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Articles 1 - 15 of 15
Full-Text Articles in Food and Drug Law
Distorted Drug Patents, Erika Lietzan
Distorted Drug Patents, Erika Lietzan
Faculty Publications
Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …
Drug Pricing—The Next Compliance Waterloo, Seth Whitelaw, Nicodemo Fiorentino, Jennifer O'Leary
Drug Pricing—The Next Compliance Waterloo, Seth Whitelaw, Nicodemo Fiorentino, Jennifer O'Leary
Mitchell Hamline Law Review
No abstract provided.
The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson
The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson
Georgia Journal of International & Comparative Law
No abstract provided.
Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman
Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings, Gabriella Tzeneva
Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings, Gabriella Tzeneva
Indiana Journal of Global Legal Studies
This Note explores the economic and social factors that drive multinational pharmaceutical companies to donate drugs to developing countries and evaluates the effectiveness of such donations in combating medicine shortages. The Note poses that such donations provide necessary economic incentives to drug companies and help curb high medical prices in developed nations while being an essential tool for ameliorating intellectual property requirements imposed by TRIPS. The Note proposes two solutions to further incorporate donations in access to medicine relief efforts and advocates increased international cooperation in the practice.
California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor
California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor
Pepperdine Law Review
The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court …
Leveraging The Dialectical Theory In Case Study Analysis: Genzyme's Ethical Dilemma, Andrei Duta
Leveraging The Dialectical Theory In Case Study Analysis: Genzyme's Ethical Dilemma, Andrei Duta
The Journal of Business, Entrepreneurship & the Law
This paper provides the theoretical framework for a case study that I share with students in my courses. The dialectical theory is used to analyze ethical conundrums pertaining to Genzyme, a successful bio-tech corporation based in Boston, Massachusetts that manufactures treatments for serious diseases such as kidney problems, immune diseases, and cancer. We discuss questions such as: is Genzyme acting unethically when averaging extremely high profit margins on drugs for rare diseases? Is the company taking advantage of the lack of pharmaceutical choices that patients have when addressing their ailments? The dialectical theory provides the framework and vocabulary for discussing, …
Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns
Villanova Law Review
The article presents information on the pharmaceutical companies manufacturing brand-name drugs and the issues related to pharmaceutical sales representative (PSR). The intensive sales training program, the exempt from overtime pay based on the U.S. Fair Labor Standards Act and the economic justice and security of low income group are discussed. The court decision of Smith v. Johnson & Johnson, white-collar exemptions and employee misclassification are also discussed.
International Drug Trafficking: A Global Problem With A Domestic Solution, Matthew S. Jenner
International Drug Trafficking: A Global Problem With A Domestic Solution, Matthew S. Jenner
Indiana Journal of Global Legal Studies
Forty years ago, the world declared war on drugs. Today, after decades of failing to adequately control drug consumption, an even graver problem has emerged: violent drug traffickers have taken the industry hostage and will stop at nothing to preserve their power. Governments have instituted dozens of programs to dismantle the illicit drug industry, but they have seen only marginal success. One strategy, however, has yet to be fully tested: universal legalization. Universal legalization of all drugs would attack the illicit drug market head-on, destroying the profit incentive for drug traffickers and placing control of the industry in the hands …
Patently Obvious: A Dual Standard Solution To The Diverging Needs Of The Information Technology And Pharmaceutical Patent Industries, Andrew Moody
Golden Gate University Law Review
This Comment proposes the use of a specifically tailored obviousness standard as a new solution to the IT and pharmaceutical patent industries' divergent needs. Part I summarizes the obviousness standard's history in patent law. Part II illustrates how the IT and pharmaceutical industries have divergent needs. Part III describes why using a single standard for the obviousness inquiry is inadequate to meet the needs of both the IT and pharmaceutical industries. Part IV illustrates why the obviousness standard needs to be specifically tailored for the IT and pharmaceutical industries. Finally, Part V concludes that a dual standard for obviousness is …
Minnesota: Leading The Way On Canadian Prescription Medicine Importation, Kevin Goodno, Karen Janisch
Minnesota: Leading The Way On Canadian Prescription Medicine Importation, Kevin Goodno, Karen Janisch
William Mitchell Law Review
In the United States, about $160 billion is spent on prescription medicines each year, with Minnesotans spending about $3 billion. The costs of prescription medicines receive so much attention in large part because, although prescription medicine costs constitute only 10.5% of total health care spending, they account for 23% of the total out-of-pocket costs that people incur when purchasing health care. Minnesota has been a leader in controlling prescription medicine costs. It has aggressively used purchasing pools when possible, and encouraged the use of lower cost, generic prescription medicines when appropriate. Even with these efforts to control costs, prescription medicines …
How A Drug Becomes ‘Ethnic’: Law, Commerce, And The Production Of Racial Categories In Medicine, Jonathan Kahn
How A Drug Becomes ‘Ethnic’: Law, Commerce, And The Production Of Racial Categories In Medicine, Jonathan Kahn
Faculty Scholarship
A drug called BiDil is poised to become the first drug ever approved by the Food and Drug Administration (FDA) to treat heart failure in African Americans - and only African Americans. This article explores the story of BiDil and considers some of its broader implications for the use of racial categories in law, medicine, and science. It argues that BiDil is an ethnic drug today as much, if not more because of the interventions of law and commerce as because of any biomedical considerations. The article is, first, a retrospective analysis of how law, commerce, science, and medicine interacted …
Dr. Joseph Rohan Lex, Jr., M.D. Faaem - The Physician-Pharmaceutical Industry Relationship, Joseph Rohan Lex Jr.
Dr. Joseph Rohan Lex, Jr., M.D. Faaem - The Physician-Pharmaceutical Industry Relationship, Joseph Rohan Lex Jr.
Journal of Law and Health
My premise is that physician interactions with marketing representatives result in inevitable and irreconcilable conflicts of interest or the appearance of conflicts of interest. Our patients in medicine are the ultimate losers from such interactions.
Don't Bite The Hand That Provides Life-Saving Drugs: Application Of The Hatch-Waxman And Sherman Acts To The Pharmaceutical Industry And The Detrimental Effects To Future Innovation In Order To Achieve Current Savings For Consumers, Edward J. King
Villanova Law Review
No abstract provided.
Patents: Help Or Hindrance To Technology Transfer?, Rebecca S. Eisenberg
Patents: Help Or Hindrance To Technology Transfer?, Rebecca S. Eisenberg
Book Chapters
Intellectual property is a broad heading used to refer to a wide variety of rights associated with inventions, discoveries, writings, artistic works, product designs, and designations of the source of goods and services. Patents and trade secrets are the most important of these sorts of intellectual properties in the field of biotechnology. One aspect of intellectual property that distinguishes it sharply from other forms of property-and for some people makes it harder to justify-is that intellectual properties may be possessed and used by many people simultaneously. This is not so for tangible property. If someone borrows my car, I cannot …