Click to buy Guest Editorial (4 pages)

Special Challenges in Applying Genomics to Population Health Gilbert S. Omenn

Abstract: With the remarkable and well-publicized progress in completing "working draft" of the sequence of all the genes on all the human chromosomes - as well as the genomic sequences of E. coli, yeast, the fruit fly Drosophila, the roundworm C. elegans, numerous pathogenic microbes, the plant Arabidopsis, and (coming soon) the mouse - attention is turning to the most useful and most appropriate applications of knowledge of these genomes. In clinical medicine, we see already emerging more specific diagnoses of clinical conditions, improvements in therapeutic margin by distinguishing patients more or less likely to benefit from or suffer adverse effects from particular pharmaceuticals, and new approaches to drug discovery and drug development.1 We also recognize numerous ethical, legal, and policy challenges, ranging from questions about what criteria should be applied to declare asymptomatic persons more or less susceptible than "normal" to develop a particular serious disease--to who owns the rights to genes identified in blood samples or tissues of specific individual patients.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature (7 pages)

Bionegotiation: Points to Consider in Negotiating Global Research & Development Agreements Raymond S. Fersko

Abstract: Given that biotechnology is a field that has grown through collaborative efforts, it is rare that one company possesses all the patents, technical information and know-how necessary to develop a product; and, even if it does, biotechnology and life science companies often may need another company's regulatory expertise and/or manufacturing and/or distribution capability to bring a product from the lab bench to the market. There are recurrent issues in all negotiations and certain rules that seem applicable and common to all transactions, yet certain distinctions are unique depending upon the parties involved. This article illustrates these common issues highlights some of the practical legal issues to consider when negotiating (R&D) agreements in domestic, international and governmental contexts.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature (5 pages)

Protecting Human Research Subjects Philip W. Fiscus

Abstract: In early November, little more than a year after 18-year-old Jesse Gelsinger died in a gene-transfer trial at the University of Pennsylvania, his family reached an unspecified settlement with the research team and institutions involved in the experiment. Although the settlement with the university brought closure to the lawsuit, Gelsinger's death raised lingering concerns about the risks of clinical trials involving human subjects. Government investigations and hearings in the wake of the tragedy have led to greater scrutiny of how organizations conduct clinical trials and efforts to strengthen protections of human subjects. This well-intended scrutiny comes at a time when clinical trials are growing dramatically in number and complexity. This article outlines some of the emerging issues concerning human subject research as well as possible procedures for handling the associated risks.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature (10 pages)

Clinical Trials Face Heightened Scrutiny as Science and Commerce Appear to Merge Alvin J. Lorman

Abstract: Clinical trials involving human subjects face increased scrutiny and regulation by the federal government that may lead to costly changes to the process. Prompted by a highly publicized death in a gene therapy trial, federal regulators are examining almost all aspects of clinical trial conduct, from how patients are recruited and how they give informed consent, to the relationship between the researchers and the company sponsoring the research. In addition to heightened regulation, the government has announced that it will seek the power to impose civil money penalties on researchers who do not observe applicable patient protection regulations. In an effort to include more senior citizens in clinical trials, the government for the first time will cover certain costs of Medicare beneficiaries who participate in clinical trials. The risk of increased government involvement includes criminal prosecution of physicians for failing to follow the rules, as an innovative case in California demonstrates.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature (5 pages)

Marketing Your Intellectual Property: Preparing for Due Diligence Kenneth H. Sonnenfeld

Abstract: Parties involved in negotiating the transfer of intellectual property (IP) rights face a variety of risks having the potential for reducing the value of the deal, or derailing it entirely. Through a process of due diligence, parties disclose information to one another so that they can identify and minimize those risks. At the heart of the intellectual property due diligence analysis is an investigation of three major issues: 1) ownership - are the intellectual property rights owned by the appropriate party?; 2) use - can the technology covered by the intellectual property rights be used, or is it dominated by patents belonging to others?; and 3) transfer - does the party offering the intellectual property rights have the lawful rights to do so?. By identifying as many facts concerning these issues as possible during due diligence, both parties increase their level of security and the probability of a successful closing on a valuable deal.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature (7 pages)

