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Biotechnology Dilemma 1: Patented Research Tools and Experimental Use

Michael A. Carrier

in Innovation for the 21st Century: Harnessing the Power of Intellectual Property and Antitrust Law

Research tools used by scientists are essential for innovation in the biotechnology industry. In recent years, the patenting of such tools has skyrocketed with many scholars and organizations ... More

Research tools used by scientists are essential for innovation in the biotechnology industry. In recent years, the patenting of such tools has skyrocketed with many scholars and organizations lamenting this development. They have focused, in particular, on reduced access to research tools and an “anticommons” characterized by multiple patentees exercising rights to exclude. This chapter addresses the question of whether scientists are able to use patented research tools. It argues that industry and academia have forged a relationship that, at least at the present time, has displaced the need for changes to the law. The chapter offers three proposals that could be implemented if the situation changes. First is to protect “experimentation” on the invention, which uses the invention to study its technology or design around the patent. Second, it offers an amendment to the Bayh–Dole Act (which encouraged the commercialization of nonprofit inventions) that would require universities and nonprofit institutions to reserve the right to use the invention for non-commercial research. Third, it recommends empirical study of user innovation among research tool innovators.Less

Commercializing University Technology and the Role of Start-Up Companies

Don Rose and Cam Patterson

in Research To Revenue: A Practical Guide to University Start-Ups

Universities are a rich source of scientific innovations. Translating these innovations into high-impact products and services involves commercialization of the innovation. The Bayh-Dole Act of 1980 ... More

Universities are a rich source of scientific innovations. Translating these innovations into high-impact products and services involves commercialization of the innovation. The Bayh-Dole Act of 1980 gave universities control over the commercialization process. As such, technology transfer offices (TTO) have been established at most universities. Their role is to both protect the innovation through patents and copyrights and license the innovation to an entity for commercialization. Heretofore, most of TTO’s have focused on licensing to large, established companies. Only in recent years have they turned to licensing to startups, many of which are founded by the inventor-faculty. Furthermore, many universities are going beyond licensing to develop programs supporting these faculty-founded startups, with the hope of achieving return on their investment, retaining and recruiting talented faculty, creating jobs, and fulfilling their mission by helping to solve significant problems such as un-met medical needs.Less

How an American technology cluster emerged and became sustainable: San Diego biotechnology

Steven Casper

in Creating Silicon Valley in Europe: Public Policy Towards New Technology Industries

The ability of the US economy to generate new technology industries, such as biotechnology, provides support to the contention that liberal market economies (LMEs) have a comparative institutional ... More

The ability of the US economy to generate new technology industries, such as biotechnology, provides support to the contention that liberal market economies (LMEs) have a comparative institutional advantage in generating radically innovative firms. However, the link between varieties of capitalism and innovation within LMEs has not been systematically explored. This chapter explores the link between institutions and the management of innovative competencies within a successful US biotechnology cluster — San Diego, California. It empirically examines whether national institutional frameworks within the US generate patterns of economic coordination in the areas of finance, employee incentive structures, and labor market organization that benefit firms, and are consistent with predictions of the varieties of capitalism approach. The policy context surrounding the US biotechnology industry is also discussed.Less

An Entrepreneur’s Guide to the University

Fiona Murray and Julian Kolev

in The Chicago Handbook of University Technology Transfer and Academic Entrepreneurship

The questions addressed in this chapter are: How can entrepreneurs engage effectively with universities to translate novel advances in science and engineering from idea to impact? What are the legal ... More

The questions addressed in this chapter are: How can entrepreneurs engage effectively with universities to translate novel advances in science and engineering from idea to impact? What are the legal rules shaping their engagement, what are the local rules and norms that entrepreneurs must understand? What incentives and expectations guide faculty attitudes towards entrepreneurs? This chapter answers these questions by examining the topic of technology transfer, not from the traditional perspective of the faculty member or technology transfer officer, but rather from the perspective of the entrepreneur.Less

The Bayh-Dole Act of 1980

Dennis Patrick Leyden and Albert N. Link

in Public Sector Entrepreneurship: U.S. Technology and Innovation Policy

This chapter argues that the Bayh-Dole Act of 1980, which allows small businesses and nonprofit organizations—especially universities—to take ownership of inventions funded with government support, ... More

