Click to buy Guest Editorial (3 pages)

Cartography, History, Genomes and Intellectual Property Juan Enriquez

Abstract: As we complete a draft of the human genome, the world is breeding three new kinds of genoskeptics. Sometimes they are scientists, like the distinguished doctor who celebrated the genome by grumbling: "They have to say something about a worthless database." Other curmudgeons act like Chicken Little, fearing we will all facekiller genes. This second variety is global, but tends to be more concentrated and vocal in Europe. A final group moans and groans because a brash upstart upstaged the work of decades. It seeks to discredit and block another groups' publications. Often members of this final group are fed by public funds.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article (7 pages)

Collaborative Agreements in Biotechnology: Issues in Global Negotiations from the U.S. Perspective Raymond S. Fersko and Richard A. Bornstein

Abstract: This article reviews the specific issues of patent misuse, a licensee's right to challenge patent validity, distinctions in United States (U.S.) federal and state law, considerations of jointly owned patents and antitrust concerns in the context of international collaborations wherein there are issues of U.S. law.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The trend for technology companies to identify partners and to develop joint research alliances and collaborations on all aspects of product development and commercialization has increased dramatically over the past decade. While all collaborative arrangements are unique, collaborations between United States (U.S.) and European partners require additional attention to specialized arrangements. This article describes the basic agreement structures commonly developed among partnerships involving the U.S. and European biotechnology sector.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The world is swiftly becoming a single marketplace. Increasingly, companies find that staying ahead in this game of global exchange means reaching beyond the confines of their borders to take advantage of opportunities and resources abroad. And for many, the pull to do business in the United States (U.S.), with its vast, sophisticated and accessible marketplace, is simply irresistible. But venturing across the Atlantic can be tricky. Upon arrival, companies find themselves confronted by intricate and complex issues in areas such as employment legislation, legal disclosure, product licensing, intellectual property protection, and securities regulation. Even executives and managers who have travelled extensively and done business in the U.S. can suddenly feel they're in a confusing universe. Newly-arrived executives are likely to encounter commercial landlords, planning authorities, state and federal regulators, and institutional lenders each speaking their own bewildering and idiosyncratic language, and each making their own specialized legal demands. This article is written to highlight the key issues and decisions that are involved for biotechnology and life science companies interested in establishing a business to make their experience in America a rewarding adventure.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: During recent years, corporate venture capitalists have become an increasingly important source of finance for technology based new firms. Earlier research suggests that both independent venture capitalists and corporate venture capitalists often provide significant value-added benefits for their portfolio companies. However, there is little research which actually compares and contrasts the value-adding capabilities of independent venture capital and corporate venture capital investors. In this paper, we focus on the differences in the value-added benefits provided by the two types of investors to their portfolio firms. The analysis is based on a survey of CEOs of U.S. technology based new firms which have been financed by both corporate venture capital investors and independent venture capital investors.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The United States (U.S.) leads the world in government support for non-military research and development (R&D), especially support for work that directly relates to health and human development. A focal point for such investments to date in biomedical research has been the National Institutes of Health (NIH), receiving $23.3 billion in fiscal year 2002. Whether internal or externally based, the biomedical research performed has led to a large variety of novel basic and clinical research discoveries - all of which generally require commercial partners in order to develop them into products for hospital, physician or patient use. This article describes the role of the NIH, including ways in which it works with corporate partners or licensees to commercialize its funded research into products in order to help fulfill it mission as a healthcare agency within the U.S. Department of Health and Human Services (DHHS).

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The ability to successfully lead a life sciences company requires not only unique managerial skills but also an acute awareness of all factors impacting research and development (R&D) and the commercialization process. In this BioLaw & Business Thought Leader Interview, we ask Dr. Una S. Ryan, CEO of Avant Immunotherapeutics to address the key science and technology policy issues facing industry, government and society today. From pharmacogenomics to ethics advisory boards, Dr. Ryan highlights the most pressing issues facing the life science companies and considers the future impact of the molecular revolution.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Employees in key technical or business positions are likely to have access to valuable trade secrets and to be highly mobile and attractive to competitors. Companies sometimes use non-compete agreements to address the risks created by the potential departure of such employees. Employees, however, anxious to preserve their ability to exploit new opportunities, often are reluctant to sign non-competes. Employers and employees alike should be aware of a doctrine that some courts have used to safeguard trade secret information of a former employer even in the absence of a written non-compete agreement: the doctrine of inevitable disclosure.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The Bush administration surprised many by the approval without major revisions of the Clinton administration's HHS medical records regulations, despite heavy lobbying from the health industry. Though these "privacy rules" are supposed to protect patient confidentiality, what has gone unmentioned are the regulations' major lapses that breach informed consent and confidentiality. Recently issued "clarifications" of the regulations reveal that they do not prevent unconsented access to sensitive medical information by marketers, health plans, health care clearinghouses, and law enforcement. These problems with the regulations constitute a serious breach of patient privacy, endangering the doctor-patient relationship and potentially driving up health care costs, and need to be addressed.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Section 505(b)(2) of the Food, Drug and Cosmetic Act provides a rapid way to obtain Federal Drug Administration (FDA) approval of National Drug Applications (NDAs) for new uses of approved drugs based on FDA's prior approval without the originator's consent. This article describes a recent petition and activities pertaining to generic drugs and emerging regulatory issues.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Young, growing companies need money. Investors want information before parting with that money. And intellectual property rights can be lost if too much is disclosed under the wrong circumstances. How do you say what must be said without compromising the future? This article describes do's and don'ts of disclosure.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Discussions of the issues arising from biotechnology are often complex and disjointed. In order to provide a framework for better policy discussion, this article presents the idea of "bio-commerce." First, this article provides a descriptive analysis of the conditions leading to this new process of providing incentives for innovation and commercialization. Second, it divides this process into four phases that can be utilized to better frame the current issues.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: EuropaBio, the European Association for Bio-industries, represents 40 corporate members operating world wide and 14 national associations (totaling up to 700 small-and medium-sized enterprises) involved in research, development, testing, manufacturing, sales, and distribution of biotechnology-derived products and services in the field of health care, agriculture, food, and the environment. AGE is a group of researchers and university professors involved in high-level professional activities related to bioethics, and particularly interested in ethical issues related to the development and use of modern technology. It is essential that industry actively participates in, and contributes to, the social debate on emerging technologies. Therefore, EuropaBio presents herein its view on gene therapy and its responsible development and use.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: In what has been a very difficult year economically around the globe and a very tough equity market, $12.9 billion was invested in the biotech sector in 2001, making this the second-best year for financing in biotech's 30-year history. Rebounding after the tragedy of 9/11, biotech raised $4.6 billion in 4Q01, double the $2.2 billion raised in the previous quarter ($2.1 billion in 1Q01 and $3.9 in 2Q01). Moreover, the market cap for the industry, $366 billion, by year-end, shot up 20% from $305 billion at the end of a devastating September 2001, yet was off by 13% from the $422 total at the end of December 2000. The announcement of four major biotech/biotech mergers-one breaking all size records-along with two IPOs, and dozens of partnerships provided plenty of stimulus during the 4th quarter as did the newly emergent biodefense industry.

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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