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.PANELISTS Daniel Butrymowicz, an attorney in the Health Care Division of the Bureau of Competition at the Federal Trade Commission, is part of the FTC team that reviews settlements of Hatch-Waxman litigation for antitrust violations. Earlier he served as a clerk at the U.S. District Court for the District of Connecticut and for the U.S. Court of Appeals for the Second Circuit.
Kevin Nelson is a partner of Duane Morris. Based in Chicago, Kevin has significant trial experience representing generic drug makers in Hatch-Waxman patent litigation. His cases have involved many big-selling pharmaceutical products in a variety of therapeutic classes.
Bruce Wexler is a partner at Paul Hastings and co-founder of its Life Sciences Patent Litigation practice. Based in New York. Bruce has extensive experience litigating Hatch-Waxman pharmaceutical patent cases, representing clients defending their patents covering multi-million and multi-billion dollar products. In one recent case, Bruce succeeded in defending Merck's patent on an anti-nausea drug for cancer patients. Earlier, Bruce was a clerk for Chief Judge Glenn Archer of the Federal Circuit.
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