Settling ANDA Litigation: Options and Risks

The recent First Circuit opinion in the In Re Loestrin reverse-payment litigation appears to have clarified that non-cash payments to a generic company from a branded pharmaceutical company can be targeted as anti-competitive under the U.S. Supreme Court 2013 decision in FTC v. Actavis. But many other antitrust-related issues about settling Hatch-Waxman litigation remain open, such as:

• How big must a reverse payment be to count as a “large and unjustified” under Actavis?
• Does the promise of “no authorized generic” amount to an unlawful reverse payment?
• May side deals that are profitable for the generic manufacturer and reflect commercially reasonable arm’s-length terms be freely entered into by settling parties
• What role will arguments about patent strength play if a reverse-payments antitrust case goes to trial?

Our panel, which will discuss these and other issues, features an attorney at the Federal Trade Commission, and two law firm litigators, one from each side of the innovator/generic divide.