Law Commons^™

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

The Politics Of Patents And Drugs In Brazil And Mexico: The Industrial Bases Of Health Policies, Kenneth C. Shadlen

Ken Shadlen

After introducing pharmaceutical patents in the 1990s, Brazil subsequently adjusted the patent system to ameliorate its effects on drug prices while Mexico introduced measures that reinforce and intensify these effects. The different trajectories are due to the nature of the actors pushing for reform and subsequent patterns of coalitional formation and political mobilization. In Brazil, government demand for expensive, patented drugs made health-oriented patent reform a priority, and the existence of an autonomous local pharmaceutical sector allowed the Ministry of Health to build a supportive coalition. In Mexico, government demand made reforms less urgent, and transformations of the pharmaceutical sector …

Constitutional Flaw?, Carl E. Schneider

Articles

Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …

Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel

Michigan Telecommunications & Technology Law Review

The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …

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 …

Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget

Michigan Telecommunications & Technology Law Review

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang

Michigan Telecommunications & Technology Law Review

China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …

Symposium Introduction: Contemporary Issues At The Intersection Of Public Health And Environmental Law, Patricia Ross Mccubbin

Patricia Ross McCubbin

This article serves as an introduction to the forthcoming symposium in the Southern Illinois University Law Journal, which presents the proceedings of a conference held at the SIU School of Law on February 27, 2009, on “Contemporary Issues at the Intersection of Public Health and Environmental Law.”

Cases And Materials On Patent Law, Martin J. Adelman, Randall R. Rader, John R. Thomas

GW Law Faculty Publications & Other Works

This casebook provides a thorough overview of the fundamentals of U.S. patent law. The book is organized in fourteen chapters. The casebook starts with the current statute in Title 35 of the United States Code. It then considers the requirement of “usefulness” necessary to receive patent protection. The book proceeds to explain the requirement of “novelty” as well as the “nonobviousness standard.” The book also examines the various roles of the United States Patent and Trademark Office (“USPTO”), as well as the basics of the patent acquisition process.

After its discussion of the USPTO, the book provides an overview of …

Compulsory Licensing Of Patented Pharmaceuticals: Why A Wto Administrative Body Should Determine What Constitues A Public Health Crisis Under The Doha Declaration, Aileen M. Mcgill

Aileen M McGill

In response to concerns that patent protection for pharmaceuticals negatively affected world health, the WTO issued the Doha Declaration in 2001, allowing member nations to issue compulsory licenses for patented pharmaceuticals during a public health crisis. The terms of this Declaration allow countries to determine what constitutes a public health crisis, what terms are appropriate for compulsory licenses, and what medications they should be entitled to produce. This article argues that the Doha Declaration has not served countries most in need of inexpensive medications: least developed countries with high rates of HIV/AIDS. The terms of the Doha Declaration are too …