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Pay to delay parts of the law prevent the development of cheaper, generic drugs- prevents access of new innovation drugs because companies extend patent exclusivity which prevents new innovations

Feldman 8/27 – Distinguished Professor of Law Chair & Director of the Center for Innovation, UC Hastings Law

Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law, Albert Abramson ’54 Distinguished Professor of Law Chair, and Director of the Center for Innovation, The Price Tag of 'Pay-for-Delay', UC Hastings Research Paper Forthcoming, 27 Aug 2021, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3846484

Despite potential remedy-related reforms, however, the most important change needed pertains to evaluating the anticompetitive nature of the agreement itself. The landmark decision in Actavis expressed optimism that courts would be able to manage the analysis in a more structured manner. That reality has not materialized. To resolve the problem, one should return to the basic notion that agreements between competitors are strongly disfavored under antitrust law.

Given that agreements between competitors are disfavored, the test for agreements between brands and generics in the context of Hatch-Waxman litigation should begin with a presumption that the agreement is anticompetitive. This approach respects the essential design of the Hatch-Waxman system to ensure rapid entry of generic drugs, in part, by providing an incentive for generic drug companies to challenge patents that are invalid or invalidly applied.182 Only when the public interest is clearly served should the presumption fall.

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