Law Commons^™

Don't Tread On My Ip Rights: A Law And Economics Analysis Of "March-In Rights" Under The Bayh-Dole Act, Caitlin Grow

Cleveland State Law Review

The Bayh-Dole Act has been imperative to the development of the United States’ dynamic pharma-biotech sector. However, the use of march-in rights under the Bayh- Dole Act has remained controversial. On the one hand, there is the idea of market equilibrium with a need to secure health care for the public. Many believe march-in rights should be used to create this balance by regulating the pricing of drugs that were developed using federally funded research. On the other hand, some advocates recognize that the current relationship between public-sector institutions and business as the developers of basic research, and private-sector biotechnology …

University Inventions Reconsidered: Debunking The Myth Of University Ownership, Patricia E. Campbell

William & Mary Business Law Review

Most universities today assert ownership rights over all patentable inventions (and many other types of intellectual property) created by members of the university community, including faculty, staff, students, visitors, and others. Universities then attempt to license that intellectual property (IP) to third parties, in order to generate revenue for the university and to give the public the benefit of innovations developed by the institution, often with the use of federal funds. This Article provides an evaluation of the technology transfer policies and practices of U.S. universities. Part I surveys the IP policies of a representative group of universities, showing that …

Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan

Articles

The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …

University Research-A New Defense Under The Patent Law, Judith L. Curry, Bruce E. O'Connor

Journal of Intellectual Property Law

No abstract provided.

Intellectual Property Revenue Sharing As A Problem For University Technology Transfer, Jennifer Carter-Johnson

Akron Law Review

The Bayh-Dole Act, often credited with the explosion of university technology transfer, requires universities to incentivize invention disclosure by sharing the royalties generated by patent licensing with inventors. Many scholars have debated the effectiveness of university implementation of this requirement, and, indeed, the low rate of invention disclosure by academic researchers to the university is often a bottleneck in the technology-transfer process.

Unfortunately, most discussions focusing on inventor compliance with Bayh-Dole Act requirements have explored faculty-inventor motivations. However, in most cases, university inventions are joint products of a group of university members including not only faculty but also post-doctoral researchers …

University Ip: The University As Coordinator Of The Team Production Process, Samuel Estreicher, Kristina A. Yost

Indiana Law Journal

This Article focuses on intellectual property (IP) issues in the university setting. Often, universities require faculty who have been hired in whole or in part to invent to assign inventions created within the scope of their employment to the university. In addition, the most effective way to secure compliance with the Bayh-Dole Act, which deals with ownership of inventions involving federally funded research, is for the university to take title to such inventions. Failure to specify who has title can result in title passing to the government. Once the university asserts ownership, it then decides whether to process a patent …

Beyond Eureka: What Creators Want (Freedom, Credit, And Audiences) And How Intellectual Property Can Better Give It To Them (By Supporting, Sharing, Licensing, And Attribution), Colleen Chien

Michigan Law Review

In the theater of the courtroom or the rough and tumble arena of intellectual property policymaking, the day-to-day lives of creators are rarely presented. We often instead see one-dimensional vignettes, for example, “the new artist or band that has just released their [sic] first single and will not be paid for its success,” described on Taylor Swift’s Tumblr last summer when she initially withdrew from Apple’s music streaming service. While instructive, this description leaves out that Swift and other artists have long relied on “free play” mediums like radio and, more recently, YouTube to develop, not cannibalize, their audiences and …

When Tigers Bare Teeth: A Qualitative Study Of University Patent Enforcement, Jacob H. Rooksby

Akron Law Review

Part I provides a brief background on patent infringement litigation involving university plaintiffs, including information on the activity’s costs, historical incidence, and how leading voices within the technology transfer community view the activity. Part II details the methodology used in the study conducted for this article. It describes the research questions that guided the study, its theoretical framework, information on participants and how they were selected for inclusion, and other information concerning data collection. Finally, Part III presents and discusses the study’s findings, which are arrayed thematically.

The National Security Implications And Potential Solutions For The Unintended Consequences Of The 1980 Bayh-­‐Dole Act On Brain-­‐Injured Veterans From The Wars In Iraq And Afghanistan, Colonel Noel Christian Pace

University of Miami National Security & Armed Conflict Law Review

Traumatic brain injury (TBI) is the “signature wound” seen in veterans from the wars in Iraq and Afghanistan, from which the U.S. now has over 20,000 young veterans living with TBI. However, some unintended consequences of the Bayh-­‐Dole Act of 1980, a law designed to tap the “secret weapon” of federally funded research & development (R&D) to help the U.S. return to competitiveness after the recession of the late 1970’s, are now preventing these heroes from getting the treatment and cures they need. This article reviews the history of American academia’s close cooperation with the U.S. government in solving military …

Dissenting State Patent Regimes, Camilla A. Hrdy

IP Theory

No abstract provided.

