GUEST EDITORIAL
	Patent Reform: Protect Patents, Foster Innovation Jim Greenwood
	FEATURES
	U.S. Supreme Court Cases Impact Life Sciences Patents David J. Dykeman and Joanna S. Toke
	The Role of Standards and Guidance in Advancing Device Technology Larry Kessler and Carol L. Herman
	The Viability of Open Source Biotechnology Kimberly B. Herman and David W. Hesford
	The Rules Are Old, But the Game Is Changing: Life Sciences and the Foreign Corrupt Practices Act Ted Acosta
	Patent Dispute Resolution (PDR): Improving Patent Adjudication through Alternative Dispute Resolution (ADR) and Court Reform Randy Berholtz, Palak Bhakta, Mary Hardy and Ken Forsgren
	Outsourcing in a Flattening World-Watch Out for Nooks and Crannies Harry Rubin
	RECENT DEVELOPMENTS
	Building on Wins and Losses in Development Bryan A. Liang
	Topical Microbicide to Prevent HIV Infection Fails Clinical Testing Samir Patel
	First Renin-Inhibtor Approved for Hypertension Treatment Kale Heiman
	Human Thrombin Approved for Topical Use in Surgery Jason J. Kennedy
	New Drug for Acromegaly Approved Sasan Mirkarimi
	Second-Generation Smallpox Vaccine Approved Joya K. Raha
	CDC Survey Reveals Strengths and Weaknesses of U.S. Childhood Immunization Genevieve A. Suzuki
	BIOCOLUMNS
	Tech Transfer/ Biotech Licensing from Universities: A Maturing of Perspective Lita Nelsen
	Healthcare/ Calling for Six Standards to Value Innovation in Healthcare Michael Leader
	Biotech Venture/ Setting Up a New Biotech Venture in India Prabuddha K. Kundu and Rajeev Soni
	Stem Cell/ New Stem Cell Legislation in Europe: Are You Ready? Helen G. Smith
	BioBusiness/Eligibility Requirements for Applicants to the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Compiled by Robin JR Blatt
	National Institutes of Health (NIH)/ NIH Launches Human Microbiome Project: NIH Roadmap Effort to Use Genomic Technologies To Explore Role of Microbes in Human Health and Disease National Institutes of Health

Abstract: No Abstract 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Strong patent portfolios are critical to the growth and success of life sciences companies as they help companies gain a competitive edge in the marketplace. The Supreme Court's recent increased involvement in patent cases threatens to change how life sciences companies approach their patent strategy. Recent Supreme Court decisions will increase the time and costs of prosecuting patents, change license agreement negotiations, alter how companies respond to claims of patent infringement, and determine where companies may litigate a potential patent infringement suit. Cases on the Supreme Court's horizon further threaten to eliminate the protection that federally regulated industries enjoy against state product liability claims and the control that companies possess over their products. Successful life sciences companies must adapt to the changing patent landscape to ensure maximum coverage of their intellectual property assets and protect themselves against competitors. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Advancing medical device technology from the design to delivery to patients takes many steps, typically including design or modification of an existing device, bench or laboratory testing, risk analysis, clinical testing (if appropriate), review of the device by regulatory agencies, and postmarket surveillance by both the regulatory agency and the manufacturer. The development of technical guidance documents or international standards has made this process more efficient in the United States, though these processes are both underutilized and underappreciated. The history of the use of these approaches will be described, as well as recent progress and how the future of guidance and standards may evolve. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Open-source biotechnology is a relatively new concept inspired by the open-source software movement. The idea behind open source biotechnology is to promote an "intellectual commons" in which biotechnology would be made freely available under license agreements that would promote further development and free use. This article explores how the open source business model, in which economic gain is derived from an increased value of a technology through user improvements, could apply to the biotechnology industry. This article also addresses current efforts in the open source biotechnology movement, obstacles that could hinder its growth, and ways that the open source model could overcome these obstacles. 4 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The Foreign Corrupt Practices Act turned 30 this year. Historically, life sciences companies have not focused extensively on compliance with this decades-old statute, as enforcement actions were relatively few, and tended to target companies in other industries. But as the biotechnology industry and the FCPA enter their fourth decade, the game is changing. Regulators are ramping up overall enforcement and increasing their scrutiny of life sciences companies. This increased enforcement coincides with industry trends towards increased cross-border relationships and access to emerging markets. This article discusses this environment of heightened risk, and provides insights for companies looking to mitigate risk and play by the changing rules of the game. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Intellectual property is the backbone of the American economy, and patent disputes are on the rise. Patent litigation in the U.S. Federal courts is relatively inefficient, extremely expensive and can last years, eating away at patent terms and company profits. Alternate dispute resolution (ADR) practices, such as mediation and arbitration, offer efficiency and cost improvements in patent adjudications, but appear to be relatively underutilized. While Congress has sought to encourage ADR and integrate such decisions into the patent adjudication process, patent holders are often not willing to give up their constitutional due process rights and settle their patent disputes by ADR. This article reviews the current court and ADR patent adjudication processes and introduces a proposed patent dispute resolution (PDR) mechanism that seeks to incorporate the benefits of traditional ADR methods while providing speedier, more reliable decisions over the U.S. District courts. 8 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The proliferation of manufacturing outsourcing and its increasing importance to the core business functions of medical device and pharmaceutical companies have profoundly affected business realities for outsourcing customers and vendors worldwide. Manufacturing outsourcing epitomizes the possibilities and limits of the new globalisms requiring the successful navigation of performance, intellectual property, liability, enforcement, and business continuity risks. Several techniques are available to manage those risks and ensure that the many important remnants of internationalism do not trap the parties in a set of unintended consequences. This article highlights emerging issues associated with outsourcing and the impact on core business functions. 4 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No Abstract 1 page

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Two clinical trials of topical microbicide to test their effectiveness in preventing the spread of HIV infection during sexual intercourse were recently halted. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: In March 2007, the U.S. Food and Drug Administration approved Tekturna, a new hypertension drug that reduces high blood pressure by inhibiting an enzyme produced by the kidneys called renin. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Omrix Biopharmaceuticals, Ltd. has manufactured the first human thrombin approved since 1954 for use as a blood-clotting protein used to help control bleeding during surgery. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: French company Ipsen Pharma Biotech has manufactured Somatuline Depot (injection) to provide long-term treatment for patients with Acromegaly, and the FDA has authorized its approval as an Orphan product under the Orphan Drug Act. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Second-Generation Smallpox Vaccine Approved

Joya K. Raha