Cisplatin patent challenge ongoing in Chicago federal court; Fujisawa ANDA tentatively approved.
Executive Summary
FUJISAWA CHALLENGE OF BRISTOL CISPLATIN PATENT will test whether Bristol-Myers Squibb can retain exclusive rights to the anticancer agent until May 8, 2012. Fujisawa's ANDA for cisplatin was tentatively approved by FDA July 29 ("The Pink Sheet" Aug. 4, T&G-11). In order to market the product, Fujisawa must prevail in patent litigation brought by Bristol in January or wait until the 30-month Waxman/Hatch patent challenge resolution period expires in mid-1999.