Genentech Inc., for a second time, has thwarted Danish drug makerNovo Nordisk A/S from selling its FDA approved growth hormonedrug in the U.S. with a preliminary injunction from the U.S. DistrictCourt in New York.
Genentech, of South San Francisco, is fighting challenges to its 75percent U.S. market share in sales of growth hormone drugs infederal lawsuits alleging patent infringement against two newcomers_ Novo Nordisk, of Bagsvaerd, Denmark, and Bio-TechnologyGeneral Corp., of Iselin, N.J. Both companies received FDAapproval for growth hormone products in May 1995.
Genentech won preliminary injunctions a year ago against Novo andBio-Technology General preventing them from launching their drugsuntil the litigation was resolved. But in February 1996, the U.S.Appeals Court for the Federal Circuit in Washington threw out theinjunction against Novo, clearing the way for the company to beginselling Norditropin, as the district court case proceeded.
The appeals court, in a separate ruling, upheld the injunction againstBio-Technology General.
In seeking a second preliminary injunction against Novo, Genentechalleged infringement of another patent, issued last year, related to theproduction of growth hormone. The patent, covering expression ofgrowth hormone in a fusion protein, was not included in the originallawsuit.
Novo officials said they will appeal the second preliminaryinjunction, which prevents them from selling Norditropin pendingoutcome of a trial on the patent infringement claims. A date for thetrial has not been set.
Novo, which sells Norditropin worldwide, had not launched its drugin the U.S. Company officials, in a prepared statement Thursday,accused Genentech of antitrust violations and said Norditropin doesnot infringe any Genentech patents.
Bio-Technology General, which markets its drug under the nameBio-Tropin, also sells its product outside the U.S.
Genentech commands about 75 percent of the $350 million in annualsales in the U.S. for growth hormone drugs. The products are used totreat short children with deficiencies in the naturally occurringhormone.
Genentech's products are sold under the brand names Protropin andNutropin. Its stock (NYSE:GNE) closed Thursday up 12 cents to$52.62.
Novo Nordisk (NYSE:NVO) ended the day down 12 cents to $34.87.Bio-Technology General (NASDAQ:BTGC) was off 12 cents at$8.06. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.