Click to buy Editorial (6 pages)

Engineering a Hybrid Cyberworld: The Convergence of Biotechnology and Information Technology Robin JR Blatt

Abstract: As the twentieth century draws to a close, the functional separation that has existed between the biotechnology and information technology (IT) sectors is disappearing as the two become increasingly interdependent on one another. The meteoric pace of biotechnology and informatics research is fueled by the fervor surrounding the use of information technology (including the Internet). Not only are global communication systems enabling rapid transmission of corporate communications and clinical trial data through electronic dossiers, but use of the Internet to raise prodigious sums of venture capital and to conduct initial public offerings (IPOs) is generating feverish growth within a number of markets. These trends impact all aspects of biotechnology and life science research, law, business, regulation and public policy. This molecular-digital convergence demands a re-engineering in order to invest in knowledge and increase the capacity necessary to respond to both the opportunities and challenges of molecular and digital age developments.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article (4 pages)

The Year 2000 Problem in the Pharmaceutical and Biotechnology Industry Isabel P. Dunst and Robert J. Kenney Jr.

Abstract: Senator Robert Bennett, Chairman of the Senate Special Committee on the Year 2000 Technology Problem opened the eighth hearing of the Committee with a statement titled: Small Business to Global Corporations: Will They Survive Year 2000? The question’s serious tone was reflective of testimony that the Committee had heard, including one recent study’s prediction that 15 percent of companies in the pharmaceutical industry will experience at least one mission-critical system failure because of the Year 2000 computer problem. However such gloomy pre-dictions eventually turn out, it is clear that pharmaceutical and biotechnology companies have the responsibility to address Year 2000 issues with speed and diligence. This article seeks to highlight the nature of the Year 2000 issues related to such companies and the role of lawyers in addressing these issues.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article provides an introduction to the negotiation of contracts between nonprofit academic institutions and industrial sponsors for the conduct of research in the health sciences. While such agreements have many elements in common with industry-to-industry contracts, fundamental differences can arise from the unique regulatory and policy context in which tax-exempt educational institutions operate, as well as from practical factors in the internal operations of such institutions.

This article begins with an overview of regulatory and policy issues likely to affect an institutions posture in research agreements with industry and, after a brief discussion of negotiation logistics and other practical considerations, identifies key negotiating points in which these issues frequently come into play. The focus is on agreements between a single industry sponsor and a single institution for basic laboratory research, in which the parties expect institutional researchers to make potentially patentable discoveries.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Biotechnology products are generally made possible by combining a multitude of innovations, most of which are patented. When a patent protecting an innovation is not owned by the product developer, there exists a significant risk that the right to the patent may be asserted against the product developer acts early in the development process, it is possible to transform these risks into assets, by either the acquisition of the patent or a license. This article does not address the complex issues that are typically involved in negotiating acquisition and licensing deals; rather, it is limited to providing BioLaw readers with insight concerning, and a proposed mechanism for managing, one aspect of biotechnology licensing obligations of the potentially burdensome cumulative licensing of royalties.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Feature Article (10 pages)

Risky Business: Managing the Principal Risks of Liability Facing Directors of Publicly Traded Technology Companies Brian E. Pastuszenski and Carl E. Metzger

Abstract: Most privately held, entrepreneurial businesses hope that one day they will have enough critical mass that they will be attractive to the public securities markets and can go public. Conducting an initial public offering (IPO) of securities enables a company to generate capital for research and development (R&D) and permits investors to achieve some return on their investment. "Going public," however, also creates significant new risks of securities related and other liability for management and boards of directors. Because of the volatility of their share prices, publicly traded biotechnology and other high technology companies are peculiarly prone to these risks. They are also the most likely to be sued in class action litigation claiming violation of the securities laws.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Federal Circuit Biocolumn (4 pages)

Federal Circuit Holds Claims Invalid over Patent's Published British Counterpart of Parent U.S. Application Federal Circuit Steven O’Connor

