Law Commons^™

I Want A New (Generic) Drug: A Comparative Case For Shifting U.S. Generic Drug Policies To Increase Availability And Lower Healthcare Costs, Immer S. Chriswell

Northwestern Journal of International Law & Business

Enacted in 1984, Hatch-Waxman was intended to increase generic drug availability and make critical healthcare more affordable for Americans. In the nearly forty years following, while it has increased availability of drugs, it has also allowed drug originators to create avenues to profit in ways not intended when the original compromise was struck, undermining its success. Moreover, given a weak antitrust standard against reverse settlement payments proscribed in Actavis, the U.S. faces a dilemma to further improve access to generic medications in the future. The E.U.’s approach to generic drugs, while presently geographically fragmented, is simpler and has a clear …

The Doha Declaration At Twenty: Interpretation, Implementation, And Lessons Learned On The Relationship Between The Trips Agreement And Global Health, Eric M. Solovy

Northwestern Journal of International Law & Business

No abstract provided.

Protection Of Test Data Under Article 39.3 Of The Trips Agreement: Advancements And Challenges After 25+ Years Of Interpretation And Application, Eric M. Solovy

Northwestern Journal of International Law & Business

Among the types of intellectual property rights covered by the TRIPS Agreement, WTO Members must, pursuant to Article 39.3, protect certain test and other data submitted “as a condition of approving the marketing of pharmaceutical or of agricultural chemical products.” Such protection provides the incentives necessary for the biopharmaceutical industry to conduct the lengthy, expensive multi-phased clinical testing that is required to demonstrate the safety and effectiveness of a new drug or vaccine.

Test data protection has become increasingly more important to the development of new medicines in the past several years. That is in significant part because biologics (i.e., …

The Liability Of Online Markets For Counterfeit Goods: A Comparative Analysis Of Secondary Trademark Infringement In The United States And Europe, Kurt M. Saunders, Gerlinde Berger-Walliser

Northwestern Journal of International Law & Business

Online trademark infringement and counterfeiting is a growing problem for luxury brands. In recent years, trademark owners have taken aim at the operators of online marketplaces and auction websites, asserting that these defendants are liable for contributory infringement due to sales of counterfeit goods on their sites. In addressing the scope of secondary liability for trademark infringement, the courts of the United States and European nations, including France, Germany, and the United Kingdom, have applied differing standards and reached inconsistent results. This article considers the question of secondary liability for trademark infringement from a comparative perspective and contrasts the rationales …

Toward A Regulatory Model Of Internet Intermediary Liability: File-Sharing And Copyright Enforcement, Christopher M. Swartout

Northwestern Journal of International Law & Business

One of the major problems presented by digital content and the internet has been the failure of traditional copyright enforcement mechanisms to adequately address infringement that takes place via online file-sharing. Recently, laws that would introduce a new copyright enforcement paradigm have been proposed in numerous countries and have received strong support from content industries seeking a more effective enforcement regime. These laws are often referred to as "graduated response" policies. Although there is some variation, graduated response laws typically impose requirements on Internet Service Providers (ISPs) to cooperate with rightsholders and government in policing illegal file-sharing. ISPs are required …

Indian Patent Law: Walking The Line, Johanna Sheehe

Northwestern Journal of International Law & Business

This comment proposes that cultural preferences have had a strong influence over the development of Indian patent law, and that these preferences influenced the court decision against Novartis. Part I will introduce TRIPS and international patent law, discuss the development of Indian patent law in the context of its colonial past and WTO membership, and explain the decisions by the Indian Patent Office and the Court of Madras in the context of Glivec's development. Part II will explore WTO attitudes and approaches to TRIPS and argue that if Switzerland were to bring India to the WTO's Dispute Settlement Board (DSB), …

Where's The Beef? Why Burger King Is Hungry Jack's In Australia And Other Complications In Building A Global Franchise Brand, Andrew Terry, Heather Forrest

Northwestern Journal of International Law & Business

The territorial nature of trademark law and the lack of a single universal registration system present challenges to franchisors and other brand proprietors expanding operations beyond the home market in which intellectual property rights have been secured. International treaties such as the Paris Convention for the Protection of Industrial Property, the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS"), the Madrid Agreement, and the Madrid Protocol have attracted worldwide support and made significant inroads towards harmonization of trademark registrability criteria and the administration of the registration process. However, intellectual property rights are, by their very nature, rights granted by …

"The Little State Department": Hollywood And The Mpaa's Influence On U.S. Trade Relations, Kevin Lee

Northwestern Journal of International Law & Business

In this article, I argue that the U.S. government has actively advocated domestic film industry interests in bilateral and multilateral trade agreements because of Hollywood's importance to the U.S. economy, and also because of the MPAA's influential lobbying efforts. Furthermore, I show that the MPAA has intervened directly in bilateral trade relations to protect its interests, even when such interests may run counter to the benefit of the U.S. economy.

Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola

Northwestern Journal of International Law & Business

The traditional research and development model of large pharmaceutical companies is arguably unsustainable in current times. For example, estimated research and development costs increased as much as twelve percent over the last year while pharmaceutical sales grew only seven percent over the same period. Current estimates put the price to develop a new drug and bring it to market between $800 million and $1.5 billion per drug. These costs are increasing, driving large pharmaceutical companies to find more cost-effective research and development models. One cost-saving initiative is to globalize the system. In particular, companies have increasingly outsourced the required investigational …

Brazil's Recent Threat On Abbott's Patent: Resolution Or Retaliation, Jennifer Bjornberg

Northwestern Journal of International Law & Business

In June 2005, Brazil threatened to infringe the patent of an anti-AIDS medication, Kaletra, patented and produced by a U.S. based pharmaceutical company, Abbott Laboratories. The resulting controversy necessarily implicated the World Trade Organization's Agreement on Trade Related Aspects of Intellectual Property ("TRIPS Agreement") as Brazil was a Member Nation under the agreement and Abbott's product was protected under that agreement. Ultimately, the threat came to a voluntary resolution between both parties, but the dispute raised a number of unique questions relating to international trade and public health concerns. This article will discuss the recent controversy between Abbott and Brazil …

Comparative Advertising In The United States And In France, Charlotte J. Romano

Northwestern Journal of International Law & Business

Comparative advertising has been widely used for over thirty years in the United States. By contrast, the use of this advertising format has traditionally been-and still is-very marginal in France. The term "comparative advertising" refers to any form of advertising in which a trademark owner draws a comparison between his product, service, or brand and that of a competitor. The central issue of this article is to determine why, despite identical guiding policies, comparative advertising remains unusual in France while it is commonplace in the United States. Attempting to answer that question unavoidably raises numerous related issues: can the two …

General Exclusion Orders Under Section 337, Gary M. Hnath

Northwestern Journal of International Law & Business

Your company, Widgets Unlimited, imports foreign-made widgets into the United States. One day, you're informed that U.S. Customs & Border Protection (Customs) has detained your goods and is determining whether they infringe a patent owned by The American Widget Corporation, based on an exclusion order issued by the International Trade Commission (ITC) after a recent ITC investigation, titled Certain Widgets with Extra Shiny Surfaces. Since you were never a party to any proceeding at the ITC, and indeed, you never even knew American Widget had patents on its widgets, you conclude that there must be some mistake and wait for …

Communication Breakdown: The Recording Industry's Pursuit Of The Individual Music User, A Comparison Of U.S. And E.U. Copyright Protections For Internet Music File Sharing, Ryan Bates

Northwestern Journal of International Law & Business

While music file sharing over the internet has become a common practice in recent years, record companies blame the illegal swapping for a 31% drop in compact disk sales since mid-2000. In an ever-evolving attempt to gain a stronghold on the distribution of digital music via the internet, the recording industry recently began filing lawsuits against the individual internet "file sharer" in both the United States the European Union.

This comment examines the development of copyright protections in the United States and the European Union, including recent legislation under each system, and argues that a balance of rights and technical …

European Community Compulsory Licensing Policy: Heresy Versus Commen Sense Symposium On European Competition Law , Frank Fine

Northwestern Journal of International Law & Business

There is a growing trend to limit the rights of intellectual property owners when the public interest warrants. Until very recently, this phenomenon has been manifested only at a transnational level.1 For example, the World Trade Organization, as recently as November 2001, in its Doha Agreement ("Doha"),2 enabled certain nations of the Asian and African subcontinents to obtain compulsory licenses to manufacture and distribute domestically certain anti-retroviral drugs by declaring a state of national health emergency. Doha raises an intriguing question: if limited intrusions into valuable intellectual property rights may be justified on public health grounds, should not such intrusions …

Trips' Rebound: An Historical Analysis Of How The Trips Agreement Can Ricochet Back Against The United States, Donald P. Harris

Northwestern Journal of International Law & Business

Recently, scholars and commentators around the world have reexamined the role intellectual property rights (IPRs) play in hindering or helping developing countries. These scholars have questioned the doctrine the IPRs help developing countries by promoting economic development, increasing foreign direct investment, stimulating domestic innovation, and improving access to new technologies, and have concluded that imposing "Western-styled" intellectual property regimes (e.g., the U.S. patent regime) on developing countries harms those countries. In particular, such regimes fail to bring any of the purported benefits, while they impose many costs, including preventing people from obtaining life-saving drugs. This Article argues that it is …

