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Full-Text Articles in Law
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 …
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Michigan Telecommunications & Technology Law Review
“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Michigan Telecommunications & Technology Law Review
Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …
Gaining Momentum: A Review Of Recent Developments Surrounding The Expansion Of The Copyright Misuse Doctrine And Analylsis Of The Doctrine In Its Current Form, Neal Hartzog
Michigan Telecommunications & Technology Law Review
The United States intellectual property ("IP") system is the foundation for incentives for authors and inventors to create and invent so that their work will be distributed to the public for the betterment of society. These incentives, in the form of limited monopolies over creations via patents, copyrights, and trademarks, are becoming increasingly important as the United States depends upon intellectual property to sustain its economy. As the intellectual property industry grows, it becomes vital to preserve the impetus behind its creation: the public good, or more specifically, the public's ability to make use of and enjoy new ideas and …
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 …
Telecommunications In Transition: Unbundling, Reintegration, And Competition, David J. Teece
Telecommunications In Transition: Unbundling, Reintegration, And Competition, David J. Teece
Michigan Telecommunications & Technology Law Review
The world economy is experiencing a technological revolution, fueled by rapid advances in microelectronics, optics, and computer science, that in the 1990s and beyond will dramatically change the way people everywhere communicate, learn, and access information and entertainment. This technological revolution has been underway for about a decade. The emergence of a fully-interactive communications network, sometimes referred to as the "Information Superhighway," is now upon us. This highway, made possible by fiber optics and the convergence of several different technologies, is capable of delivering a plethora of new interactive entertainment, informational, and instructional services that are powerful and user-friendly. The …
Unconstitutional Telco-Cable Cross-Ownership Ban: It Seemed Like A Good Idea At The Time, Arthur Bresnahan
Unconstitutional Telco-Cable Cross-Ownership Ban: It Seemed Like A Good Idea At The Time, Arthur Bresnahan
Michigan Telecommunications & Technology Law Review
This article is a survey of the law regarding the federal government's ability to regulate a telephone company's provision of video programming to subscribers in its service area. Part I of the article is a history of the telco-cable cross-ownership ban. Part II is an analysis of the cases striking down the ban, exploring the rationale of these cases on a consolidated basis. Part III is a summary of the applicable standards by which to evaluate future attempts by Congress or the FCC to regulate telephone companies' provision of video programming.