Click to buy Guest Editorial (3 pages)

Restoring Public Trust in Gene Therapy Senator Edward M.Kennedy

Abstract: A new era has dawned in science and medicine. In the year 2000, scientists completed the awesome task of deciphering the DNA sequence of the human genetic code, which has been called the very book of life. Much work remains to be done before the meaning of that achievement is fully understood, but doctors and scientists have already begun developing new cures for the deadly diseases that now bring disability or death to millions of Americans.
The understanding of the genetic code may have its greatest impact in the field of gene therapy. The ability to introduce therapeutic genes safely and reliably into patients promises to revolutionize the treatment of illnesses ranging from cancer to Parkinson 's to heart disease. With the recent successful treatment of two young children suffering from a rare disorder of the immune system, gene therapy has now shown its first signs of success, and ongoing clinical trials raise the hope that coming months will see further breakthroughs.
Clinical trials are as essential for continued progress in gene therapy as they are in all areas of medical research. Patients who serve as research subjects in these trials must be protected from unnecessary dangers, and must be fully informed about the risks or benefits of the trials in which they are participating. The death of Jesse Gelsinger clearly illustrates the tragic consequences of failing to protect research subjects adequately.

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

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Click to buy Feature (7 pages)

Transaction Trends -Equity Separation:Amicable Corporate Divorce Benefiting the Biotechnology and Pharmaceutical Industries? Eileen Smith-Ewing

Abstract: The biotechnology and pharmaceutical industries are witnessing rapid growth through “equity separation,” the splitting off of a division or subsidiary from its parent corporation in order to maximize shareholder value. One impetus behind equity separation may be the expansion of the industry into revolutionary areas, such as genomics and information technology. Equity separation can take any of three forms: tracking stock, equity carve-out, or spin-off. This article explores the equity separation phenomenon in the biotechnology and pharmaceutical arenas and identifies benefits, drawbacks, and key issues arising in these transactions.

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

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Click to buy Feature (8 pages)

Use and Internet Sale of Biotechnology Products Kent Stormer

Abstract: Biotechnology research involves, by its very nature, novel and newly-created materials, genetically engineered substances, bio-active materials, immunotoxins, radiolabelled compounds, and viruses. This article provides an overview of various regulatory requirements, agency-by-agency, that can affect the novel compounds that are essential to the biotech industry. It also discusses the importance of having a proactive compliance program in order to avoid regulatory enforcement difficulties, which can be costly and distracting.

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

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Click to buy Feature (8 pages)

Intellectual Property Strategic Planning for Biotechnology Startups Thomas C.Meyers

Abstract: Intellectual property (IP) strategic planning can add significant value to a company ’s business. An intellectual property plan that is integrated with the company’s business focus can create barriers to entry, attract investment, and foster development of the company ’s own expertise. This article explores some of the considerations that go into developing a strategic plan.

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

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Click to buy Feature (9 pages)

Implications of Biology for Free Will,Moral Responsibility, and Criminal Law:What if Science Can Explain Actions? Martin Frith

Abstract: As our understanding grows of the physiological mechanisms which generate actions, the role we attribute to ‘free will’ shrinks, seemingly to an infinitesimal point. Yet it is often said that free will is the foundation of criminal law. Genetic influences on behavior do not determine specific acts and so their discovery will not have drastic implications for criminal law. However, genes and environmental factors together, interacting via the physiological mechanisms which generate behavior, seem to constitute the entire explanation of how actions arise. Modern philosophy contains arguments for and against the possibility of free will, but their implications for moral responsibility are not clear. An analysis of criminal law shows that defenses of automatism and irresistible impulse could be raised if the alleged criminal act has been explained in terms of a physiological mechanism. Scientific discoveries logically cannot have consequences for fundamental moral principles, but they might have the psychological power to bring traditional moral opinions to a crisis point.

