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Articles 1 - 22 of 22
Full-Text Articles in Law
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann
Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann
Michigan Telecommunications & Technology Law Review
In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …
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 …
Copyright And Youtube: Pirate's Playground Or Fair Use Forum?, Kurt Hunt
Copyright And Youtube: Pirate's Playground Or Fair Use Forum?, Kurt Hunt
Michigan Telecommunications & Technology Law Review
The entertainment industry has a history of framing new technology as piracy that threatens its very existence, regardless of the potential benefits of the technology or the legal limits of copyright rights. In the case of YouTube, copyright owners' attempts to retain content control negatively impact the public's ability to discuss culture in an online world. This implicates the basic policy behind fair use: to prevent copyright law from "stifl[ing] the very creativity which that law is designed to foster." The internet has become a powerful medium for expression. It is a vital tool in today's world for sharing original …
Software Development As An Antitrust Remedy: Lessons From The Enforcement Of The Microsoft Communications Protocol Licensing Requirement , William H. Page, Seldon J. Childers
Software Development As An Antitrust Remedy: Lessons From The Enforcement Of The Microsoft Communications Protocol Licensing Requirement , William H. Page, Seldon J. Childers
Michigan Telecommunications & Technology Law Review
An important provision in each of the final judgments in the government's Microsoft antitrust case requires Microsoft to "make available" to software developers the communications protocols that Windows client operating systems use to interoperate "natively" (that is, without adding software) with Microsoft server operating systems in corporate networks or over the Internet. The short-term goal of the provision is to allow developers, as licensees of the protocols, to write applications for non-Microsoft server operating systems that interoperate with Windows client computers in the same ways that applications written for Microsoft's server operating systems interoperate with Windows clients. The long-term goal …
Economics And The Design Of Patent Systems, Robert M. Hunt
Economics And The Design Of Patent Systems, Robert M. Hunt
Michigan Telecommunications & Technology Law Review
I use intuition derived from several of my research papers to make three points. First, in the absence of a common law balancing test, application of uniform patentability criteria favors some industries over others. Policymakers must decide the optimal tradeoff across industries. Second, if patent rights are not closely related to the underlying inventions, more patenting may reduce R&D in industries that are both R&D and patent intensive. Third, the U.S. private innovation system has become far more decentralized than it was a generation ago. It is reasonable to inquire whether a patent system that worked well in an era …
Patents And Diversity In Innovation, Brian Kahin
Patents And Diversity In Innovation, Brian Kahin
Michigan Telecommunications & Technology Law Review
Over the past quarter-century, the patent system has expanded in scope and significance, claiming a central position in a U.S. economy increasingly based on knowledge and intangible assets. This historic expansion has come at the cost of controversy and, within the past five years, growing public scrutiny from outside the system--from the press, business, Congress, and finally the Supreme Court. However, proposed reforms are marked by deepening divisions between sectors of the economy. The information technology (IT) and services industries favor strong reforms while pharmaceutical and biotech industries, as well as the patent bar, favor modest, incremental reforms. This yawning …
Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss
Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss
Michigan Telecommunications & Technology Law Review
Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the …
The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm
The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm
Michigan Telecommunications & Technology Law Review
Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …
Justice, And Only Justice, You Shall Pursue: Network Neutrality, The First Amendment And John Rawls's Theory Of Justice, Amit M. Schejter, Moran Yemini
Justice, And Only Justice, You Shall Pursue: Network Neutrality, The First Amendment And John Rawls's Theory Of Justice, Amit M. Schejter, Moran Yemini
Michigan Telecommunications & Technology Law Review
As broadband becomes the public's technology of choice to access the Internet, it is also emerging as the battlefield upon which the struggle for control of the Internet is being fought. Operators who provide physical access to the service claim the right to discriminate among the content providers who use the infrastructure in which the operators have invested. In contrast, content providers warn that exercising such a policy would "undermine the principles that have made the Internet such a success."[...] For academic observers, analysis of this issue has thus far been confined to the areas of property law, innovation, and …
The Myth Of Inherent And Inevitable Industry Differences: Diversity As Artifact In The Quest For Patent Reforms, Robert A. Armitage
The Myth Of Inherent And Inevitable Industry Differences: Diversity As Artifact In The Quest For Patent Reforms, Robert A. Armitage
Michigan Telecommunications & Technology Law Review
The University of Michigan Law School hosted a two-day conference entitled "Patents and Diversity in Innovation." The morning of the first day featured a panel devoted to "industry differences." This panel took up the task of dealing with the following questions: How has diversification of innovation and the expansion of patentable subject matter affected patent practice? How do markets for technology vary from sector to sector? And how do they reflect or influence patent practice? To what extent are business practices and competitive markets shaped by the nature of the technology, product, or service?[...] A conference titled "Patents and Diversity" …
Patent Injunctions And The Problem Of Uniformity Cost, Michael W. Carroll
Patent Injunctions And The Problem Of Uniformity Cost, Michael W. Carroll
Michigan Telecommunications & Technology Law Review
In eBay v. MercExchange, the Supreme Court correctly rejected the Federal Circuit's general rule requiring that a permanent injunction follow from a finding that a patent is valid and infringed. Recognizing that one size does not fit all in patent law, the Court returned traditional equitable discretion to the district courts. With this discretion, district courts can now deploy remedies for patent infringement that are sensitive to relevant differences among industries, technologies, and entities. This Essay sets the Court's rejection of a uniform remedial regime in a larger context concerning the role of uniformity in patent law. It then explores …
