An Updated Guide to the Bayh-Dole Act

Ah, COGR has not contacted me yet for help in revising their long-neglected Guide to the Bayh-Dole Act. While I waited for their call, I put together this text for a brochure that might serve until they have finished revising, correcting, and updating their Guide. It’s a draft, of course, and I expect I will be revising it in the coming days.

The Bayh-Dole Act:  An Updated Guide
to the Law, Implementing Regulations, and Impact

 

The Bayh-Dole Act Today

The Bayh-Dole Act, Public Law 96-517, has had far-reaching consequences. Bayh-Dole limits how federal agencies may require assignment of title to inventions made in faculty-led research supported with federal funds. The Act requires agencies to offer university-hosted inventors using federal funds a fundamental option for any invention they may make:  choose an invention management agent or allow the government to decide the disposition of the invention.

This freedom of choice gained by faculty, staff, and student inventors in directing their scholarly work, however, has been steadily eroded by university administrators lured by a desire to obtain windfall royalties promised by a coalition of patent licensing professionals. These professionals argued that the Bayh-Dole Act vested ownership of inventions with the university that hosted the research, giving administrators federal encouragement, if not approval, to license patent rights for profit.

Their arguments dominated university policies and practices until June 2011, when the U.S. Supreme Court in Stanford v Roche rejected the vesting argument and ruled that the Bayh-Dole Act manages only the claims that federal agencies may make on title to inventions made with federal support, not whether a university hosting federally supported research has any right to such title.

Today, federal research and innovation policy works in the environment created by the exploitation of the administrative misreading of the Bayh-Dole Act. Short of a substantial re-evaluation by university administrators and faculty, policy-makers must revise the Act to provide protections for inventors, so that they have the freedom to innovate that was originally enabled by the Bayh-Dole Act.

Introduction

As David Mowery and others have demonstrated, university involvement in invention management was robust by the 1970s. Archie Palmer’s work spanning three decades to encourage universities to adopt formal research and patent policies laid the groundwork for federal funding to scale at universities. Similarly, Research Corporation’s efforts in the 1970s to develop university technology transfer offices to support the identification and referral of faculty inventions to Research Corporation (and other invention management agents) for review played a significant role in institutionalizing support for invention management.

The Bayh-Dole Act proved attractive because of the strength of these university programs, and transformed them rather than created them. Technology transfer offices at universities moved from offering assistance to university-hosted inventors in their choice of invention management agent to displacing other agents with their own patenting and licensing services. To consolidate their positions, these offices shifted university policies from ones based on invention equity, under which a university might be granted rights, or income, or ownership based on a review of the circumstances of its direct support for the inventive work, to policies based on a claim of outright ownership. The Bayh-Dole Act was construed to make compulsory the university ownership of federally supported inventions. The compulsory requirement was then extended readily to all other inventions, and indeed to many forms of scholarly work that are not either inventive or patentable, such as data, materials, documentation, software, and instructional materials.

In June 2011 in the case of Stanford v Roche the Supreme Court ruled against the prevailing administrative interpretation of the Bayh-Dole Act, but university administrators have made little move to alter correct policies, practices, or educational materials pertaining to the Bayh-Dole Act. The implication is that despite the successful work of a diversity of invention management agents prior to Bayh-Dole, and the demonstrated flexibility of invention equity policies in place at the time,  the benefits of inventions made in faculty-led research will not be realized unless university administrators own, control, and have a majority financial stake in these inventions.

Background

The transfer of new technology by university faculty using the patent system was brought to national attention by the creation of Research Corporation in 1912 by University of California professor Frederick Cottrell, who had invented, with industry encouragement, a way to remove soot from smoke.(1) Cottrell simultaneously established an attractive way for university faculty to take an interest in patents without themselves leading commercial endeavors, demonstrated the effectiveness of using a nonprofit research foundation–itself a new concept–for the purpose, and in doing so created a national resource to which any faculty inventor could bring inventions for possible management, with proceeds after expenses shared with the inventors and their institutions, with any remainder dedicated to support meritorious research wherever in the country it might be found.

Just over a decade later, in 1925, Professor Harry Steenbock helped to create the Wisconsin Alumni Research Foundation (WARF) to manage his discovery that irradiated food protected rodents from vitamin D deficiencies. WARF was modeled on Research Corporation but was organized to benefit solely the University of Wisconsin. WARF demonstrated that an institution could partner with an affiliated invention management agent and so direct all funds after expenses back to the institution. Many research universities created similar research foundations over the next four decades, often contracting with Research Corporation for invention management services. By 1962, Archie Palmer counted more than fifty university-affiliated research foundations.

