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Articles 1 - 16 of 16
Full-Text Articles in Law
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 …
Is Novelty Obsolete - Chronicling The Irrelevance Of The Invention Date In U.S. Patent Law, Dennis D. Crouch
Is Novelty Obsolete - Chronicling The Irrelevance Of The Invention Date In U.S. Patent Law, Dennis D. Crouch
Michigan Telecommunications & Technology Law Review
This paper presents a normative study of patent prosecution by examining the role that invention-date-based novelty rights play in U.S. patent law. Three sources inform the primary results: the prosecution history files of 21,000+ patent applications filed in the past decade; a survey of 1,000+ patent practitioners regarding their use of the novelty provisions of the Patent Act; and a collection of 11,000,000+ prior art references cited in recently-issued patents. Additional compilations of prosecution file histories for patents identified as either (1) valuable or (2) worthless supplement these data sets and allow for an evaluation of the differential importance of …
Wireless Net Neutrality Regulation And The Problem With Pricing: An Empirical, Cautionary Tale, Babette E.L. Boliek
Wireless Net Neutrality Regulation And The Problem With Pricing: An Empirical, Cautionary Tale, Babette E.L. Boliek
Michigan Telecommunications & Technology Law Review
I present here a unique empirical analysis of the consumer welfare benefits of prior regulation in the mobile telecommunications industry. In particular, I analyze the relative consumer benefits of state rate regulation and federal entry regulation. The institution of filing requirements and FTC review and approval of various consumer pricing regimes is highly analogous to the consumer price controls imposed by various state level public utility commissions in the past. Furthermore, the imposition of a zero-price rule is analogous to past rate regulation; in particular it is similar to past wholesale regulation with its underlying principles of open access and …
The Failure Of Sexting Criminalization: A Plea For The Exercise Of Prosecutorial Restraint, Robert H. Wood
The Failure Of Sexting Criminalization: A Plea For The Exercise Of Prosecutorial Restraint, Robert H. Wood
Michigan Telecommunications & Technology Law Review
The purpose of this Essay is to explore the various legal approaches to the sexting phenomenon through an analysis of a decision by the United States District Court for the Middle District of Pennsylvania, which granted a temporary restraining order enjoining the prosecution of sexting teens on constitutional grounds, and an examination of current and pending legislative attempts to deal with the sexting phenomenon. Section I describes the facts leading up to the district court decision and its subsequent holding. Section II examines the approaches to sexting prosecution and legislation taken by other states. Section III analyzes the legal issues …
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 …
Corporate Cooperation Through Cost-Sharing, Nicola Faith Sharpe
Corporate Cooperation Through Cost-Sharing, Nicola Faith Sharpe
Michigan Telecommunications & Technology Law Review
Applying a game-theoretic approach based on the classic prisoners' dilemma provides valuable insights into corporate managers' decision-making incentives under existing discovery rules. It demonstrates that the fee structure imposed by current discovery rules leads to inefficiency and motivates corporate litigants on either side of a controversy to employ abusive discovery practices, although each party would benefit from cooperation. Using this framework, this Article shows how a cost-sharing regime can motivate litigants to engage in cooperative discovery and, as a consequence, facilitate more efficient and less abusive discovery practices. To date, scholars, who have posited that cooperative behavior in the discovery …
Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray
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. …
Regulating Robocalls: Are Automated Calls The Sound Of, Or A Threat To, Democracy, Jason C. Miller
Regulating Robocalls: Are Automated Calls The Sound Of, Or A Threat To, Democracy, Jason C. Miller
Michigan Telecommunications & Technology Law Review
African-American voters receive a phone message implying that they are not registered to vote. Others hear "an almost threatening male voice," a "fake New York accent," factual distortions about legislation, false endorsements from controversial groups, calls promoting one candidate claiming to be from his opponent, and a constant barrage of annoying phone calls designed to make voters think a different candidate was sponsoring them. These messages were delivered through automated political telephone calls, also known as robocalls. Robocalls are cheap and efficient--one can deliver a pre-recorded message through 100,000 automated phone calls in one hour for only $2000. Consequently, robocalls …
The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang
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 …
The Super Brawl: The History And Future Of The Sound Recording Performance Right, Brian Day
The Super Brawl: The History And Future Of The Sound Recording Performance Right, Brian Day
Michigan Telecommunications & Technology Law Review
On February 4, 2009, Senator Patrick Leahy introduced the Performance Rights Act ("PRA") to the Senate, joined by Representative John Conyers in the House of Representatives. Thirty-eight years after sound recordings were first granted federal copyright protection against unauthorized reproduction and distribution--and more than ten years after gaining a limited digital performance right--legislation is pending that would once again expand the scope of sound recording copyright to encompass terrestrial radio broadcasts. Historically, such broadcasts have been exempt from sound recording performance royalties.[...] Instead of (or in addition to) seeking remuneration from terrestrial radio stations, this Note suggests that sound recording …
Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah
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 …
Appellate Review Of Patent Claim Construction: Should The Federal Circuit Be Its Own Lexicographer In Matters Related To The Seventh Amendment, Eileen M. Herlihy
Appellate Review Of Patent Claim Construction: Should The Federal Circuit Be Its Own Lexicographer In Matters Related To The Seventh Amendment, Eileen M. Herlihy
Michigan Telecommunications & Technology Law Review
The Federal Circuit stated in an en banc decision in Cybor Corp. v. FAS Technologies, Inc. that the construction of patent claims is "a purely legal issue," and is therefore subject to de novo review on appeal. The Cybor decision reaffirmed the position of the majority of the Federal Circuit which had been announced in its en banc Markman decision, and proclaimed that the de novo standard of review is supported by the Supreme Court's Markman decision, a Seventh Amendment opinion. However, Cybor included strong opposition to a de novo standard of review from some of the judges of the …
Legislation For Effective Self-Regulation: A New Approach To Protecting Personal Privacy On The Internet, Richard M. Marsh Jr.
Legislation For Effective Self-Regulation: A New Approach To Protecting Personal Privacy On The Internet, Richard M. Marsh Jr.
Michigan Telecommunications & Technology Law Review
How can we best reap the benefits of online profiling while avoiding the privacy pitfalls plaguing the e-commerce community? Experts advocate legislation, civil litigation, or self-regulation to provide the ideal solution. Analyzing these proposals reveals a conflict between two basic principles: the need to preserve personal privacy and the desire to foster a thriving Internet-based industry. This Note argues that each approach tends to favor one principle at the expense of the other. This Note also proposes a new solution which creates incentives for effective self-regulation backed with legal enforcement. This scheme strikes an appropriate balance between privacy and e-commerce …
Fcc Jurisdiction Over Isps In Protocol-Specific Bandwidth Throttling, Andrew Gioia
Fcc Jurisdiction Over Isps In Protocol-Specific Bandwidth Throttling, Andrew Gioia
Michigan Telecommunications & Technology Law Review
Over the past decade, the Internet has matured from its dial-up infancy into the nation's dominant communications infrastructure. Such rapid growth and accessibility--while fostering free speech and innovation like nothing before--has nonetheless created complex regulatory and policy questions for both the Federal Communications Commission (FCC) and the cable companies providing the nation's broadband Internet access. For instance, Comcast, one such Internet provider, has recently brought to the fore the question of how, and to what extent, the FCC can ensure an open and accessible Internet through the company's recent actions in selectively targeting and interfering with the connections of certain …
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 …