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Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
All Faculty Scholarship
As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …
Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin
Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin
All Faculty Scholarship
Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …