Five days before Novo Nordisk A/S was to begin selling itsrecombinant human growth hormone, Norditropin, in the U.S., afederal court judge in New York shut down the Denmark-basedcompany's product launch.
U.S. District Judge Constance Motley issued a temporary restrainingorder on sales of Norditropin in response to a request from NovoNordisk's competitor, Genentech Inc., which controls 75 percent ofthe U.S. growth hormone market with its two products, Protropin andNutropin.
The 10-day restraining order, which halted a planned launch ofNorditropin Monday, is part of the ongoing growth hormone patentbattle Genentech has waged against Novo Nordisk and Bio-Technology General Corp., of Iselin, N.J.
The federal court next week is expected to hear arguments onGenentech's request for another restraining order to prevent Bio-Technology General's entrance into the market with its product, Bio-Tropin.
Genentech, of South San Francisco, has claimed the two would-beU.S. competitors' products infringe on its patents related torecombinant human growth hormone, which Genentech has sold inthe U.S. since 1985. Novo-Nordisk and Bio-Technology General,both of whom won FDA approval of their drugs in May, have suedGenentech, seeking to invalidate its patent claims. All the lawsuitswere consolidated in U.S. District Court in New York.
In issuing the restraining order against Novo Nordisk, Motley said:"Genentech has shown a strong likelihood of success" that its patent"is valid and that Novo Nordisk's product would infringeGenentech's patent if permitted to immediately launch sales of itsproduct before a decision on the motion [for a preliminaryinjunction]."
The restraining order will remain in effect pending the judge'sdecision on Genentech's request for a preliminary injunction.Although the restraining order is scheduled to expire June 24, Motleysaid she may extend it an additional 10 days if she has not reached adecision on the injunction.
Motley said, "The immediate entrance of Novo Nordisk into the U.S.market would, at the very least, throw the market place intounnecessary confusion and anxiety about the use of the unusualproduct involved here."
If the judge issues the injunction, Novo Nordisk would be barredfrom selling Norditropin in the U.S. until the patent lawsuits areresolved.
Aside from Genentech's products, the only other growth hormone onthe U.S. market is Humatrope, which has been sold by Indianapolis-based Eli Lilly and Co. since 1987. Genentech and Lilly wereembroiled in a patent dispute for eight years until Lilly in Januaryagreed to pay Genentech $145 million to settle the battle out of court.
The U.S. market for growth hormone is between $300 million and$400 million annually.
Novo Nordisk already sells Norditropin in 66 countries outside theU.S. and Bio-Technology's Bio-Tropin is on the market in sevencountries.
Novo Nordisk's stock (NYSE:NVO) closed Thursday at $26.25,down 13 cents. Genentech (NYSE:GNE) ended the day at $48.88,down 38 cents, and Bio-Technology General (NASDAQ:BTGC) wasoff 6 cents to $3.38. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.