ONE PILL, ONE MARKET: REVIEWING A RECENT TREND IN REVERSE PAYMENT ANTITRUST CASES
For more than a decade, ‘pay for delay’ settlements have sat at the crossroads of patent law and antitrust enforcement. These agreements – where a brand‑name drug manufacturer compensates a potential generic rival as part of resolving patent litigation – continue to raise difficult questions about how courts should assess competitive harm.
Central to that inquiry is the definition of the relevant market, a task that has taken on new significance as plaintiffs challenge these arrangements and defendants defend them as legitimate exercises of patent rights. A noticeable shift has begun to emerge in the case law: courts are increasingly willing to define the market in narrower terms than in the past.
That shift, and what it may mean for the future of reverse‑payment litigation, is becoming an important fault line in the ongoing debate over how antitrust law should respond to pharmaceutical settlement practices.
Reverse-payment lawsuits typically arise after companies settle pharmaceutical patent litigation under the Hatch-Waxman Act. The Hatch-Waxman framework allows drug developers to sell their drugs exclusively for a period of time at above a competitive price. Once the period of exclusivity expires, generic competitors can enter the market using a less onerous process for regulatory approval, the abbreviated new drug application (ANDA) process.
Apr-Jun 2026 issue
Goldman Ismail Tomaselli Brennan & Baum LLP