GUEST EDITORIAL
	Making the World Safe for Biotech Patents Bruce A. Lehman
	FEATURE ARTICLES
	Patent Infringement in the Life Sciences Arena: Navigating Your Way through the Experimental Use Exception to Patent Infringement Hollie Baker and Emily Whelan
	Surviving A Catastrophe: Are You Prepared? Philip W. Fiscus
	The Sarbanes-Oxley Act of 2002: A Changing Landscape for Corporate Conduct Eugene W. McDermott, Jr.
	A Physician's Duty to Warn Family Members of Genetic Risks: Limiting the Importance of Tarasoff Scott Russell
	Patent Protection As A Paradigm Against Bio-Terrorism Boris Shakhnovich
	SPECIAL SEGMENT BIO-ASIA™
	Recent Landmark Biotech Patent Law Developments In Japan John A. Tessensohn and Shusaku Yamamoto
	The Life Sciences Industry in Singapore Khor Hwee Ping and Yvette S. Flanigan
	Informed Consent in Clinical Research: Policies and Practices in Singapore A.J. Ramachandran
	BIOCOLUMNS
	Business Strategy Biotechs: Turning The Corner to Profitability Suzanne K. Sterling, Andrew Sherman, Joshua M. Kaye
	Federal Circuit Describing Your Biotechnology: The Significance of Enzo Biochem & Eli Lilly Ashe Puri
	Financing Biotech Endures: Looking Back at 2002 and Ahead to 2003 G. Steven Burrill

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Making the World Safe for Biotech Patents Bruce A. Lehman

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

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Abstract: The economic realities of operating research laboratories on limited budgets, together with the potential for unintentional infringement, have prompted serious discussions among the academic, business, and legal communities about whether there should be a statutory infringement exemption for academic research. While Congress has the power to enact a statutory provision exempting certain research from patent infringement, so far it has declined to do so. The enactment of a statutory research exception defining permissible noninfringing uses of a patented invention in academic research would inform both scientists and industry of their rights and obligations toward patented technology. While granting a patent right to an inventor is intended to be a motivation to invent, yet that same right may act as a barrier to others in developing future inventions. For now, with the exception of selected activities exempted under current law, scientists who rely on the experimental use defense to shield their research activities apparently do so at their peril. This article highlights the key issues impacting the life sciences sector as a result of the lack of statutory provision for a broad research or experimental use exception in the United States (U.S.).

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

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Abstract: As biotech executives move to the front lines with patriotic and commercial fervor, many of their own firms remain vulnerable to terrorist threats and other catastrophes. From a business standpoint, a key lesson of September 11 was that companies that survive a catastrophe with a minimum amount of damage are inevitably those that plan ahead. However obvious the message, many biotechnology companies do not take the time to develop comprehensive plans that would reduce the likelihood and impact of a disaster; enable them to respond quickly and effectively to an emergency to ensure the safety of employees and to contain losses; and establish contingencies to stay in business during a disaster and resume normal business operations as quickly as possible. This article discusses specific protective measures that biotechnology companies should consider.

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

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Abstract: Corporate accountability, accounting reform and other governance issues have been making headlines since the current wave of corporate scandals began. Public reaction to real or perceived abuses or questionable accounting and disclosure practices have forced rulemakers at all levels to address issues of corporate governance and accountability. On July 30, 2002, President Bush signed the Sarbanes-Oxley Act of 2002 (the “Act”) into law. The Act addresses a wide range of issues relevant to publicly-held companies and their auditors, including auditor oversight and independence, corporate responsibility for financial reports, audit committee independence and enhanced financial disclosures. While the Act by its terms applies only to public companies, it also may have the effect of setting standards of conduct that many private biotechnology and life science companies will want to emulate, or at least consider, in order to meet investor expectations in corporate governance areas. This article provides an overview of the new legislation and issues pertaining to corporate governance.

