The U.S. National Institutes of Standards and Technology has
released its Final Green Paper on its Return on Investment: Unleashing American
Innovation Project. Essentially, the ROI
project is intended to ensure that the United States receives an improved
return on investment with respect to public funding for research and
development. The Green Paper includes
stakeholder data identifying potential issues as well as proposals to improve
the technology transfer process. For
example, the Green Paper on stakeholder data states:
Return on Investment Initiative
– Summary of NIST’s Findings Based on Input from Stakeholders
Strategy 1 Identify regulatory impediments and
administrative improvements in Federal
technology transfer policies and practices
Government Use License: According to
stakeholders, the scope of the “government use license” is not well defined
March-In Rights: According to stakeholders,
the circumstances under which the government may appropriately exercise
march-in rights to license further development of an invention to achieve
practical application are not clear
Preference for U.S. Manufacturing: According
to stakeholders, existing statute supports the preference for U.S. manufacturing
but the process to obtain a waiver is confusing
Copyright of Software: According to
stakeholders, the “Government Works” exception to copyright protection for
software products of Federal R&D at Government-Owned, Government-Operated
Laboratories constrains commercialization
Proprietary Information: According to
stakeholders, an expanded protection period for proprietary information under a
Cooperative R&D Agreement would encourage greater collaboration with
Federal Laboratories Strengthen Technology Transfer at Federal Laboratories:
According to stakeholders, updates to policies and practices under the
Stevenson-Wydler Act could be simplified
Presumption of Government Rights to Employee
Inventions: According to stakeholders, the process to determine a present
assignment of invention rights by Federal employees to the Federal Government
is overly burdensome
Strategy 2 Increase
engagement with private sector technology development experts and investors
Streamlined Partnership Mechanisms:
According to stakeholders, improved clarity and use of best practices
government wide would streamline agreements and ensure greater transparency for
R&D partners
Expanded Partnership Mechanisms: According
to stakeholders, private sector investment for translational R&D and
technology maturation could be increased through expanded partnership
agreements and nonprofit foundations
Technology Commercialization Incentives:
According to stakeholders, recipients of Federal funding could benefit from a
limited use of R&D funding awards to enable intellectual property
protection
Strategy 3 Build a more entrepreneurial R&D workforce
Technology Entrepreneurship Programs:
According to stakeholders, expanding technology entrepreneurship programs at
Federal R&D agencies government-wide will help build a more entrepreneurial
workforce
Managing Conflicts of Interest: According to
stakeholders, current requirements for managing conflicts of interest pose
challenges to build a more entrepreneurial R&D workforce Strategy
Strategy 4 Support
innovative tools and services for technology transfer
Federal IP Data Reporting System(s):
According to stakeholders, a secure, modern platform is not available for
reporting data on intellectual property resulting from Federal R&D
Access to Federal Technologies, Knowledge,
and Capabilities: According to stakeholders, a federated data portal is not
available to easily access, use, and analyze information on federally funded
technologies, knowledge, and capabilities that are available to the public
Strategy 5 Improve understanding of global science and
technology trends and benchmarks
Benchmarking and Metrics: According to
stakeholders, current metrics to capture, assess, and improve broad technology
transfer outcomes and impacts based on federally funded R&D and underpinning
operational processes are inadequate
The Green Paper contains discussion and findings on all of
the strategies and subpoints. For example,
on the government manufacturing clause:
NIST Finding 1.
According to stakeholders, the scope of the “government use license” is
not well defined. Market uncertainty is created by the lack of a clear
definition of “government use” that is limited to use directly by the
government—or a government contractor in the performance of an agreement with
the government—for a government purpose only, including continued use in
research and development by the government. The scope of the government use
license should not extend to goods and services made, sold, or otherwise
distributed by third parties if the government—or a government contractor in
the performance of an agreement with the government—does not directly use,
provide, or consume those goods and services.
On using “march in rights” as a
form of price control, the Green Paper notes:
Stakeholders pointed to potential consequences from using
march-in rights as a price control. These reasons include impeding the creation
of new drugs and discouraging university and medical school licensees from
making the substantial additional investments necessary to develop and
commercialize new drug discoveries. A 2019 report from the Information Technology
and Innovation Foundation drew similar conclusions, noting that “[m]isusing the
“march-in right” provision of the Bayh-Dole Act could negatively impact U.S.
life-sciences innovation and result in fewer new drugs.”67 Other responses
focused on ensuring that new drugs reach the people that helped fund work
through Federal basic research.
The finding on “march in rights”
states:
NIST Finding 2. According to stakeholders, the circumstances
under which the government may exercise march-in rights are not well-defined.
Market uncertainty is created by the lack of a clear definition of the use of
march-in rights that is consistent with statute, rather than as a regulatory
mechanism for the Federal Government to control the market price of goods and
services.
The Green Paper also notes that stakeholders are very
concerned about the inconsistent and poor approach by the Federal Government to
the protection of trade secrets, which puts a damper on collaboration between the
public and private sectors. On page
121-125, there is a summary chart of strategies and findings, including an indication whether the solution should be legislation, regulation or both. The Green Paper is available, here.
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