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Full-Text Articles in Law
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Improving Patent Notice And Remedies: A Critique Of The Ftc's 2011 Report, Alan Devlin
Michigan Telecommunications & Technology Law Review
2011 was an eventful year for those interested in patent law. In March, the Federal Trade Commission ("FTC") released a report that urges the Patent and Trademark Office ("PTO") and courts to remedy perceived inadequacies underlying the U.S. patent system. The FTC observes that people of skill in the art routinely encounter difficulty in determining the meaning, and hence exclusive scope, of a patent's claims. Not only does this failure of notice stymie the efficient dispersion of technology throughout the economy, the FTC argues, but the judicial process can aggravate the problem by granting inappropriate remedies in patent-infringement cases. Then, …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Michigan Telecommunications & Technology Law Review
The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Michigan Telecommunications & Technology Law Review
Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …
The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm
The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm
Michigan Telecommunications & Technology Law Review
Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …