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ORTHO EPO MARKETING INJUNCTION

Executive Summary

ORTHO EPO MARKETING INJUNCTION v. AMGEN WILL BE HEARD during the week of March 6 in Delaware Federal Court, Johnson & Johnson said. Ortho filed a motion for a preliminary injunction on Jan. 31 seeking to prohibit Amgen from "further prosecuting its ]FDA product applications[ for EPO and from marketing EPO pending arbitration unless it makes the necessary FDA filings to permit Ortho to sell in its agreed-upon market." Ortho is also asking the court to assure that Amgen provide it with EPO supplies. The complaint alleges that Amgen has not held up its side of a 1985 agreement, under which Ortho received U.S. marketing rights to the non-dialysis anemia indications for recombinant erythropoietin. Amgen has retained exclusive U.S. rights to the dialysis anemia indication, an orphan use which could earn Amgen seven years of exclusive marketing. Ortho specifically alleges that Amgen: "has failed to complete the appropriate filings with the FDA needed to enable Amgen to supply Ortho pursuant to the agreement; has refused to include Ortho's predialysis clinical studies in its PLA/ELA; ]and[ since July, 1987, has continually refused to supply finished EPO to Ortho." Moreover, Ortho maintains that "Amgen has embarked upon a course of conduct designed to prevent Ortho from distributing Amgen's EPO to Ortho's licensed market." On Jan. 23, Ortho filed a request for arbitration with the American Arbitration Association claiming that Amgen is obligated, under the 1985 agreement, to supply Ortho with erythropoietin and help the company seek marketing approval for the non-dialysis anemia indication. "We believe Ortho's request that the court prohibit Amgen from selling Epogen until Amgen files a Product License Application for EPO on Ortho's behalf with the FDA is highly unusual and completely unjustified," Amgen CEO George Binder declared in a Feb. 2 release. "Johnson & Johnson should suffer the commercial consequences of its inability to prepare and file a PLA for Epogen on a timely basis." Epogen is the U.S. brand for Amgen's EPO product. Ortho's attempt to delay approval of Epogen compounds a confusing situation for Amgen: the company may also be caught in the stewing Capitol Hill debate over orphan indications and exclusivity. In a separate erythropoietin development, a Boston federal judge ruled Feb. 2 to deny an Amgen motion for a preliminary injunction that would prohibit Genetics Institute from exporting recombinant EPO. While acknowledging the likelihood that Amgen's patent valid and enforceable, Judge William Young said that he would allow the export of EPO by Genetics Institute under certain conditions. According to a Genetics Institute press release, the company must "deposit into an escrow account maintained by the District Court a specified amount for each gram of erythropoietin shipped by Genetics Institute, up to a maximum of $15 mil.," for possible future damages to Amgen. At the same time, after Genetics Institute has exported the first 50 grams of EPO, "Amgen must post a $21 mil. bond," the release states. A same-day Amgen release said that Genetics Institute must deposit $15 mil. "for every 100 grams shipped" and did not specify the amount to be posted by Amgen. The Feb. 2 ruling is part of an ongoing patent infringement litigation between the two companies.

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