les Nouvelles September 2023 Article of the Month:
The Critical Importance Of The Bayh-Dole Act In The U.S. Energy Transition

Eric Payne

Graduate student
Colorado School of Mines
Golden, Colorado, USA

Abstract

To respond to the looming threat of climate change, the global community must transition to a low carbon energy economy. A robust pipeline of innovative technologies is needed to drive this transition. An often-overlooked law in the United States that promotes the commercialization of inventions developed by academic research organizations represents an expansive pipeline of innovative clean energy technologies needed to accelerate our transition to renewable energy. The Bayh-Dole Act provides academic research organizations the ability to own and license innovations they develop during government grants, therein generating massive economic benefits to the U.S. economy. In addition to generating novel technologies for commercialization, the government patent policies codified in the Bayh-Dole Act provide strong patent rights needed for startup company formation and investment while promoting public-private partnerships critical to advancing the diffusion of clean energy technologies to address rising greenhouse gas emissions. Several recent challenges to the Bayh-Dole Act have the potential to significantly compromise the effectiveness of the law in promoting the development and transfer of clean energy technologies from research organizations to the private sector for effective commercial development. Recent government investments in cleantech deployment will rely on clear government patent policies as enumerated in the Bayh-Dole Act to drive the U.S. transition to a low carbon economy.

1. Introduction

The United States has a rich history of supporting scientific research and development (R&D), which grew significantly during World War II and generated numerous technological innovations that were developed into products for civilian applications, including radar, jet engines, nuclear power, digital computers, mobile telecommunications, mass-produced penicillin, and anti-malarial drugs while driving massive economic growth (Mowery 2004, 22 and Gross 2020, 2). During the height of the war, federally funded innovation accounted for one out of every eight U.S. patent applications filed (Gross 2020, 28). From 1945 through the late 1970s it was the policy of the U.S. government to take ownership of patents developed during federal research grants. This policy impeded the ability of patent owners to effectively commercialize inventions they developed and led to a stockpile of innovations that were never commercialized. Prior to 1980, the U.S. government had accumulated over 28,000 patents with less than 4 percent of these inventions licensed to industry for commercial use (House hearings 94th Congress, 1976). Beginning in 1968, the U.S. government started to experiment with nongovernmental ownership of patents, where a small number of universities were allowed to own the inventions they developed in conjunction with federal grants as long as the U.S. government retained the right to “march-in” if the owner of the patent refused to grant a license such that the invention didn’t achieve practical application (Latker 1977 and Whalen 2015, 1098). As a result, between 1968 and 1978 university patent application filings increased by 300 percent, and the percentage of patents licensed to industry grew to 37 percent (Allen 2016 and Government Accountability Office 1998, 3). Policymakers observed that private sector players were significantly more motivated to commercialize inventions if the patents were assigned to the university so that exclusive licenses could be granted. Several high-profile innovations developed by universities and small businesses were held up by government ownership of patents, and these academic organizations started to lobby their lawmakers for change. In 1978, Purdue University approached Senator Birch Bayh (D-IN) about several important inventions developed by faculty with federal research grants where the university had tried, unsuccessfully, to secure ownership rights from the government needed to file patent applications and commercialize their inventions (Stevens 2001, 94). Thereafter Senator Birch Bayh partnered with Senator Bob Dole (R-KS) to develop and propose the Bayh-Dole Act to the Senate on November 21, 1980, where it was passed by unanimous consent and was then sent to outgoing President Carter for signature.

The Bayh-Dole Act emerged in the 1970s as the U.S. economy suffered through several massive energy shocks stemming from the 1973 OPEC embargo of oil exports to the United States. The DOE was only three years old when the Bayh-Dole Act passed in 1980 and the department was tasked with advancing energy R&D across several technical areas from nuclear, fossil, renewable energy, and energy efficiency under the paradigm of the Bayh-Dole Act where federally funded inventions would be transitioned to the private sector for commercialization. Renewable energy research at the DOE accelerated significantly in the mid-1990s after the passage of the Kyoto Protocol (Popp 2011, 649). The Energy Policy Act of 1992 established the DOE’s Office of Energy Efficiency and Renewable Energy to advance cleantech R&D priorities. As a result of sustained federal energy R&D investments over the past 50 years, the United States has significantly reduced per capita energy usage while aggressively driving down the cost of wind power, solar power, light-emitting diodes, and lithium-ion batteries, corresponding with a significant deployment of these technologies in the United States (IEA 2022). The DOE invested in several critically important energy saving programs that included vehicle fuel efficiency, advanced refrigeration, low e-glass and compact fluorescent lights while funding research to advance promising early-stage technologies that included high-capacity batteries, solar photovoltaics, proton exchange membranes for hydrogen fuel cells, and advanced wind turbine systems. Between 1975 and 2015, the DOE invested $12 billion in energy efficiency and renewable energy, which produced approximately $388 billion in net economic benefits (Dowd 2017, 2). These economic benefits were realized in large part because the Bayh-Dole Act enabled innovations funded by the DOE to be transitioned to the private sector for commercialization.