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

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Abstract: This paper addresses whether a physician should be held liable for failing to warn family members of potential risks of genetic disease. Resolution of this complex issue requires consideration of physician-patient confidentiality, the psychological impact of the warning, the efficacy of genetic testing, and the need to protect the physical well being of family members. The paper concludes that application of the Tarasoff factors, which focus primarily on the foreseeable aspect of the threat and the identifiable nature of the third parties, is an insufficient means for determining whether this duty to disclose exists. Instead, in addition to the Tarasoff factors, a physician must consider a number of case-specific factors in deciding whether the benefits of disclosure outweigh the psychological effects of knowing of the disease and the public policy reasons behind physician-patient confidentiality. Likewise, a court should consider these same factors as applied to a hypothetical "reasonable physician" before concluding that a specific physician has a duty to warn family members potential of genetic threats. (11 pages)

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

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Abstract: In light of the tragic events of September 11, 2001 in NY, and the forthcoming anthrax cases, the determination and destructive power of terrorists are at the forefront of today’s sociopolitical debate. In this paper, the possible implications of recent developments in biotechnology with respect to making a weapon as well as creating paradigms for protection are explored. Further, this paper considers this problem in the framework of the United States (US) patent system and intellectual property protection rights. It is clear that viable strategies have to be developed in order to protect civilian populations against possible use of biological weapons against populated areas.

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

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Abstract: The ability to harness scientific breakthroughs through the establishment of patent rights is fundamental to the competitiveness of the world's biotechnology industry. Recently, Japan witnessed a pair of landmark patent developments that will affect the biotechnology industry in Japan - the world's second largest modern economy. This article discusses these developments and summarizes Japanese Patent Office's position on reach-through claims of so-called research tool patents thereby providing important signposts on the scope of patentable biotechnology inventions in Japan.

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

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Abstract: To create a favorable environment for biomedical sciences to flourish, Singapore’s Government is committing extensive resources and finances to establish a comprehensive infrastructure favorable for the development of the biomedical sciences industry in Singapore. In fact, the Government has set a formidable target of being the key business base of 15 world-class companies and a regional center for clinical trials and drug development by 2010. This article provides an overview of the Life Science industry in Singapore and describes the government initiatives designed to achieve these goals.

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

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Abstract: The policies and practices for obtaining informed consent from research subjects in clinical research play a vital role in determining a nation’s success as a center for clinical research. The difficulty lies in the fact that while on one hand, informed consent is a necessary pre-condition for ethical clinical research, a scrupulous observance of the guidelines for informed consent could, on the other hand, cripple medical research. Crippling of ethical medical research can be adverse to public interest and, consequently, unethical. Hence, a fine balance must be struck in the application of the guidelines for obtaining informed consent. This, in turn, would depend on the constitution and skill of research ethics committees who are appointed to consider and approve clinical research proposals. The discussion below addresses the above difficulty with recommendations that could further enhance Singapore’s image as a regional clinical trial hub.

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

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Abstract: Bringing a product from conception to market is no easy task regardless of the product type. In biotechnology, the task is complicated by uncertainties relating to financial support, Food and Drug Administration (FDA) approval, and third-party reimbursement. This article briefly highlights the hurdles faced by biotechnology companies in bringing a product to market and suggests possible strategies to achieve profitability. “We didn't realize that the science part, while difficult, is only the first step.”

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

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Abstract: This article addresses the Federal Circuit’s recent decisions in Enzo Biochem v. Gen-Probe and Regents of the University of California v. Eli Lilly concerning the validity of biotech patents under the written description requirement of 35 U.S.C. § 112, 1. The issues raised by Enzo Biochem and Eli Lilly are revealed by an analysis of the court’s application of the written description requirement to the original disclosure of the patent. The article concludes with a summary of the current state of the law of the written description requirement.

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

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Abstract: Having been in Wall Street’s penalty box for the entire year, the publicly traded biotech sector has finally bottomed, reversing its downward trend. Market capitalization for the biotech industry rose from $219 billion at the end of October to $225 billion as of December 9, 2002-an increase of 3% for the month and a half. Yet biotech’s down dramatically from its February 2000 high of $490 billion (down 54%), also down by 47% from its 2000 year-end market cap of $422 billion and its starting 2002 market cap of $382 billion (down 41% year to date). Despite significant revaluation and massive restructuring, biotech is in better shape than many expected...even prospering, contrary to public perception.

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

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