Intellectual Property: Additional Agency Actions Can Improve Assistance to Small Businesses and Inventors

What GAO Found

The U.S. Patent and Trademark Office (USPTO) offers multiple programs that help small businesses and inventors with acquiring intellectual property protections, which can help protect creative works or ideas. These programs, such as the Inventors Assistance Center, are aimed at assisting the public, especially small businesses and inventors, with intellectual property protections. Several stakeholders GAO interviewed said that USPTO programs have been helpful, but they were also not aware of some USPTO programs. Although these programs individually evaluate how they help small businesses and inventors, the agency does not collect and evaluate overall information on whether these programs are effectively reaching out to and meeting the needs of these groups. Under federal internal control standards, an agency should use quality information to achieve its objectives. Without an agency-wide approach to collect information to help evaluate the extent to which its programs serve small businesses and inventors, USPTO may not have the quality information needed to fully evaluate the effectiveness of its outreach and assistance for these groups and thus make improvements where necessary.

Although the Small Business Administration (SBA) coordinates with USPTO through targeted efforts to provide intellectual property training to small businesses, it has not fully implemented some statutory requirements that can further enhance this coordination. While SBA and the Small Business Development Centers (SBDCs) coordinate with USPTO programs at the local level to train small businesses on intellectual property protection (see figure), this coordination is inconsistent. For example, two of the 12 SBDCs that GAO interviewed reported working primarily with USPTO to help small businesses protect their intellectual property, but the other 10 did not. The Small Business Innovation Protection Act of 2017 requires SBA and USPTO to coordinate and build on existing intellectual property training programs, and requires that SBA’s local partners, specifically the SBDCs, provide intellectual property training, in coordination with USPTO. SBA officials reported that they are in the process of implementing requirements of this act. Incorporating selected leading practices for collaboration, such as documenting the partnership agreement and clarifying roles and responsibilities, could help SBA and USPTO fully and consistently communicate their existing resources to their partners and programs, enabling them to refer these resources to small businesses and inventors.

Figure: The Small Business Administration (SBA) and the U.S. Patent and Trademark Office (USPTO) Coordinate at the Local Level, but Are Inconsistent

Why GAO Did This Study

Small businesses employ about half of the U.S. private workforce and create approximately two-thirds of the nation’s jobs. For many small businesses, intellectual property aids in building market share and creating jobs. Among the federal agencies assisting small businesses with intellectual property are USPTO, which grants patents and registers trademarks, and SBA, which assists small businesses on a variety of business development issues, including intellectual property.

GAO was asked to review resources available to help small businesses and inventors protect intellectual property, and their effectiveness. This report examines, among other things, (1) the extent to which USPTO evaluates the effectiveness of its efforts to assist small businesses and (2) SBA’s coordination with USPTO to assist small businesses. GAO analyzed agency documents and interviewed officials who train and assist small businesses. GAO also interviewed stakeholders, including small businesses, and, among other things, reviewed federal internal control standards and selected leading practices for enhancing interagency collaboration.

What GAO Recommends

GAO is making four recommendations, including that USPTO develop an agency-wide approach to evaluate the effectiveness of its efforts to help small businesses and inventors, and that SBA document its partnership agreement with USPTO and clarify roles and responsibilities for coordinating with USPTO to provide training. Both agencies agreed with GAO’s recommendations.

For more information, contact John Neumann, (202) 512-6888, NeumannJ@gao.gov

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OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.
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