The Spirit Of Trips And The Importation Of Medicines Made Under Compulsory License After The August 2003 Trips Council Agreement, Jessica J. Fayerman

Northwestern Journal of International Law & Business

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement has changed prospects for access to necessary medications in the developing world. The use of compulsory licensing for pharmaceutical products embodied in Article 31 of TRIPS has been a contentious issue. Prior to 2003, countries with no manufacturing capacity of their own were not allowed to import medicines made under compulsory license, rendering the protections of Article 31 of little use to them. The 2003 Motta Agreement changed this. This expansion of the compulsory licensing power is both an impractical solution and it dilutes the premises upon which TRIPS was originally …

Should China Provide Intellectual Property Protection For Genetically Modified Animals?, Ke Geng

Northwestern Journal of International Law & Business

The advent of recombinant genetic engineering techniques has revolutionized biotechnology. The biomedicine and biotechnology industries have extensively employed these techniques to improve the quality of agricultural crops and livestock and to create genetically modified organisms ("GMOs") in order to produce drugs. Since as much as twenty-five percent of the world's intellectual property-related trade involves biotechnology, many countries have realized the importance of providing intellectual property protection for biotechnological technologies, including GMOs. In the past decade, China's booming economy has helped make its biotechnological market the fastest growing market in the world. To stimulate innovation and attract private investment in its …

The Protection Of Test And Other Data Required By Article 39.3 Of The Trips Agreement, G. Lee Skillington, Eric M. Solovy

Northwestern Journal of International Law & Business

This article provides a comprehensive analysis of the origins, purpose and scope of protection for test and other data required by TRIPS Article 39.3. Through this analysis, which looks to the ordinary meaning of the provision in proper context in the same manner as would a WTO dispute settlement panel or the WTO Appellate Body, we conclude that Article 39.3 provides protection against the unjust or unfair application or conversion of certain test and other data to make a profit or to obtain a benefit. Such protection must be provided long enough to allow the originator to at least recoup …

How Far Have We Come, And Where Do We Go From Here: The Status Of Global Computer Software Protection Under The Trips Agreement, Aaron D. Charfoos

Northwestern Journal of International Law & Business

The TRIPS agreement made significant advances over the pre-TRIPS international regime with respect to the protection of computer software. There are at least two significant advances. First, computer software protections have been embedded into the new dispute resolution procedures. Second, both object and source code are protected under the copyright sections of the Agreement. The dispute resolution procedures provide back-end protection (protection after offenses have occurred), while new copyright provisions provide affirmative front-end protection (protection deterring such offenses). However, the Agreement could have, and should have, gone farther to protect the software industry. By not formally deciding on the ability …

Knowledge, Legitimacy, Efficiency And The Institutionalization Of Dispute Settlement Procedures At The World Trade Organization And The World Intellectual Property Organization, Michael P. Ryan

Northwestern Journal of International Law & Business

International legal research regarding international economic dispute settlement tends to be a-theoretical. A theoretically-grounded analytic framework is employed in this article which draws from scholarship from political science, sociology, and economics regarding institutions and international governmental organizations. The knowledge-legitimacy-efficiency analytic framework is applied in this article to studies of General Agreement on Tariffs and Trade (GA TT)/World Trade Organization (WTO) dispute settlement in order to relate this relevant scholarship to the economic field under primary study, Internet domain names. GA TT/WTO knowledge regarding international trade law has thickened through multi-lateral trade negotiations and dispute settlement decisions. The WTO's legitimacy is …

Levi Strauss V. Tesco And E.U. Trademark Exhaustion: A Proposal For Change, Kimberly Reed

Northwestern Journal of International Law & Business

When the European Court of Justice ("ECJ") issued its final decision in the case of Levi Strauss & Co. v. Tesco Stores Ltd. in November 2001, affirming Levi Strauss' right to keep cut-price imported Levis out of the European Union ("E.U."), the general public was outraged at the perceived blow to consumer rights. The ECJ's decision to allow Levi Strauss to prohibit "gray market" imports of its jeans from the United States for resale in the United Kingdom at prices much cheaper than Levi Strauss' own U.K. prices was characterized as protecting "big business" at the expense of consumers. While …

Enforcement Against Counterfeiting In The People's Republic Of China, Daniel C.K. Chow

Northwestern Journal of International Law & Business

Although the discussion in this Article is limited to counterfeiting in China, many of the issues discussed are endemic to the Chinese legal system as a whole, and apply also to other intellectual property rights, such as copyright piracy and patent infringements. Moreover, many of the themes raised in this Article also illuminate the current state of the nascent Chinese legal system as a whole and how its capacity is tested as it continues the struggle to keep pace with China's many economic reforms and accompanying social changes. Part I of this Article begins with a review of the enforcement …

Licensing On The Global Information Infrastructure: Disharmony In Cyberspace, Raymond T. Nimmer

Northwestern Journal of International Law & Business

This article explores some of the issues in international licensing and, particularly, in the evolution of information-based contracts.

Special 301 And Taiwan: A Case Study Of Protecting United States Intellectual Property In Foreign Countries, Y. Kurt Chang

Northwestern Journal of International Law & Business

On April 30, 1993, the United States Trade Representative (USTR) placed Taiwan on the "priority watch list" of countries that failed to protect United States intellectual property rights.' Although countries on the priority watch list are not as egregious in violating United States intellectual property rights as those identified as "priority foreign countries," Taiwan was targeted for an immediate action plan, requiring it to take specific actions before July 31, 1993, or else risk being the subject of a trade sanction. Under the intense pressure from the United States, the ruling party of Taiwan rammed through the legislature the first …

Chinese Traditions Inimical To The Patent Law, The Symposium: Doing Business In China, Liwei Wang

Northwestern Journal of International Law & Business

These phenomena remind us of a common view that China's modernization of science and technology is "burdened by a number of constraints, primarily constraints in traditional culture and in the Marxist-Leninist one-party state." 5 More specifically, in discussing the patent law of the People's Republic of China (PRO), Beaumont claimed that the "two-fold problem in stimulating innovation" is "a residual mistrust of innovation as a result of years of foreign imperialistic colonization," and of "finding ways to encourage and reward innovation which are congruent with Marxist thought."6 This article asserts that China's traditional culture is probably as inimical to patent …

Field-Of-Use Restrictions As Precompetitive Elements In Patent And Know-How Licensing Agreements In The United States And The European Communities, Thomas C. Meyers

Northwestern Journal of International Law & Business

The courts of both the United States and the European Communities have upheld the legality of various licensing restrictions. One such restriction, the "field-of-use" restriction, is the subject of this article. A field-of-use restriction prohibits a licensee from realizing the benefits of the license in certain technical fields. Field-of-use restrictions are usually written as restricting use to a particular field rather than listing prohibited fields… This article first sets forth an economic justification for the legality of field-of-use restrictions, concluding that such restrictions are usually pro-competitive. The article then analyzes the relevant law in both the United States and the …

Copyright Protection For Data Obtained By Remote Sensing: How The Data Enhancement Industry Will Ensure Access For Developing Countries, J. Richard West

Northwestern Journal of International Law & Business

The use of remote sensing of the earth by satellite has grown tremendously since the United States launched the first such satellite, Landsat 1, in 1972. In 1984, the Land Remote Sensing Commercialization Act began the gradual transfer of the United States Landsat program to the private sector. The Earth Observation Satellite Company (EOSAT) is the private operator licensed pursuant to the Act, and is preparing to launch the first privately-operated remote sensing satellite, Landsat 6, in 1991. The Commercialization Act requires operators to make raw data available to all users on a nondiscriminatory basis, but it does not preclude …

Compulsory Patent Licensing In The United States: An Idea Whose Time Has Come, Cole M. Fauver

Northwestern Journal of International Law & Business

This Comment will consider several of the more common grounds justifying compulsory licenses, particularly as they affect international transactions. After analyzing the dynamic between each theory's practical economic effect and general economic philosophy, the Comment will then question whether the current United States policy against general compulsory licenses remains viable in today's economic markets.

Section 337 And Gatt And The Akzo Controversy: A Pre- And Post-Omnibus Trade And Competitiveness Act Analysis, Mark Modak-Truran

Northwestern Journal of International Law & Business

The burgeoning of new technology such as semiconductor chips, computer software, genetic engineering, pharmaceuticals and other chemical processes raises important international trade issues for the protection of intellectual property rights. Inadequate protection has left the door open for pirating and counterfeiting. Section 337 of the United States Tariff Act of 1930 ("Section 337") protects intellectual property rights from international pirating and counterfeiting. It provides a mechanism for excluding fringing imports from the United States marketplace. In Re United States Litigation between E.I. Dupont de Nemours & Co. and Akzo N.V., the EC Commission determined that the procedure followed under Section …

Toward Negotiating A Remedy To Copyright Piracy In Singapore, James W. Peters

Northwestern Journal of International Law & Business

The pirates of modern Singapore threaten to undermine the international trade of copyrighted works. Advancements in technology have facilitated the inexpensive reproduction of books, audio and video cassettes, and computer programs. Printing, video, and audio pirates have found Singapore well suited to the unauthorized copying of protected works. Literature and music reproduced in Singapore has found its way to markets throughout the world. To persuade Singapore to protect intellectual property, United States and British business organizations, the United States government, and the governing bodies of international intellectual property conventions have proposed measures ranging from educational programs to economic reprisals. Still, …