Click to buy Guest Editorial (3 pages)

The First Technological Revolution of the New Millennium Charles DeLisi

Abstract: Major new technologies drive change; and, once assimilated by society, immeasurably improve our quality of life. But during that period of assimilation, which can vary from decades to generations, the social fabric is often stretched to its limit, changing demographics, income distribution, and patterns of wealth and power, both within and between nations. Nuclear energy is an example of a technology that for two generations defined the international power balance and shook the economic foundations of two world powers; however, its promise as an energy source has yet to be fulfilled, and its impact on international relations is far from stable. On the other hand, the automobile is an example of a technology that has been fully assimilated. In 1999 alone, we accepted, in exchange for the benefits provided by automobile production and use, more than 3 million injuries and 41,000 fatalities. The impact of technology on demography and power balance is not new to this century, nor is it peculiar to modern engineering. The invention of hay in the Dark Ages had a deep effect on European commerce and demography, and may have been a prime factor in the ascendancy of the North. More recently, the apparently benign introduction of steel axes as a replacement for stone axes by Australian missionaries led to the disintegration of the Yir Yornot culture. Thus, it is not surprising that the emergence of biotechnology is accompanied by tensions and disputes between public and private sector executives; conflicts over intellectual property, which threaten industrial gridlock; and by age old ethical dilemmas that now, more than ever before, are in urgent need of resolution.

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

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Click to buy Feature (9 pages)

The Life Science Revolution: A Rough Map Juan Enriquez

Abstract: Few discoveries are likely to impact business, law, and our daily lives more than the ability to redesign life. Life sciences provide humans with unprecedented power to expand their life span and improve living conditions. It also presents extraordinary challenges. Many companies have already bet their future on the life sciences. But the outcome is by no means clear. As the life sciences continue their bid to become the largest driver of the global economy, only a rough map of its course is currently available.

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

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The Research Exemption to Patent Infringement: The Time Has Come for Legislation M. Patricia Thayer and Richard A. De Liberty

Abstract: United States (US) patent law grants patent holders the right to exclude others from making, using, selling, offering for sale or importing the patented invention, but does not specifically address whether patent owners should be able to enjoin pure scientific research, as contrasted with commercial sales or uses of a patented invention. Many research scientists never question that a patent infringement lawsuit could be brought to stop scientific experiments. However, lawyers and business executives are now asking whether patents should apply to research, especially as academic institutions receive funds from private companies in return for exclusive marketing rights and as more scientists parlay their discoveries, and venture and corporate funding, into a commercial business. While many foreign countries have codified a patent infringement exemption for research activities, US legislative proposals over the past fifteen years have died in committee. The common law of patents does recognize a limited exemption from patent infringement for scientific experiments, but the doctrine has not been applied frequently or evenly, resulting in a murky legal situation. It is therefore time for Congress to strike a balance among the competing interests to protect, first and foremost, the progress of science. The legislation should distinguish between research conducted or building on new discoveries and research using new inventions that are simply research tools. Finally, the legislation should make clear that the source of funding, or ultimate success of the research in identifying a commercial product or process, is irrelevant.

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

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The Art of Satisfying Due Diligence Mark Hofer

Abstract: Due diligence is the process of comprehensively determining, in a timely fashion, all you need to know in order to act intelligently. The due diligence process is essential to generating information about a company that is necessary to make strategic business decisions. Conducting due diligence should be done not only on a specific one-to-one basis (such as in connection with acquiring a business), but also on a dynamic basis as an overall part of running a business effectively. The benefits of conducting good due diligence will lead to security in the knowledge of what the new activity or transaction will entail, and an improved business plan which allows operation of the business with lowered risk accompanied by better profits in an environment of reduced uncertainty. This article highlights some of the unique features associated with the art of satisfying the art of due diligence.

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

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Outsourcing Regulatory Affairs Christine E. Leduc and David S. Mantus

Abstract: Outsourcing of all aspects of biotechnology development is increasing in scope and complexity. The outsourcing of the regulatory affairs (RA) function is a growing trend, yet is a topic that has been the subject of very little discussion. Outsourcing RA as a necessity for success for a small company, rather than as a necessary "evil" is our thesis and ways to optimize outside regulatory resources are discussed. We initiate the discussion by detailing the many roles of RA within a biotechnology company and presenting some advantages and disadvantages of outsourcing each role. Several case studies are presented to illustrate the pressures that can lead to an outsourced solution. It should become clear that the survival of many biotech products and companies will depend on the intelligent use of the vast array of available outsourced regulatory resources. Access to these resources allows smaller, newer organizations to make rapid, well-reasoned strategic and tactical decisions based on real-world experience and data.

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

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Degeneracy in the Legal Code: Can the PTO and the Federal Circuit Reach a Consensus Regarding Patenting Biotech Inventions? Sharon E. Crane, Steven B. Kelber, and Marc R. Labgold

Abstract: Intellectual property is a valuable asset to any biotechnology company, and therefore, it is important to understand what positions the U.S. Patent and Trademark Office (PTO) and the Court of Appeals for the Federal Circuit (Federal Circuit) will take regarding patenting biotechnological inventions. Unfortunately, the positions of the PTO and the Federal Circuit are not always entirely consistent. This paper discusses the inconsistencies among (1) the industry's need for predictability and adequate coverage; (2) the Federal Circuit's decisions; and (3) the PTO's policies and implementation of the applicable law.

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

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Click to buy Biocolumn Risk Management (5 pages)

Managing Risk to the Balance Sheet Philip W. Fiscus

Abstract: A microorganism found in purified water prompted the Food and Drug Administration (FDA) to shut down one company's research facility for six weeks. The FDA found that a research manager at another company falsified clinical trial data. A research manager falsified clinical trial data, leading the FDA to order a total recall of the company's product. A United States (US)-based biotech company recently learned that the European Patent Office (EPO) revoked its patent. A foreign government seizes and nationalized a another US company's research facility, leading to a write-off of a loss of $225 million. Although risk and success often go hand-in-hand, these true stories make investors cringe. In a hot economy that offers significant opportunities for high returns, the best product ideas are not going to attract investors if the risks are too great and unmanageable. This article provides a number of practical suggestions for managing risk and increasing stakeholder value in the biotechnology and life science sectors.

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

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Click to buy Biocolumn Bioconversations (6 pages)

Intellectual Property: What Every Life Science Researcher Needs to Know Robin JR Blatt

Abstract: Many researchers working in biotechnology and the life sciences are interested in protecting their contributions to scientific discoveries. Bio Online, a leading life science Internet portal providing news, research products and career development for the life sciences community hosts a series of live, interactive online forum events on a variety of life science oriented issues. This Column provides an edited summary of the Bio Online interactive event, Intellectual Property: What Every Life Science Researcher Needs to Know, co-hosted by The Journal of BioLaw & Business. During this interactive forum, participants talk with leading Intellectual Property experts about the type of partnering arrangements that can be made among researchers, their academic or corporate institutions, and research sponsors and offer insight into expert perspectives, practical points to consider, and the tools necessary when thinking about the protection of contributions made during the discovery process.

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

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Click to buy Biocolumn Regulation (3 pages)

Manufacturers Stuck With Needlestick Prevention Requirements Face Product Design Changes Edward C. Wilson, Jr., Scott H. Reisch

Abstract: Manufacturers of pre-filled syringes are among the many companies faced with the challenge of ensuring that their products meet new and proposed federal and state needlestick prevention requirements. Legislators and regulators have been promoting initiatives designed to force hospitals and other health care providers to implement needlestick reduction technologies. At the federal level, both houses of Congress are considering legislation that would require the Occupational Safety and Health Administration (OSHA) to mandate the use of specific needlestick reduction technologies. OSHA has already issued a compliance directive interpreting the current Bloodborne Pathogens Standard (Standard) to require employers to use state-of-the-art needlestick prevention technologies. At the state level, a growing number of states have proposed or already enacted legislation similar to the pending federal bills. These initiatives could dramatically affect the ability of pharmaceutical and biotech companies to market existing and future products, such as pre-filled syringes, across the nation. Firms may be forced to modify or discontinue selling products that have already received market approval from FDA, as customers seek to comply with these newly enacted and proposed standards. As such, pharmaceutical and biotech manufacturers should pay close attention to the rapidly evolving developments in the needlestick prevention area so that they are not stuck with damaging consequences down the road.

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

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Click to buy Biocolumn International (3 pages)

The European Orphan Medicinal Products Dr. Erik T. Tambuyzer

Abstract: An orphan drug is a medicinal product without a sponsor to develop it into a commercially available treatment. These orphan drugs treat diseases which are rare and for which incentives are needed to stimulate industry to invest in the development of such drugs. To define a disease as rare in the European Community, the prevalence of that disease, according to the new regulation, should be less than 5 per 10,000 affected Europeans in the European Community. The majority of rare diseases are thought to be genetic in origin, and many are caused by mutations of a single gene. For those not caused by a single gene mutation, it is increasingly apparent that many of those eventually becoming ill, carry in their genes a genetic predisposition to the disease. Over 5,000 different rare disorders have been identified worldwide, however, many others claim that the number of such rare diseases is closer to 8,000. Patient associations in Europe estimate the total number of European citizens, European patients affected by these rare diseases, to be in the order of 25 to 30 million. Rare diseases are often difficult to diagnose, and, in the absence of a known treatment, there is mostly no incentive for the physician to investigate them. When a treatment becomes available, it is found that very rare diseases often become a little less rare. This article discusses advances in European orphan medicinal products regulation, and highlights EU developments.

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

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Click to buy Biocolumn Finance (5 pages)

Another Busy Quarter for Biotech as the Second Quarter 2000 Ends on a High Note-Announcement of the Sequencing of the Human Genome Rekindles the Biotech Blaze G. Steven Burrill

Abstract: The second quarter of the "biotech century" started and ended with events typical of the unpredictable nature of the industry: just two weeks before the beginning of the quarter, President Clinton's and Prime Minister Blair's unnecessary comments on genomic patenting sent biotech stocks into a tail spin; however by the end of the quarter, Celera and the Human Genome Project announced that they had fully sequenced the human genome, claimed by many to be equal in importance to landing a man on the moon and/or the invention of the wheel. The biotech industry has shown amazing resilience; just within a short time, we've seen the industry loose $100 billion in market cap in a week (after the Clinton-Blair debacle), then just three months later, complete one of the industry's most successful IPO quarters in recent years.

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

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