GUEST EDITORIAL
	Preparing the Path for Biotechnology and Nanotechnology: Perspectives from the U.S. Department of Commerce Technology Administration PHILLIP J. BOND
	FEATURE ARTICLES
	Non-Public Commercial Activity, the On Sale/Public Use Bar and Biotechnology SCOTT A.M. CHAMBERS AND MARC R. LABGOLD
	Food and Drug Modernization Act (FDAMA) Section 113: Status Report on Implementation THERESA TOIGO
	The Role of Special Purpose Entities in the Biotechnology Industry LEORA SCHIFF
	Material Transfer Agreements HOWARD G. ZAHAROFF
	SPECIAL SEGMENT
	The First Amendment and Scientific Freedom in the Era of Bioterrorism BRIAN P. ANTON
	A Look Behind the Scenes: Bioterrorism, Smallpox, and Public Health Policy JENNIFER BEANE
	BIOCOLUMNS
	Intellectual Property / Taking a Global View of a Life Sciences Company’s Patent Position CHRISTINE C. VITO AND JENNIFER A. CAMACHO
	BioCase Note / Supreme Court of Canada Hears Schmeiser v. Monsanto CYNTHIA TAPE
	Bio-Real Estate / BioSTATus: Trends in Bio-Real Estate JOHN LAVENDER
	International / Australia’s Bio-Regulatory Framework: Leading the Way for Stem Cell Research HELEN HILL

Click to buy Guest Editorial (5 pages)

Preparing the Path for Biotechnology and Nanotechnology: Perspectives from the U.S. Department of Commerce Technology Administration Phillip J. Bond

