Tahir Amin: Pay-for-Delay Settlements and Patient Access

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses how settlements can impact patient access to biosimilars.


What is a “pay-for-delay” strategy, and what effect does it have on generic drugs or biosimilars reaching patients?

So using the Humira example, Amgen recently tried to come into the marketplace with its own biosimilar, and has now settled with AbbVie rather than go through the whole litigation process. Rumor has it that Amgen won’t get into the market until 2023, whereas it could’ve potentially come into the market now. So that’s a classic example of a settlement where litigation is involved.

Today, since the Supreme Court ruling on “pay-for-delay” settlements, we don’t see as many that are coming through, but there are other types of settlements which are happening [that] we don’t know the terms and conditions of. It might not involve money, but it may involve some other incentives or some other payback in a different way which may not be monetary, but could be other ways; we may give you another market but don’t come into the [United States]—it could be various things.

Ultimately, these deals are actually designed to maintain the maximum profit for the brand holder, the patent holder, and give some kind of exclusivity to whoever they’re settling with, but it doesn’t open the market. It allows the control of the marketplace which unfortunately all falls back on the payer and the public.

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