Global Trademark Protection for Biotech and Life Science Companies: What It Takes to Get through the Trademark Thicket Bruce D. Sunstein

Abstract: For trademark protection of it goods and services, the biotechnology company must consider the scope of the business encompassed by products or services to be branded with the trademark. For a domestic business, there must be considered issued and pending United States (US) federal trademark registrations as well as trademark uses that have not be the subject of such registrations. Increasingly, foreign trademark considerations enter the picture, however, and need to be considered at the same time. Moreover, the widespread use of web sites means that Internet domain name registrations must also be taken into account. If the product is a drug, a further layer of regulation is added by the Food and Drug Administration (FDA) and foreign counterpart agencies. When all of these points of reference are considered, one may finally settle on a trademark, which can be made the subject of US (and typically within six months thereafter) foreign trademark filings; at the same time as the US filing, one should also register pertinent domain names. A coordinated strategy is necessary in order to maximize trademark protection. This article provides an overview of the key issues that biotechnology and life science companies must address branding strategies and seeking global trademark protection.

 ©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Biocolumn Genome Issues (3 pages)

Mapping of Human Genome Raises Serious Issues For Individual vs. Corporate Rights Jamie Court

Abstract: Unrestricted corporate control of genetic technologies opens a pandora's box for the balance of power between individuals and corporations. This column provides an overview of the issues raised by commercialization of the human genome from a citizen advocate's perspective.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Biocolumn Medicare (3 pages)

New Criteria for Medicare Coverage Decisions Will Impact Medical Technology David Szabo and Maria Buckley

Abstract: Medicare is changing its rules for the coverage of new medical technology. At one time, new medical technology, whether in the form of an innovative medical procedure, new technology, or a new drug or biological, could readily find a place in the market once is was approved for sale by the United States (US) Food and Drug Administration (FDA). Increasingly, however, the successful diffusion of medical technology is influenced by policies and procedures of third party payers, most especially Medicare. Providers and suppliers of new medical technology have been waiting for the past eleven years for the Health Care Financing Administration (HCFA) to finalize new coverage Medicare criteria. The authors review HCFA's recent proposal for Medicare coverage criteria and raise key issues attendant to the implementation and use of the coverage criteria. These coverage criteria should hold special interest for the biotechnology and life sciences community as their products begin to emerge from the pipeline.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Biocolumn Screening (8 pages)

An Analysis of the Proposal for Population Based Screening for Hereditary Hemochromatosis in Massachusetts Joan M. LeGraw

Abstract: The Massachusetts Senate is considering a bill which would require a screening test for iron overload diseases when such a test is medically necessary. The legislation is also authorized to establish, promote, and administer a statewide early detection program for the detection of hereditary hemochromatosis. Despite the challenges to a successful screening program which have been documented in the medical literature and the potential for genetic discrimination, the public health benefits justify this legislation as long as the necessary modifications and precautions are established.

 ©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Biocolumn Advertising (7 pages)

Pharmaceutical Advertising as a Consumer Empowerment Device Paul H. Rubin

Abstract: Pharmaceutical companies have greatly increased their level of "direct-to-consumer" (DTC) advertising in recent years. For 1998, estimates are that over $1.1 billion was spent on this form of advertising, increased from $850 million in 1997 and $600 million in 1996. In 1998, 84 separate drugs were advertised to consumers. The impetus was a decision in August of 1997 by the Food and Drug Administration to reduce the restrictions on DTC advertising on television. As a result, such ads have become very common on TV, and 32 products were advertised on TV in 1998. Pharmaceutical companies advertise because they think that advertising will make money for them. But how will this make money? It will make money by providing consumers with the information they need to make proper decisions about medication. That is, DTC advertising is profitable exactly because it empowers consumers and enables them to purchase useful drugs. The goals of advertising companies and consumers are both for consumers to have information about the most beneficial drug for particular conditions, and so advertising is beneficial both to manufacturers and to consumers. This article describes emerging trends in DTC within the context of the life sciences sector.

©2001 by The Journal of BioLaw & Business. All Rights Reserved.

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