AMGEN APPEALS BOSTON COURT INJUNCTION AND CONDITIONS IMPOSED

AMGEN APPEALS BOSTON COURT INJUNCTION AND CONDITIONS IMPOSED by District Court Judge William Young. In an April 3 motion, Amgen requested that the federal circuit court in D.C. issue an order "staying, modifying or suspending" the injunction handed down by the district court on March 14. The decision requires that Amgen and Genetics Institute and Chugai enter into a royalty-free cross-licensing agreement and that Amgen remove its opposition to the entry of Chugai-Upjohn's erythropoietin product (Marogen) into the U.S. market ("The Pink Sheet" March 19, p. 12). Amgen's appeal comes 10 days before the company must comply with the conditions of the Boston court order or face a permanent injunction barring sales of Epogen. Chugai must agree to a royalty-free cross-licensing agreement by that time, as well. Judge Helen Nies of the D.C. circuit court asked Chugai to respond to Amgen's motion for appeal by April 10. Maintaining that Judge Young's order was not clear about what Amgen must do to alleviate an "objection" or "obstacle" to Chugai's "entry into the market," the firm argued that "Amgen is left at sea in knowing what it is required to do in order to obtain its conditional stay and how to avoid contempt if it is later found not to have complied with the mandatory conditions for obtaining the stay." When Judge Young was asked by Chugai attorneys to clarify his order at the March 14 hearing, he said: "Interpret it as any obstacle to you coming on the market." Amgen argued that the terms of the injunction are not equitable since allowing Chugai onto the market is an irreversible act, while the royalty-free agreement is temporary pending an appeal of the patent litigation decision. "The district court seems to be saying to Amgen that it can remain in the market pending appeal only at the cost of permanently and irrevocably surrendering its limited orphan exclusivity to Chugai," the firm asserted. Furthermore, Chugai-Upjohn's approval for Marogen does not depend on whether Amgen relinquishes orphan exclusivity for several reasons, the company maintained. The delay in approval may be due to the fact that Chugai-Upjohn submitted its PLA for Marogen almost one year after Amgen's Epogen submission. In addition, Amgen pointed out that Chugai-Upjohn could avoid Amgen's orphan exclusivity for anemia associated with chronic renal failure by gaining Marogen approval for any number of other EPO indications, such as anemias associated with cancer or AIDS. Amgen also objects to the inclusion in the injunction of its marketing partner Ortho, which is not involved directly in the suit. "No finding has been made as to why the mere deriving of rights under the '008 patent (as its licensee, Johnson & Johnson, has done) would justify an injunction, without a hearing, against Johnson & Johnson's infringement of the '195 patent," the firm maintained. * The filing of Amgen's appeal was the final company duty for Amgen Senior VP and General Counsel Robert Weist, who resigned on April 2. Weist, 50, had led Amgen's patent litigation with Genetics Institute. Amgen said that Weist will remain as a legal consultant to the company. No replacement for general counsel has yet been named.