GUEST EDITORIAL
	Sustaining Innovation and Growth in the Global Arena Mike Ruettgers
	FEATURE ARTICLES
	An Assessment of the Effect of Authorized Generics on Consumer Prices Aidan Hollis and Bryan A. Liang
	Waiver of Attorney-Client Privileges: Points to Consider Jaime Guttman
	Nanotechnology: An Update on Business Opportunities and Regulatory Challenges Barry M. Hartman and B. David Naidu
	The Supreme Court: Increasing Costs in the Biotechnology Industry Ann Mills and Patti Tereskerz
	Conducting International Clinical Trials in Israel: Benefits, Opportunities and the Unique Role of Pharmacists Ayelet Levanon
	RECENT DEVELOPMENTS
	Costs and Concerns Bryan A. Liang
	Civil Lawsuits Filed Against Pharmaceutical Companies Erizen Sei Bowles
	Fireflies Illuminate Cancer Research C.M. Tryon
	Study Finds Health Care Spending in the U.S. is Generally Worth the Cost Aline Gaba
	Health Care Enters the Electronic Age: The Emergence of Health Information Technologies Troy Krich
	Medicare to Cut Physician Reimbursements Octavio Cardona-Loya
	The World Trade Organization Makes a Final Ruling on Genetically Modified Organisms Danielle Gleason
	Hwang Woo Suk's Research Shown to be Fabricated Danielle Gleason
	BIOCOLUMNS
	BioCase Study/ Supreme Court Rules that a Licensee Need Not Breach Their License in Order to Challenge the Underlying Patent Medimmune, Inc. v. Genentech, Inc., 549 U.S. ___ No. 05-608 (January 9, 2007) Diana M. Steel and Alfred L. Browne, III
	Regulatory/ Institute of Medicine (IOM) Report on Drug Safety Chilton Varner, Mark Brown and Ted Hester
	BioFuture/ 20/20 Vision of the Healthcare Market in the Year 2020 Hillel Bachrach, Martin D. Mann and Maayan Wenderow
	BioStategy/ The Value of Decision Tree Analysis for Life Sciences Companies at the Intersection of Business and Litigation Edward J. Dailey
	Generics/ Generic Biologic Approved in U.S. and Europe: Regulatory Update Dale L. Rieger
	EU BioTech/ Building a Bio-Based Economy in the European Union (EU) Adeline Farrelly, Camille Burel and Dirk Carrez

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Sustaining Innovation and Growth in the Global Arena Mike Ruettgers

Abstract: At the top of every ambitious organization's agenda today-no matter its industry-is growth. In business there appears to be no Rosetta Stone for understanding what it takes to sustain success. This article highlights factors that contribute to sustaining growth in the global arena. 3 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Authorized generics have become a major policy issue in the US. An IMS Consultant report using wholesale data concluded that authorized generics markets have lower prices and thus is favorable to consumers. In the present study, we review the IMS Consultant report and find that its methodology is flawed. Using its identical drugs, we find that retail prices in markets with authorized generics are virtually identical than those without them, and, in fact, brand name prices in markets with authorized generics rise faster. Based on these findings, we conclude that the consumer benefits associated with authorized generics are limited. 9 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Since the Enron debacle, both the government and the private sector have grappled with the issue of internal investigations and the very likely request of waiver of the privileges. However, such waivers come with a host of concerns that both the government and the target company must consider before "fully cooperating." This article discusses some of the implications, doctrines, and constitutional issues that should be contemplated before acceding to waive the privileges. 6 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Nanotechnology -the deliberate engineering of particles that are too small for the eye to see in order to create matter that has different properties than those at the conventional scale- has come of age. There are reportedly over 300 consumer products world-wide that contain some nanomaterials.1 According to some experts, the global sales of nanoscale materials could exceed $1 trillion by the year 2015.2 Not surprisingly, over the last year, significant debate has begun, and action is being undertaken-to decide how this technology should be regulated. Businesses already involved in nanotechnology products and those interested in getting involved, need to be aware of regulatory developments and should be willing to educate regulators to ensure that new and changing rules do not undermine the promise of this technology. Inevitably, concerns over the potential impacts of this new and largely unseen technology on human health and the environment have arisen. As with other scientific advances, this one may not fit neatly into current regulatory regimes designed to address these concerns. This Alert gives a snapshot of how agencies and the public are responding to this-and how nanotechnology is and may be regulated 4 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The recent Supreme Court decision in Ebay Inc v. MercEchange, L.L.C. held that injunctive relief is not automatic on finding infringement of a valid patent but rather rests with the discretion of the courts in applying a four pronged equitable test. The ruling alarms the patent dependent biotechnology industry because historically the pattern has been to grant injunctions automatically once infringement on a valid patent has been established. Thus, the Biotechnology Industry Organization (BIO) argued in its amicus brief to the Supreme Court that such a holding would introduce uncertainty into patent law and frighten investors by weakening the tools which are used to protect patents. BIO concluded that the result would be less investment and hence less innovation in the industry which would be detrimental to society, and we concur for another reason. This article discusses why, by highlighting the uncertainty of patent law, the Supreme Court's ruling may increase costs in the biotechnology industry, which in turn could hamper successful innovation and commercialization of biotechnological advances for society's use. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Israel is increasing recognized for its important clinical trials sector and its contribution to healthcare research. Approximately 800 international clinical trials take place in Israel each year, with the numbers steadily increasing. Such trends bring many advantages, including exposure to new research and products. In addition, exposure to world-class trial protocols in accordance with accepted international standards contribute to educating a new generation of physicians, and pharmacists, which has contributed to advancing independent clinical trials in Israel. This process has led to the creation of a strong workforce in Israel and as well as enhanced economic development and work for new immigrants. The Israeli medical teams involved in clinical studies are well informed regarding new technologies being developed worldwide; and, as a result, the quality of treatment provided to the public continues to improve along with Israel's contribution to the literature in the field. This article highlights the important clinical trials infrastructure that exists in Israel today as well as the role of trained pharmacists involved in the execution and monitoring of clinical trials research. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No Abstract 1 page

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Numerous civil lawsuits alleging overpricing of pharmaceuticals have been filed against pharmaceutical companies in recent years. However, the pharmaceutical industry maintains the high cost of R&D justify its pricing practices. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The chemiluminescent properties in fireflies enable researchers to observe the effects of a compound in real-time, making it possible to amass the same amount of data as traditional research models, but using only one-tenth the amount of test subjects and in as little as five as opposed to 180 days. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Study finds the rising costs of health care in the U.S. over recent decades have generally provided good value to patients. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The emergence of Health Information Technologies (HIT) will revolutionize the health care industry by introducing an electronic system that can instantly transfer medical information among health care professionals. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Medicare reimbursements for physician services will be cut by 5.1 percent for 2007 and continue to be reduced through January 2012. 2 pages

©2007 by The Journal of BioLaw & Business. All Rights Reserved.

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The World Trade Organization Makes a Final Ruling on Genetically Modified Organisms

Danielle Gleason