This chapter argues that the Bayh-Dole Act of 1980, which allows small businesses and nonprofit organizations—especially universities—to take ownership of inventions funded with government support, is a prime example of public sector entrepreneurship. After presenting a description of the Act’s legislative history, the chapter turns to a discussion of the implications of the Act for private sector entrepreneurial activity. Particularly important in that respect are its facilitation of university technology transfer offices and the birth of proof of concept centers. The chapter then analyzes the Bayh-Dole Act as an example of public sector entrepreneurship using the conceptual structure developed in Chapter 3. Finally, the chapter closes with a detailed empirical analysis of the substantial economic impact of the Act and a formal model of university technology transfer.Less

Accountability, Government Rights, and the Public Interest: A Thirty-Year Retrospective

Arti Rai and Bhaven Sampat

in The Chicago Handbook of University Technology Transfer and Academic Entrepreneurship

This chapter examines the public interest provisions of the Bayh-Dole Act. A key aspect of protecting the public interest, in terms of this legislation, was a set of compliance and reporting ... More

This chapter examines the public interest provisions of the Bayh-Dole Act. A key aspect of protecting the public interest, in terms of this legislation, was a set of compliance and reporting provisions. These include the requirements to disclose government interests in federally funded patents and to report these patents to funding agencies. There have been few studies of compliance with these provisions and this chapter seeks to fill this gap. Evidence is offered on noncompliance in the biomedical area and in drug development.Less

Who Owns What? Private Ownership and Public Interest

Doogab Yi

in The Recombinant University: Genetic Engineering and the Emergence of Stanford Biotechnology

Chapter 5 analyzes how academic institutions, government agencies, and the nascent biotechnology industry argued about the legal ownership of recombinant DNA technology in the name of the public ... More

Chapter 5 analyzes how academic institutions, government agencies, and the nascent biotechnology industry argued about the legal ownership of recombinant DNA technology in the name of the public interest. It further reconstructs how a small but influential group of government officials and university research administrators introduced a new framework for the commercialization of academic research by linking private ownership and the public interest.Less

Philanthropy, Self-Interest, and Accountability: American Universities and Developing Countries

Devesh Kapur

in Giving Well: The Ethics of Philanthropy

This chapter looks at the role that academics have come to play in the developing world as consultants, educators, and practitioners. Universities and academics stand to profit enormously from these ... More

This chapter looks at the role that academics have come to play in the developing world as consultants, educators, and practitioners. Universities and academics stand to profit enormously from these activities and, despite the vulnerability of people in developing countries, and the potential influence that academics from elite universities can have, there is little to no monitoring or accountability. Academics who may have conflicts of interest, such as financial interests in patented technologies, which they recommend to developing countries, currently are not required to disclose the conflict. The author suggests transparency, possible fiduciary duties, and greater emphasis on strengthening the academy of developing countries.Less

Intellectual Property: Who Owns Your Inventions, Words, Data, and Specimens?

in Law in the Laboratory: A Guide to the Ethics of Federally Funded Science Research

This chapter examines intellectual property—patents and copyrights and the laws that govern ownership, including the Bayh–Dole Act, and the Federal Technology Transfer Act of 1986. It also examines ... More

This chapter examines intellectual property—patents and copyrights and the laws that govern ownership, including the Bayh–Dole Act, and the Federal Technology Transfer Act of 1986. It also examines tangible property in the form of biological specimens the value of which derives primarily from the information that can be extracted from those specimens. Case studies are included at the end of the chapter.Less

A Better Remedy

Fran Quigley

in Prescription for the People: An Activist's Guide to Making Medicine Affordable for All

Current law, along with limited changes to existing law, both provide many opportunities for access to affordable generic medicines. There are far better ways to develop medicines and to ensure ... More

Current law, along with limited changes to existing law, both provide many opportunities for access to affordable generic medicines. There are far better ways to develop medicines and to ensure access that the current system, and these better approaches recognise the human right to access essential medicines.Less

What Is Academic Research?