2. Patent Policy under the Bayh-Dole Act

The statutory regulations that implement the Bayh- Dole Act provide uniform patent policy across all agencies of the U.S. government. The Act provides certain non-federal entities (universities, small businesses, and non-profit organizations, including operators of federal laboratories) whose employees created the invention the right to elect title to subject inventions. The following conditions apply and are outlined in 35 USC §§200-212 and 37 CFR §§401.1-401.17. Exclusively licensed technologies used or sold in the United States must be ‘substantially manufactured in the United States’ unless a waiver is granted (35 USC § 204). The U.S. government retains a nonexclusive license to practice, and have practiced on its behalf, inventions made with federal funding (35 USC § 202). During the legislative development of the Bayh-Dole Act, several federal agencies expressed concerns that the proposed policy reforms may impact government interests in federally funded research (Stevens 2001, 98). To address these concerns, Senators Bayh and Dole introduced amendments, which were approved as part of the final law, that provided for a set of limited exceptions to the ownership paradigm in 37 CFR § 401.14 (Allen 2010). These exceptions (found in 37 CFR § 401.3.a.1-6) allow a federal agency to provide an alternative to the standard patent rights clause if the agency determines that exceptional circumstances exist that warrant a deviation so that the government can place additional requirements and obligations on ownership of inventions. The government also retains the ability to ‘march-in’ and utilize inventions in the case of a demonstrated need or when inventions have not been effectively commercialized (35 USC § 203). The Bayh- Dole Act specifies four circumstances under which the U.S. government can exercise march-in rights:

1. When the patent owner has not taken effective steps to achieve practical application of the subject invention,
2. When action is necessary to alleviate health or safety needs that are not satisfied by the patent owner,
3. When action is necessary to meet a public use specified by federal regulations, and
4. When the patent owner has failed to manufacture substantially in the United States.

3. The Bayh-Dole Act Promotes Economic Development and Cleantech Innovation

A globally meaningful response to climate change will require deep investments in R&D necessary to create a pipeline of clean energy innovations and careful consideration of the policy factors that effectively promote the commercialization of these inventions. In addition to establishing policies to promote clean energy adoption like standards, tax incentives, and rebates, governments play an important role in establishing policies that promote the commercial uptake of innovations developed by academic research organizations. Government patent policy under the Bayh-Dole Act has created immense economic value, has promoted the adoption of technologies, supported public-private partnerships, and helped companies secure the funding they need to further develop early-stage technologies into products and services in the market. Economic Development

Combined with increasing federal research funding, the passage of the Bayh-Dole Act in 1980 radically transformed the innovation ecosystem for government- funded innovations. The new patent policy significantly increased the industrial uptake of innovations, contributing significant economic, technical and social benefits to the United States. Between 1996 and 2020, it’s estimated that universities and small businesses operating under the Bayh-Dole Act have contributed between $333 billion and $1 trillion to U.S. gross domestic product and between $631 billion to $1.9 trillion to U.S. gross output, while creating between 2.356 million and 6.499 million jobs in the United States (Pressman 2022, 3). Similarly, the National Institute of Standards and Technology found that federal laboratories have contributed between $10.6 billion and $34.6 billion to U.S. gross domestic product and between $23.1 billion to $76.5 billion to U.S. gross output, and supported between 86,000 and 265,000 person hours of employment in the United States between 1996 and 2015 (Pressman 2018, 6). The Bayh-Dole Act also kickstarted an entrepreneurial revolution at American research organizations resulting in over 17,000 startup companies (Athanasia 2022 and Bayh-Dole Coalition).

