GUEST EDITORIAL
	The Burgeoning Science of Genetics and the Impact on Public Policy SENATOR ORRIN G. HATCH
	FEATURE ARTICLES
	Setting Values and Royalty Rates for Medical and Life Science Businesses HOWARD G. ZAHAROFF
	Embryonic Stem Cells Research in Israel: A Legal and Ethical Inquiry GIL SIEGAL
	The Business of Human Embryonic Stem Cell Research and an International Analysis of Relevant Laws ELLA DE TRIZIO AND CHRISTOPHER S. BRENNAN
	Conducting a Licensing and/or Acquisition Evaluation: Due Diligence from the Corporate Perspective JENNIFER TEGFELDT
	Towards Understanding the “Generic” Debate about Biologics EDWARD L. KORWEK
	SPECIAL SEGMENT
	Making Every Patent Count—Maximizing the Value of a Patent Portfolio SHANN KERNER, JANE LOVE, COLLEEN SUPERKO AND HENRY WIXON
	Emerging from the Laboratory: Regulatory Considerations MARK HELLER, MELISA MOONAN AND STEPHANIE PHILBIN
	Preparing To Go Public: Practical Insights for Biotech Companies STUART FALBER, ANDREW GILBERT, STUART R. NAYMAN AND BELINDA JURAN
	Practical Advice on Litigating a Patent Case in the U.S. WILLIAM DISALVATORE AND REBECCA PETERSON
	20 Questions for Your Lawyer About Biotech Alliances DAVID E. REDLICK, STEVEN D. SINGER AND STEVEN D. BARRETT
	BIOCOLUMNS
	BioCase Note / Chiron Corporation v. Genentech, Inc. Intervening Technology and its Impact on Priority N. SCOTT PIERCE
	Regulatory / New European Union Pharmaceutical Rules Published LINDA R. HORTON, JACQUELINE MAILLY, JAIME A. TOMHAVE
	Clinical Tr i a l s / Establishing Pan-European Clinical Trials: Regulatory Compliance and Other Practical Considerations AURÉLIE GRIENENBERGER
	Generics / Canadian Generic Drug Manufacturers to Be Allowed to Produce Patented Drugs for Export JENNIFER A. ORANGE
	Clinical Tr i a l s / Clinical Trial Activity in Australia is Booming HELEN HILL

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The Burgeoning Science of Genetics and the Impact on Public Policy Senator Orrin G. Hatch

Abstract: The legislative branch of government often wrestles with the challenges of public policy issues in the health care arena that raise multi-dimensional questions that cut across disciplines of science, law, economics, and ethics. Sometimes the purely scientific issues can be confounding by themselves. This article highlights some key policy issues that require consideration in the post-genome era.(4 pages)

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Abstract: Founders and funders of medical and life science companies must often determine the value of particular technologies and establish appropriate royalty rates to charge for their use. This article will describe the three basic methods used to determine the value of intangible assets; summarize the 25% rule and the 5% rule for setting royalty rates; and identify the key business factors that must be considered in any final determination of an appropriate royalty. (3 pages)

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Abstract: Embryonic stem cell research (ESCR)] holds great promise for future remedies, coupled with gainful venture opportunities. However, the possibility to benefit to the full extent from this modality is contingent to the resolution of significant ethical and legal difficulties. Currently, a myriad of international laws and regulation preclude a systematic, singular point of view, necessitating a nation-by-nation analysis. This article focuses on the legal and ethical framework of ESCR in Israel, where significant scientific and entrepreneurship activities are taking place. The article highlights the current legislation and regulation, and presents the prevailing guidelines developed by national advisory committees in authorizing stem cell research. The main issues presented include the status of pre-embryos, rights of gamete donors and the breadth of informed consent required, the concept of benefit-sharing and limitation on oocyte retrieval, critical in this arena. Such description is meant to enable the understanding of current trends in legal and ethical research scrutiny in Israel, illuminate the duties and restraints of researchers and their financing companies, thereby fostering a more rationalized prospective of biotechnology endeavors. (4 pages)

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Abstract: Few sciences have held out such therapeutic promise and correspondingly stirred so much controversy in countries throughout the world as the developing science surrounding human embryonic stem cells. Since the first reported development of several lines of human embryonic stem cells in 1998, many governments around the world have attempted to address the thorny ethical issues raised by human embryonic stem cell research by the passage of laws. In some cases these laws have directly regulated governmental funding of the science; in other cases they have created a legal environment that has either encouraged or discouraged both governmental and private funding of the science. This article first differentiates human embryonic stem cells from other types of stem cells and frames the ethical controversy surrounding human embryonic stem cell research, then surveys laws governing human embryonic stem cell research in various scientifically advanced countries located throughout the Pacific Rim, Europe and North America and explains the impact these laws have had on governmental and private funding of human embryonic stem cell research. (9 pages)

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Abstract: This article considers due diligence not from the perspective of a punch list of materials that must be evaluated before a business commitment is made, although such punch lists are invaluable tools to ensure an informed business decision. Rather, this discussion considers the goals of the due diligence process, and how that process can be tailored to adjust to newly discovered information or changes in business objectives. It is based on the premise that efficient use of the due diligence resources, including human resources, contributes greatly to the time line for decision, and indirectly, to the efficient evaluation of future related opportunities. (4 pages)

