The U.S. Appeals Court for the Federal Circuit in Washington uphelda lower court's injunction preventing Bio-Technology General Corp.from selling its FDA-approved growth hormone in the U.S. pendingresolution of the company's patent fight with Genentech Inc.
The decision represented a victory for Genentech, of South SanFrancisco, following a ruling in February 1996 from the same appealscourt that lifted a similar injunction against Novo Nordisk A/S, ofBagsvaerd, Denmark.
Genentech has accused both Novo Nordisk and Bio-TechnologyGeneral, of Iselin, N.Y., of patent infringement related toGenentech's growth hormone products, Protropin and Nutropin. Thedrugs are used to treat short children suffering from deficiencies ingrowth hormone.
The patent litigation is being waged in U.S. District Court in NewYork. Last summer a judge issued injunctions against Novo Nordiskand Bio-Technology General stopping them from selling their growthhormones until the cases were resolved.
Novo Nordisk and Bio-Technology received FDA approvals of theirproducts in May 1995. Novo's growth hormone is called Norditropinand Bio-Technology General's is called Bio-Tropin. Both companiessell their drugs outside the U.S.
Novo Nordisk can sell Norditropin in the U.S. as the patent fightproceeds. Bio-Technology is barred from the market until the closeof the battle, which may last years.
Sim Fass, president and CEO of Bio-Technology General, called theappeals court ruling "disappointing," but added, "It doesn't crippleus."
The variance of the appeals court rulings for Novo and Bio-Technology General, Fass said, focused on the production process forrecombinant growth hormone. Novo's method of expressing thehormone was judged different from that of Genentech and Bio-Technology General.
Fass said his company achieved its first year of profitability in 1995without U.S. sales of Bio-Tropin and expects to perform better thisyear. The company in December 1995 launched its first U.S. product,Oxandrin. The anabolic steroid is sold for promoting weight gain in avariety of diseases, including cancer and AIDS.
Fass said Oxandrin would be the company's biggest selling drug thisyear even if Bio-Tropin were on the market in the U.S. The growthhormone generated $14 million in sales outside the U.S. in 1995.
Genentech commands 75 percent of the U.S. growth hormonemarket, which is estimated at more than $350 million a year.
Bio-Technology General's stock (NASDAQ:BTGC) closed Tuesdayat $5.81, down 94 cents, a 14 percent drop. Genentech (NYSE:GNE)ended the day down 25 cents to $52.50. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.