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Articles 331 - 360 of 372
Full-Text Articles in Food and Drug Law
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
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 …
Volume 6 Issue 3, Sustainable Development Law & Policy
Volume 6 Issue 3, Sustainable Development Law & Policy
Sustainable Development Law & Policy
No abstract provided.
Has The Supreme Court Incorrectly Expanded § 271(E)(1) To Risk A Regulatory Taking?, 5 J. Marshall Rev. Intell. Prop. L. 216 (2006), Tara Stuart
UIC Review of Intellectual Property Law
The U.S.S.C. expanded the scope of the Hatch-Waxman Act’s safe harbor provision in Merck III to include protection for infringing use of any type of invention as long as a researcher intended to perform research reasonably relevant to FDA approval. This broad interpretation is inconsistent with the legislative intent of the Hatch-Waxman Act, and the policies of the U.S. patent system. Many patent owners may unnecessarily experience such a reduction in their property rights as to constitute a regulatory taking. The proposed narrow interpretation would rectify the constitutional problems and inconsistencies in infringement exemptions. Section 271(e)(1) should apply only to …
Suppression Of Innovation Or Collaborative Efficiencies?: An Antitrust Analysis Of A Research & Development Collaboration That Led To The Shelving Of A Promising Drug, 5 J. Marshall Rev. Intell. Prop. L. 348 (2006), Saami Zain
UIC Review of Intellectual Property Law
This article discusses antitrust issues present in research and development collaborations between competitors. In particular, it illustrates that, although often very beneficial, these collaborations may have the potential for considerable harm via suppression of innovation. The article examines a recent case involving a collaboration to develop drugs, which arguably resulted in the suppression of a promising drug.
Merck V. Integra And Its Aftermath: A Safe Harbor For The Commercial Use Of Biotechnology Research Tools?, Brendan M. O'Malley
Merck V. Integra And Its Aftermath: A Safe Harbor For The Commercial Use Of Biotechnology Research Tools?, Brendan M. O'Malley
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates
Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates
ExpressO
The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
ExpressO
No abstract provided.
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Michigan Telecommunications & Technology Law Review
Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …
Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh
Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh
UIC Law Review
No abstract provided.
Patients Beware: Preemption Of Common Law Claims Under The Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005), Michael P. Dinatale
Patients Beware: Preemption Of Common Law Claims Under The Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005), Michael P. Dinatale
UIC Law Review
No abstract provided.
Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera
Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera
UIC Law Review
No abstract provided.
"As The Federal Circuit Turns": The Supreme Court's Consideration Of Merck V. Integra And The Safe Harbor Provision, 4 J. Marshall Rev. Intell. Prop. L. 368 (2005), Blair M. Jacobs, Christina A. Ondrick
"As The Federal Circuit Turns": The Supreme Court's Consideration Of Merck V. Integra And The Safe Harbor Provision, 4 J. Marshall Rev. Intell. Prop. L. 368 (2005), Blair M. Jacobs, Christina A. Ondrick
UIC Review of Intellectual Property Law
The Hatch-Waxman Act was enacted to balance the competing interests in the pharmaceutical marketplace between brand name and generic drug manufacturers. In the twenty years since its inception, the safe harbor provision contained in § 271(e)(1), has been interpreted to provide broad protection to those involved in research activities. However, in 2003, the Federal Circuit narrowly interpreted the safe harbor provision in a move that could potentially frustrate future research and improvements on patented technologies. Merck v. Integra is currently before the United States Supreme Court, who has the challenge of unraveling the competing interests involved. In order to encourage …
Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck
William Mitchell Law Review
This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
The Experimental Purpose Doctrine And Biomedical Research, Tao Huang
The Experimental Purpose Doctrine And Biomedical Research, Tao Huang
Michigan Telecommunications & Technology Law Review
The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …
Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland
Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland
ExpressO
This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jonathan H. Adler
Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jonathan H. Adler
Faculty Publications
What I want to talk about are some legal issues relating to labeling and, in particular, constitutional issues relating to mandatory labeling for genetically modified foods or food products that may contain genetically modified components. This is a separate issue from whether or not the FDA, or some other agency, has sufficient statutory authority at present to mandate labeling, and that is something worth discussing. Even if they do have such authority, or even if Congress tomorrow were to give the FDA such authority or were to require the FDA to impose labels on genetically modified foods, or if a …
Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone
Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone
Michigan Law Review
With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …
Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg
Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg
UIC Law Review
No abstract provided.