Abstract: When prosecuting the applications of a biotechnology invention, early entry into the patent system is particularly important, due in part to the rapid pace at which progress in the biotechnological arts can occur. In view of a recent court holding, practitioners must now exercise caution where broad claims that are not supported by an earlier application will be pursued in a continuation-in-part (CIP) application. When a foreign application corresponding to an earlier case has been filed, one must ensure that any CIP applications are filed before the one-year anniversary of the publication date of the foreign application in order to preclude the U.S. Patent and Trademark Office (PTO) as well as potential infringers from using the earlier published application to invalidate the broad claims. Most privately held, entrepreneurial businesses hope that one day they will have enough "critical mass" that they will be attractive to the public securities markets and can "go public." Conducting an initial public offering (IPO) of securities enables a company to generate capital for research and development (R&D) and permits investors to achieve some return on their investment. "Going public," however, also creates significant new risks of securities related and other liability for management and boards of directors. Because of the volatility of their share prices, publicly traded biotechnology and other high technology companies are peculiarly prone to these risks. They are also the most likely to be sued in class action litigation claiming violation of the securities laws.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This paper addresses an important policy question "how do government policies to further innovation in health care balance the wish of the government (but not necessarily the same department within the government structure) " to contain the increasing costs in the public sphere of health care? For purposes of our discussion, several examples are given from technology policies in the United States and Japan and from health policy measures in Germany and Canada. The biological revolution has lead governments to strongly support the development of the core biotechnology industries. This paper provides examples of public research and development (R&D) funding. Considerable challenges exist for the paradigm of R&D. Through diverse but interdependent means, technology policies as well as cost containment measures can greatly affect the governance of biopharmaceutical innovation. To choose and prioritize technology and to design insurance schemes, assessment techniques help to provide solutions for being able to remain at the pharmaceutical biotechnology frontier within the constraints of health care budgets.

 ©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: With the advent of platform technologies and information technology progress, alliances have become increasingly important to help biotechnology companies bring their products to market or increase their commercial sustainability. The following two case analyses describe the experiences of biotechnology companies developing and obtaining results from alliances with other biotechnology companies as well as with pharmaceutical companies and research institutions. First, Raul Rodriguez shares insights from the Ontogeny-Biogen partnership to develop the applications of hedgehog proteins. Next, Steve Holtzman relates the development of the partnership between Millennium Pharmaceuticals, Bristol-Myers, Affymetrix, and the Whitehead Institute. This column has been developed based on remarks presented at the Massachusetts Biotechnology Council’s (MBC) 1998 Annual Meeting.

Biotech-Biotech Alliances: Case Study of Ontogeny and Biogen
Raul Rodriguez

Alliances Between Biotechnology and Pharmaceutical Companies
Steve Holtzman

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The U.S. and Canada, partners of Mexico under the North American Free Trade Agreement (NAFTA,) have taken the lead in developing strategic biosafety regulations aimed at establishing a suitable climate for investment and trade. These countries have implemented safety mechanisms to protect the environment and health based on principles of risk assessment. Mexico is now facing the challenge of developing a regulatory framework adapted to its specific ecological and socioeconomic conditions while fulfilling standards deriving from NAFTA and other international commitments. From the Mexican perspective, strengthening biosafety regulation requires acknowledging the fact that the country is extremely diverse in character and yet is technologically dependent. In this context, Mexico must take into consideration the implications of transgenic food products being introduced from Canada and the U.S.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: When I was invited to serve on a distinguished panel at the World Economic Forum, I was intrigued by the way our topic had been framed. The question before us was, "Who will pay for 21st century health care?" In my view, that question is easily answered. Health care in the 21st century will be paid for by the productive members of society, as it is now. Employed individuals will bear the cost of health care for themselves, their families and those unable to pay for themselves. It is a pleasant fiction to think that someone else, whether employers or governments, will relieve them of that burden. The more important question is this "how will we pay for health care in the 21st century?" The answers to that question and each nation or society may have a different one" will have enormous implications for innovation, for the quality of care, and for the vitality of our economies as a whole. Much will depend upon how we approach this issue.

 ©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Financing Biocolumn (4 pages)

A Tough Year for Financing in Biotech G. Steven Burrill

Abstract: The biotechnology industry in the United States raised a total of $4.0 billion in financing during 1998, a decrease of 44% compared to 1997 ($7.1 billion) . Initial public offerings (IPOs), of which 14 were completed, accounted for $371 million compared to $709 million (27 IPOs) for 1997. Disclosed figures in upfront and milestone payments for strategic alliances totaled an additional $6.2 billion, an increase of 5% from 1997 ($5.9 billion). 1998 and $2.4 billion for the fourth quarter 1997. In the fourth quarter 1998, only one public offering happened, raising $17 million, while partnering activities accounted for $1.4 billion. The capital markets for biotech companies virtually dried up during the last half of 1998, with the moneys raised in 1998 approximating only half that raised in 1997. Many companies are quietly waiting out the storm and looking for the upturn in 1999.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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