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TRENDS IN BIOTECHNOLOGY PATENT LITIGATION THE SEARCH FOR ELUSIVE CERTAINTY Jerry Cohen and Chester A. Bisbee

Abstract: Biotechnology patent litigation continues to increase. After 20 years of experience, some trends are identifiable that can inform the strategic management and defense of biotechnology inventions. Simultaneous inventions are often the rule in this field. In such cases, challengers to patent validity bear the burden of proof. Similarly, co-inventorship is often common, making the authorship on prior publications important. While the courts have clearly ruled that gene sequences cannot be obvious in light of previous partial sequence information, the result of future litigation over the partial DNA sequences called expressed sequence tags remains unclear. In addition, in patents from early stages in the development of biotechnology, the claims must be carefully drafted to be commensurate with the scope of the invention if the patent is to be upheld. The courts have also ruled that, even in the face of significant unpredictability in the art, biotechnology patent disclosures must be detailed enough to support the claims made. All of these factors serve to further heighten the difficulty for biotechnology companies and their patent counsel in successfully navigating the path to commercial success, a research scientist and more recently as an attorney and business consultant.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Material transfer agreements (MTAs) are legal agreements stating the terms and conditions under which proprietary research material—including, for example, cells, cell lines, chemical compounds, reagents, and other organisms—may be transferred from one investigator, institution, or company to another. MTAs are important because they require the recipient to exercise care in the handling of the materials and to maintain control over their distribution, to acknowledge the provider in publications, and to follow relevant Public Health Service (PHS) guidelines relating to recombinant DNA, the protection of human subjects in research, and the use of animals.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Although the United States government initiated the Human Genome Project (HGP) as a public research project, the HGP now attracts large amounts of funding from private research firms.1 Economic and financial forces play a substantial role in driving genetic research, which results in public and private firms collaborating to patent and ultimately to provide commercial use of genetic inventions. While this system adequately protects the financial risk and the genetic discoveries of the firms, the current patent system ignores the privacy and property interests of the donors who contribute the genetic information.2 Currently, there are no legal compensation plans for the donors, although some donor source groups have genetic information that may prove commercially valuable.

This article examines the competing and complementary interests of groups that provide genetic information and the research entities whose work may result in commercially viable medical innovations. Presently, the donor groups are relinquishing their proprietary interest in their personal genetic information for the public good, while the research entities that patent resultant medical innovations are reaping the financial rewards. This paper argues that, in the interest of equity, research firms should compensate the donor groups for disclosure of private genetic information. There are several options available to remedy this inequity, but any compensatory mechanism must be sensitive to costs and how such a mechanism would affect the efficacy of the genetic research. Further, this article analyzes current statutory and common law and discusses alternatives that balance the competing interests of the researchers and the donor populations. We conclude with a short summary of the issues and a look at future prospects.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Pharmaceutical firms are joining together as never before to produce more efficient and successful research and development (R&D) departments. Multibillion-dollar international mergers are creating headlines almost daily. For as many years as these firms have been combining their R&D departments, competition authorities have been watching the industry. As several analysts have recognized, the authorities’ attempts to regulate how pharmaceutical firms combine their R&D programs is currently an important antitrust issue.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Raising capital can be the most challenging task of a biotechnology company. The risk and uncertainty of new science and its applications are weighed against the potential benefits for end users, investors, and the company. In this column, the authors focus on the experiences of U.S. and European venture capital providers, as well as on the experience of a U.S. company. Barbara Piette and Joachim Rothe present the investor’s perspective of the factors that attract venture capital to a biotechnology company. Richard Woodrich shares insights about the business issues associated with the raising of capital from the biotechnology company’s perspective. This column is based on remarks provided at the Massachusetts Biotechnology Council (MBC) Annual Meeting (1998) held in

Insights from a U.S. Investor’s Perspective

Barbara Piette

Insights from a European Investor’s Perspective

Joachim Rothe, PhD

Insights from a Company’s Perspective

Richard H. Woodrich

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Xenotransplantation, the transplantation of tissue from one species to another, has become an area of active research and clinical development. This activity has spread into commercial development both at small biotechnology-based companies and in large pharmaceutical companies. This column highlights the scientific advances in solid organ xenotransplantation and presents them in the context of the safety and ethical issues that arise as this work progresses to the forefront of the clinical and commercial world.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Some groups have adopted a position of unqualified opposition to transgenic animal (TA) research, while the U.S. scientific research establishment takes a position of unqualified endorsement. I argue for an intermediate position. How we decide which type of TA research is justifiable depends on where we draw the line between animals entitled to the most basic of moral rights and animals that are not. I draw the line at those animals capable of desires or preference-interests, defined in terms of conscious practical reasoning.

Gary Comstock is a professor in the Philosophy and Religious Studies Department at Iowa State University. Some of the material in this paper was presented at the Iowa Philosophical Society in November 1990, at the American Philosophical Association in December 1991, the Texas A&M University Center for Biotechnology Policy and Ethics Discussion Paper Series in 1992, and in Ethics and Patenting of Transgenic Organisms, National Agricultural Biotechnology Council, 159 Biotechnology, Cornell University, 1992. The Bioethics Program at Iowa State University supported the author’s research. The author is grateful for the comments of Ned Hettinger, Steve Sapontzis, and colleagues at Iowa State University.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Despite a high media profile during the second quarter of 1998, Wall Street has shown little interest in the performance of biotechnology stocks. The sector is still underperforming the market as a whole, with biotech industry’s stock market average down 10 percent for the quarter. And despite product approvals for COR Therapeutics and Organogenesis, and extremely positive Phase III data from Genentech, Coulter, and Gilead Sciences, the investment community continues to be ambivalent to biotech industry’s progress. Instead, the market has been dictated by short-term profit takers, and new biotech issues are being greeted with muted enthusiasm. The small-cap portion of the market is not having a great year, and the biotech world is hurting even more.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Government representatives from both industrialized and Third World nations as well as many nongovernment organizations (NGOs) have argued that there is a need for both an international, legally binding "Biosafety Protocol" and the adoption of national regulatory frameworks in countries in which these are currently lacking. This is a positive development with which we concur. However, regulation of agribiotechnology must properly reflect both a perception of risk and an assessment of the possible social and economic impacts of a transgenic crop. In Third World countries (developing nations), assessments of relative risk and benefit will assume a different weighting. It is our premise that biotechnology should not be regulated in the Third World countries according to frameworks developed by industrialized countries.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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