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Full-Text Articles in Antitrust and Trade Regulation
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 …
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
The Institutions Of Antitrust Law: How Structure Shapes Substance, William E. Kovacic
The Institutions Of Antitrust Law: How Structure Shapes Substance, William E. Kovacic
Michigan Law Review
Daniel Crane's The Institutional Structure of Antitrust Enforcement ("Institutional Structure") may do for antitrust law what Essence of Decision did for public administration. Unlike most literature on antitrust law, this superb volume does not address pressing issues of substantive analysis (e.g., when can dominant firms offer loyalty discounts?). Instead, Institutional Structure studies the design and operation of the institutions of U.S. antitrust enforcement. Professor Crane skillfully advances a basic and powerful proposition: to master analytical principles without deep knowledge of the policy implementation mechanism is dangerously incomplete preparation for understanding the U.S. antitrust system, or any body of competition law. …
Antitrust Rulemaking As A Solution To Abuse On The Standard-Setting Process, Adam Speegle
Antitrust Rulemaking As A Solution To Abuse On The Standard-Setting Process, Adam Speegle
Michigan Law Review
While many recognize the critical role that technology plays in modern life, few appreciate the role that standards play in contributing to its success. Devices as prevalent as the modern laptop computer for example, may be governed by over 500 interoperability standards, regulating everything from the USB drive to the memory chip. To facilitate adoption of such standards, firms are increasingly turning to standard-setting organizations. These organizations consist of members of an industry who agree to abide by the organization's bylaws, which typically regard topics such as patent disclosure and reasonable licensing. Problems arise, however, when members violate these bylaws …
Unfit For Prime Time: Why Cable Television Regulations Cannot Perform Trinko's 'Antitrust Function', Keith Klovers
Unfit For Prime Time: Why Cable Television Regulations Cannot Perform Trinko's 'Antitrust Function', Keith Klovers
Michigan Law Review
Until recently, regulation and antitrust law operated in tandem to safeguard competition in regulated industries. In three recent decisions-Trinko, Credit Suisse, and Linkline-the Supreme Court limited the operation of the antitrust laws when regulation "performs the antitrust function." This Note argues that cable programming regulations-which are in some respects factually similar to the telecommunications regulations at issue in Trinko and Linkline-do not perform the antitrust function because they cannot deter anticompetitive conduct. As a result, Trinko and its siblings should not foreclose antitrust claims for damages that arise out of certain cable programming disputes.
Reflections On Section 5 Of The Ftc Act And The Ftc's Case Against Intel, Daniel A. Crane
Reflections On Section 5 Of The Ftc Act And The Ftc's Case Against Intel, Daniel A. Crane
Articles
The Federal Trade Commission’s (“FTC’s”) unprecedented enforcement action against Intel raises profound issues concerning the scope of the FTC’s powers to give a construction to Section 5 of the FTC Act that goes beyond the substantive reach of the Sherman Act. While I have urged the FTC to assert such independence from the Sherman Act, this is the wrong case to make a break. Indeed, if anything, Intel poses a risk of seriously setting back the development of an independent Section 5 power by provoking a hostile appellate court to rebuke the FTC’s effort and cabin the FTC’s powers in …
Linkline's Institutional Suspicions, Daniel A. Crane
Linkline's Institutional Suspicions, Daniel A. Crane
Articles
Antitrust scholars are having fun again. Not so long ago, they were the poor, redheaded stepchildren of the legal academy, either pining for the older days of rigorous antitrust enforcement or trying to kill off what was left of the enterprise. Other law professors felt sorry for them, ignored them, or both. But now antitrust is making a comeback of sorts. In one heady week in May of 2009, a front-page story in the New York Times reported the dramatic decision of Christine Varney-the Obama Administration's new Antitrust Division head at the Department of Justice-to jettison the entire report on …
The Problem Of New Uses, Rebecca S. Eisenberg
The Problem Of New Uses, Rebecca S. Eisenberg
Articles
Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …
Antitrust Enfocement And High-Technology Markets, William J. Baer, David A. Balto
Antitrust Enfocement And High-Technology Markets, William J. Baer, David A. Balto
Michigan Telecommunications & Technology Law Review
Although the antitrust laws apply to all industries, the application must be tempered in each case by the myriad ways in which competition can be modified by structural, behavioral, technological, regulatory, and other characteristics. The Commission applies the antitrust laws with sensitivity to the special characteristics of high-tech industries and of intellectual property, but also with the recognition that--as in other industries--competition plays an important role in spurring innovation and in spreading the benefits of that innovation to consumers. This focus is not new. This balanced approach has roots that go back at least to the 1977 Antitrust Guide to …
Cease And Desist: The History, Effect, And Scope Of Clayton Act Orders Of The Federal Trade Commission, Thomas E. Kauper
Cease And Desist: The History, Effect, And Scope Of Clayton Act Orders Of The Federal Trade Commission, Thomas E. Kauper
Michigan Law Review
A cease and desist order is not entered in a vacuum. What an order should say or require depends upon the effect which the order is to have. A substantial portion of the present study is therefore concerned with the array of effects which may result from the order's entry, and with the relationship between those effects and the order itself. Not all of the detailed discussion of enforcement procedures which follows may seem directly relevant to the content of the FTC's orders. There are important unresolved issues within the enforcement procedures themselves which warrant examination for their own sake …