James W. Dean Jr. and Deborah Y. Clarke

in The Insider's Guide to Working with Universities: Practical Insights for Board Members, Businesspeople, Entrepreneurs, Philanthropists, Alumni, Parents, and Administrators

This chapter explains the nature and importance of university research in various fields, how and what research is funded, and the management and monetization of intellectual property.

Uneven Ascent 1980–1994

Robert McCaughey

in A Lever Long Enough: A History of Columbia's School of Engineering and Applied Science Since 1864

This chapter examines developments at Columbia University's School of Engineering and Applied Science (SEAS) during the years 1980–1994. The departure in 1980 of William J. McGill as Columbia ... More

This chapter examines developments at Columbia University's School of Engineering and Applied Science (SEAS) during the years 1980–1994. The departure in 1980 of William J. McGill as Columbia president marked the end of a crucial turnaround chapter in the school's history. His successor was Michael I. Sovern, the first Jew to become president of Columbia. This chapter first considers the changes implemented at SEAS's Department of Computer Science before discussing Columbia's response to the 1980 Bayh-Dole Act. It then evaluates the deanships of Robert A. Gross and David H. Auston, efforts to establish bioengineering at Columbia on a firmer foundation, and the establishment of the Morris A. Schapiro Center for Engineering and Physical Science Research. It also discusses the hiring of more women in the engineering faculty and the increase in SEAS admissions.Less

Funding

Jean E. Schelhorn and Joan M. Herbers

in Beyond Discovery: Moving Academic Research to the Market

Chapter 5 describes funding streams available for researchers and intellectual property (IP) obligations that accompany the award. The responsibility for initiating reports of inventions rests with ... More

Chapter 5 describes funding streams available for researchers and intellectual property (IP) obligations that accompany the award. The responsibility for initiating reports of inventions rests with the researcher, and thereafter other institutional offices become involved. The four major types of funding are intramural funds, external grants, industry sponsored agreement, and crowdfunding; they have variable expectations for how the results stemming from that funding can be commercialized. Consulting activity and special programs to promote commercialization such as I-Corps are treated briefly. Finally, we explore the crowdfunding environment, which has emerged as a source of early support for commercialization.Less

What Is to Be Done

Benjamin Ginsberg

in The Fall of the Faculty: The Rise of the All-Administrative University and Why It Matters

Professors, Taken As a group, are far from perfect. They can be petty, foolish, venal, lazy, and quarrelsome. Nevertheless, at its best, the university is a remarkable institution. It is a place ... More

Professors, Taken As a group, are far from perfect. They can be petty, foolish, venal, lazy, and quarrelsome. Nevertheless, at its best, the university is a remarkable institution. It is a place where ideas are taken seriously; where notions that are taken as givens elsewhere are problematized; where what has seemed to be reality can be bent and reshaped by the power of the mind. The university is also a vitally important social institution. Chief Justice Warren, quoted in chapter 2, said American society would “stagnate and die” without free scholarly inquiry. In truth, society would not die, but it would become more stagnant without the philosophical and scientific concepts that are conceived and debated on university campuses. In the sciences, university laboratories continue to be a source of ideas that promise not only to improve established technologies but, more important, to spark the development of new technologies. This is why the Bayh-Dole Act and its encouragement of patent thickets and an anticommons in the scientific realm is potentially so destructive. In the humanities, the university is one of the few institutions to encourage and incubate new visions and modes of thought. Where else are smart people paid primarily to think and rewarded for thinking things that haven’t been thought before? The university, moreover, is a bastion of relatively free expression and, hence, one of the few places where new ideas can be discussed and sharpened. The old left, new left, neocons, and neoliberals of recent years all had their roots in academia. Political impulses that changed American life, including the “new politics movement,” the peace movement, civil rights movement, feminist movement, gay rights movement, environmental movement, the conservative legal movement, and a host of others were nurtured, if not launched, on university campuses. And why not? The university is a natural center of ideological ferment and dissent. The recipe is a simple one. simple one. Take large numbers of young people, add a few iconoclastic faculty members, liberally sprinkle with new ideas, place into a Bohemian culture, and half bake. Less