Amgen presses ahead with its case

The heart of Amgen Inc.'s complaint against Transkaryotic Therapies Inc. is an assertion that TKTX is using a "loophole" in the Waxman-Hatch Amendments to prevent AMGN from filing a patent infringement case against TKTX's GA-EPO version of erythropoietin, at least until clinical trials have been completed.

Peter Teeley, vice president for government and public affairs at AMGN, is telling Congress that TKTX and the federal judge who ruled in its favor have misconstrued the intent of Waxman-Hatch by stating that the exemption from patent infringement litigation for clinical development programs should be available to all product sponsors. AMGN argues that the provision was intended to apply only to sponsors seeking approval to market a generic using an ANDA or a "paper NDA."