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Full-Text Articles in Antitrust and Trade Regulation

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 Jan 2024

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 …


Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola Jan 2007

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 …


Comparative Advertising In The United States And In France, Charlotte J. Romano Jan 2005

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 …


European Community Compulsory Licensing Policy: Heresy Versus Commen Sense Symposium On European Competition Law , Frank Fine Jan 2004

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 …


Should China Provide Intellectual Property Protection For Genetically Modified Animals?, Ke Geng Jan 2003

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 …


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 Jan 1991

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 …