FEATURE ARTICLES
	ECJ Decisions Signal End to Cross-Border Jurisdiction in European Patent Infringement Actions Corinne Elisabeth Atton
	Beyond Patents and Royalties: Perception and Reality of Doing Business with the NIH Gil Ben-Menachem, Steven M. Ferguson, and Krishna Balakrishnan
	Pharmaceutical Originators' Protection in China Kin-Wah Chow
	Medical Confidentiality and Use of Medical Information in Israel Ayelet Levanon, Limor Sobol, and Hila Tzur
	The Orphan Drug Pricing Dilemma: How Do We Measure Affordability? Jordan B. Michael
	SPECIAL SEGMENT: MEDICINE SECURITY AND TERRORISM
	Terrorism, International Crime, and Medicine Security: Issues in a Global Marketplace Bryan A. Liang
	Crime, Terrorism, and Counterfeit Drugs: Addressing the International Regime Bryan A. Liang
	An Overview of Pharmaceutical Smuggling Cases in San Diego: It Goes Better When Agencies Work Together Greg Schulte
	Counterfeit Pharmaceuticals: Understanding the Threat John Theriault
	Pharmaceutical Counterfeiting Trends: Understanding The Extent of Criminal Activity Thomas T. Kubic and Sebastian J. Mollo
	Dangerous Doses Katherine Eban
	Medication, ID Theft, and Health Care: A Haven for the Criminal Element Alan Cates
	The European Pharmaceutical Supply Chain: Implications for the USA Jim Thomson
	RECENT DEVELOPMENTS
	Counterfeit Tamiflu Seized in U.S. Erizen Sei Bowles
	Holograms, RFID Lead the Fight Against Counterfeits in the U.S. Andrea G. Fiore
	Proposed Legislation to Combat Counterfeit Pharmaceutical Trafficking in the U.S. April C. Ness
	Technology and International Cooperation Combat Internet Drug Trafficking Bart Parsley
	Stronger International Criminal Penalties Proposed for Counterfeiting Summer Peard
	Medicare's Prescription Drug Plan May Reduce Demand for Individual Drug Imports Melanie Porter
	BIOCOLUMNS
	BioRegulation/New FDA Rules On Prescription Drug Labeling Alan Bennett
	BioR&D/BIRD Foundation: Funding Israeli-American Collaborations for Developing and Commercializing Innovative Technologies Eitan Yudilevich

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ECJ Decisions Signal End to Cross-Border Jurisdiction in European Patent Infringement Actions Corinne Elisabeth Atton

Abstract: This article examines the complexities surrounding the enforcement of European patent rights. Setting out the framework of European patents and the rules for cross-border dispute jurisdiction, this Article comments, first, on the inconsistent approaches taken by the various national courts to date; second, on two significant recent rulings of the European Court of Justice. Then, introducing the frustrated proposals for a unified European Community Patent and a centralized European Patent Litigation Agreement, this article concludes that the debate over harmonization is unlikely to be resolved in the foreseeable future. 6 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Young, and mid size biotech companies can benefit hugely from the US National Institutes of Health (NIH), not least because of the agency's non-dilutive funding, guidance, and opportunities for collaboration. Increasingly, however, there is a fair bit of misunderstanding about what the NIH can and cannot do for a biotech entrepreneur. 6 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The protection of original drugs in China has evolved considerably over the last ten years. Notwithstanding views that China laws accord data exclusivity to results of clinical trials to new drug launches, the author explained why China's laws does not truly accord data exclusivity to new drugs. Instead of a drug exclusivity regime, originator drug companies will have to rely on the "monitoring period" for drugs that are newly admitted into the national standards to keep the competition out. This article examines the various forms of protection available to drug originators and the challenges they face in China. In addition, it highlights certain features of patent litigation peculiar to China; further, this article explains why it is unrealistic to expect full redress in patent infringement litigation and that the objective should be to use the quickest means to stop the infringement early. 5 pages

©2006 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. 9 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article explores the Orphan Drug pricing dilemma experienced by consumers who need these drugs to stay alive. The article reviews FDA regulation and law in this area and expresses modern day concerns from legal, regulatory and public policy perspectives. 4 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No Abstract 3 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Producing counterfeit drugs is a lucrative, low risk, high return business. Organized criminal elements and terrorist organizations are exploiting this reality across borders to fund their activities. An interdisciplinary, multi-focal strategy to raise awareness of the issue, establish stakeholder reporting systems, reform penalties to fit the crime, and invest in technology must be engaged to protect the public health and bring those who would exploit the sick and vulnerable to justice. 5 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The U.S. Customs Service and its successor agency U.S. Immigration and Customs Enforcement (ICE), which is now located within the Department of Homeland Security, have conducted investigations into the illegal importation of unapproved and counterfeit pharmaceuticals for decades. Other federal and state agencies have conducted similar investigations. Advances in technology have created an increasingly favorable climate for such crime. In response, law enforcement agencies on the federal and state level will have to work more closely with each other and with various regulatory agencies, foreign governments, private industry trademark holders, and consumers to address this public health and intellectual property issue. 5 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The manufacture and distribution of counterfeit medicines is big business. Counterfeits threaten the health and safety of patients around the world, who depend upon authentic medicines prescribed by their doctors to save or improve the quality of their lives. The sale of counterfeit medicines not only funds criminal enterprises and terrorist organizations, but also undermines the ability of research-based pharmaceutical companies to discover, develop and market new medicines to the present and future generations. Pfizer has engaged in a focused anti-counterfeiting program that strives to ensure that patients receive authentic Pfizer products in partnership with enforcement agencies around the world. Despite our best efforts, we alone cannot ensure the integrity of the medicines supply chain. In seeking a sustainable system for ensuring access to medicines, policymakers must not view the security of our medicines supply chain as an obstacle to be gotten around. Ensuring the integrity of the drug supply is an issue of national security and public safety. 5 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Pharmaceutical crime is a tremendously challenging and growing facet of international trade. In an effort to understand the scope and nature of the problem, cooperative strategies through the Pharmaceutical Security Institute have been instituted. PSI utilizes a broad range of skills and approaches to detect and provide information on this critical issue for public and private stakeholder use against the criminal element to promote safety in the drug supply. 6 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: For years, the nation's medicine has moved through a thriving gray market of middlemen, who buy and sell medicine to one another. These middlemen often resort to fraud in order to obtain medicine for resale more cheaply through drug diversion. Soaring prices, weak laws and numerous opportunities for arbitrage have attracted narcotics traffickers and organized crime into this activity. With the growth of this crime-riddled gray market has come troubling evidence of a new problem: the exploitation of this traffic in counterfeit, adulterated and substandard medicine by terrorist networks seeking ways to finance their activities. 4 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Fraud in medication claims results in significant false claims. Yet the systems that purportedly are designed to detect such claims are limited in effectiveness. In combination with the porousness of the US drug supply, the criminal element has entered into the pharmaceutical distribution world with little risk and high returns. To address this combination, spot testing and patient education is important so as to reduce the millions in fraudulent expenditures associated with false drug claims and to protect the public's health. 4 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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The European Pharmaceutical Supply Chain: Implications for the USA

Jim Thomson