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Full-Text Articles in Law
Update On Antitrust And Pay-For-Delay: Evaluating “No Authorized Generic” And “Exclusive License” Provisions In Hatch-Waxman Settlements, Saami Zain
San Diego Law Review
In Federal Trade Commission v. Actavis, the United States Supreme Court held that a patent litigation settlement where a branded drug company pays a generic drug company to end the litigation and delay launching its generic may violate the antitrust laws. Although the decision ended years of controversy over whether such settlements were subject to antitrust scrutiny, many issues remain unresolved concerning the lawfulness of these settlements. In particular, courts have struggled in assessing the legality of patent settlements between branded and generic drug manufacturers involving non-cash compensation or benefits. This article discusses one type of non-cash compensation that is …
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Articles
In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …