Brief Amici Curiae of 53 Law, Economics, and Business Professors, the American Antitrust Institute, and Consumers Union in Support of Appellants
Third Circuit brief in In re: Lamictal Direct Purchaser Antitrust Litigation, 2014
41 Pages Posted: 29 Apr 2014
Date Written: April 28, 2014
In FTC v. Actavis, the Supreme Court held that a brand payment to a generic to delay entering the market could have "significant anticompetitive effects" and violate the antitrust laws. In a narrow, formalistic ruling, the court in In re Lamictal held that such payments were limited to cash. On behalf of 53 professors, the American Antitrust Institute, and Consumers Union, this Third Circuit amicus brief urges reversal.
Exclusion payments today take myriad forms, with roughly half taking the form of “no-authorized-generic” agreements by which a brand agrees not to launch an authorized generic during the generic's 180-day exclusivity period. Because the launch of an authorized generic dramatically reduces the generic’s profits, a brand’s promise not to introduce one provides substantial value to the generic.
No-authorized-generic agreements, which a brand enters into in exchange for a generic’s agreement to delay entry into the brand’s market, are simply a variation on a type of unlawful market-allocation agreement with which courts have long been familiar. The two parties make reciprocal agreements not to compete in the other’s allocated portion of the market: the brand agrees not to launch an authorized generic that would compete against the generic, and the generic agrees to delay launching its product that would compete against the brand.
In holding that only cash payments are subject to antitrust scrutiny under Actavis, the Lamictal court created a loophole large enough to accommodate an entire industry’s worth of supracompetitive profits and missed dosages. Nor would scrutiny of agreements like the one in this case, which provides the generic with a type of consideration it could never have obtained by winning a patent case, have any effect on legitimate settlements that fall within the boundaries of patent litigation.
Finally, the district court’s analysis purported to apply Actavis but was closer to defying it in (1) using factors the Supreme Court invoked to require heightened scrutiny to instead justify reduced scrutiny; (2) misunderstanding the valuable no-authorized-generic period; (3) deeming procompetitive the elimination of risk that Actavis held is anticompetitive; and (4) divining, on its mere say-so, an absence of harmful “intent.”
Keywords: patent, antitrust, drugs, pharmaceuticals, authorized generics, settlements, reverse payments, exclusion payments, Hatch Waxman Act, Lamictal
JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38
Suggested Citation: Suggested Citation