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Full-Text Articles in Law
An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel
Michigan Law Review
Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Michigan Telecommunications & Technology Law Review
Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …
Going Nowhere Fast (Or Furious): The Nonexistent U.S. Firearms Trafficking Statute And The Rise Of Mexican Drug Cartel Violence, Stewart M. Young
Going Nowhere Fast (Or Furious): The Nonexistent U.S. Firearms Trafficking Statute And The Rise Of Mexican Drug Cartel Violence, Stewart M. Young
University of Michigan Journal of Law Reform
Drug trafficking violence in Mexico, now reaching epidemic proportions, greatly impacts both the Mexican and United States governments. Despite the escalation of the "War on Drugs, " drug trafficking from Mexico to the United States continues largely unabated, stifling tourism revenue and lawful economic opportunities, and causing violence previously unknown in Mexico. Thus far, the United States' efforts to deal with this drug trafficking and violence include the recent debacle of Operation Fast and Furious. News regarding this Bureau of Alcohol, Tobacco, Firearms and Explosives'(ATF) operation shocked citizens and lawmakers alike, as Fast and Furious allowed firearms to "walk" down …
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
University of Michigan Journal of Law Reform Caveat
Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
University of Michigan Journal of Law Reform
Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …
Teva V. Eisai: What's The Real Controversy, Grace Wang
Teva V. Eisai: What's The Real Controversy, Grace Wang
Michigan Telecommunications & Technology Law Review
This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …
Falling Through The Crack: How Courts Have Struggled To Apply The Crack Amendment To Nominal Career And Plea Bargain Defendants, Maxwell Arlie Halpern Kosman
Falling Through The Crack: How Courts Have Struggled To Apply The Crack Amendment To Nominal Career And Plea Bargain Defendants, Maxwell Arlie Halpern Kosman
Michigan Law Review
Under the Federal Rules of Criminal Procedure, a defendant is normally obligated to attend all of the proceedings against her. However Rule 43(b)(2) carves out an exception for organizational defendants, stating that they "need not be present" if represented by an attorney. But on its face, the language of 43(b)(2) is ambiguous: is it the defendant or the judge who has the discretion to decide whether the defendant appears? That is, may a judge compel the presence of an organizational defendant? This Note addresses the ambiguity in the context of the plea colloquy, considering the text of several of the …
Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier
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 …
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
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
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
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 …
When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller
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 …
Vindicating The Matriarch: A Fair Housing Act Challenge To Federal No-Fault Evictions From Public Housing, Melissa A. Cohen
Vindicating The Matriarch: A Fair Housing Act Challenge To Federal No-Fault Evictions From Public Housing, Melissa A. Cohen
Michigan Journal of Gender & Law
Pearlie Rucker, sixty-three years old, had been living in public housing in Oakland, California for thirteen years. Ms. Rucker lived with her mentally disabled adult daughter, Gelinda, as well as two grandchildren and one great-grandchild. Ms. Rucker regularly searched Gelinda's room for signs of drugs, and had warned Gelinda that any drug activity on the premises could result in eviction. Nevertheless, Gelinda was caught with drugs three blocks from the apartment. Despite the fact that Ms. Rucker had no knowledge of Gelinda's drug activity, and in fact had been carefully monitoring what happened in her apartment, the Oakland Housing Authority …
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Michigan Journal of Gender & Law
In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
University of Michigan Journal of Law Reform
This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.
When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher
When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher
Michigan Law Review
This Note argues that sentence manipulation should be a legally viable partial defense - a defense that does not warrant complete exoneration, but does warrant a reduced sentence when the government's investigative techniques place a quantity of drugs before the court that overrepresents the defendant's culpability, or individual blameworthiness. Part I describes the policies and objectives that underlie the Guidelines, but then demonstrates how the rigid application of quantity-based sentencing provisions can lead to sentence manipulation that thwarts these goals, particularly the goal of sentencing according to culpability. Part II describes how courts have responded to sentence manipulation claims. It …
Continuing Criminal Enterprise, Conspiracy, And The Multiple Punishment Doctrine, Kenneth G. Schuler
Continuing Criminal Enterprise, Conspiracy, And The Multiple Punishment Doctrine, Kenneth G. Schuler
Michigan Law Review
This Note argues that the Multiple Punishment Doctrine prohibits the imposition of concurrent convictions and sentences upon criminal defendants found guilty of engaging in a CCE and conspiring to violate narcotics laws. Part I surveys the values underlying the Multiple Punishment Doctrine and traces the evolution of the Supreme Court's application of the doctrine to modern criminal law. Part II examines the various methods employed by the circuit courts of appeals to deal with simultaneous convictions and sentences for CCE and conspiracy. Part III reviews the test, identified in Part I, that the Supreme Court has implicitly utilized to analyze …
Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier
Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier
Michigan Law Review
A Review of Beyond the War on Drugs: Overcoming a Failed Public Policy by Steven Wisotsky
Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta
Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta
Michigan Law Review
This Note offers two justifications for narrowing the scope of section 881 forfeiture. Part I argues that courts should apply the substantial connection test to section 881 forfeitures. This Part analyzes the statute using the traditional tools of statutory interpretation. While the text of the statute seems to support the broadest possible interpretation, the legislative history and context of adoption suggest that the substantial connection test is consistent with Congressional intent. In amending section 881, subsequent Congresses have favored application of the substantial connection test. Consistent with this narrower reading, present strategy in the "war on drugs" focuses stiff penalties …
The Contours Of Extraterritorial Jurisdiction In Drug Smuggling Cases, Stephen E. Chelberg
The Contours Of Extraterritorial Jurisdiction In Drug Smuggling Cases, Stephen E. Chelberg
Michigan Journal of International Law
This note examines the contours of U.S. jurisdiction over drug smugglers on the high seas. After a brief discussion of the two principal U.S. drug statutes, the note considers the territorial and protective principles of jurisdiction as defined by U.S. courts. Controversy currently centers around whether U.S. drug laws apply to foreign ships, carrying controlled substances on the high seas, where there has been no showing of an intent to import the drugs into the United States.
Decriminalizing The Marijuana User: A Drafter's Guide, Richard J. Bonnie
Decriminalizing The Marijuana User: A Drafter's Guide, Richard J. Bonnie
University of Michigan Journal of Law Reform
The article does not discuss the arguments in favor of decriminalization, a matter which the author' and others have covered elsewhere. Nor does the article consider the even more difficult questions involved in a legislative decision to legalize the drug and authorize its distribution for nonmedical uses. International obligations, federal law, and current political realities preclude enactment of a regulatory approach toward the availability of marijuana, including any variant of the so-called alcohol model. Although a state conceivably could repeal its laws against cultivation and distribution of marijuana, including only the federal prohibitions in effect, such an overt departure from …
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
Michigan Law Review
Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …
Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof
Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof
University of Michigan Journal of Law Reform
This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.