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CPMP recommends TKTX's Dynepo

December 12, 2001 8:00 AM UTC

The EMEA's Committee for Proprietary Medicinal Products recommended approval of Dynepo epoetin delta from Transkaryotic (TKTX) and partner Aventis (AVE) to treat anemia associated with renal disease. AVE has EU marketing rights to the compound, which is the subject of ongoing litigation with Amgen (AMGN). In April, the High Court of Justice (London, U.K.) ruled that, under the U.K. version of the U.S. doctrine of equivalents, TKTX and AVE infringe a claim in AMGN's European Patent No. 0148605B2 covering erythropoietin (EPO). TKTX and AVE are appealing the ruling, and said their ability to market Dynepo hinges on the appeal outcome. Michael Astrue, SVP of administration and general counsel at TKTX, told BioCentury that oral arguments for the appeal hearing are slated for June 2002, with a decision expected in December 2002. ...