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Guest Editorial
(5 pages)
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Cross-Border Joint Ventures: A Summary of Critical Planning Steps and Substantive Legal Areas
Stuart N. Brotman
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Abstract: Establishing joint ventures requires a combination of legal and business advice in forming the venture. This article provides guidelines for the hybrid business-legal information necessary for planning strategic alliances in the life sciences. It discusses the increasing opportunities for forming international joint ventures and the role of the lawyer in cross-border joint venture formation. In addition, it describes several key substantive legal areas affecting international transactions. The article concludes with a summary checklist in forming cross-border joint ventures.(5 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(5 pages)
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Will Your Firm Be a Victim of Medical Technology Error & Omissions Litigation?
Philip Fiscus
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Abstract: Whether a drug or device, the process of designing and developing a medical product today requires successful business relationships among multiple parties. While this business model offers the potential for great rewards, it also presents many risks-including the risk that a failed business relationship will give rise to a lawsuit or at the very least an insurance claim. This article highlights best risk management practices for companies, with a focus on errors and omissions (E&O) liability and insurance protection.(5 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(6 pages)
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Industrial Biotechnology
G. Steven Burrill
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Abstract: Industrial biotechnology is rapidly taking its rightful place alongside healthcare and agricultural biotechnology as a transformative technology (the Europeans refer to Industrial Biotechnology as "white" biotech, with red biotech for its healthcare implications and "green" biotech for agbio and the environment). In recent years, steady progress was made in the development of new processes in which renewable, environmentally sound biomass will be used to produce energy and products that today are processed primarily from petroleum. This article highlights scientific developments and selected collaborations between industrial biotech companies and pharmaceutical companies related to the use of industrial biotechnology processes.(6 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(11 pages)
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Synthetic Biology: Navigating the Challenges Ahead
Arjun Bhutkar
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Abstract: The emerging field of synthetic biology is broadly defined as the area of intersection of biology and engineering that focuses on the modification or creation of novel biological systems that do not have a counterpart in nature. Potential applications of this technology range from creating systems for environmental cleanup tasks, for medical diagnosis and treatment, to economical generation of hydrogen fuel. This technology is in its nascent state and there are a number of concerns surrounding its potential applications and the nature of research being performed. With the potential to create hitherto unknown "living organisms", it raises a number of challenges along different dimensions. This article reviews the current state of the technology and analyzes synthetic biology using different lenses: patentability, ethics, and regulation. It proposes a classification system for the products of synthetic biology and provides recommendations in each of the above areas (patentability, ethics, and regulation) in the context of this classification system. These recommendations include an improved framework for patentability testing, ethical principles to guide work in this area, a controlled approval process, and reference frameworks for regulation.(11 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(13 pages)
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Regulation of Biotechnology by Executive Orders: Questions about Constitutionality, Legality and Overall Fairness to the American Public
Peter Cuomo
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Abstract: In the biotechnology field, researchers often face complex moral and social issues while pursuing their scientific goals. Congress may regulate much of that research by debating the issues and placing restraints on funding granted by the government. In modern times, our presidents have also made some of those funding decisions through the issuance of executive orders. Presidents may issue executive orders with binding legal effect, despite having little constitutional authority to do so. Unless a new president takes office, only Congress or the courts can invalidate an executive order. In the regulation-sensitive biotechnology industry, presidents may exert profound influence by announcing executive orders. Former President Clinton and President George W. Bush are just the latest presidents who have used such orders to influence biotechnology as they have deemed appropriate. In doing so, those presidents have assumed a degree of unilateral lawmaking power over an industry that is fundamentally important to every citizen. This article stresses the need for the other branches of our government to discontinue granting unconstitutional legislative power to the president, and bring more social and scientific balance to important biotechnology policy decisions.(13 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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The Implications of Research
Bryan A. Liang
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Abstract: It would seem that the results of biotechnology research are obvious. Improved quality of life and hope for potential cures come to mind as important implications of research. But from a health policy and law perspective, other issues also arise, including legal obligations, debate about the appropriateness of research use and disclosure, and incentives to encourage its development. All of these are highlighted in this issue's Recent Developments.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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Gene Mutation Found for Parkinson's Disease
Arlene D. Luu
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Abstract: Researchers find new gene mutations for Parkinson's disease.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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California Makes Unprecedented Commitment to Fund Stem Cell Research
Erik Matala
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Abstract: Legislation in both houses of Congress, scientific calls, and voluntary efforts appear to indicate that publishing all clinical trial results may become standard. (2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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Publishing All Clinical Trial Results May Become Standard Policy
Erik Matala
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Abstract: Legislation in both houses of Congress, scientific calls, and voluntary efforts appear to indicate that publishing all clinical trial results may become standard. (2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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Violation of Intellectual Property Agreements May Create Fiduciary Duty and Potential for Punitive Damages
Elisabeth M. W. Trefonas
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Abstract: Businesses dealing with intellectual property agreements that breach a fiduciary duty owed to their inventors may be liable for punitive damages.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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The U.S. Government Awards First Contract under BioShield Act But Industry Doubts Remain
Laura A. Lin
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Abstract: The U.S. Government encourages the manufacture of bioterrorism countermeasure products but broad industry participation may be lacking.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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RECENT DEVELOPMENTS
(2 pages)
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Paraguay Officially Approves Genetically Modified Soy Seeds
Mary E. Grounds-Pérez
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Abstract: Paraguay continues the rising international biotechnology trend by passing legislation authorizing the use of genetically modified soybean seeds.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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BIOCOLUMNS
(3 pages)
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Clinical Trials / Clinical Trial Databases: A Potential New Source of Liability For Drug Manufacturers
Bret Koplow
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Abstract: In the wake of recent revelations regarding previously undisclosed risks associated with several popular prescription drugs, the pharmaceutical industry has begun to provide the public with an increasing amount of information regarding the clinical trials they sponsor. Legislation currently before Congress would require further expansion of such disclosures. This article explores potential sources of liability that may attach to participation in a trial database.(3 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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BIOCOLUMNS
(5 pages)
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Product Liability / New Swords and Shields: The Canadian Regulatory Approval Process and Novel Claims and Defenses in Product Liability Litigation
Barry Leon and Cynthia Tape
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Abstract: The regulatory approval process for biologics, pharmaceuticals and medical devices continues to give rise to novel claims and defenses against manufacturers and regulatory authorities in Canada. This article highlights recent court decisions and pharmaceutical product liability issues.(5 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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BIOCOLUMNS
(6 pages)
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IP Strategy / Patent Prosecution Strategies for Biotechnological Inventions
Jenny J. Yeh and Dennis Fernandez
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Abstract: This article describes patent prosecution strategies for new biotechnological inventions. The first part of the article discusses general strategies for patent prosecutors, including several prosecution considerations and methods for increasing patent prosecution speed. The second part of the article presents patent prosecution challenges in genomics and bioinformatics-related patents and provides solutions to these challenges. The last part of the article discusses how ethical and public policy issues play a role in the patentability of biotechnological inventions.(6 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
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