Robert Cerwinski: Pay-for-Delay Settlements and Agency Scrutiny

Robert Cerwinski, JD, partner at Goodwin, discusses the potential for government agencies to weigh in on pay-for-delay settlements in the biosimilars space.


Do “Pay-to-Delay” agreements affect biosimilars in the way they affect small-molecule drugs?

The FTC hasn’t really weighed in on that, and it’s really the [Federal Trade Commission, FTC] and the Department of Justice who have been driving a lot of the activity and the activism around pay-for-delay suits. The long and short is that policy is really kind of behind the Justice Department and the FTC’s concern about pay-for-delay. The basic proposition is that: We want to make sure that access to generic drugs happens as soon as possible, so we want to police settlements to make sure that the public is not being prejudiced by private settlements between generic drug companies and branded drug companies. The same policy rationale could very well exist with biosimilars. The policy behind the [Biologics Price Competition and Innovation Act, BPCIA] is at least roughly the same as the policy behind the Hatch-Waxman laws, which is: Let’s encourage early biosimilar entry by giving a mechanism for resolving patent infringement lawsuits prior to actual marketing—let’s incentivize both sides to get this dispute out of the way early, so that biosimilars can reach the market as soon as possible. So, because the policies behind the Hatch-Waxman laws and the BPCIA are roughly aligned, we may very well see some scrutiny by the Justice Department and the FTC of such settlements.

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