Patent Protection

The Bayh-Dole Act supports strong patent protection for early-stage clean energy technologies so that the private sector can further invest in the development of these innovations needed for gigaton-scale carbon emission reduction. Economists and policy experts have studied the various factors that support the adoption of clean energy technologies and have found that strong patent rights promote clean energy technology diffusion (Lee 2009, 8 and Du Plooy 2013, 14). A study of patent data from 1990 to 2005 in over 120 countries found that robust patent protection enhances the willingness of IP owners to license and sell their innovations overseas (Park 2008, 28). Specifically, strong intellectual property rights have been found to promote investment in and deployment of renewable energy technologies (Tee 2021, 11).

Public Private Partnerships

Through policies established in the Bayh-Dole Act, the U.S. government and the private sector are complementary players in the commercialization of clean energy innovations through the formation of public-private partnerships (Ezell 2019). Government funding helps create and de-risk inventions at the earliest stages of research so that the private sector is more inclined to further invest in dedicated prototyping, scale-up, demonstration and distribution of clean energy technologies (Engel-Cox 2022, 9). As a result of the passage of the Bayh-Dole Act, nearly all major research universities and federal laboratories have specific missions focused on partnering with the private sector to commercialize innovative technologies. Partnerships between industry and academic research organizations often happen in the form of collaborative research grants, industry sponsored cooperative research and patent license agreements that accelerate early-stage research ideas toward market deployment. Private firms get access to government-funded intellectual capital in exchange for their financial capital and these public private partnerships add significant value to cleantech companies who increase their patenting activity by 73.7 percent for each additional government alliance they form (Doblinger 2019, 1468). Patent filings and commercial licenses enabled by the Bayh-Dole Act provide credibility to cleantech companies, improving their ability to secure financing from the private equity community (Conti 2013, 593 and Islam 2018, 49). Additionally, partnerships with government research organizations send an important legitimacy signal to investors, thereby increasing private financing of cleantech companies by 155 percent for every additional commercial license with a government organization (Doblinger 2019, 1468). The benefits of these public-private partnerships rely on clear and consistent government patent policy provided for in the Bayh-Dole Act.

Support for Cleantech Startup Companies

The Bayh-Dole Act provides strong support for cleantech startup companies who face unique development and fundraising challenges. Early-stage energy innovations developed by academic researchers often require significant amounts of additional funding to further develop technologies to a point where they are ready for commercial deployment. It’s estimated that for every $1 in federally funded research that results in technology, at least another $10 of private capital is needed to develop that technology into deployable products and services (Quinn 2013). Cleantech startup companies face significant challenges securing early-stage financing because they often have development timelines that are far too long for most traditional venture capital funds who look to exit within the first five years (Gaddy 2016, 2). As a result of these capital needs and long development timelines, cleantech venture capital has historically shifted its focus to investing in later stage startups who are closer to revenue (Saha 2017).

Given these long development timelines, cleantech startup companies rely heavily on U.S.-government- funded support for R&D where 34.6 percent of patent applications filed by new ventures from 1976 to 2016 cite federal grants (Fleming 2019, 1140). The Bayh-Dole Act allows startup companies using government research funds to own the inventions they develop and, as a result, cleantech startups increase venture capital funding by 67 percent within the first three years after their patent applications are filed, while increasing their initial public offer valuation by 128 percent (Farre-Mensa 2016, 28 and Farre-Mensa 2020, 667). Very little private capital would be invested in new energy ventures if these companies had to navigate the significant bureaucracy involved in securing patent rights directly from a federal agency. The Bayh-Dole Act has created a synergistic continuum of research, development and deployment of clean energy innovations that has become essential to the advancement of the cleantech movement.

4. Recent Activity in Bayh-Dole Act Implementation

Despite its resounding success at stimulating economic growth through the effective commercialization of government funded innovations, the Bayh-Dole Act is currently being challenged by several groups who want greater U.S. government control of inventions developed with federal support.