During World War II, Vannevar Bush led the federal government’s effort to mobilize university and industry research talent to develop new technologies responsive to the war effort. Advances in radar, sonar, atomic weapons, and digital computers were among the resulting innovations. Asked by Roosevelt for recommendations about how such teamwork might be employed for civilian interests, Bush and his colleagues produced Science the Endless Frontier in 1945, proposing the formation of a National Research Foundation, which would undertake to develop teamwork similar to what Bush had organized during the war–hosted by institutions but working independently on projects relying on the introduction of scientific knowledge slant from what established interests were aware of. The aim would that the results would provide security, health, and jobs.  Bush’s proposal resulted in the creation of the National Science Foundation, and started a substantial ramp up in government funding of faculty-proposed research.

The Bayh-Dole Act in 1980 transformed three decades of established national policy with regard to inventions made with federal support.(2) The incumbent policy emphasized federal agency flexibility in procuring and promoting the use of inventions made with federal support. Flexibility led to differences. Some agencies, such as National Science Foundation and Department of Defense, allowed contractors, including universities, to retain rights to inventions made with federal support that the contractors had obtained from inventors, while others, such as the Department of Energy, and especially the Public Health Service, did not. The National Institutes of Health, a unit of the Department of Health, Education, and Welfare, had worked out a scheme of case-by-case approvals for non-federal ownership of inventions, formalized by “institutional patent agreements” with a handful of universities and affiliated research foundations. The HEW patent policy was particularly disliked by the pharmaceutical industry, which had in the early 1960s launched a boycott against testing of NIH identified compounds. The NIH and WARF worked together to extend the institutional patent agreement model to all federal agencies, while simultaneously removing the opportunity for case-by-case agency review of invention management plans.(4)

Advocates for the Bayh-Dole Act offered various statistical arguments that the federal government was failing to manage patents on inventions that it owned.(3) By contrast, invention management agents appeared to be more successful in their patent licensing. Central to the advocates’ claims was that invention management agents were ready to offer exclusive licenses, while federal agencies preferred non-exclusive relationships. Since the passage of Bayh-Dole, universities and their invention management agents have repeated claims of success, but have not made public the raw data from which the claims are drawn. While it is entirely possible that university licensing offices have played important and beneficial roles in the development of certain inventions made with federal support, it is also possible that availability, development, or use of many inventions has been suppressed by universities adopting compulsory invention ownership policies inspired by Bayh-Dole.

In 2011, the U.S. Supreme Court ruled that the Bayh-Dole Act did not vest title of federally supported inventions in the universities that hosted the research. As a result, some universities have sought to augment compulsory assignment policies by adopting a present assignment approach under which faculty, staff, and in some institutions, even volunteers and visitors, are required to assign all future inventions they may make to the university. The argument now being made is that only by comprehensive, compulsory university ownership can the present system of university-run patent licensing offices be kept in place.

Evolution

After the passage of the Bayh-Dole Act, university administrators began a transformation in university invention policies and practices to better orient their institutions, according to their understanding, to best capture the royalties possible from exploiting patents. Invention policies were changed to indicate that federally supported inventions were owned by the university. Technology transfer offices were granted the authority to offer licenses directly rather than working through a contracted invention management agent.  Universities that referred inventions to external invention management agents were encouraged to create their own internal licensing programs.

As a result, the number of administrators involved in university-owned invention management soared. The administrative diversion of funds to support licensing operations is reflected in growth of the Association of University Technology Managers, a professional organization for which dues are routinely paid for members by university administrations.  According to the Council on Governmental Relations, in 1979, AUTM had 113 members.  Today AUTM has over 3,000 members. The rate of university-owned patents issuing has increased nearly twenty-fold from 1980 to 2011, although the relationship is not well established between university-owned patents and patents having university inventors, which may have been assigned to the government or industry, or owned at issuance by the inventors.(5)

The growth in university administration to manage patenting and licensing follows the growth of federal funds allocated to support faculty-led research. Major changes in what could be patented, including life forms and software, increased the scope of what could be claimed by patent. The introduction of provisional patent applications in 1996 that required no claims and could be filed at very low cost further increased the level of patenting activity, and associated administrative costs, without necessarily resulting in a greater proportion of federally supported inventions achieving practical application with benefits available to the public. While there is no question that universities are spending more money in the pursuit of profits from patent positions, there is scant evidence that their efforts have done anything to improve the productivity or impact of federally supported university research.