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

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Click to buy Special Segment (3 pages)

Genetic Testing Policy Issues for the New Millenium:Organization for Economic Cooperation and Development (OECD) Elettra Ronchi

Abstract: This purpose of this article is to provide a brief overview of the policy considerations underlying the Organization for Economic Cooperation and Development (OECD) workshop, “Genetic Testing: Policy Issues for the New Millennium,” which was organized and hosted by the governments of the United Kingdom (UK) and Austria in Vienna, 23-25 February 2000, with the support of the European Commission (EC).It reviews the various topics presented at the meeting and offers a brief summary of its main conclusions.

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

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Click to buy Biocolumn Regulation (4 pages)

Regulation Edward C.Wilson, Jr.and Scott H.Reisch More Needlestick Prevention Technologies Are Likely to Emerge in Wake of New Federal OSHA Rules

Abstract: In Volume 4, Number 1 of The Journal of BioLaw and Business, we reported on the status of various federal and state legislative initiatives designed to force hospitals and other health care providers to implement needlestick reduction technologies at their work sites. Since that article went to print, significant developments have occurred at the federal level that will impact the selection of engineering controls used to eliminate or minimize the risk of occupational exposure to bloodborne pathogens. This article discusses the Needlestick Safety and Prevention Act (“NSPA”) that President Clinton signed into law last fall and the Occupational Safety and Health Administration’s (“OSHA ”) implementing regulations that were promulgated earlier this year. Although employers are still afforded flexibility in selecting appropriate engineering and work practice controls, the new regulations require them to formally consider the use of certain needlestick prevention technologies. Companies that market sharps will need to understand the current requirements facing their customers and to appreciate the impact that the new regulations are likely to have on the market.

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

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Click to buy Biocolumn Alliances (5 pages)

Alliances Clifton A.Baile and Mary Anne Della-Fera A Model Partnership of Research Universities,Business Communities and State Government -The Georgia Research Alliance

Abstract: Founded in 1990,the Georgia Research Alliance (GRA) represents a partnership of the state’s research universities, the business community and state government. Its mission is to foster economic development within Georgia by developing and leveraging the research capabilities of the research universities within the state and to assist and develop scientific and technology-based industry, commerce and business. The GRA ’s research initiative in biotechnology is represented in part by the Applied Genetic Technology Resource (AGTEC). AGTEC brings together diverse areas of expertise and resources in plant and animal biotechnology and provides facilities that stimulate the development and application of these technologies. AGTEC has provided funds for buildings and equipment, endowed chairs for Eminent Scholars, and Technology Development Partnerships between biotechnology companies and university laboratories. Georgia’s commitment to research and development in an environment of cooperation among universities, businesses and government will help to assure continued economic growth, providing jobs and opportunities for Georgia ’s citizens and industries.

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

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Click to buy Biocolumn Intellectual Property (4 pages)

Intellectual Property Kawai Lau New Legal Strategy for the Business of Biotechnology

Abstract: In an unparalleled move in late 1999,Congress enacted, and President Clinton signed into law, major changes in US intellectual property law that affect the business of biotechnology. In one aspect of the changes, the business methods used by biotechnology companies, as well as other business-related methods used by them, may now be the subject matter of the First Inventor Defense Act of 1999.This unprecedented "prior use " defense provides a new shield against certain patent infringement suits, renewed vigor for trade secrecy as a form of intellectual property protection, and a new opportunity in patent infringement suits against competitors. These new defensive and offensive legal options are expected to significantly affect both the intellectual property (IP)and business decisions of biotechnology companies. All such companies should consider how best to incorporate these new legal opportunities as part of their overall business strategy.

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

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Click to buy Biocolumn Patents (4 pages)

Patents Thomas M.Saunders Patent Reach and Reality:Tolls on the Patent Highway

Abstract: Outside of genomics, only market exclusivity can justify the huge cost of new drug regulatory approval. Market exclusivity is a relative term, but the promise of sufficient market exclusivity is required to first, raise capital and second, offset the huge cost of regulatory approval. This article considers why marketing gene information based inventions may not require patents, how to obtain patent based market exclusivity without invention, and ways to squander proprietary protection.

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

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