Technology Transfer Laws Governing Federally Funded Research And Development, James V. Lacy, Bradford C. Brown, Michael R. Rubin

Pepperdine Law Review

No abstract provided.

Strict Interpretation Of 35 U.S.C. § 112: Requires Universities To Examine Their Patenting Methods, Sharon Barkume, Michael R. Bielski

Touro Law Review

No abstract provided.

Accountability In Patenting Of Federally Funded Research, Arti K. Rai, Bhaven N. Sampat

Faculty Scholarship

Bayh-Dole allows academic grantees to patent federally-funded research for purposes of promoting the commercialization of this research. To ensure commercialization goals are achieved, the Act requires grantees to report to funding agencies not only the existence of federally-funded patents but also utilization efforts they and their licensees/assignees are making.

Although reporting is a cornerstone of accountability under Bayh-Dole, information about grantee compliance with reporting requirements is incomplete and dated. In fact, the last significant study of the question dates back to the late 1990s and analyzes only 633 patents. Since that time, concerns have emerged that federally-funded university patents are …

Serious Flaw Of Employee Invention Ownership Under The Bayh-Dole Act In Stanford V. Roche: Finding The Missing Piece Of The Puzzle In The German Employee Invention Act, Toshiko Takenaka

Articles

This article argues that the current Bayh-Dole Act is incomplete because the Act fails to provide a mechanism for contractors to secure the ownership of federally funded inventions from their employees. Part I of this Article discusses this flaw in the current Bayh-Dole Act, highlighted by Stanford v. Roche, and argues that a historical accident resulted in this flaw due to Congress's failure to pass a series of bills based on the German EIA. Passages in the Bayh-Dole Act suggest that the Act assumes a transfer by operation of law to secure the ownership of federally funded inventions through …

Intellectual Property And Policy Issues In Biotechnology, Amy Iver Yancey

Masters Theses

Intellectual property, particularly patents, plays a major role in innovation and discovery in biotechnology. Likewise, since the passage of the Bayh-Dole Act in 1981, patents have become an increasingly important factor in U.S. university-driven basic research, especially in the life sciences where patented technologies have transformed agriculture. Specifically, this paper looks at the potential impacts of these trends on university driven research, the university researcher, the pharmaceutical industry, and the farm sector with an emphasis on recent and pending court cases and legislation. This paper examines policy and adoptions issues in biotechnology and biomedicine in depth and touches on important …

The Aftermath Of Stanford V. Roche: Which Law Of Assignments Governs?, Sean M. O'Connor

Articles

The discovery and commercialization of biotechnology innovations often rely on collaborations between universities and for-profit firms. In the United States, the federal government funds much of university life sciences research and, under the Bayh-Dole Act, has some rights to research arising from that funding.

Two important strands of invention ownership issues in this web of collaboration arose under litigation that culminated in the recent United States Supreme Court decision Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc. (“Stanford v. Roche” or “Stanford”). The first is the question of whether Bayh-Dole …

Unveiling The Distinction Between The University And Its Academic Researchers: Lessons For Patent Infringement And University Technology Transfer, Jennifer Carter-Johnson

Vanderbilt Journal of Entertainment & Technology Law

This Article explores the idea that a faculty member acting in the role of an academic researcher in the scientific disciplines should be viewed in the context of patent law as an autonomous entity within the university rather than as an agent of the university. The structure of the university laboratory within the university and the social norms associated with the activities that members of the research laboratory conduct supports such a view. Additionally, the data from the implementation of the Bayh-Dole Act reveal that universities and faculty scientists have different goals and motivations regarding the transfer of new technology …

University Software Ownership And Litigation: A First Examination, Arti K. Rai, John R. Allison, Bhaven N. Sampat, Colin Crossman

Faculty Scholarship

Software patents and university-owned patents represent two of the most controversial intellectual property developments of the last twenty-five years. Despite this reality, and concerns that universities act as "patent trolls" when they assert software patents in litigation against successful commercializers, no scholar has systematically examined the ownership and litigation of university software patents. In this Article, we present the first such examination. Our empirical research reveals that software patents represent a significant and growing proportion of university patent holdings. Additionally, the most important determinant of the number of software patents a university owns is not its research and development ("R&D") …

Is Bayh-Dole Good For Developing Countries?: Lessons From The Us Experience, Arti K. Rai, Jerome H. Reichman, Robert Weissman, Amy Kapczynski, Robert Cook-Deegan, Bhaven N. Sampat, Anthony D. So

