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Feature
5 pages
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The Scourge of Counterfeit Drugs: No Easy Answers
Bryan A. Liang
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Abstract:
Counterfeit drugs are a scourge known throughout the world, and patients have been harmed and killed because of their presence. Regulation and penalties are weak against purveyors of fake medicines, yet entering and profiting from this illicit business is low cost with high returns. The Internet has fueled the sale of these counterfeits, while the current state of technology is inadequate to secure the safety of the drug supply. A multi-disciplinary effort across public and private actors focusing on technological investment, increased legal penalties, professional and public education, and international cooperation is essential to address the harm associated with counterfeit drugs.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(4 pages)
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Contingency Planning: Preparation Is the Key to Recovering from Disasters
Aaron Kalisher, Christopher Dorko and Phil Jensen
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Abstract:
Businesses in any industry can reel from the repercussions of electrical outages, fires, computer hackers or the ravages of Mother Nature. When such disruptions occur, these companies may be forced to halt operations for days, weeks or even months. These businesses can and do recover, but in some sectors, like biotechnology, business interruptions that result from such events are potentially catastrophic. This article provides an overview of practical items that should be considered by all life science companies as part of contingency planning.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(9 pages)
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35 U.S.C. § 154: Provisional Rights Coverage
Mark S. Cohen and Assaf M. Geyra
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Abstract:
Under AIPA provisions, the publication of a U.S. patent application (or the publication of an international patent application that designates the United States and is published in English) marks the beginning of the provisional rights that a patentee may enforce after a U.S. patent issues from the published application. Provisional rights provide a patentee with the opportunity to obtain a reasonable royalty from a third party that infringes a published application claim. These provisional rights are subject to a number of limitations, the most significant being that the invention claimed in the patent must be substantially identical to the invention as claimed in the published application. For this reason, upon request by the applicant accompanied by payment of a publication fee, the PTO will republish an application in its amended form so that the published claims are substantially identical to the claims in the patent that eventually issues from the published application. Another limitation is that an actual notice should be given to the third party by the applicant.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(7 pages)
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The Negotiation and Development of a Clinical Trial Agreement
Peter B. Finn
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Abstract:
A carefully negotiated clinical trial agreement will protect a biotechnology and medical device company in critical areas, including the management and control of data and confidential information, defining publication rights and the ownership of intellectual property. Properly constructed, the agreement can increase a company's value. This article will review the major provisions of a standard industry sponsored clinical trial agreement; the principle areas where there is likely to be differing views that need to be reconciled and interrelated ethical concerns. A form of clinical trial agreement designed for a single site therapeutic trial in the United States follows the article.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
(6 pages)
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Biopharmaceutical Industry Contributions to State and U.S. Economies
Ross C. DeVol, Perry Wong, Armen Bedroussian, Lorna Wallace, Junhgoon Ki, Daniela Murphy, and Rob Koepp
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Abstract:
The pharmaceutical industry is one of the most enduring, largest and most critical knowledge-intensive sectors in the U.S. economy. And, there is a good reason why governments across the country and around the world are fighting hard for biopharmaceutical dollars: These companies have the potential to add thousands of jobs and millions of dollars to their economies. America's biopharmaceutical companies are responsible for creating over 2.7 million jobs across the United States (U.S.). In addition, over 400,000 Americans are directly employed in the biopharmaceutical industry and, on average, 5.7 jobs are created economy-wide for each biopharmaceutical job. This article highlights the key findings from the "Biopharmaceutical Industry Contributions to State and U.S. Economies," conducted by the Milken Institute.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Recent Developments:
(2 pages)
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The Varying Interface Between Science and Law
Bryan A. Liang
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Abstract:
No Abstract
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Recent Developments:
(2 pages)
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Medicare Part D: Challenges in Implementation
Amir Alavi
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Abstract:
Medicare Part D prescription medication benefit creates difficulties for the pharmacy industry and complexities for Americans who must choose to enroll.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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European Union Members Say No to Marketing Genetically Modified Maize
Joya K. Raha
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Abstract:
European Union members reject market approval of two genetically modified maize seeds despite their approval by the European Food Safety Agency and the European Commission
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Legitimacy of Mammograms in Preventing Breast Cancer Deaths
Aline Gaba
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Abstract:
A new study published has found that mammograms contributed to a significant decrease in the mortality rate of women with breast cancer in the U.S. 1 page
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Africa's Mass Departure of Medical Professionals
Emma Bennett-Williams
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Abstract:
Wealthy countries are the destinations of choice for the mass departure of medical professionals from Africa.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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Inter-Academy Panel Statement on Biosecurity: A Focus on Biological and Toxin Weapons Convention and International Customary Law
Nicole Bates and Tiffany Hancock
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Abstract:
Inter-Academy Panels set of principles outlines how the scientific communities can maintain international peace.
2 pages
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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BioProspecting/Marine Bioprospecting and Sustainable Regional Development Policies
Harlyn O. Halvorson and Fernando Quezada
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Abstract:
The promises of discovering successful drugs leads from bioactive marine molecules are yet to be realized. However the mega-diverse countries of the world continue to explore both land-based and marine bioprospecting activities as part of their overall sustainable development programs and policies. Several such countries are preparing to increase their investments in the necessary science and technology infrastructure for this purpose. In this regard the mega-diverse countries are reviewing their needs in intellectual property protection, regulatory frameworks, value chain opportunities and overall commercialization efforts.
4 pages
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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