Click to buy Guest Editorial (2 pages)

The Challenge of Biotechnology: The Need to Share the Benefits of Recent Advances Representative Fortney Pete Stark

Abstract: In September 1999, the Joint Economic Committee (JEC) held a Biotechnology Summit on Capitol Hill. The day-long hearing provided legislators the opportunity to learn about the latest advances in biotechnology, many of which have the potential to save lives. Recent innovations in biotechnology are allowing us to determine which genes lead to breast cancer, downs syndrome, leukemia, severe drug allergies and other diseases. New medications now offer rheumatoid arthritis sufferers independence from their pain, and promising stem cell research may produce cures for Alzheimer's, Lou Gehrig's, Multiple Sclerosis and other diseases. Although we anxiously anticipate these advances, we must also be aware of some of the challenges which advances in biotechnology present, including the use of fetal tissue in experiments, ensuring adequate safeguards to participants in medical experiments, and figuring out how everyone can fairly share in the benefits of biotechnology's new discoveries.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Feature (11 pages)

Patentability Requirements for Genes and Proteins: Perspectives from the Trilateral Patent Offices Philip B.C. Jones

Abstract: The United States Patent and Trademark Office (USPTO), the Japanese Patent Office (JPO), and the European Patent Office (EPO), the so-called "Trilateral Offices," have been formulating guidelines for examination of claims to new genes and proteins. Although the three patent offices adhere to similar legal bases for patentability, the application of patentability requirements, at least for biotechnological inventions, has been evolving in different directions. The following presents a snapshot of the Trilateral Offices' current views on the eligibility of new genes and new proteins for patent protection.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Feature (5 pages)

Pharmacogenomics: Implications for Individual Privacy and Drug Development Alberto Grignolo and Maria Schroeder

Abstract: Pharmacogenomics is emerging as the next breakthrough in drug development, promising new and improved medicines and better responses to pharmacological therapy based upon correlating specific genetic mutations with certain diseases. The discovery of new genes and their functions will enable researchers to develop drugs tailored to a specific disease. Furthermore, genetic testing for disease predisposition will become reality. At that point, pharmacogenetics will become readily feasible, using genomics to target subpopulations for increased drug efficacy or decreased risk. Mutation-based therapies may dramatically alter the way drugs are developed, marketed and used by the patient. The now-likely possibility of linking genomic information with patient medical data raises issues of confidentiality and patient privacy, which may require new laws and regulations governing the use of such detailed genomic information. These are just beginning to be developed, and more oversight is likely.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Feature (X pages)

Cloning in America: Constitutional Rights and Limits Cheryl Erwin

Abstract: : This article is not available at this time. Please check back later.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Special Segment (2 pages)

Putting a Human Face on Biotechnology Senator Edward M. Kennedy

Abstract: The United States (US) biotechnology industry is one of the most successful and promising parts of our economy. Not only is it changing our quality of life, but it has been critical to our current prosperity and economic growth. Never before have the pipelines of biotechnology companies held so many promising products for the care and treatment of disease. Biotechnology is leading a revolution.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Special Segment (11 pages)

Putting a Human Face on Biotechnology: A Report on the Joint Economic Committee™s (JEC) Biotechnology Summit Senator Connie Mack

Abstract: The growth of America's biotechnology industry has resulted from a remarkable combination of entrepreneurship, innovative capital markets, and federal research investments. The United States (US) leads the world in biotechnology, which is contributing to our strong economic growth and creating substantial improvements in our quality of life. With the pathbreaking success of biotechnology in mind, the Joint Economic Committee (JEC), chaired by Senator Connie Mack (R-FL), held a one-day Summit (September 29, 1999) which focused on "Putting a Human Face on Biotechnology." The Summit heard from over two dozen witnesses including industry experts, doctors, and patients who are benefiting from biotechnology medicines. This report provides a brief overview of the policy issues raised during the Summit, and summarizes the benefits to be gained from biotechnology research, as discussed by Summit participants.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Biocolumn Patents (4 pages)

When Is It Safe to Tout Technology? Avoiding Unintended Patent Consequences Resulting from Premature Announcements Bruce Sunstein

