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Articles 1 - 5 of 5
Full-Text Articles in Intellectual Property Law
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
Michigan Telecommunications & Technology Law Review
The United States spends nearly $1,000 per person annually on drugs—forty percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …
An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel
Michigan Law Review
Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …
The Medical Liability Exemption: A Path To Affordable Pharmaceuticals, Carrie E. Rosato
The Medical Liability Exemption: A Path To Affordable Pharmaceuticals, Carrie E. Rosato
Florida State University Law Review
Patent monopolies are tolerated because we believe they promote progress that benefits society. What should be done when these monopolies actually increase human suffering? Drug prices in America are fifty to eighty percent higher than the rest of the world, meaning many cannot afford drugs that will improve or even save their lives. When striking a balance between the interests of the patent holder and that of the public, it is important to bear in mind that the rewards granted to patentees are secondary to the public benefit derived from their labors. The ideal solution would come from Congress creating …
Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho
Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho
Vanderbilt Journal of Entertainment & Technology Law
Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.
This Article brings valuable insight into this area at a critical …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …