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2006

Food and Drug Law

Food and Drug Law

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A Complete Property Right Amendment, John H. Ryskamp Oct 2006

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.


Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy Sep 2006

Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy

ExpressO

Trade, economists and trade theorists advise, is a mutually beneficial exercise. Among this group, a particular set of advocates, claim that “Free Trade” is in the interest of all parties. As will be demonstrated, Free Trade is not truly “free” but an exercise of foreign policy and the implementation of policies favouring wealthy corporate interest groups. Free Trade is controlled by wealthy nations who have stacked the rules in favour of themselves, and in particular their corporate interests, and against the poor producers in poor nations. This control is used contrary to fairness, economic and ecological logic. Fair trade, by …


On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco Aug 2006

On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco

ExpressO

This article is devoted to copyright protection for one of the restaurant industry’s most valuable assets – original recipes. The two most recent appellate courts to consider the issue have been hostile to the notion that recipes are copyrightable, but given the enormous amount of money at stake, litigation in this area is likely about to expand. The article begins by critiquing the courts’ conclusions. Following an analogy to musical composition, I argue that recipes are simply the means of fixation for culinary works of authorship, i.e, dishes. Next, based on interviews with some of America’s leading chefs, including Thomas …


The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis Aug 2006

The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis

ExpressO

The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal prescription drug labeling regulations preempt common law tort claims until the last few years, beginning with Motus v. Pfizer in 2002. This position, radical to many and rational to others, places federal preemption of prescription drug …


In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski Aug 2006

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski

ExpressO

The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the Security …


Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu Jul 2006

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …


Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp Jun 2006

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.


Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis Apr 2006

Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis

ExpressO

Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In …


Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson Mar 2006

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …


Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson Mar 2006

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …