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Articles 211 - 240 of 310
Full-Text Articles in Food and Drug Law
Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie
Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie
Marquette Intellectual Property Law Review
This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.
Protecting Wisconsinites From Trolls: The Federal Circuit's "Bad Faith" Preemption And Its Restrictive Effect, Andrew Salomone
Protecting Wisconsinites From Trolls: The Federal Circuit's "Bad Faith" Preemption And Its Restrictive Effect, Andrew Salomone
Marquette Intellectual Property Law Review
In this comment, I use Wis. Stat. Ann. § 100.197 (“Wisconsin’s anti-PAE statute”) to demonstrate the significant degree to which the Federal Circuit’s current preemption regime restricts states’ abilities to regulate the behavior of PAEs. In Part II, I summarize Wisconsin’s legislative response to PAEs. In Part III, I contrast the Federal Circuit’s preemption doctrine and the Supreme Court’s doctrine as it relates to state laws similar to anti-PAE statutes. Paying particular attention to Wisconsin’s patent notification statute, I provide a brief preemption analysis in Part IV. Finally, in Part V, I conclude by arguing that the severe consequences of …
The Antitrust Duty To Charge Low Prices, Ramsi A. Woodcock
The Antitrust Duty To Charge Low Prices, Ramsi A. Woodcock
Cardozo Law Review
Over the past forty years, antitrust has come to embrace a goal of consumer welfare maximization that cannot be achieved solely through condemnation of collusive or exclusionary conduct. To address cases in which firms achieve the power to raise prices and harm consumers without engaging in collusive or exclusionary conduct, antitrust should impose a general duty on businesses to charge a price no higher than economic cost. Courts would not need to set prices to enforce this duty, because violations would be punishable only by nominal damages, and shame, rather than by an injunction setting a reasonable price. Although the …
A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan
A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan
Faculty Publications
This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …
Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd
Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd
Faculty Articles
Recent changes in the pharmaceutical industry have spurred an unprecedented wave of mergers and acquisitions. Some researchers and agencies have questioned whether pharmaceutical consolidation could impede drug innovation. However, as I explain in this Article, these concerns are largely based on an outdated understanding of the drug innovation ecosystem. Whereas a few decades ago almost all drug discovery took place inside traditional pharmaceutical companies, today most drug innovation is externally-sourced from biotech companies and smaller firms. Internal R&D is no longer the primary source, or even an important source, of drug innovation. As a result, analyses that focus on the …
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.
From Pay-For-Delay To Product Hopping: The Limited Utility Of Antitrust Law In The Pharmaceutical Industry, Joseph Fielding
From Pay-For-Delay To Product Hopping: The Limited Utility Of Antitrust Law In The Pharmaceutical Industry, Joseph Fielding
Cardozo Law Review
The note examines the intersection of patent law and antitrust policy, particularly in the context of pharmaceutical drug competition. It argues that while antitrust enforcement is an effective solution to address "pay-for-delay" agreements, it is less suitable for resolving "product-hopping" issues. Instead, the article contends that closing regulatory loopholes in the Hatch-Waxman framework would be a more effective approach to curbing anticompetitive product-hopping practices. The analysis focuses on two key cases—Federal Trade Commission v. Actavis, Inc. and Schneiderman v. Actavis LLC—to illustrate the legal and economic implications of these strategies.
Is "Product Hopping" Anti-Competitive Or Fair Game?: A Look At The Second And Third Circuit Divisions In Actavis Plc And Mylan Pharmaceuticals, Alexis S. White
Is "Product Hopping" Anti-Competitive Or Fair Game?: A Look At The Second And Third Circuit Divisions In Actavis Plc And Mylan Pharmaceuticals, Alexis S. White
North Carolina Central University Science & Intellectual Property Law Review
No abstract provided.
Innovation And Reverse Payments, Ramsi A. Woodcock
Innovation And Reverse Payments, Ramsi A. Woodcock
Florida State University Law Review
Settlements of patent litigation between branded and generic drug makers that include a promise by the generic maker to stay out of the market, sometimes in exchange for a ‘reverse’ payment, increase the profits of drug makers at the expense of consumers. Some commentators argue that drug makers will invest these profits in innovation, ultimately making consumers better off. Drug market data suggest, however, that the resulting gains to consumers may still be insufficient to offset consumer losses from delayed access to generics. Even when innovation is taken into account, antitrust can most efficiently eliminate the risk of consumer harm …
Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti
Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti
American University Law Review
No abstract provided.
The Craft Brewing Boom And Minnesota's Three-Tier System: The Case For Change, Jeffrey C. O'Brien
The Craft Brewing Boom And Minnesota's Three-Tier System: The Case For Change, Jeffrey C. O'Brien
Mitchell Hamline Law Review
No abstract provided.
Abilify, Brintellix, Champix: The Abcs Of Fda Proprietary Name Disputes, M. Dinora Smith
Abilify, Brintellix, Champix: The Abcs Of Fda Proprietary Name Disputes, M. Dinora Smith
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Product Hopping: Antitrust Liability And A Per Se Rule, Justine Amy Park
Product Hopping: Antitrust Liability And A Per Se Rule, Justine Amy Park
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher
Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher
Brooklyn Journal of Corporate, Financial & Commercial Law
The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is intended to lower the average price paid by consumers for prescription drugs. The Hatch-Waxman Act attempts to do so by simplifying the application process for generic drug manufacturers, allowing generic drug applications to circumvent the lengthy FDA testing and approval process that brand-name manufacturers must undergo. Though the Hatch-Waxman Act has successfully created a clear path to the market for generic drugs, it contains loopholes that allow brand name and generic companies to engage in practices aimed at maximizing monopoly profits, effectively …
Pharmaceutical M&A Activity: Effects On Prices, Innovation, And Competition, Barak D. Richman, Will Mitchell, Elena Vidal, Kevin Schulman
Pharmaceutical M&A Activity: Effects On Prices, Innovation, And Competition, Barak D. Richman, Will Mitchell, Elena Vidal, Kevin Schulman
Faculty Scholarship
The rise of blockbuster pharmaceutical acquisitions has prompted fears that unprecedented market concentration will weaken competition. Two of the most prominent concerns focus on the upstream and downstream ends of the pharmaceutical industry: (1) the concern that these mergers will concentrate the market for discovery and will therefore lead to fewer discoveries; and (2) the concern that merging large marketing, sales, and distribution forces will strengthen the hands of select pharmaceutical manufacturers and weaken downstream competition. Having considered potential dynamic effects in the industry and conducted a series of preliminary interviews with knowledgeable observers, though, this Article argues that neither …
Local And State Governments Are Taking The Stage When It Is Fda's Curtain Call - Are Local And State Governments' Safety Warnings Preempted By Federal Law?, Melissa M. Card
Journal of Food Law & Policy
Eliminated from fad diets, sworn off by celebrities, and frantically reformulated out of processed foods, added sugars have been deemed the new nutritional scoundrel. Recent studies from the American Heart Association, the World Health Organization, and the American Cancer Association demonstrate that the consumption of added sugar leads to increased risks of obesity, diabetes, heart disease, and gout. While all foods containing added sugar are deemed unhealthy, Sugary-Sweetened Beverages ("SSBs") are said to be especially toxic by the American health community, by virtue of these beverages' being excessively high in added sugar content, low in satiety, and incomplete in compensation …
Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets
Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets
Journal of Food Law & Policy
We are now less dependent on locally available food resources that we have ever been. The continuing industrialization of food production, the advancement in technologies and the rapid development of supply chains granted us the luxury of immediate access to a variety of products originating from local supermarkets all over the world. This, along with the greater level of food production industrialization, inevitably comes the rise of related food safety risks. Because of the enlargement of producing operations, an emerging safety threat in one place may result in a foodborne illness outbreak thousands of miles away from its place of …
Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat
Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat
Journal of Food Law & Policy
In the 1900s, the United States began to sell genetically engineered foods. One of the first genetically engineered foods sold in the United States and approved by the Food and Drug Administration (FDA) was the Flavr Savr tomato. The tomato's genetic structure was modified to prevent softening which allowed it to ripen after being picked. In the United States, statistics demonstrate that 92% of com, 94% of soybeans, and 94% of cotton sold is genetically engineered. In addition, it is estimated that 75% of the processed foods sold in supermarkets around the United States contain ingredients that are products of …
Energy Drink Regulations: Why The Time For More Fda Authority Is Not Ripe And How States Can Protect Children Without Unjustly Infringing On Adult Autonomy, Larry D. Treat
Journal of Food Law & Policy
In December of 2011, Anais Fournier ("Anais"), a fourteen-year-old from Maryland, was at the mall with her friends when she drank a twenty-four ounce Monster energy drink. Within twenty-four hours, Anais consumed a second twenty-four ounce energy drink. Together, the two Monster energy drinks Anais consumed contained around 480 milligrams ("mg") of caffeine. A few hours after the second drink, Anais went into cardiac arrest and later died from cardiac arrhythmia. An autopsy found that caffeine toxicity caused Anais's arrhythmia and impeded her heart's ability to pump blood. As it turns out, Anais suffered from a preexisting heart condition called …
2016 China Food Law Update, Michael T. Roberts, Ching-Fu Lin
2016 China Food Law Update, Michael T. Roberts, Ching-Fu Lin
Journal of Food Law & Policy
This update of China food law builds on a unique feature for the Journal of Food Law & Policy that has been provided since the Journal's inception - separate food law updates for both the United States and European Union. "Recognizing the globalness of the modem food system, these updates have served an invaluable role in keeping scholars and practitioners abreast of the world's leading food regulatory systems." China's emergence as a developed, modem food regulatory system with the potential of being a leading food regulatory system makes sense given its position as a world economic powerhouse. China's role in …
Getting A Handle On Growler Laws, Adam Star
Getting A Handle On Growler Laws, Adam Star
Seattle University Law Review
This Note will begin with a brief general history of growlers in the United States and the benefits they provide to consumers, retailers, and small craft brewers. Part II will provide an overview of national alcohol distribution regulation and how the present growler law exists within this larger framework. To complete the necessary background information, Part III will provide context to the competitive landscape by way of an examination of the craft beer industry’s explosive growth. The substantive portion of the Note will follow in Part IV, beginning with an outline of the various key types of growler restrictions such …
"All I Do Is Win": The No-Lose Strategy Of Cafo Regulation Under The Caa, Karl J. Worsham
"All I Do Is Win": The No-Lose Strategy Of Cafo Regulation Under The Caa, Karl J. Worsham
Journal of Food Law & Policy
Corporate farms, often known as concentrated animal feeding operations ("CAFO'), provide inexpensive animal products but do so by externalizing the cost of their operation in the form of environmental harms and risks to human health. This article explores one possible approach to mitigating CAFO-caused harms. It argues that CAFO regulation under any one of three Clean Air Act ("CAA ") programs will result in net benefits, not just for air quality, but also for other CAFO-caused harms and thus, that CAA regulation of CAFOs is a no-lose strategy. The article then goes further to conclude that, while regulation under any …
Recent Developments And Future Prospects Of The Common Market, Michael Waelbroeck
Recent Developments And Future Prospects Of The Common Market, Michael Waelbroeck
Georgia Journal of International & Comparative Law
No abstract provided.
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier
Akron Intellectual Property Journal
Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …
Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States, 15 J. Marshall Rev. Intell. Prop. L. 228 (2016), Daria Kim
UIC Review of Intellectual Property Law
The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question …
The Food And Drug Administration Versus The Federal Trade Commission: Reconciling Their Interests In Regulating Homeopathic Products, 49 J. Marshall L. Rev. 1193 (2016), Jordannah Bangi
UIC Law Review
This Comment suggests that the FDA should require homeopathic products to carry a disclaimer label similar to those used on prescription drugs or certain food or food products.
Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd
Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd
Faculty Articles
This Article examines a relatively new business strategy in the pharmaceutical market -- "product hopping" or "product replacement" -- in which brand pharmaceutical companies shift their marketing efforts from a drug nearing the end of its patent period to a new, substitute drug with a longer patent life. In July 2015, the Second Circuit issued an opinion in the first appellate case addressing pharmaceutical product replacement, New York ex rel. Schneiderman v. Actavis PLC. This Article explains that product replacement is the predictable business response to the incentives created by patent law and state substitution laws, and withdrawing an …
A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise
A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann
Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Introductions, Tatsuya Adachi
Introductions, Tatsuya Adachi
Cardozo Arts & Entertainment Law Journal
No abstract provided.