March-In Rights

Public health activists are lobbying the U.S. government to exercise its ‘march-in’ rights enumerated in the Bayh-Dole Act to control healthcare costs, arguing prices alone have impeded public access to therapeutic drugs that were discovered with government support (Feldman 2015, 4 and Arno 2001). These groups invoke 35 USC § 201.f, which requires Bayh-Dole entities to achieve practical application of inventions developed with federal funds or risk a potential ‘march-in’ by the U.S. government. Since 1980, there have been six petitions for the U.S. government to utilize its march-in rights, and all of these petitions have been denied with the U.S. government maintaining that the use of 35 USC § 203 to control prices is not statutorily supported (Thomas 2016, 8 and Whalen 2012, 1106). The most recent petition was submitted in 2022 by Senator Elizabeth Warren asking Health and Human Services to exercise its rights to authorize generic production of prostate cancer drug enzalutamide, sold under the name Xtandi (Warren 2022). Enzalutamide was discovered in 2000 at the University of California, Los Angeles through NIH and Department of Defense research grants totaling $500,000 (Cullinan, 2022 and Thomas 2016, 9). The university then exclusively licensed the drug to pharmaceutical company Medivation, which was eventually acquired by Astellas who went on to invest over $1.4 billion in further development of the drug through clinical trials (Astellas 2022). The NIH recently denied this petition, pointing out that public access to Xtandi had significantly increased as a result of the drug being licensed to Astellas (NIH 2023). However, the NIH announced an inter-agency review of the government’s march-in rights authority to include price as a consideration.

5. Conclusions and Policy Consideration

The Bayh-Dole Act emerged because of inefficiencies associated with government ownership of patents and federal agency involvement in the commercialization process. By providing appropriate incentives, academic research organizations developed the technology transfer expertise and infrastructure needed to identify and protect inventions and then license these inventions to the private sector for commercialization. U.S. government patent policy under the Bayh-Dole Act has produced a plethora of revolutionary innovations that have radically transformed the U.S. economy. Recent significant government investments in clean energy research, development and demonstration projects in the Inflation Reduction Act and Bipartisan Infrastructure Law have positioned the U.S. to aggressively transition to a low carbon energy economy. One study estimates the combination of BIL and IRA could reduce U.S. carbon emissions from the electricity grid 90 percent by 2030 (Budryk 2023).

The Bayh-Dole Act will be critical to ensuring that clean energy innovations developed at academic research labs are effectively transferred to industry for practical application to reduce our carbon footprint in the energy sector while promoting economic development. However, the Bayh-Dole Act currently faces significant challenges from organizations wanting to leverage a provision of the law to advance short-term political agendas that have the potential to significantly damage the U.S. innovation ecosystem.

A growing number of groups representing both academic research organizations and industry staunchly oppose the use of march-in rights, citing their concerns that such a move would destroy private sector investments in revolutionary innovations needed to better the human condition (AAMC 2022, NIST 2019 and GAO 2009, 14). An extensive review of the legislative history of the Bayh-Dole Act, including the U.S. government use license under 35 USC § 202 and the U.S. government march-in rights under 35 USC § 203, indicates Congress had no intention for either of these provisions to be used to control prices (Kersten 2022, Ezell 2016 and NIST 2019, 30). Further, several policy experts and even the NIH have evaluated the potential use of the U.S. government march-in rights and conclude that it would have little to no actual impact on lowering drug prices (Treasure 2015, 783). Proponents of using the march-in rights to control costs invoke 35 USC § 201.f which requires Bayh-Dole entities to achieve practical application of inventions developed with federal funds on reasonable terms. Practical application is defined in 37 CFR § 401.14(a) to mean the “manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.”

As it relates to research organizations operating under the Bayh-Dole Act, the ‘reasonable terms’ language refers to the financial terms of a license agreement between the patent owner and the company who licenses the patent for commercialization. Where the owner of IP rights resulting from government research refuses to grant a license on reasonable terms, the government can compel the patent owner to grant licenses or assume title of subject inventions and march-in to grant licenses itself to ensure the technology reaches practical application. There is no reference to ‘reasonable terms’ in the relevant regulations that would infer that the price of a product is an appropriate factor for the government to consider in its assessment of march-in petitions (NASEM 2020, 37). The use of march-in rights can be appealed by an affected “contractor, inventor, assignee, or exclusive licensee”, further supporting the position that the reasonable price provision of 37 CFR § 401.14(a) refers to commercial license agreements to functionally achieve the practical application threshold.

In responding to a 2012 petition asking the U.S. government to exercise its march-in rights to control the price of HIV drug Norvir, the Director of the NIH expressed the following concern regarding use of marchin rights under 35 USC § 203: “In addition, because the market dynamics for all products developed pursuant to licensing rights under the Bayh-Dole Act could be altered if prices on such products were directed in any way by NIH, the NIH agrees with the public testimony that suggested that the extraordinary remedy of march-in is not an appropriate means of controlling prices. The issue of drug pricing has global implications and, thus, is appropriately left for Congress to address legislatively.” (Zerhouni 2004, 5).