A Method For Reforming The Patent System, Peter S. Menell
A Method For Reforming The Patent System, Peter S. Menell
Michigan Telecommunications & Technology Law Review
The principal recent studies of patent reform (NAS (2004), FTC (2003), Jaffe and Lerner (2004)) contend that a uniform system of patent protection must (or should) be available for "anything under the sun made by man" based upon one or more of the following premises: (1) the Patent Act requires this breadth and uniformity of treatment; (2) "discriminating" against any particular field of "technology" would be undesirable; (3) discrimination among technologies would present insurmountable boundary problems and could easily be circumvented through clever patent drafting; and (4) interest group politics stand in the way of excluding any subject matter classes …
The Fcc Complaint Process And Increasing Public Unease: Toward An Apolitical Broadcast Indecency Regime, Kurt Hunt
Michigan Telecommunications & Technology Law Review
[...]I propose depoliticizing the broadcast indecency regime by utilizing polling to determine the average broadcast viewer's opinion, divorced from all the pressures inherent in relying on the complaint process as a proxy. In section II, I will discuss the background and development of the broadcast indecency doctrine from the days of the Federal Radio Commission in the 1920s through the present day. I will also explain why the apparent increasing public unease is misleading, and why valid First Amendment concerns are steamrolled by the fiery nature of the debate. In section III, I will explain why the FCC's reliance on …
Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali
Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali
Michigan Telecommunications & Technology Law Review
The main questions addressed in this Article are thus: given that growth is a highly desirable phenomenon and that it is primarily spurred by technological innovation, how should society solve the problem of favoring a sufficient level of investments in R&D? In particular, is it necessarily true and always desirable that, independent of any other consideration, society should protect innovators from competition and shelter them in a legally protected and enforced monopoly? Is it true that the real source of economic value of new recipes is only found in the blueprints of ideas that those recipes implement? Is it necessarily …
What Is Hiding In The Bushes - Ebay's Effect On Holdout Behavior In Patent Thickets, Gavin D. George
What Is Hiding In The Bushes - Ebay's Effect On Holdout Behavior In Patent Thickets, Gavin D. George
Michigan Telecommunications & Technology Law Review
Importantly, at least a few relevant patent holders are inevitably left out of an industry organization's collection of patents. These left-out patent holders, known as "holdouts," can undermine the collective arrangement with demand letters and infringement suits.[...] The first part of this Note explains why holdouts exist in the first place, given the benefits of joining an organization of collected patents. In the second part of this Note, I explore the lack of legal protections against holdout demands offered by pre-eBay patent law. The third part of this Note introduces the eBay decision as revolutionary addition to list of legal …
Compulsory Patent Licensing: Is It A Viable Solution In The United States, Carol M. Nielsen, Michael R. Samardzija
Compulsory Patent Licensing: Is It A Viable Solution In The United States, Carol M. Nielsen, Michael R. Samardzija
Michigan Telecommunications & Technology Law Review
As technology continues to advance at a rapid pace, so do the number of patents that cover every aspect of making, using, and selling these innovations. In 1996, to compound the rapid change of technology, the U.S. Supreme Court affirmed that business methods are also patentable. Hence in the current environment, scores of patents, assigned to many different parties, may cover a single electronic device or software--making it increasingly impossible to manufacture an electronic device without receiving a cease and desist letter or other notice from a patentee demanding a large royalty or threatening an injunction. Companies, particularly those in …
Fair Use And The Digital Millennium Copyright Act, Thomas J. Loos
Fair Use And The Digital Millennium Copyright Act, Thomas J. Loos
Michigan Telecommunications & Technology Law Review
In the last decade of the 20th Century, more than 200 years after the first Copyright Act of 1790, the rights of copyright owners have increased relative to those of the public. The Visual Artists Rights Act of 1990 provided a limited right to visual artists to control their work; even after sold, limiting first use rights. The first copyright act had a 28 year term; in 1998, the term of copyright was increased to the life of the author plus 70 years. The Digital Millennium Copyright Act (DMCA) of 1998 dramatically shrank the fair use rights provided under 17 …
The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh
The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh
Michigan Telecommunications & Technology Law Review
Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree …
Biometrics: Weighing Convenience And National Security Against Your Privacy, Lauren D. Adkins
Biometrics: Weighing Convenience And National Security Against Your Privacy, Lauren D. Adkins
Michigan Telecommunications & Technology Law Review
The biometric identifier relies on an individual's unique biological information such as a hand, iris, fingerprint, facial or voice print. When used for verification purposes, a "one-to-one" match is generated in under one second. Biometric technology can substantially improve national security by identifying and verifying individuals in a number of different contexts, providing security in ways that exceed current identification technology and limiting access to areas where security breaches are especially high, such as airport tarmacs and critical infrastructure facilities. At the same time, a legitimate public concern exists concerning the misuse of biometric technology to invade or violate personal …
Microsoft Tying Consumers' Hands - The Windows Vista Problem And The South Korean Solution, Daniel J. Silverthorn
Microsoft Tying Consumers' Hands - The Windows Vista Problem And The South Korean Solution, Daniel J. Silverthorn
Michigan Telecommunications & Technology Law Review
Currently, more than ninety percent of the world's PCs operate under Windows. To cement its market power, Microsoft has engaged in controversial business practices. Those practices have led to adverse antitrust decisions in the United States, the European Union (EU), and South Korea. Many of these decisions, both judicial and administrative, revolve around Microsoft's bundling, or "tying," of certain subsidiary applications with the Windows operating system, including Internet Explorer and Windows Media Player. In doing so, Microsoft arguably gains a greater than deserved market share with these bundled applications, inhibiting fair competition in the software marketplace. The United States, EU …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …