Open Access. Powered by Scholars. Published by Universities.®
- Institution
-
- Seattle University School of Law (191)
- UIC School of Law (29)
- University of Michigan Law School (23)
- Yeshiva University, Cardozo School of Law (13)
- Schulich School of Law, Dalhousie University (9)
-
- BLR (8)
- Brooklyn Law School (8)
- Georgia State University College of Law (8)
- American University Washington College of Law (5)
- Marquette University Law School (5)
- Maurer School of Law: Indiana University (5)
- Fordham Law School (4)
- University of Arkansas, Fayetteville (4)
- University of Minnesota Law School (4)
- Boston University School of Law (3)
- New York Law School (3)
- Pepperdine University (3)
- Southern Methodist University (3)
- The Catholic University of America, Columbus School of Law (3)
- University of Georgia School of Law (3)
- Villanova University Charles Widger School of Law (3)
- William & Mary Law School (3)
- Louisiana State University Law Center (2)
- Texas A&M University School of Law (2)
- University of Florida Levin College of Law (2)
- University of Missouri-Kansas City School of Law (2)
- Washington and Lee University School of Law (2)
- West Virginia University (2)
- Barry University School of Law (1)
- Brigham Young University (1)
- Keyword
-
- Pharmaceuticals (21)
- Drugs (20)
- Regulation (17)
- FDA (16)
- Law (15)
-
- Patent law (14)
- Biotechnology (13)
- Food and Drug Administration (11)
- Food and Drug Law (10)
- Health Law and Policy (9)
- Patents (9)
- Science and Technology (9)
- Corporations (8)
- Research and development (8)
- Medical Jurisprudence (7)
- Public health (7)
- SFFA (7)
- Technology (7)
- Affirmative Action (6)
- Antitrust (6)
- Artificial intelligence (6)
- ESG (6)
- Economics (6)
- Intellectual Property Law (6)
- Intellectual property (6)
- International Trade (6)
- Law and Economics (6)
- Law and Society (6)
- Law and Technology (6)
- Privacy (6)
- Publication Year
- Publication
-
- Seattle University Law Review (189)
- UIC Review of Intellectual Property Law (14)
- UIC Law Review (13)
- Articles, Book Chapters, & Popular Press (8)
- ExpressO (8)
-
- Articles (7)
- Faculty Scholarship (7)
- Michigan Telecommunications & Technology Law Review (7)
- Faculty Publications By Year (6)
- Brooklyn Law Review (5)
- Faculty Publications (5)
- Marquette Intellectual Property Law Review (5)
- Fordham Law Review (4)
- Journal of Food Law & Policy (4)
- Minnesota Journal of Law, Science & Technology (4)
- Other Publications (4)
- Book Chapters (3)
- Cardozo Law Review (3)
- Catholic University Journal of Law and Technology (3)
- Michigan Law Review (3)
- SMU Science and Technology Law Review (3)
- Sustainable Development Law & Policy (3)
- Cardozo Arts & Entertainment Law Journal (2)
- Cardozo International & Comparative Law Review (2)
- Cardozo Journal of International and Comparative Law (2)
- Cardozo Public Law, Policy & Ethics Journal (2)
- Faculty Works (2)
- Georgia Journal of International & Comparative Law (2)
- Georgia State University Law Review (2)
- Indiana Journal of Global Legal Studies (2)
- Publication Type
Articles 301 - 330 of 372
Full-Text Articles in Food and Drug Law
Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich
Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich
Faculty Scholarship
This Article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …
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, …
Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer
UIC Law Review
No abstract provided.
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled
Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled
Faculty Publications By Year
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …
Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012), Benjamin Liu
UIC Review of Intellectual Property Law
Countries after countries are adopting a controversial regulatory system of linking the market approval for pharmaceuticals to the status of potentially blocking patents as part of their bilateral and multilateral trade agreement package with the United States. Surprisingly, China took up pharmaceutical patent linkage in the absence of any treaty obligations and became the first country to adopt this regulatory regime outside of North America, despite the presence of a flourishing generics pharmaceutical industry and its developing country status. In fact, the Chinese regulation promised more intellectual property ("IP") protection than what even the United States FDA is capable of …
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
Other Publications
The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.
The History And Future Of Genetically Modified Crops: Frankenfoods, Superweeds, And The Developing World, Brooke Glass-O'Shea
The History And Future Of Genetically Modified Crops: Frankenfoods, Superweeds, And The Developing World, Brooke Glass-O'Shea
Journal of Food Law & Policy
In a 1992 letter to the New York Times, a man named Paul Lewis referred to genetically modified (GM) crops as "Frankenfood," and wryly suggested it might be "time to gather the villagers, light some torches and head to the castle." Little did Lewis know that his neologism would become the rallying cry for activists around the world protesting the dangers of genetic engineering. The environmental activist group Greenpeace made great use of the "Frankenfood" epithet in their anti-GM campaigns of the 1990s, though they have since backed away from the word and the hardline stance it represents. But genetically …
The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison
The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison
UIC Review of Intellectual Property Law
The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …
Patent Office As Biosecurity Gatekeeper: Fostering Responsible Science And Building Public Trust In Diy Science, 10 J. Marshall Rev. Intell. Prop. L. 423 (2011), Brian J. Gorman
UIC Review of Intellectual Property Law
When the fields of intellectual property law and biotechnology intersect, most analysis is driven byeconomic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free from oversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of syntheticbiology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government …
Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker
Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker
UIC Review of Intellectual Property Law
Since 1984, generic pharmaceuticals have continued to grow, and are an important element in our national struggle to increase affordable health care options in the United States. The Hatch-Waxman Act has played a pivotal role in helping to create a regulatory environment that fosters the development of generic pharmaceuticals, thereby increasing access to lower-cost alternatives to more expensive drugs. An important part of balancing the interests of the generic manufacturers against those of the primary pharmaceutical makers is the thirty-month stay provision of the Hatch-Waxman Act. This comment begins by taking a look at the history of the Hatch-Waxman Act …
From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah
From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah
Faculty Publications By Year
Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …
Nanofood: Legal And Regulatory Challenges, Abu Bakar Munir, Siti Hajar Mohd. Yasin
Nanofood: Legal And Regulatory Challenges, Abu Bakar Munir, Siti Hajar Mohd. Yasin
Journal of Food Law & Policy
Nanotechnology will have a significant impact on food production in a variety of ways, both directly and indirectly. The growth and complexity of nanotechnology in food applications poses new challenges for the existing food regulation as well as the regulatory authority. This article seeks to examine the legal and regulatory challenges posed by the nanotechnology applications in the food industry. This article reviews some of the relevant legislation in the U.S. and E.U. in dealing with nanofood and the industry. This article also provides an assessment on the adequacy of those laws and identifies the possible gaps and weaknesses in …
Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman
Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman
Elisabeth Haub School of Law Faculty Publications
This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …
The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler
The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler
Faculty Publications By Year
No abstract provided.
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Journal Articles
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder
Articles, Book Chapters, & Popular Press
The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …
State Government Speech In A Federal System, Laura J. Hendrickson
State Government Speech In A Federal System, Laura J. Hendrickson
Cardozo Public Law, Policy & Ethics Journal
No abstract provided.
Commentary Genetically Modified Organisms And Global Hunger: A Real Solution?, Simon Nicholson
Commentary Genetically Modified Organisms And Global Hunger: A Real Solution?, Simon Nicholson
Sustainable Development Law & Policy
No abstract provided.
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Articles
This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …
Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason
Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason
San Diego International Law Journal
At a fundamental level, pharmaceuticals serve two roles: both as a cure for disease and as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. In least developed nations the barriers to drug access are not solely economic. National regulatory systems for market approval are being used to prevent external pharmaceutical manufacturers from participating in a national market. This article will address how the regulatory framework of pharmaceutical registration may serve as a barrier to trade in drugs, …
The Fda And The Future Of The Brain-Computer Interface: Adapting Fda Device Law To The Challenges Of Human-Machine Enhancement, 25 J. Marshall J. Computer & Info. L. 117 (2007), Eric Chan
UIC John Marshall Journal of Information Technology & Privacy Law
No abstract provided.
Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann
Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann
Michigan Telecommunications & Technology Law Review
In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …
Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick
Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick
Cardozo Public Law, Policy & Ethics Journal
The article examines the escalating strain on Medicaid due to rising long-term care costs and an aging population, emphasizing the ineffectiveness of current policies promoting private insurance. It critiques traditional economic models for neglecting behavioral factors like emotional resistance to planning for aging and underestimating future care needs. The analysis concludes that voluntary measures, such as tax incentives and partnership programs, are insufficient and advocates for a universal compulsory program to ensure adequate preparation for long-term care, thereby reducing Medicaid reliance.
A Complete Property Right Amendment, John H. Ryskamp
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.
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Michigan Telecommunications & Technology Law Review
Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …
A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner
A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner
West Virginia Law Review
No abstract provided.
In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski
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
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
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.