Genentech Inc. has won market exclusivity in Japan for itstissue plasminogen activator, the company announced onMonday.

In a preliminary injunction issued last week, an Osaka DistrictCourt ruled that sales of t-PA by Toyobo Co. Ltd. infringedGenentech's Japanese patent for the heart attack drug. A finalruling is expected on Wednesday.

The action makes Genentech's product the only t-PA sold inJapan. Genentech's licensees are Mitsubishi Kasei Corp. andKyowa Hakko Co. Ltd. Mitsubishi has a co-marketing partner,Tanabe Seiyaku.

Genentech shares (NYSE:GNE) rose $2 to $33.88 on Monday.

Genentech received the patent in 1988. "It's not hard to getpatents in Japan," said Genentech spokesman Jack Murphy. "Thehard thing is to enforce them. Intellectual property protectionis not very solid at all."

Murphy said Genentech expects Toyobo to appeal. Appealsusually take about two years, during which time the infringingproducts can't be sold. Genentech must post a bond of $770,000(100 million yen) to cover damages for lost sales if the rulingis eventually reversed.

Japan's National Health Insurance has set a price of about$2,250 (315,000 yen) for a 40 mg. dose. Genentech estimatesthat 140,000 Japanese patients are eligible for treatmentannually. The company will earn about $20 million from bulksales of t-PA this year.

The products ordered removed from the market were sold byToyobo and its marketing partner, Daiichi Pharmaceuticals,under license from Genzyme Corp.

Toyobo had licensed rights to a pending patent from IntegratedGenetics in 1985. Genzyme Corp. acquired those rights when itpurchased Integrated Genetics in 1987. That patent has notissued.

A Genzyme spokeswoman told BioWorld that the company hasnever factored potential royalties from Japanese sales into itsforecasts because of the uncertain patent situation.

In 1989, Genentech sued Sumitomo Pharmaceutical Co. Ltd.,which has licensed t-PA from the Wellcome Foundation. Thatproduct hasn't received marketing approval. -- Karen Bernstein

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