IP Law Alert

IP Law Alert

Practical Perspectives on Intellectual Property Legal Developments

Tag Archives: Reverse Payments

Proposed Bill Seeks to Answer the Pay for Delay Debate

Posted in Pharmaceuticals
As the so-called pay for-delay case is ripening for Supreme Court oral argument on March 25, 2013, on Tuesday a bi-partisan group of senators introduced legislation meant to strongly deter such arrangements. The introduction of the bill, known as the "Preserve Access to Affordable Generics Act," follows an annual FTC report disclosing 40 potential pay-for-delay deals struck in the 2012 fiscal year -- a jump from 28 such deals in 2011. The goal of the bill is "to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market." Such reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry) are considered lawful by some, and anti-competitive by others, including the … Continue Reading

District of New Jersey Stays Pay-For-Delay Cases Pending High Court’s Decision in K-Dur

Posted in Patent
Defendants in reverse-payment actions pending in the Third Circuit (New Jersey, Pennsylvania, and Delaware) take note: in In re Effexor XR Antitrust Litigation the Honorable Joel A. Pisano, U.S.D.J., of the District of New Jersey has stayed several class-action litigations challenging the legality of certain reverse-payment settlement agreements between Wyeth and generic drug manufacturer Teva Pharmaceuticals, pursuant to which Wyeth allegedly paid Teva to delay its marketing of a generic counterpart to Wyeth's Effexor XR drug… Continue Reading

FTC Petitions for Certiorari in Reverse Payments Dispute

Posted in Patent
As we anticipated, the Federal Trade Commission ("FTC") filed a petition for certiorari yesterday with the Supreme Court in FTC v. Watson Pharmaceuticals, Inc. In that case, the Eleventh Circuit upheld reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry under the scope-of-the-patent approach, i.e., as long as the anti-competitive effects fall within the scope of the exclusionary potential of the patent, absent sham litigation or fraud), as lawful. The Second and Federal Circuits follow that approach. In contrast, the Third Circuit has held that such payments are presumptively anti-competitive under the "quick look rule of reason analysis" that may be rebutted by showing that the payments was for something other than delay or that the payment has a competitive benefit, and thereby increases competition… Continue Reading

Will the Supreme Court Weigh in on Reverse Payments in ANDA Cases — Revisited

Posted in Patent
We have written previously on numerous developments concerning reverse payments in Hatch-Waxman litigation settlements (i.e., payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry of proposed generic products). Earlier this month, we reported that Merck & Co. had filed a petition for a Writ of Certiorari seeking to challenge the Third Circuit's decision in In re K-Dur Antitrust Litig. holding that reverse payments are prima facie evidence of an antitrust violation… Continue Reading

Update – Hatch-Waxman Settlements: The FTC Regains Traction After Third Circuit Rules That Reverse Payments Violate Antitrust Law

Posted in Patent
As a follow-up to a previous article, the FTC has finally gotten an Appeals Court to take its view of reverse payments - Wile E. Coyote won this one. The FTC previously unsuccessfully attempted multiple avenues to invalidate reverse payments as part of Hatch-Waxman settlements - via the District Courts, proposed legislation, state court systems, and even the Supreme Court - but the Third Circuit has finally bitten, setting a clear circuit split… Continue Reading