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Full-Text Articles in Law
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Michigan Journal of Race and Law
With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …
Breaking Patents, Daniel R. Cahoy
Breaking Patents, Daniel R. Cahoy
Michigan Journal of International Law
In the 1970s and 1980s, the Boeing aircraft company worked to address the rising cost of jet fuel by inventing lighter metal alloys for use in aerospace materials. Among its discoveries was a method of producing aluminum-lithium alloys with high "fracture toughness," and in 1989, Boeing received a patent for the process. Five years later, another aerospace company working as a National Aeronautics and Space Administration (NASA) contractor, Lockheed Martin, was attempting to solve a similar problem related to materials used in the space shuttle. Lighter materials were necessary for future shuttle missions to transport components of the International Space …
Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo
Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo
Michigan Journal of International Law
Suppose a relatively prosperous nation with universal public health coverage faces an HIV/AIDS crisis. It refuses to negotiate with the patent-holding manufacturers of the best antiretrovirals (ARVs) available, instead issuing compulsory licenses. Compulsory licenses permit the generic drug manufacturers designated in the compulsory licenses to make, use, import, and sell the patented ARVs without the permission of the patent owners, increasing competition and lowering prices. Realizing that drugs are much cheaper without patents, the nation decides to issue another round of compulsory licenses for an extensive list of patented drugs for its universal health care program. While improving public access …
Hatch-Waxmanizing Copyright, Michal Shur-Ofry
Hatch-Waxmanizing Copyright, Michal Shur-Ofry
Michigan Telecommunications & Technology Law Review
This Essay presents a novel proposal for counter balancing "copyright overspills." In the background of the discussion is the common reality of users succumbing to rights holders' attempts to license uses which are most likely fair uses or completely free of copyright protection. These practices have attracted considerable attention in recent literature. Most scholarly proposals in this context emphasize the need to clarify the contours of the fair use doctrine and to remove doctrinal ambiguities. Yet these initiatives are probably insufficient to overcome users' risk aversion in copyright markets due to an inherent structural imbalance within copyright law. While the …
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 …