Bio-Technology General Corp. is seeking damages of $100 millionin a lawsuit filed Monday in federal court in New York againstGenentech Inc. over patents for recombinant human growthhormone.
Bio-Technology General's spokeswoman, Leah Berkovits, said thecourt action was spurred, in part, by a patent infringement lawsuitfiled last December in Delaware federal court by Genentech Inc., ofSouth San Francisco.
Genentech has alleged that growth hormone products made by Bio-Technology General, of Iselin, N.Y., and Denmark-based Novo-Nordisk AS violate Genentech's patents.
Bio-Technology General, in its lawsuit, is seeking a judgmentdeclaring that its growth hormone product, Bio-Tropin, does notinfringe on Genentech's patents and wants $100 million incompensatory damages. Bio-Technology General also accusesGenentech and its lawyers of malicious prosecution related to patentinfringement litigation initiated by Genentech.
In a prepared statement, Genentech said, "Bio-Technology General'slawsuit is without merit and frivolous. We believe our patents arevalid and are infringed by Bio-Technology General."
Genentech suggested the Bio-Technology General suit was aresponse to an out-of-court settlement last week between Genentechand Eli Lilly and Co., of Indianapolis. Lilly has agreed to payGenentech $145 million to end patent infringement litigation relatedto growth hormone and other products. Some of the patents involvedin the Lilly-Genentech settlement are involved in the battle with Bio-Technology General. (See BioWorld Today, Jan. 6, 1995, p. 1.)
Genentech, the first company to receive FDA approval forrecombinant human growth hormone, markets its products under thenames Protoprin and Nutropin. Lilly's Humatrope, approved by theFDA in 1987, is the only other human growth hormone sold in theU.S.
The fight between Genentech and Bio-Technology General dates to1993 when Genentech filed a patent infringement complaint with theInternational Trade Commission (ITC) to prevent Bio-TechnologyGeneral and Novo-Nordisk from selling their growth hormones inthe U.S.
An ITC judge last year dismissed Genentech's complaint. Genentechappealed and the full commission is expected to issue a ruling inMarch.
In the meantime, Bio-Technology General and Novo Nordisk markethuman growth hormone products outside the U.S. as doesSwitzerland-based Ares Serono Group. Novo Nordisk's growthhormone is called Norditropin and Ares Serono's product is Saizen.All three companies have filed for approval with the FDA. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.