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Abstract: Much has been written debating different aspects of the same controversial topic variably known as "generic biologics," "follow-on biologics," "follow-on biotechnology products," "follow-on therapeutic proteins" and "generic biopharmaceuticals." Many considerations pertaining to various legal, scientific, economic, policy and social issues involving the legislative, executive, and judicial branches of the government are relevant though the debate is especially complicated because of definitional and interpretative problems. Further, the controversies themselves are often confused and confusing due to the use of different terminology. While this article cannot clarify or simplify in the limited space available all of the complexities, it is designed to further understanding of the multiple issues related to the "generic" debate about biologics. (5 pages)

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Abstract: In an academic setting, innovation is typically developed without a specific business context. Even in this situation, however, only innovations with real-world value will be of interest to prospective investors, business partners or licensees. While companies recognize the importance of patents for protecting their R&D efforts, many companies administer their patent portfolio as a largely administrative function that is not effectively aligned with their business. To maximize the value that patents contribute to the business, it is important to remember that innovation does not occur in a vacuum. To be most effective, innovation occurs in an environment where the inventor and patent counsel are constantly mindful of the business goals of the company. This article touches on some general issues that should guide the development of an effective strategy for properly aligning innovation with business objectives, and thus for maximizing the value of a patent portfolio. (3 pages)

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Abstract: When a drug, device or biological product moves from the product development phase toward the marketplace, the U.S. Food and Drug Administration (FDA) is the ultimate gatekeeper that permits or prohibits its entry into commercial distribution. Evolving legislative and regulatory requirements shape and reshape the course that must be followed through the agency's review process. This article discusses some of the current legislative and regulatory issues confronting FDA and regulated industry, and concludes that public participation in the challenges confronting FDA will be critical to ensuring an effective and efficient FDA. (4 pages)

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Abstract: After a rather quiet IPO market in 2002 and early 2003, the world of biotech IPOs began to show signs of life in late 2003 and biotech IPO activity has continued into early 2004. This article presents an overview of the financial and legal climate facing biotech IPOs today, and the experiences of biotechs which have recently undergone the registration process, so potential issuers can determine whether they are ready to invest the time and effort necessary to have a successful offering. (4 pages)

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Abstract: Patent litigation is often referred to as a high stakes game, by virtue of what you may invest, and what you could lose, but it must be approached in a strategic economic business manner. Therefore, whether you are a plaintiff or a defendant, it is important to recognize all of the choices to be made, and to make an informed decision based on technical and economic reality. Before making the decision to protect intellectual property investments by filing a patent lawsuit in the United States (U.S.), it's critical to assess the strength of the patent claims and evaluate how well the claims match up with potentially infringing products. This article provides a practical overview of key considerations relating to litigating a patent case in the U.S. (4 pages)

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Abstract: Corporate partnering transactions between biotechnology companies and pharmaceutical companies are an important vehicle by which biotechnology companies bring their technologies to market. Given potential benefits for biotechnology companies and the complexities inherent in negotiating transactions that maximize such benefits, biotechnology companies often find themselves seeking guidance from their counsel on a broad range of substantive issues and negotiation strategy relating to proposed corporate partnering transactions. The following 20 questions and answers address many of the more important and more common of such issues often faced by biotechnology companies. (5 pages)

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Abstract: The Court of Appeals for the Federal Circuit held that a continuation-in-part (CIP) patent is not entitled to the priority date of a parent CIP application when the parent does not enable emerging, or "nascent," technology. The court also held that a CIP is not entitled to the priority date of an earlier-filed application that precedes such technology because, by definition, the earlier application cannot describe non-existent technology. The later holding is contrary to stated public policy of precedent case law wherein invention is stimulated by encouraging early disclosure and by providing broad patent protection for pioneer inventions. (3 pages)

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Abstract: New European Union (EU) rules on pharmaceuticals were published on April 30, 2004. The new legislation covers the authorization and regulation of human and veterinary medicines, provides for an increased role for the re-named European Medicines Agency (EMA),1 and aims to speed up product approvals. The new rules also simplify authorization procedures and improve transparency without changing the basic principles of the existing system in which a centralized authorization procedure exists alongside a decentralized procedure based on mutual recognition. (3 pages)

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Abstract: There are currently many concerns in the pharmaceutical and scientific community working in or around clinical research on the EU Directive 2001/20/EC or Clinical Trials Directive.1 The Directive introduces regulatory requirements for all phases of study in human subjects, drawing no distinction between commercially funded drug trials and non-commercial/academic research. The Directive makes Good Clinical Practice (GCP) a legal requirement in Europe and all clinical research will be subjected to the same rigorous standards including GCP and Good Manufacturing Practice (GMP) application even at the early clinical phases as well as exhaustive pharmacovigilance and protection of trial subjects. Some of these requirements may be seen as additional burden and a brake to clinical research in Europe. However, the application of the directive should provide a single and highly regulated market of 25 European countries for investigational medicinal products. This article reviews the main aspects and areas of concern of the Directive and provide US sponsor with useful references. (6 pages)

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Abstract: In a bold move, Canada's federal government has introduced legislation, Bill C-9, that will allow Canadian generic drug manufacturers to produce patented drugs for export. The purpose of Bill C-9 is to facilitate the developing world's access to drugs in an effort to stem public health problems resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. This article provides an overview of the bill and highlights the authorization process, requirements of exported drugs and the key issues and concerns generated by recent developments in this area. (3 pages)

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Abstract: The high quality of research and clinical medicine in Australia, coupled with relatively low overheads, has meant that Australia has garnered a reputation in recent years as an excellent location for clinical trials. More and more studies planned for the Northern Hemisphere are now simultaneously started in Australia.1 This article highlights the role of Australia in the global clinical trials market and how it is competing to gain an even greater share. (3 pages)

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