usage of the same in advancing company objectives.


1 https://www.uspto.gov/coronavirus/uspto-covid-19-response-resource-center

2 https://www.uspto.gov/about-us/news-updates/uspto-launches-platform-facilitate-connections-between-patent-holders-and; https://developer.uspto.gov/ipmarketplace/search/patents

3 https://www.uspto.gov/initiatives/covid-19-prioritized-examination-pilot

4 https://www.uspto.gov/initiatives/deferred-fee-provisional-patent-application-pilot-program-and-collaboration-database

5 https://www.uspto.gov/trademark/laws-regulations/covid-19-petition-prioritize-applications

6 See id.

 

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