Amgen, TKTX aftermath

AMGN was up $7.625 (13 percent) to $67.625 on Monday, and Transkaryotic Therapies (TKTX) was off $10.875 (32 percent) to $23.125, with a market cap of $524.8 million following last Friday's after-market ruling by Judge William Young of the U.S. District Court for the District of Massachusetts that TKTX and partner Aventis (AVE) literally infringed two of five patents in dispute in the erythropoietin patent suit brought by AMGN. Young also found that TKTX infringed a third patent under the doctrine of equivalents (see BioCentury Extra, Friday Jan. 19; and BioCentury, Jan. 22). On a conference call on Monday, TKTX President and CEO Richard Selden called Judge Young's ruling an "interim decision," saying that half of all biotech cases are overturned on appeal. TKTX's Michael Astrue, senior vice president of administration and general counsel, said he expects the appeal process to take 12-18 months, which falls in line with the company's expected FDA review time for Dynepo, its GA-EPO product that was the subject of the litigation. In November, the company announced that the FDA required additional data on the Dynepo BLA, which TKTX expects to submit mid-year. Although he would not discuss specific arguments for appeal, Selden said that Judge Young relied in Friday's opinion on the plain language interpretation of claims in AMGN's patents outside the context of prosecution history - a point that could be revisited on appeal. Selden also pointed to Judge Young's decisions on enablement of AMGN's patents, saying that the judge "agonized" over them in language that also could be useful on appeal. ...