University-based technology transfer offices offer a range of important services beyond that of patenting and licensing inventions. Such offices may advise faculty and other research personnel on matters of policy, law, and innovation practice. They may participate in negotiating intellectual property provisions in research agreements and consortium agreements. They may assist inventors and entrepreneurs in starting new companies to develop university inventions. And they may build relationships with state and federal policy-makers concerned with science and research policy, economic development, and innovation. These functions are important contributions to a broad approach to university-facilitated innovation. None of these specialized functions, however, depends on a university claiming the exclusive right to own the creative work of faculty, staff, and students.

As university administrators moved toward increasingly arbitrary claims to ownership of creative work, supported by their reading of the Bayh-Dole Act, faculty collaborations with industry were adversely affected. In 2001, students at Yale University created Universities Allied for Essential Medicines, which challenged university patent positions and exclusive licensing practices with regard to important medicines that were not being made available in developing countries at affordable prices, even as universities were reaping millions of dollars in royalties. The active export worldwide of American university administrative interpretation of the Bayh-Dole Act has resulted in a number of countries adopting laws that require university ownership of faculty inventions.(6) The effect has been at many universities to allow the pursuit of exclusive licensing deals to take precedence over providing broad access to new medicines.(7)

Reciting a concern for compliance with Bayh-Dole, university administrators also demanded ownership of inventions and other developments made in research sponsored by industry, and at some institutions broadened their claims to ownership of inventions made in faculty consulting with industry. The standoff between university administrators and company sponsors resulted in the formation in 2003 of the University-Industry Demonstration Partnership, which aimed to negotiate new relationships between universities and industry, despite the implementation of the Bayh-Dole Act at universities. Other organizations have taken universities to task for patenting and exclusively licensing DNA and disease assays, practices enabled by the position that university administrators have taken on the Bayh-Dole Act. In recent years, universities have brought infringement litigation against a range of industry partners, increasing the level of distrust and uncertainty between universities and companies.(8)

Over time, the university administrative position on faculty inventions has come to resemble, in its arbitrary demand for institutional ownership of faculty creative work, that of the federal agencies that university administrators criticized in their advocacy of Bayh-Dole. The administrative position, however, has at some universities gone further and championed exclusive licensing, profit-seeking from patent positions, and direct institutional participation in speculative stock ventures as unquestioned public goods in support of innovation, enabled by the Bayh-Dole Act and implicitly endorsed by federal policy.

Some Perspective

The Bayh-Dole Act arose through the efforts of patent counsel at the NIH, allied with associates representing university-affiliated invention management organizations, to liberalize HEW policies with regard to ownership of patents made with federal support.  These efforts were supported by U.S. Senators Robert Dole and Birch Bayh. The Act was characterized by Senator Long as “the worst bill I’ve seen in my life,” and there is no question that Bayh-Dole suffers from defects in drafting and implementation that have permitted widespread misinterpretation of the Act, its implementing regulations, and the patent rights clauses that govern the disposition of inventions made in funding agreements between federal agencies and universities to support faculty-led research.

One of the primary arguments by advocates of the Bayh-Dole Act was that the law provide “certainty of title” to the owner of an invention made with federal support. By “certainty of title” was meant that under the appropriate conditions, an inventor and any assignee of the inventor would not be exposed to a claim to ownership by a federal funding agency. However, in the subsequent interpretation of the Bayh-Dole Act by some of its most vocal administrative supporters, certainty of title came to mean that the university as employer was assured by operation of federal law of the right to compel assignment of inventions made in faculty-led, federally funded research. These are very different meanings of certainty of title.

Advocates for the Bayh-Dole Act may argue that universities adopting compulsory invention ownership policies have been remarkably successful. However, universities have not publicly reported their activity specific to federally funded inventions. Although under Bayh-Dole universities may be required by federal agencies to report their invention management activities, the information provided to federal agencies is exempted by Bayh-Dole from federal government disclosure under the Freedom of Information Act.

Much of the dissonance between the Act and its implementing regulations as written and the subsequent re-interpretation of the Act stems from whether a given commentator follows the Supreme Court and construes certainty of title to pertain to federal agency claims, or follows now widespread administrative practice and construes certainty of title to mandate institutional ownership of faculty-led inventive scholarship. Underlying these two competing positions lies choices regarding the value of faculty independence in their research, instruction, and practice of what they discover and invent; the proper role and potential for subversion of university values with regard to commercial affairs; and the effects on fundamental research and industry collaboration of long-term compulsory institutional ownership and monopoly licensing.

These are not issues that Bayh-Dole properly anticipated and addressed. Indeed, it would not have been at all easy for the law to do so. These are, rather, issues that are latent in the conduct of university research, brought to light first by the intervention of substantial federal funds for the support of faculty-led research, and heightened by the expansion of patentable subject matter into areas that formerly were largely considered to be public domain.

It remains to be seen whether university administrators and faculty come to view Bayh-Dole as an inspired tool provided by the federal government that will transform universities into entrepreneurial invention developers or as a defective and misappropriated government intrusion that has diverted universities from their public mission to windfall profits from patents rather than contributing broadly and disinterestedly to the common good by making creative work widely and liberally available. It is possible that administrators and faculty may yet find a workable middle ground between these two positions, but to achieve such a compromise, university administrators will surely have to accept the basic freedom of choice provided to inventors by the Bayh-Dole Act.

How the Bayh-Dole Act Operates

The federal framework for managing inventions made with federal government support begins with the Bayh-Dole Act, at 35 USC 200-212, a part of US patent law. The Act delegates to the Secretary of Commerce the responsibility to create implementing regulations and standard funding agreement provisions, which are found at 37 CFR 401. Universities agree to a standard patent rights clause in each funding agreement. That patent rights clause is at 37 CFR 401.14(a). There are other patent rights clauses, and agencies may tailor clauses, so one has to check each funding agreement to know the requirements.

The premise of the standard patent rights clause is simple: inventors may assign title to an invention made with federal support to an invention management agent, which may also be their employer; otherwise, the federal agency that funded the research gets to decide whether the inventors may retain ownership of their invention, or whether the agency will request that they assign the invention to the federal government.

When inventors assign their invention, the invention management agent must decide whether it is going to retain that title, and if so, then the agent must use the patent system to promote the use of the invention. Much of the complexity of the law pertains to the minimum standards for such efforts and situations in which these standards are not met.  Additional requirements are placed on nonprofit organizations, including universities, regarding assignment of inventions, use of licensing income, and marketing efforts and preferences in licensing.

Current Regulations

Inventions made under a funding agreement are “subject” to the Act’s provisions, including the standard patent rights clause, when the inventions come to be owned by a contractor. The selected summary that follows focuses on universities, but unless noted the obligations are requirements that pertain to all contractors other than inventors who do not assign title to their inventions and are allowed by the federal funding agency to retain ownership of their inventions.

Universities are required to pass through the standard patent rights clause to any subcontractors. The patent rights clause also applies to anyone to whom the university assigns or delegates the university’s obligations under the funding agreement, including the patent rights clause itself.

Universities agree to delegate to their faculty and technical staff employees certain responsibilities under the standard patent rights clause.  The university must require inventors to make a written agreement to protect the federal government’s interest in subject inventions. Under the written agreement, inventors agree to report inventions to the university, sign paperwork to permit patent applications to be filed, and sign paperwork to establish the government’s rights in inventions. By delegating these obligations to inventors as substituted parties, the university makes the inventors parties to the funding agreement and therefore the inventors are “contractors” within Bayh-Dole’s definitions.

The university is required to report subject inventions within two months of receiving written notice of an invention to the federal agency that funded the research, to maintain a list of reported inventions, and to confirm at the end of each grant whether any subject inventions have been made.

If a university obtains title to a subject invention by assignment from the inventors, then it must undertake various minimum actions if it desires to retain that title.  The university must notify the government that it chooses to retain title, it must file a patent application [but only if it publicly discloses the invention, per the 2011 AIA amendment to Bayh-Dole–but the regulations ignore the amendment and continue to require a patent application within a year of election to retain title], and it must prosecute the application and maintain any resulting patents, or offer the invention to the federal government. The university must grant to the federal government a royalty-free, non-exclusive license to practice (make, use, and sell) and have practiced the invention. The university must report when requested by a federal funding agency on the status of subject inventions that the university owns, including state of development and licensing, the date of first commercial sale or use, and any royalties received.

As for licensing, a university must require in exclusive licenses for the right to use a subject invention or to sell products in the United States based on a subject invention that the product is substantially manufactured in the United States, unless the federal funding agency approves otherwise. If the university fails to bring an invention to practical application, or the university, any assignee and licensees are unable to reasonably satisfy health or safety needs, meet federal requirements for public use, or comply with the requirement for substantial manufacture in the United States, then the federal agency may “march-in” and require that the university, or any assignee, or exclusive licensee grant a license to one or more applicants, and if the university refuses to do so, then the federal funding agency may grant such a license.

