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Articles 451 - 480 of 611
Full-Text Articles in Food and Drug Law
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.
Food Safety And Security In The Monsanto Era: Peering Through The Lens Of A Rights Paradigm Against An Onslaught Of Corporate Domination, Saby Ghoshray
Maine Law Review
Since our earliest ancestors’ desire for a better hunting weapon to procure food or a better storage facility to avoid spoilage, food safety and security has shaped human social and technological evolution like no other essential element. The need to procure food has shaped our civilization since the first human graced our planet. Food continues to be a pivotal force in humankind’s saga for life and death. Yet, despite stratospheric progress in scientific application surrounding food, food security and safety for all citizens continues to elude mankind. Why do some enjoy a feast, while others suffer in famine? This essay …
Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince
Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince
South Carolina Law Review
No abstract provided.
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob
Washington Journal of Law, Technology & Arts
The Future of Innovation in Medicine Conference (“Conference”) proceedings contained in this Symposium Issue are about the problem of incentivizing research into new uses for established medicines. Putting the problem into the wider context of financing pharma research generally gives an important perspective.
The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka
The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka
Washington Journal of Law, Technology & Arts
Japan is one of most innovative drug manufacturer-friendly countries because it revised its patent and drug regulation systems for providing patent and non-patent incentives for new use and treatment R&D based on its pro-patent and pro-medical science policies. This article provides an overview of the pharmaceutical industry and examines patent and non-patent incentives for drug R&D in focusing on incentives for developing new uses of and treatments for known drugs from a comparative law perspective. After discussing the difficulties in establishing infringement and in obtaining injunctions against generic drug manufacturers who infringe new use product patents, the article reviews measure …
Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann
Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann
Washington Journal of Law, Technology & Arts
Following recent regional court decisions on the infringement of second medical use patent claims, the German concept of manifest arrangement—previously believed to provide a safe harbor for generic pharmaceutical companies as long as they skinny-labeled their products—may be subject to a new interpretation. The German decisions are part of a Europe wide series of decisions on the same or similar subject matter and prove to be patent owner friendly.
Innovation In Known Drugs—The European Angle, Galit Gonen
Innovation In Known Drugs—The European Angle, Galit Gonen
Washington Journal of Law, Technology & Arts
Research into new uses for known drugs should be encouraged because the “repurposing” of known drug molecules can be a highly effective route of innovation for pharmaceutical companies. Investment in the development of these products should be rewarded. However, incentives that are designed to reward innovation must be in line with the size and value of the innovation in order to maintain a sustainable balance between incentivizing research and developing and encouraging a competitive market. In the context of encouraging innovation of new uses for known drugs, factors that facilitate access to drug development and innovation should also be considered …
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon
Washington Journal of Law, Technology & Arts
A transcript of the symposium's proceedings.
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 …
Big Pharma Versus Inter Partes Review: Why The Pharmaceutical Industry Should Seek Logical Hatch-Waxman Reform Over Inter Partes Review Exemption, 50 J. Marshall L. Rev. 337 (2017), Francisco Javier Espinosa
Big Pharma Versus Inter Partes Review: Why The Pharmaceutical Industry Should Seek Logical Hatch-Waxman Reform Over Inter Partes Review Exemption, 50 J. Marshall L. Rev. 337 (2017), Francisco Javier Espinosa
UIC Law Review
No abstract provided.
Avoiding The Chaos Of Maryjane - A Conventional Approach To Intellectual Property Protection Of Marijuana, 17 J. Marshall Rev. Intell. Prop. L. 278 (2017), Kaylee Willis
UIC Review of Intellectual Property Law
Whether you are considering the ever-popular recreational use, or recent medicinal developments, marijuana is a highly discussed controversial substance. With revenue from marijuana into the billions of dollars, it is no wonder it has been trying to reach into the intellectual property arena. This comment specifically looks into the patent arena and the obstacles that come with an attempt to seek, and enforce protection of marijuana-based patent applications. With the USPTO’s plant and utility patent options, there is perhaps more than one way to pass marijuana-based substances as patent-eligible subject matter. The largest obstacle for this type of intellectual property …
Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris
Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris
SMU Science and Technology 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.
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 …
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.
A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo
A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo
Journal of Intellectual Property Law
No abstract provided.
Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox
Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox
Journal of Intellectual Property Law
No abstract provided.
Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer
Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer
Journal of Intellectual Property Law
No abstract provided.
Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An
Minnesota Journal of Law, Science & Technology
No abstract provided.
Food Patents: The Unintended Consequences, Jay Dratler Jr.
Food Patents: The Unintended Consequences, Jay Dratler Jr.
Akron Intellectual Property Journal
This short paper explores the unintended consequences of this strong economic incentive. The underlying assumptions of patent law and its economic incentive are that innovation is good, and newer is better. But is that always so? Science and history suggest maybe not, for some very fundamental reasons. And there are reasons to believe that the risks of unintended consequences of innovation in food may be more hazardous than those in other fields of innovation.
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Law & Economics Working Papers
Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …
Keeping It In The Kitchen: An Analysis Of Intellectual Property Protection Through Trade Secrets In The Restaurant Industry, Sarah Segal
Cardozo Law Review
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 …
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Articles
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food 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 Art Of Food Placement: Will The U.S. Follow Germany's Lead In Copyrighting Artistic Food Placement?, 15 J. Marshall Rev. Intell. Prop. L. 565 (2016), Julianna Walo
UIC Review of Intellectual Property Law
Recently, German courts created groundbreaking precedent allowing copyright protection for the artistic placement of food on a plate. The rulings allow chefs to prohibit people from taking pictures of the copyrighted food placement. While Germany’s moral-based legal system allows for such copyright protections, this comment compares the U.S. legal system to that of Germany and examines if and how such copyright protection could extend to food placement in the U.S.
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Indiana Law Journal
This Note investigates the origins of Inwood that led to the slim opinion with wide influence. It argues that the very vagueness for which scholars and practitioners have decried Inwood is the case's greatest virtue: Inwood provides a flexible standard that has allowed the common law to evolve and address new business models. Part I discusses the origins of contributory infringement in intellectual property. Part II investigates the Inwood case and the climate of trademark law at the time Inwood was litigated. It also dissects the majority opinion and Justice White's concurrance. Part III examines the Inwood standard's evolution at …
Foreword: The Food Law Era, Nathan Cortez
Foreword: The Food Law Era, Nathan Cortez
SMU Science and Technology Law Review
No abstract provided.
Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens
Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens
Reports & Public Policy Documents
In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
Michigan Telecommunications & Technology Law Review
The United States spends nearly $1,000 per person annually on drugs—forty percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …