Amgen/Genetics Institute EPO patent dispute
Executive Summary
Hearing in Massachusetts federal court began on Aug. 8 and is expected to last approximately one month. Amgen filed a patent infringement suit against Genetics Institute in late 1987, shortly after it filed an NDA for its erythropoietin product Epogen, which gained FDA approval on June 1. Genetics Institute licensed its product Marogen to Chugai, which has filed an NDA with FDA and is expecting approval by 1990. In February 1988, Judge William Young preliminarily determined that Amgen's Epogen infringes on Genetics Institute's patent.