Schering Corp., a subsidiary of Schering-Plough Corp., has filed suitagainst Amgen Inc., charging that Amgen's manufacture and use ofits consensus interferon product Infergen infringes U.S. Patent No.4,530,901, held by Biogen Inc.

Schering said it is the exclusive licensee of the Biogen patent, as wellas the related Biogen alpha interferon patent rights throughout theworld. The Biogen alpha interferon patent rights cover, among otherthings, the recombinant production of alpha interferons, includingSchering-Plough's Intron A, Schering said.

David Kaye, associate director of corporate communications atAmgen, told BioWorld Today, the lawsuit was the "least surprisingevent in biotech this year."

"We filed a product license application with the FDA for hepatitis Cearlier this year," Kaye said. "We have anticipated that if we came inand competed with Schering-Plough, they would file suit."

According to the complaint, in 1985, The U.S. Patent and TrademarkOffice issued the patent entitled "Recombinant DNA Molecules AndTheir Use In Producing Human Interferon-Like Polypeptides" toBiogen N.V.

Biogen N.V., a corporation organized under the laws of theNetherlands, Antilles, assigned the patent to Biogen Inc., ofCambridge, Mass.

In the early 1980s, Biogen granted an exclusive license to Schering,of Madison, N.J., which did the development and marketing of theproduct.

Robert Consalvo, director of media relations at Schering, saidAmgen's product infringes upon the patent held by Biogen thatSchering licensed.

"The complaint enjoins them from manufacturing or selling thatpatent," Consalvo said.

Biogen had no comment.

Joyce Lonergan, an analyst with Cowen & Co. of Boston, Mass.,said the suit was "fully anticipated" and there was "no change to ourAmgen outlook."

"We reiterate a strong buy rating," Lonergan said. "We have highconfidence in our earnings estimates and would not be surprised tosee Amgen beat our $2.80 1997 estimate."

This year, Amgen licensed to the Japanese pharmaceutical company,Yamanouchi, of Toyko, the rights to develop, manufacture andcommercialize Amgen's consensus interferon around the world,except in the U.S. and Canada. In 1994, Biogen filed a patentinfringement lawsuit against Amgen Ltd., in Japan, charging thatAmgen's efforts to develop and market consensus interferon in Japaninfringe against one of Biogen's Japanese alpha interferon patents.The suit is still ongoing.

Intron A (interferon alfa-2b) is marketed in 68 countries worldwidefor as many as 16 indications, Consalvo said. The product has beenapproved in the U.S. for treating chronic hepatitis B and C, venerealwarts, hairy cell leukemia, AIDS-related Kaposi's sarcoma andadjuvant therapy for malignant melanoma.

Amgen's product, Infergen, is a consensus alpha interferon that wasexpected to perform better than other alpha interferon products on thebasis of efficacy or safety. In 1995 Amgen, of Thousand Oaks, Calif.,said Phase III trial results of the product were good enough to applyfor FDA approval, but not so exciting as to give the company a salesedge over two pharmaceutical firms already marketing the antiviralprotein for the same disease.

Amgen's stock (NASDAQ:AMGN) closed Wednesday unchanged at$61.625. Schering-Plough's (NYSE:SGP) stock closed at $67.484,down $1.641. n

-- Frances Bishopp

(c) 1997 American Health Consultants. All rights reserved.

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