Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Antitrust
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On Wednesday, May 2nd, two subcommittees of the House Committee on Energy and Commerce will hold hearings of importance to pharmaceutical companies: first, on legislation to establish an abbreviated pathway for FDA approval of follow-on biologics; second, on a pending bill to ban “reverse payment” settlements of Hatch-Waxman litigation. At 10 a.m. ET, the Subcommittee…
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Warner Chilcott announced in a press release today that it has reached tentative settlements with thirty-four states and the District of Columbia and indirect pharmaceutical purchasers that brought antitrust lawsuits concerning Warner Chilcott’s oral contraceptive Ovcon 35. Under the terms of the settlements, all claims will be dismissed in exchange for cash payments and/or product…
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Adams Respiratory and Mutual Pharma settle guaifenesin patent litigation: press release FTC subpoenas Cephalon over Provigil patent litigation settlements: AP; Phil. Bus. J. Glenmark first to file Zetia ANDA with paragraph IV certification: Bloomberg Senate holds hearing on pediatric exclusivity: Reuters Takeda awarded $16.8 million in fees in pioglitazone patent case: NY Law J.; Reuters
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According to this article in today’s Legal Times, the Supreme Court may decide as early as next Monday whether or not to grant certiorari in In Re: Tamoxifen Citrate Antitrust Litigation, the latest "reverse payment" settlement case to be presented to the Court. In the case, patients, health insurance companies, and consumer advocacy groups are…
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Bloomberg reports that the topic of reverse payment settlements of Hatch-Waxman litigation came up in a recent Senate hearing. Bloomberg TV interviewed me yesterday about reverse payment settlements. On Pharma has the video. DUSA Pharmaceuticals announced that a federal court recently lifted the preliminary injunction that prevented River’s Edge Pharmaceuticals from selling generic Nicomide, a…
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The Senate Judiciary Committee passed the "Preserve Access to Affordable Generics Act" (S. 316) today by unanimous consent. If enacted, the bill would prohibit "reverse payment" settlements of Hatch-Waxman litigation, in which an innovator drug company pays a generic drug company to delay marketing its generic drug product. Specifically, the bill would amend the Clayton…
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Federal Trade Comm’n v. Warner Chilcott Holdings, No. 05-2179 (D. D.C. 2007) Judge Colleen Kollar-Kotelly of the U.S. District Court for the District of Columbia recently denied Barr Laboratories’ motion to dismiss a Federal Trade Commission lawsuit stemming from Barr’s agreement with Warner Chilcott concerning generic Ovcon 35. The opinion is available here. In 2001,…
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The Antitrust & Competition Policy Blog reports on a new paper by Prof. Christopher Leslie of Chicago-Kent College of Law advocating the use of antitrust law to challenge the licensing of invalid patents. Richard Epstein, my law school Property professor, has a new book out entitled Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation. Judy…
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In testimony yesterday before the Senate Committee on the Judiciary, Federal Trade Commission Commissioner Jon Leibowitz voiced support for legislation to prohibit litigation settlement agreements between generic and pharmaceutical brand manufacturers that include both payments to the generic manufacturer and a delay in generic drug market entry ("reverse payment" agreements). Leibowitz argued that such reverse…
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