More money, more problems: Using ‘pay-for-delay’ deals after FTC v. Actavis

Lawyers' Forum

By Ann K. Kotze, Jessica M. Tyrus and Robert F. Green

Ann K. Kotze, an associate at Leydig, Voit & Mayer, focuses her practice on patent litigation and prosecution in pharmaceutical and chemical technologies.

Jessica M. Tyrus, also a Leydig associate, focuses her practice on intellectual property law with particular emphasis in patent prosecution and litigation in the chemical arts.

Robert F. Green, a Leydig shareholder, practices law exclusively in the field of intellectual property, concentrating in the areas of pharmaceutical, biochemical and chemical litigation and opinions with emphasis in patent litigation and consultation arising under the Hatch-Waxman Act and the Federal Food, Drug and Cosmetic Act.

Posted July 21, 2014 2:53 PM

Hatch-Waxman litigation often results in a settlement prior to a trial on the merits, and due to the lucrative nature of pharmaceutical products as well as the unique regulatory framework of the Hatch-Waxman Act, these agreements are often structured as “pay-for-delay” or reverse payment settlements. A “pay-for-delay” settlement consists of the brand patentee paying the generic challenger in exchange for the generic agreeing to delay its market entry until a specified date, thereby protecting …

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