Monday, 29 April 2019

The U.S. National Institute of Standards and Technology Green Paper on Improving Technology Transfer

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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