Reaching Through The Genome, Rebecca S. Eisenberg
Reaching Through The Genome, Rebecca S. Eisenberg
Book Chapters
The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
Book Chapters
The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …
Food Systems And Dietary Perspectives: Are Genetically Modified Organisms The Best Way To Ensure Nutritionally Adequate Food?, Ellen Messer
Food Systems And Dietary Perspectives: Are Genetically Modified Organisms The Best Way To Ensure Nutritionally Adequate Food?, Ellen Messer
Indiana Journal of Global Legal Studies
No abstract provided.
Genetically Modified Organisms In Peasant Farming: Social Impact And Equity, Stephen B. Brush
Genetically Modified Organisms In Peasant Farming: Social Impact And Equity, Stephen B. Brush
Indiana Journal of Global Legal Studies
No abstract provided.
Self-Prescribing Medication: Regulating Prescription Drug Sales On The Internet, 20 J. Marshall J. Computer & Info. L. 57 (2001), Kristin Yoo
UIC John Marshall Journal of Information Technology & Privacy Law
"Online pharmacies, your friendly neighborhood drugstores." The Internet is not only a great telecommunication medium but also a low-cost and convenient commercial marketplace. It is no exception that online pharmacies flourished as a result, but the consequences of such development pose grave danger to the public and great challenges to regulations. The author discusses the benefits and risk of online pharmacies, the different types of online pharmacies, state governments' involvement in regulating online prescriptions and federal involvements. Despite both state and federal legislations and regulations, proliferation of online pharmacies, established inside and outside of the US, proves to be a …
Computer-Aided Drug Design Using Patented Compounds: Infringement In Cyberspace?, 34 J. Marshall L. Rev. 1001 (2001), Ted L. Field
Computer-Aided Drug Design Using Patented Compounds: Infringement In Cyberspace?, 34 J. Marshall L. Rev. 1001 (2001), Ted L. Field
UIC Law Review
No abstract provided.
Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse
Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse
Michigan Law Review
Among the most common critiques of globalization is that it increasingly constrains the ability of democratic communities to make unfettered choices about policies that affect the fundamental welfare of their citizens, including those of health and safety, the environment, and consumer protection. Traditionally, free trade rules were about constraining border measures such as tariffs and quantitative restrictions on imports. Increasingly, however, such rules include requirements and constraints addressed directly to domestic regulation. For example, a country's policies with respect to intellectual property rights or its regulatory approach to network industries, such as telecommunications, may now be fundamentally shaped by rules …
Two Degrees Of Speech Protection: Free Speech Through The Prism Of Agricultural Disparagement Laws, Howard M. Wasserman
Two Degrees Of Speech Protection: Free Speech Through The Prism Of Agricultural Disparagement Laws, Howard M. Wasserman
Faculty Publications
In the wake of a 1989 national television broadcast reporting the alleged cancer risk of a chemical applied to apples on trees, many states passed agricultural product disparagement (APD) statutes. These statutes grant civil causes of action to the growers and sellers of perishable food products, against anyone who speaks negatively or disparagingly, without basis in scientific evidence, about the product's safety. In this Article, Howard M Wasserman explores the interplay between the APD statutes and the First Amendment. First, Mr. Wasserman discusses the three categories of restrictions on the freedom of speech, focusing primarily on private civil tort actions …