Food and Drug Law Commons^™

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

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

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 …

Patents And The Pharmaceutical Industry: Curbing The Abusive Practices Employed By Blockbuster Drug Companies To Prolong Market Exclusivity, Kelley Chandler

Cornell Journal of Law and Public Policy

Patent law in the pharmaceutical space presents unique challenges. Interactions between patent terms, the FDA, the drug development process, and the need for quality medical solutions create a complex dynamic which leads to uncertainty. This uncertainty makes it difficult to discern between solutions which might be effective, and solutions which will spawn new challenges where they so intently sought to eliminate old ones. Although Hatch-Waxman was a success in many ways, in other ways it has proven to frustrate the purposes behind its enactment. The suggestions presented here are a sound starting point for alleviating some of the burden plaguing …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Craft Beer And The Rising Tide Effect: An Empirical Study Of Sharing And Collaboration Among Seattle's Craft Breweries, Zahr K. Said

Lewis & Clark Law Review

This qualitative empirical research project studies Seattle’s craft brewing industry as a thriving entrepreneurial ecosystem that displays widespread collaboration and innovation. Drawing on data collected in 22 face-to-face formal interviews conducted with industry participants, the Article explores the community’s attitudes, practices, and norms with respect to collaboration and intellectual property (IP). It joins a growing body of qualitative empirical IP scholarship that maps misalignments between law and practice “on the ground,” seeking to offer a more accurate and pluralistic account of an innovative industry. The craft brewing community in Seattle cooperates extensively while continuing to compete actively for consumers. In …

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Ships In The Night: Resolving Administrative Conflict Between Fda- And Patent-Related Legislation, Carlos Garcia, Jonathan Stroud

American University Law Review

No abstract provided.

A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch

Seattle University Law Review

The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this Note …

Administering Health Innovation, Rachel E. Sachs

Cardozo Law Review

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent and Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly …

Serving Pets In Poverty: A New Frontier For The Animal Welfare Movement, Amanda Arrington, Michael Markarian

Sustainable Development Law & Policy

No abstract provided.

How Fast Is Too Fast? Osha’S Regulation Of The Meat Industry’S Line Speed And The Price Paid By Humans And Animals, Israel Cook

Sustainable Development Law & Policy

No abstract provided.

The Farts Heard ‘Round The World: Where Cow-Tapping Falls On The International Agenda Of Sustainable Development, Alexandra C. Nolan

Sustainable Development Law & Policy

No abstract provided.

This Is Not The Bee’S Knees: A Critical View Of The Government’S Lack Of Policy To Conserve The Pollinators, Savannah Pugh

Sustainable Development Law & Policy

No abstract provided.

Legislative Efforts To Increase State Management For Imperiled Species Should Be Rejected, Stephanie Kurose

Sustainable Development Law & Policy

No abstract provided.

Anthropogenic Noise And The Endangered Species Act, Carolyn Larcom

Sustainable Development Law & Policy

No abstract provided.

Cruelty To Human And Nonhuman Animals In The Wild-Caught Fishing Industry, Kathy Hessler, Rebecca Jenkins, Kelly Levenda

Sustainable Development Law & Policy

No abstract provided.

The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith

Sustainable Development Law & Policy

Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.

Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely

Sustainable Development Law & Policy

No abstract provided.

About Sdlp

Sustainable Development Law & Policy

No abstract provided.

Editor's Note, Luke Trompeter, Ingrid Lesemann

Sustainable Development Law & Policy

No abstract provided.

Privacy Of Information And Dna Testing Kits, Shanna Raye Mason

Catholic University Journal of Law and Technology

In modern times, consumers desire for more control over their own health and healthcare. With this growing interest of control, direct to consumer DNA testing kits have never been more popular. However, many consumers are unaware of the potential privacy concerns associated with such use. This comment examines the popularity and privacy risks that are likely unknown to the individual consumer. This comment also addresses the shortcomings of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Genetic Information Nondiscrimination Act of 2008 (GINA) in regard to protecting individual’s genetic information from misuse. This comment …

Delaying Competition: How Sound Public Policy And Rigorous Antitrust Scrutiny Can Be Applied To Controversial Patent Settlements, 17 J. Marshall Rev. Intell. Prop. L. 655 (2018), Sam Hensel

UIC Review of Intellectual Property Law

The rising costs of prescription drugs are a growing concern for many Americans. The restraint of trade for pharmaceutical drugs is a cause of rising costs for consumers, as companies seek to push potential competitors out of the market to maintain profits. This unlawful restraint of trade will be discussed in this comment. Specifically, this comment will focus on "Pay for Delay" agreements, mostly between generic versus brand name pharmaceutical manufacturers. The proliferation of these agreements only leads to an unsustainable market that discourages innovation and advancement, and promotes fraud, as invalid patents are used as leverage to prevent generics …

The Fda's Priority Review Voucher Program's Role In Bringing Benznidazle To Chagas Disease Patients In The United States, Lisa Cline

Cybaris®

No abstract provided.

What Is Useful And Novel? The Collision Between Intellectual Property Protection And Regulation Regarding Medical Devices, James Sutherland

Cybaris®

No abstract provided.

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …