Month: April 2007
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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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Law Seminars International will be holding a conference on Pharmaceutical Antitrust next week in Washington. David Balto, one of the co-chairs of the conference, recently made the following announcement: There will be a keynote address by FTC Commissioner Tom Rosch, who has interesting views on the ever contentious patent settlement issues. Rosch is expected to say something new and noteworthy that will provide…
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Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007) A year ago, Merck sued Apotex alleging that Apotex’s ANDA for generic Fosamax infringed nine patents on pharmaceutical formulations of alendronate, the active ingredient in Fosamax. Apotex answered with counterclaims of patent invalidity and noninfringement. Then, after Merck reviewed portions of Apotex’s ANDA, Merck granted…
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Norvasc update: FDA Law Blog reports that the district court has extended FDA’s deadline and that Zydus has filed a new citizen petition. Pharmalot reports on Barr Labs’ efforts to protect its Seasonale oral contraceptive from generic competition. The WSJ Health Blog summarizes today’s front-page WSJ article on Amgen’s recent troubles. The Business Standard and…
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This is just a quick reminder of two upcoming conferences from ACI that should be of interest to Orange Book Blog readers: "Paragraph IV Disputes" and the "3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust." "Paragraph IV Disputes," to be held April 23-24 in New York, will offer "expert insights on Hatch-Waxman litigation strategies for…
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A dozen companies have submitted letters in response to FDA’s March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues. Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for…
