Law Commons^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

Does Trips Stop International Ip Free-Riders, Sam F. Halabi

Faculty Publications

Innovation policy-a relatively new phrase for an old set of top-down competitiveness approaches (e.g. "industrial policy," "science policy," "research policy," and "technology policy")-is necessarily a combination of centralized investment, structure of private-sector incentives, and public policy priorities.This combination has always been unwieldy, multivariate, and politically charged. As a result, constituencies favoring one or other approaches (e.g. longer patent protection, more funding of public universities and research infrastructure, tariff or non-tariff import measures) have lacked a unifying framework through which to analyze shared problems. In Innovation Policy Pluralism, Daniel J. Hemel and Lisa Larrimore Ouellette provide that framework. With a focus …

The Drug Repurposing Ecosystem: Intellectual Property Incentives, Market Exclusivity, And The Future Of "New" Medicines, Sam F. Halabi

Faculty Publications

The pharmaceutical industry is in a state of fundamental transition. New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is "drug repurposing"-finding new ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This Article …

International Intellectual Property Shelters, Sam F. Halabi

Faculty Publications

The battle over the reach and strength of international protections for intellectual property rights is one of the critical flashpoints between wealthy and low-income countries: those protections are perceived to obstruct access to essential medicines, thwart regulatory efforts to promote individual and population health, and undermine traditional forms of agriculture and food production. While scholars have thoroughly tracked the bilateral and multilateral trade and investment treaties responsible for the expansion of international intellectual property rights worldwide, they have paid significantly less attention to the strength and form that opposition to international intellectual property expansion has taken. This Article examines the …

The Myths Of Data Exclusivity, Erika Lietzan

Faculty Publications

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …

Book Review: Reviewing Part Iii Of Innovation For The 21st Century: Harnessing The Power Of Intellectual Property And Antitrust Law, Dennis D. Crouch

Faculty Publications

I have very much enjoyed reading Professor Michael Carrier's important new book on the intersection of law and innovation, and greatly appreciate his contributions to the field. In this short essay, I will focus my discussion on my sole area of expertise—patent law. Carrier takes-on the subject of patents in Part III of his book. I agree with most of what Carrier writes. To make this essay more interesting, I focus on some of our areas of apparent disagreement.

Intellectual Property Resources In And For Space: The Practitioner's Experience, Gary Myers

Faculty Publications

Today, our inquiry is timely because, increasingly, intellectual property law is becoming more important in space activities. The increasing sophistication of international cooperation and the growth of commercial and private space activities have brought intellectual property issues to greater prominence.

Statutory Interpretation, Property Rights, And Boundaries: The Nature And Limits Of Protection In Trademark Dilution, Trade Dress, And Product Configuration Cases, Gary Myers

Faculty Publications

This article, however, takes the view that the basic landscape in trademark law is unlikely to change in the near future. Congress has only recently enacted the Trademark Dilution Act, and there seems to be little movement to amend it dramatically, let alone repeal it. There have been several recently enacted amendments to the Lanham Act addressing functionality that make great sense and are consistent with the principles suggested here, as will be discussed below. Moreover, the Supreme Court in Two Pesos, Qualitex, Park ‘n’ Fly, and Samara has recently set forth rules that will allow trade dress claims to …

The Restatement's Rejection Of The Misappropriation Tort, Gary Myers

Faculty Publications

Some legal theories, like the proverbial vampire, refuse to die. The common law tort of misappropriation is one such legal theory, and the recent Restatement (Third) of Unfair Competition (Restatement) may finally lead to the demise of this outdated cause of action. Misappropriation began advisedly enough as a means of protecting certain intellectual property rights from unjust usurpation, often by direct competitors employing improper means. Arising before comprehensive copyright, patent, and trademark laws were fully developed, the tort may have played an important role in protecting intangible proprietary interests.The tort's high water mark was the 1918 Supreme Court decision in …

Trademark Parody: Lessons From The Copyright Decision In Campbell V. Acuff-Rose Music, Gary Myers

Faculty Publications

Parodies have long provided many of us with amusement, entertainment,and sometimes even information. An effective parody can convey one or more messages with powerful effect. The message may be a political statement, social commentary, commercial speech, a bawdy joke, ridicule of a brand name, criticism of commercialism, or just plain humor for its own sake. Often someone's ox is being gored, or someone feels that a property right has been infringed. The party so injured often contemplates a lawsuit, and an array of legal theories are available to further that impulse. Perhaps copyright infringement is the claim, if some protectable …

Banning The Cultural Exclusion: Free Trade And Copyrighted Goods, S. I. Strong

Faculty Publications

For centuries people have expressed themselves through creative works of art and literature, and since 1557 artists and authors have been able to protect their rights to their creative works through various national copyright laws. National copyright laws basically grant a monopoly in the use of the work to its creator. Copyrighted goods, however, are often easily transported across national boundaries, and thus national copyright laws may provide inadequate copyright protection in the international marketplace. The necessity for international copyright protection has been met to some extent by copyright conventions. International copyright conventions, like national copyright laws, define the scope …

What's New In Intellectual Property - Business Is Booming In Copyright, Trademark And Patent Law, Richard C. Reuben

Faculty Publications

Forget the trendy law practice areas of the 1980s, such as mergers and acquisitions, real estate and antitrust. Intellectual property is where the action will be in the 1990s.