Abstract: The need for recognition, particularly on the part of early stage biotechnology ventures, puts them in search of newsworthy events to announce. The achievement of a research milestone is a newsworthy event and therefore a prime candidate for an announcement. Nevertheless, announcements of technological achievements can cause the irreparable loss of critical patent rights. As a result, public relations activities of a biotechnology venture must be coordinated with its patent activities, and its patent activities should in turn be conducted pursuant to an articulated plan. This article examines a series of research milestones and presents an analysis of the effects on patent rights of publicizing achievements at each stage.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Biocolumn Venture Capital (5 pages)

An Interview with Jonathan Fleming: Financing Biotech Companies in the New Millennium Robin JR Blatt

Abstract: In this exclusive interview with Jonathan Fleming - world-reknown venture capitalist (VC) and General Partner at Oxford BioScience (a leading venture capital firm located in Boston, Massachusetts) - Mr. Fleming talks about what he looks for when evaluating a business plan for a biotechnology and life science start-up company, and, the key elements necessary to succeed in obtaining venture financing in the New Economy.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Biocolumn Risk Management (3 pages)

Risk Exposures to Venture Capital Firms Michael J. Andersen

Abstract: Venture capitalists who have suffered through the agony of litigation can tell you how time consuming and distracting such lawsuits can be, not to mention how costly. Until a venture capitalist has experienced a management liability claim and/or litigation first hand however, it is easy to ignore the exposures and simply hope to avoid being mired in a claim from any number of potential sources. Like directors in business corporations, the general partners of venture capital funds have obligations to their limited partners. Unlike directors of corporations however, the general partners also have potential liability to the fund's portfolio companies. In fact, claims against venture capital management teams (and their principals) by portfolio companies and their constituents, such as investors and founders, are common. But what are the exposures? Where are the real sources of liability facing venture capitalists on a daily basis? And what are some of the typical allegations found in law suits filed against both individual general partners and Partnership management groups? And most importantly, what can general partners do for protection against personal liability? This article will attempt to answer some of these questions by reviewing recent case law involving venture capitalists, as well as review viable, cost effective options to transfer these risks to the greatest extent possible through newly created risk transfer mechanisms.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Biocolumn BioHumor (6 pages)

Dealing with Big Pharma Martin F. Savitzky

Abstract: What does Big Pharma want? I've asked myself this question time and again without much response. However, this time, I believe that The Journal of BioLaw & Business (BioLaw) provides a more responsive medium for the question. But if you are expecting a fly on the wall presentation, you will be disappointed. The attorney-client privilege prevents me from divulging client confidences, and discretion is the better part of avoiding slander lawsuits. Nonetheless, without naming names or being too specific, BioLaw readers will be exposed to this attorney's view of working on the Big Pharma deal team.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Biocolumn BioSafety (X pages)

A Brief History and Analysis of the Cartagena Protocol on Biosafety James D. Kerouac

Abstract: This article provides a history of the negotiations leading to the recent agreement on the Cartagena Protocol on Biosafety, focusing on the main points of contention between the parties. It also discusses the most salient features of the Protocol, including the advanced informed consent procedures and requirements and the Protocol's relationship with previous international trade agreement, such as. the World Trade Organization (WTO). Finally, this article provides a brief critique of the Protocol's impact on the agricultural biotech industry, concluding that the agreement's failure to settle on a concrete relationship between the Protocol and the WTO and its failure to adopt liability and redress provisions indicate a failure of the parties to reach agreement on the most difficult and contentious issues raised by the Protocol. Also, the author notes that the Protocol may aid in assuaging consumer distrust of genetically modified food products and the agricultural biotech industry.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Biocolumn Finance (7 pages)

First Quarter 2000 Ends with the Biotech Bulls and Bears in a Tug of War-Clinton-Blair Comments on Genomics Patents Dampen Market Enthusiasm G. Steven Burrill

Abstract: The industry raised $12 billion in the first quarter of 2000, an incredible 420 percent increase from the same quarter last year ($2.3 billion). For an industry which raised only $5 billion in each year '96, '97 and '98, raising $12 billion this quarter is a significiant feat. Further, just two weeks before the end of what had been the hottest quarter ever for biotech, a joint Clinton-Blair announcement regarding the "proprietorship" of the human genome quelled the enthusiasm for biotech, stock prices dropped dramatically, and industry analysts reconsidered their "biotech is back" thesis. Even though the industry lost almost 25 percent of its value after President Clinton and Prime Minister Blairís joint announcement, the industry has recovered. This Column highlights results of biotechnology and life science activity in the first quarter of 2000.

©2000 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top