If the U.S. government now decides to expand the governments march-in rights authority to include the consideration of price, this poses substantial risks to the U.S. innovation ecosystem. Inappropriately threatening march-in rights to control prices would decouple the public-private partnerships that the Bayh-Dole Act has effectively promoted over the past 43 years. Investments in clean energy technology would face significant collateral damage, cutting off an important pipeline of inventions from government funded research organizations to the energy sector. Weakening patent rights under the Bayh-Dole Act would hobble the cleantech industry at a time when the global community desperately needs low carbon energy innovations. Further, if agencies of the U.S. government arbitrarily expand marchin rights as an instrument to control pricing, foreign governments will likely follow suit, either nationalizing patent assets or developing their own policies to fix prices. This will make companies licensing government funded innovation less willing to invest in and deploy cleantech innovations in developing nations where low carbon energy technologies are needed to substantially curb emissions. It’s imperative that the global clean energy community rally behind the Bayh-Dole Act so that lawmakers and federal agencies preserve the parts of the law that have made it so successful.

For example, investments in clean energy technology would face significant collateral damage, cutting off an important pipeline of inventions from government funded research organizations to the energy sector. Weakening patent rights would hobble the cleantech industry at a time when the global community desperately needs low carbon energy innovations. Further, if agencies of the U.S. government arbitrarily expand march-in rights as an instrument to control pricing en masse, foreign governments will likely follow suit, either nationalizing patent assets or developing their own versions of arbitrary laws to fix prices for innovations funded by governments. This will make companies licensing government funded innovation less willing to invest in and deploy cleantech innovations in developing nations where low carbon energy technologies are desperately needed to curb emissions. It’s imperative that the global clean energy community rally behind the Bayh-Dole Act so that lawmakers and federal agencies preserve the parts of the law that have made it so successful.

Recommendation—March-In Rights

The working group established by the U.S. Department of Health and Human Services (HHS) and the Department of Commerce to review the U.S. government’s authority under march-in rights should seek broad stakeholder input from public and private audiences to assess the potential impacts of the use of march-in rights on public-private partnerships and commercialization of federally funded innovations. In particular, the working group should engage industry, entrepreneurs, venture capitalists and startup companies who rely on stable government patent policies to raise funds necessary to invest in the development and commercialization of early-stage technology. Next, the working group and NIST should work to develop clear guidance on the appropriate use of the government march-in rights as specified in 35 USC § 203. The original legislative intent of the march-in provision of the Bayh-Dole Act should be considered. 35 USC § 203 was originally designed to provide the U.S. government the ability to compel patent owners to license their inventions or practice those inventions if they had not been licensed and effectively utilized. This guidance should include more extensive criteria used when assessing the potential use of the march-in provision of the Bayh-Dole Act. Remaining regulatory ambiguity will be leveraged by future activist groups to submit petitions for use of the march-in rights as a price control, thereby damaging trust in the patent system while straining public-private partnerships focused on developing innovative early- stage technologies.

Congress should consider adding clarity and specificity to both the ‘practical application’ and ‘reasonable terms’ definitions of 35 USC § 201(f). Practical application should be defined as ‘utilization increasing over time’ using an evidence-based method to measure public access to the invention as a result of the technology being licensed. This would allow a federal agency to rely on quantifiable measures of increasing availability to determine if the public benefits of the innovation are being fully realized. The ‘available to the public on reasonable terms’ provision of 35 § 201(f) should differentiate circumstances where the patent owner is a small business capable of directly selling products as opposed to a university or federal lab who rely on their licensees to sell products. In cases where patents are licensed to companies for commercialization, the reasonable term provision should apply to license financial terms and this distinction would significantly resolve concerns about the arbitrary use of government march-in rights. In addition to clarifying the ‘practical application’ and ‘reasonable terms’ provisions of march-in rights, the working group should consider other clarifications to 35 § 203, including limiting the use of government march-in rights once an invention is made available to the public as long as deployment consistently increases over time, accounting for the initial phase of development. Limiting the ability of the government to marchin after a private sector partner has invested significant resources in an invention protects industrial investment in early-stage ideas while preserving the governments interest if the technology has not yet been commercialized. Providing clear guidance on the appropriate use of march-in rights will dissuade spurious march-in petitions from being submitted. ■

Disclamer

This article represents the opinions of the author and the views expressed herein do not necessarily represent the views or policies of the National Renewable Energy Laboratory, the U.S. Department of Energy or the U.S. Government.

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