Abstract: Technology remains a powerful job creator. Over half of this country’s economic growth in the last 50 years has been related to technology. The recent wave was driven by information technology (IT) and the Internet. The next wave will be driven by biotechnology, nanotechnology, and other emerging technological advances which will create jobs and prosperity for those who are ready, and, at the same time, will raise new ethical and social issues that society must confront. This article highlights selected projects and perspectives of the United States (U.S) Department of Commerce Technology Administration related to emerging technologies that have the potential for contributing to economic growth. (5 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The on-sale/public use bar is well established by statute, case law and policy. The bar prohibits and applicant from obtaining any commercial advantage in excess of that contemplated by Congress. Thus, an applicant must choose between trade secret protection and patent protection. Biotechnology research tools can represent a trap for the unwary because of the on-sale/public use. Use of such tools internally in furthering the commercial research interests of the biotechnology company cannot operate as an exception to the on-sale/public use bar. Assertions of reduction to practice long before the filing of an application on a research tool may create problems for future patent protection, if the invention was used internally to advance commercially motivated research. (4 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The Food and Drug Administration Modernization Act (FDAMA; herein referred to as the “Modernization Act”), enacted November 21, 1997, amended the Federal Food, Drug, and Cosmetic Act. Section 113 of FDAMA directed the Secretary of the Department of Health and Human Services (DHSS), acting through the Director of the National Institutes of Health (NIH), to establish a publicly accessible data bank of information about clinical trials for serious or life threatening diseases and conditions. The National Library of Medicine made the first version of the Clinical Trials Data Bank available to the public on February 29, 2000, on the Internet at http://clinicaltrials.gov. The data bank included mainly NIH-sponsored trials. On March 18, 2002, the Food and Drug Administration (FDA) issued a final guidance entitled Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. One and one-half years after publication of the final guidance, FDA issued a press release acknowledging the listing of the 1,000th industry-sponsored study in ClinicalTrials.gov. Although this milestone is gratifying, more needs to be done by FDA, pharmaceutical companies, and other sponsors. The challenge for FDA is to assess the need for further efforts to facilitate or perhaps to compel the pharmaceutical industry’s participation in ClinicalTrials.gov. (3 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The biotechnology industry is faced with a difficult dilemma: how can biotechnology companies finance the early-stage R&D necessary for developing sustainable drug pipelines while concurrently developing the downstream assets and capabilities needed to become fully integrated, sustainable biopharmaceutical companies? While the equity markets and corporate alliances have provided the vast majority of the external financing supporting biotechnology companies, neither source of funding has provided a good solution to this fundamental problem. Certain types of off-balance sheet financing vehicles, known as special purpose entities, appear to have helped a select group of biopharmaceutical companies solve this difficult dilemma. This article reviews the historical roles that special purpose entities have played in the biotechnology industry. (6 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: A Material Transfer Agreement (“MTA”) is an agreement that establishes the terms under which one entity or scientist will transfer unique biologic materials to another person for purposes of research and testing. This article will describe the origin of MTAs and of the widely used form developed by the National Institutes of Health (NIH), known as the “Uniform Biological Material Transfer Agreement.” It will then summarize the most important issues that must be covered by MTAs, including scope of use, ownership and IP rights, redistribution, liability, publication, compliance with law, term, applicable costs, payment terms and publication issues. (6 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The events of 9/11 have raised awareness that certain scientific research in the public domain may aid terrorists in their quest to develop biological weapons, and there is legitimate cause for concern in rare cases. Proposed executive branch responses are consistent in their approach to the problem: restrain the offending research by restricting public access to it in some form or another. This paper explores some of the history of the United States (U.S.) government’s restrictions on scientific communication and the protection that the First Amendment affords scientists against such restrictions. It focuses in particular on biological science, which has in recent years come under increased scrutiny due to fears of “bioterrorism.” It concludes that science needs to be vigilant against government encroachment, but also needs to become the first line of defense in preventing dissemination of potentially dangerous research data. Should the exercise of prior restraint against biological research become necessary, the guidelines developed at the 2002 Monterey workshop provide a useful framework for determining what biological research might cause “direct, immediate, and irreparable” harm to national security under the New York Times Co. v. United States precedent. (13 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The September 11, 2001 terrorist attacks on the World Trade Center and continued conflict in Middle Eastern countries has provoked a strong interest in issues of national security. On December 13, 2002 the Bush Administration announced its smallpox vaccination policy, the first nationwide “proactive” measure to address the threat of bioterrrorism. The Program has received mixed reactions as a result of partisan issues, tensions in public health policy and federal and state jurisdiction, conflicting scientific views, and different risk assessments. The slow pace of the program, the difficulties surrounding its implementation, and the debate regarding its validity serves as a “case study” to demonstrate current short-comings in federal and state anti-terrorist and public health policies. The focus will be on the states’ public health laws and emergency preparedness plans through an analysis of the proposed Model State Emergency Preparedness Act. Updating current public health laws combined with increased funding of scientific research and the foresight to act “proactively” will reach far beyond improving national security. These efforts serve the dual purpose of deterring future terrorist attacks while greatly improving responses to a number of other health emergencies and disasters. (14 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The ability of a life sciences company to capture the interest of today’s venture capital marketplace depends significantly upon the strength of the company’s patent portfolio. Indeed, the patent portfolio is often the only asset an early-stage life sciences company may have. As such, the patent portfolio may be the strongest harbinger of the potential value of a life sciences company. This article provides an overview of intellectual property issues for consideration by life sciences companies, and the venture capitalists who invest in these companies, with respect to patentable subject matter, disclosure grace periods and co-owned patents. (2 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: The patentability of higher life forms was in the spotlight recently in Ottawa, as the Supreme Court of Canada heard arguments in the Schmeiser v. Monsanto appeal. The Court’s decision—not expected for several months—will most likely contain key rulings on the validity and scope of gene and cell claims in patents in Canada, and on the infringement of patents claiming life forms that are self-replicating and able to spread. (2 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: Real estate activity has increased with potential improvement in capital markets, such as traditional VC financing and pending initial public offerings (IPOs). This has resulted in tenant’s aggressive demands extending deal cycle and rents decreasing due to increased sublease supply. Large users are also struggling to dispose of sublease space. This article reviews emerging trends in this area. (3 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top

Abstract: Biotechnology in Australia has flourished over the past five years. During this time the number of companies has doubled to over 370, and over 40 companies are now publicly listed. The total market capitalization of the biotechnology companies listed on the Australian Stock Exchange (ASX) in 2003 was US$1.5 billion. Total market capitalization of the health and biotech companies on the ASX was US$13 billion. The size of the total Australian pharmaceutical market in 2003 was US$9 billion. This article highlights the role of Australia in advancing stem cell research and its contribution to biotechnology research, development and commercialization. (4 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

Back to Top