Episode 1. California's “Pay-for-Delay” Law - The Center for Biosimilars

Now Playing: Episode 1. California’s “Pay-for-Delay” Law

For a legal perspective on the past year in biosimilars and a look ahead at 2022, Tony Hagen, senior editor for The Center for Biosimilars®, spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.

Landmon discusses a decision by US District Court Judge Troy Nunley this month to block California from enforcing a law that would bar “pay for delay” settlements between reference drug companies and biosimilar and generic drug manufacturers. The judge said the law was unconstitutional in that it would effectively regulate out-of-state commerce. The law was opposed by the Association for Accessible Medicines, a trade association of biosimilars and generics manufacturers.

Pay-for-delay settlements involve agreements, sometimes an exchange of value, between drug companies to delay the marketing of a rival product. The US Supreme Court ruled in 2013 that such agreements may violate antitrust laws; and the California law (AB 824; 2019) barred pay-for-delay agreements on grounds that they are anticompetitive.

source: https://www.centerforbiosimilars.com/view/biosimilar-legal-and-business-developments-in-2021

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