Law Commons^™

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

Prescription Restriction: Why Birth Control Must Be Over-The-Counter In The United States, Susannah Iles

Michigan Journal of Gender & Law

This Note argues that it is harmful and unnecessary to require women to obtain prescriptions for access to hormonal birth control. Requiring a prescription is necessarily a barrier to access which hurts women and hamstrings the ability to dictate their own reproductive plans. It is also an irrational regulation in light of the relative safety of hormonal birth control pills, particularly progestin-only formulations, compared to other drugs readily available on the shelves.

Leading medical organizations, including the American College of Obstetrics and Gynecologists, advocate for over-the-counter access to hormonal birth control. While acknowledging that not every woman will have positive …

The Pharma Perspective: The Double-Edged Sword Of Direct-To-Consumer Advertising, Ela H. Yalcin

Health Law Outlook

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.

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran

Brooklyn Law Review

Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs in …

The Future Of Health Law: How Can Law Meet Emerging Health Challenges?, Colleen M. Flood, Lorian Hardcastle

Dalhousie Law Journal

Canadians have often prided themselves on having one of the best health-care systems in the world, but in recent years our system has fallen to the bottom of relevant international comparisons. Incremental attempts to improve the system have not resulted in significant improvements and the reality is that our most pressing challenges can be addressed only through ambitious, systemic reforms. For example, it is well established that Canada's patchwork scheme for providing long-term care will not scale to meet growing needs as a quarter ofthe population enters retirement age over the next two decades.' As yet further examples, the Canadian …

Modernizing The Canada Health Act, Colleen M. Flood, Bryan Thomas

Dalhousie Law Journal

The Canada Health Act (CHA) was adopted in 1984, to shore up a health-care system conceptualized in the 1960s. Under the CHA, universal coverage is limited to "medicallynecessary" hospital and physician services, to the exclusion of vital goods and services such as outpatient pharmaceuticals, dental care, long-term care, and many mental health services. Inequities resulting from these gaps in public coverage are partly to blame for pushing Canada's health system to the bottom ofrecent international rankings. But there is more to modernizing Canada s health care system, we argue, than filling these gaps in universal coverage. Every major health system …

Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes

Journal of Intellectual Property Law

No abstract provided.

The Health Impact Fund Proposal: Application In The United States' Era Of Comparative Effectiveness, Katherine Jeanne Racz

Journal of Intellectual Property Law

No abstract provided.

Pharmaceuticals And Biopiracy: How The Aia May Inadvertently Reduce The Misappropriation Of Traditional Medicine, Ryan D. Levy, Spencer Green

University of Miami Business Law Review

For decades, Eastern traditional medicine has been misappropriated by others who claim it as their own and attempt to obtain patent protection for it. As long this practice has existed, the international community has pushed back against it. Several countries and international bodies have created databases of traditional knowledge, hoping to preclude the issuance of patents on that knowledge. Other countries, like Thailand, have extended intellectual property protection to the traditional knowledge stakeholders themselves. However, a recent change to US patent law may have the unintended consequence of helping resolve the issue of biopiracy

Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese

Brooklyn Journal of International Law

Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The …

The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman

Journal of Law and Health

The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes …

Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky

West Virginia Law Review

The legal status of medical marijuana in the United States is something of a paradox. On one hand, the federal government has placed a ban on the drug with no exceptions. On the other hand, forty percent of states have legal- ized its cultivation, distribution, and consumption for medical purposes. As such, medical marijuana activity is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented, nebulous zone of legality in which an activity is both legal and illegal, what …

Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller

Catholic University Law Review

No abstract provided.

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn

Michigan Journal of Race and Law

With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …

Will Everyone Get Their Best Medicine? Implications For Off-Label Use Of Pharmaceuticals In An American Universal Healthcare Regime, Kathryn Young

Saint Louis University Journal of Health Law & Policy

No abstract provided.

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 First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross

Journal of Law and Health

Stricter government regulations regarding commercial speech that promotes weight-loss or diet products should be considered for three reasons. First, studies have shown that diet industry advertising often makes weight loss claims that are scientifically impossible. Second, consumers have suffered adverse health effects as a result of trying weight-loss programs or diet products. Third, current FTC regulations are not curbing the problem. Part II of this note outlines the history of commercial speech and its protections under the First Amendment, along with the history of the rapidly expanding diet industry and its regulatory framework. Part II examines the three arguments in …

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.

Sell V. United States: Involuntary Administration Of Antipsychotic Medication To Criminal Defendants, Brandy M. Rapp

University of Richmond Law Review

No abstract provided.

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

Global Responses: The Search For Cures In The Development Of Pharmaceuticals, Stuart R. Walker

Indiana Journal of Global Legal Studies

In this article, Professor Stuart Walker examines several challenges that

will be faced by the global pharmaceutical industry in the near future. These

involve the question of improving the overall quality of life and care for

millions in an era of cost containment. In order to respond to the increasing

demands for advances in medicine while simultaneously retaining an

industrially strong, innovative, and resilient economy, responsibility for the

necessary changes will need to be shared among governments, the

pharmaceutical industry, and health care professionals.

In particular, four challenges faced by the global pharmaceutical industry

and their responses to each are …