Four additional requirements of the standard patent rights clause apply expressly to nonprofit organizations. Nonprofit organizations (i) may assign subject inventions only to organizations that have as a primary function the management of inventions. unless they get federal agency approval; (ii) must share royalty income with inventors as an expense incidental to the management of inventions; (iii) must use any remaining income after expenses for scientific research or education; and (iv) must make an effort to attract small business licensees (not merely license to some small businesses) and give these potential licensees preference to the extent that they present plans likely to bring the subject invention to practical application.

Compliance with Bayh-Dole’s Standard Patent Rights Clause

While a number of safeguards are built into the Bayh-Dole Act, universities have been selectively compliant and federal agencies vary in their oversight of the requirements of the standard patent rights clause. University administrators have chosen not to comply with the requirement for written agreements to protect the government interests. Instead, they have substituted increasingly draconian requirements that faculty, staff, and even non-employees assign all inventions to the university for management. By making such assignments take place at the earliest possible moment, administrators aim to mitigate exposure to a finding of non-compliance while eliminating the possibility that a university inventor be allowed to own and manage an invention made with federal support. The possibility that inventors retain ownership is expressly anticipated by the Bayh-Dole Act, but there has been no audit by the federal government of practices that have precluded the operation of this portion of Bayh-Dole.

Federal agencies have not, in over thirty years, ever used their “march-in” powers to grant licenses when subject inventions have not been timely developed for practical application.  In some cases, it appears that federal agencies have not been diligent in reviewing licensing programs for compliance with the U.S. manufacture requirement or efforts to attract and give licensing preference to small businesses.  Nor have federal agencies uniformly required substantive reporting of the status of subject inventions owned by universities. Finally, the federal government has not regularly reviewed the use that universities and other nonprofits have made of royalty income, to see determine that such income has been properly applied for expenses related to subject inventions (not all inventions and licensing generally) and that any remainder after expenses is used for scientific research or education (not research generally).

University requirements for assignment of inventions and other creative work developed in faculty-led research raise serious questions with regard to compliance with state laws limiting employer claims on employee inventions, academic freedom, proper use of eminent domain (especially in the case of public universities), and the effect of arbitrary institutional claims of ownership on independent initiative, economic development, and innovation.

Impact of the Bayh-Dole Act

The Bayh-Dole Act restricted the claims that federal funding agencies could make on the procurement of inventions in faculty-led research supported by the federal government.  That restriction in turn has created the opportunity for university administrators to adopt policies that compel assignment of those same inventions to the university or to the university’s designated invention management agent. Such university licensing programs have focused primarily on monopoly licensing to generate profits. To that end, these licensing programs have sought out licensees proposing to create and sell commercial products to the exclusion of broad, non-exclusive access for practice, further research in industry, and development.

While a few highly visible inventions have made it through this thicket of institutional controls and profit-seeking, a great many inventions have not. The story of the impact of the Bayh-Dole Act will be told not by a few stories of “success” resulting in windfall profits for exclusive licensees and university patent owners, but rather in the number of unlicensed subject inventions, and the subject inventions that were licensed but which never achieved practical application for public benefit.  The standard patent rights clause authorized by the Bayh-Dole Act expects the patent owner to use reasonable efforts for each subject invention, not to hold many subject inventions on the hope that a select few will be financially successful. There is no such concept of a “patent portfolio” approach in the Bayh-Dole Act or the standard patent rights clause.

The Bayh-Dole Act offered university administrations the opportunity to extend the robust, diverse approach to inventions made in faculty-led research that flourished in the 1970s by making available the inventions made with federal support. At the heart of this opportunity was the prospect that faculty and other inventors could choose their preferred invention management agents, and negotiate financial and operating obligations as conditions of assignment of subject inventions. University administrators with rare exceptions, have not allowed such choices to be made, choosing instead to eliminate such choice in favor of compulsory assignment and unilateral institutional control over patenting and licensing decisions.

While the growth of university administration expenditures in support of patenting and licensing of inventions arising in faculty-led research supported by the federal government is remarkable, the overall effect of the Bayh-Dole Act must be evaluated in the context of the loss of faculty choice and leadership in the management of their inventive scholarship, the dismantling of an independent and competitive marketplace for private invention management services, and the accumulation of substantial numbers of university-owned but unlicensed and unworked inventions, approaching the numbers that led to such sharp criticism in the late 1970s of federal agency invention management practices.