Faculty Scholarship

Recently, countries from China and Brazil to Malaysia and South Africa have passed laws promoting the patenting of publicly funded research, and a similar proposal is under legislative consideration in India. These initiatives are modeled in part on the United States Bayh-Dole Act of 1980. Bayh-Dole (BD) encouraged American universities to acquire patents on inventions resulting from government-funded research and to issue exclusive licenses to private firms, on the assumption that exclusive licensing creates incentives to commercialize these inventions. A broader hope of BD, and the initiatives emulating it, was that patenting and licensing of public sector research would spur …

Asking For Money Back - Chilling Commercialization Or Recouping Public Trust In The Context Of Stem Cell Research?, Matthew Herder

Articles, Book Chapters, & Popular Press

As publicly funded institutions have increasingly embraced the goal of commercializing scientific research, concerns about private appropriation have become familiar refrain. One commonly suggested remedy is to create some kind of 'recoupment' provision whereby the State, on behalf of the public, receives a certain percentage of profits realized. The Bayh-Dole Act originally included a recoupment provision but it was deleted by a legislative committee. Countries around the globe attempting to emulate Bayh-Dole have, whether by design or default, reinforced the underlying logic against recoupment, which is essentially as follows: obligations to provide direct financial returns undermine the commercialization process and …

Freedom To Explore: Using The Eleventh Amendment To Liberate Researchers At State Universities From Liability For Intellectual Property Infringements, Gary Pulsinelli

Scholarly Works

In its 1999 decision in Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank, the Supreme Court held that the Eleventh Amendment protected states from suit for patent infringement, effectively making state universities immune from intellectual property suits. This Article analyzes how the Florida Prepaid decision affects researchers at state universities, and how those researchers may avoid liability under existing law. It first concludes that researchers at state universities might still be subject to injunctions against future infringement. The Article next observes that individual researchers at state universities might also face personal liability for damages, but then suggests that …

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

Academic Discourse And Proprietary Rights: Putting Patents In Their Proper Place, Margo A. Bagley

Faculty Articles

This Article provides a fresh perspective on the Bayh-Dole debate by focusing on the impact of patent novelty rules on academic discourse. The Article proposes that to begin to reverse an observed deterioration in disclosure norms, flexibilities must be built into the patent system so that patents can be facilitators of the academic knowledge dissemination enterprise. In particular, the Article advocates creation of an opt-in extended grace period that would provide more time for academic researchers to publish and present early-stage research before having to file a patent application. Such an extension, coupled with early application publication, would both address …

Harnessing And Sharing The Benefits Of State-Sponsored Research: Intellectual Property Rights And Data Sharing In California's Stem Cell Initiative, Rebecca S. Eisenberg, Arti K. Rai

Articles

This Article discusses data sharing in California's stem cell initiative against the background of other data sharing efforts and in light of the competing interests that CIRM is directed to balance. We begin by considering how IP law affects data sharing. We then assess the strategic considerations that guide the IP and data policies and strategies of federal, state, and private research sponsors. With this background, we discuss four specific sets of issues that public sponsors of data-rich research, including CIRM, are likely to confront: (1) how to motivate researchers to contribute data; (2) who should have access to the …

Share And Share Alike: Increasing Access To Government-Funded Inventions Under The Bayh-Dole Act, Gary Pulsinelli

Scholarly Works

The Bayh-Dole Act attempts to utilize the incentives of the patent system to persuade companies to develop inventions arising from government-funded research, allowing recipients of government funding to patent their inventions and then sell or license those patents as they see fit. The Act has, in many respects, succeeded in its goal of getting the results of government-funded research into the hands of industry, but sometimes at the cost of limiting or taxing future research. Thus, commentators have proposed changes to the Act that will help avoid these costs without destroying the benefits. One such proposal would require the National …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.

Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno

Law Faculty Articles and Essays

This Article discusses drug pricing in the context of federally funded inventions. It examines the “march-in” provision of the Bayh-Dole Act, a federal statute that governs inventions supported in whole or in part by federal funding. It discusses technology-transfer activity as a whole and the often-conflicting roles of the government, academia, and industry. The Article discusses the mechanisms of the Bayh-Dole Act and examines its legislative history. It notes that the Act has had a powerful price-control clause since its enactment in 1980 that mandates that inventions resulting from federally funded research must be sold at reasonable prices. The Article …

Ownership, Commercial Development, Transfer And Use Of Publicly Funded Research Results: The United States Legal Regime, Rebecca S. Eisenberg

Other Publications

This report summarizes key provisions of the United States. legal regime concerning ownership, dissemination and commercialization of the results of publicly funded research as background for a study on the feasibility of improving access by developing countries and economies in transition to environmentally sound technologies (ESTs) developed in other parts of the world.