Patent Law Weblog
Category: Hatch-Waxman
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By Kevin E. Noonan — Late last week, District Court Judge Peter Sheridan (D.N.J.) dismissed with prejudice the complaint for antitrust injury by the so-called "End Payor Class Purchasers" against the parties in previous ANDA litigation in the case styled In re Lipitor Antitrust Litigation (Order). The gravamen of the complaint was that the defendants…
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By Kevin E. Noonan — In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust laws, the District Court of New Jersey (P. Sheridan, J.) granted defendants' motion to dismiss under Fed.…
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By Kevin E. Noonan — Federal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's crusade against the pharmaceutical industry (branded and generic). Seemingly emboldened by its partial victory at the Supreme Court in…
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By Kevin E. Noonan — In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its application to exclude practice of an infringing article. The case involved a…
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By Andrew Williams — Can filing a lawsuit under the Hatch-Waxman scheme of 35 U.S.C. § 271(e)(2)(A) ever give rise to antitrust liability? The Federal Circuit last week indicated in the affirmative. That statute provides that: It shall be an act of infringement to submit— (A) an application under section 505(j) of the Federal Food, Drug,…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners…
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By Kevin E. Noonan — In a move that will surprise almost no one (except perhaps members of the Supreme Court majority in FTC v. Actavis), the Federal Trade Commission has filed an amicus curiae brief with the District Court of New Jersey in In re Effexot XR Antitrust Litigation. This time the issue is…
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By Andrew Williams — Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm. v. Amphastar Pharm., 686 F.3d 1348 (2012). In fact, one of the cases was the Momenta…
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By Kevin E. Noonan — Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse payment settlement agreements in ANDA litigation. Such agreements have long been vilified by the Federal Trade Commission and have been the subject of extensive litigation that…
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By Kevin E. Noonan — The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the "safe harbor" provisions on 35 U.S.C. § 271(e)(1). Specifically, two panels of the Court, both consisting…
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