Conclusions

The Bayh-Dole Act is a study in contrasts. The Act made a bold restriction on the power of federal agencies to use the offer of funding to leverage ownership of faculty-led research inventions. The standard patent rights clause was brilliantly drafted to allow universities a wide array of opportunities for addressing the matter of patents in academia, from keeping the institution from any involvement in patent affairs to taking an active institutional role, even to the point of transforming the university into a corporate-style research organization.

But there are defects, too. The Bayh-Dole Act has failed to provide adequate protection for the choices of faculty inventors,  who were prized by Vannevar Bush for their independence from established institutional interests, whether of the military, medicine, or industry. The Act also failed to provide for adequate federal oversight of efforts to bring inventions to practical application so the benefits are available to the public. While investors and speculators in patent positions have found university ownership and monopoly licensing at times profitable, as have those offering legal services to universities, the impacts of the Bayh-Dole Act have not been reliably documented. There is little to indicate that the financial benefits accruing to speculators and law firms justify the subordination of university values to that of attempting to profit from patent positions.

The future of the Bayh-Dole Act remains in doubt. Strong institutional interests stand ready to defend the Act from any substantive review or revision. A new generation of faculty investigators lack the experience of working under a university invention equity regime rather than an institutional ownership regime, and may acquiesce in institutional ownership and control of their inventive scholarship. Industry may come to accommodate the fact that it must negotiate with university administrators and their contracted agents for each and every invention made with federal support, even if doing so fragments emerging technology platforms across multiple universities and exclusive licensees, with little prospect for interoperability, cross-licensing, or the formation of industry standards. However, universities have for the past century been a place of innovation when it comes to the management of discovery, and an approach that does not work may well be set aside in preference to practices better tuned to present circumstances, capabilities, and opportunities.

Notes

(1) Read Cottrell’s discussion of his reasoning here.

(2) Government-wide policy was established and confirmed through a series of executive orders beginning with President Roosevelt. The fundamental principles in place prior to Bayh-Dole was one of flexibility and promotion of use. Federal agencies should adapt their policies with regard to ownership to meet their operational needs, as supported by the circumstances.  See Sean O’Connor’s useful discussion.

(3) COGR recites a frequently repeated claim that the US Government held 28,000 patents in 1980, but that fewer than 5% of these were licensed to industry. These figures, while repeated in various combinations,  have never been substantiated. Rebecca Eisenberg has show that many of the government-owned patents were defense-related, and were inventions that defense contractors had declined to own. Eisenberg points out that the  licensing rate for federally owned biomedical patents was 23%–comparable to the best university practices for non-federally supported inventions.

(4) Reasons why federal agencies might not jump at the chance to allow university-affiliated invention management agents, or the universities themselves, to own inventions made with federal support include: i) university invention agents, unlike industry, lacked direct capability to develop inventions; ii) WARF in particular had had multiple run-ins on antitrust charges with the government; iii) exclusive patent licensing in private hands was not uniformly attractive to the advancement of research and outcomes, such as competitive bidding based on capabilities and efficiencies rather than patent monopolies.

(5)  AUTM membership and patenting figures for 2011 are here [that link is long gone. Here’s a summary of activity for 2011]. AUTM reports “fewer than 250” patents owned by universities and issued in 1980. A USPTO search for patents issued in 1980 to American universities returns at least 289 (more could have been assigned after issue). Research Corporation is listed as assignee of 109 patents in 1980.  WARF is listed as assignee on 28 patents in 1980. An additional 83 patents issued in 1980 to research foundations other than WARF, most of which represented university-based inventors. This count does not include patents made by university inventors and assigned to the federal government, or to companies, or owned by the inventors themselves. The number of patents issued on university inventions in 1980 is therefore at least twice the number cited by AUTM in its public information.

(6) AUTM lists fifteen countries that have adopted some version of Bayh-Dole.

(7) For an account of recent efforts to unwind Bayh-Dole inspired exclusive licensing, see Chen, et al., “The Silent Epidemic of Exclusive University Licensing Policies on Compounds for Neglected Diseases and Beyond.”

(8) Recent litigation includes Cornell University (against Hewlett Packard), University of Rochester (Pfizer), University of Illinois (Fujitsu), Stanford University (Roche Molecular), Boston University (Apple), University of California (Facebook), Columbia University (Illumina), Northeastern University (Google), University of New Mexico (Intel), University of South Florida (Elan), and University of Washington (General Electric).

 

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