Monday, Oct 28, 1991

Genentech Wins First Major Japanese Biotechnology Patent Case

South San Francisco, Calif. -- October 28, 1991 --

In Japan's first major biotechnology patent case, the Osaka District Court has ruled in a preliminary injunction in favor of Genentech, Inc. (NYSE: GNE) in a suit brought against Toyobo Co., Ltd. in 1987. The court ruled that the sale of the heart attack drug t-PA by Toyobo infringed Genentech's Japanese t-PA patent.

Following a preliminary injunction issued last Tuesday, court bailiffs today (10/28) seized the t-PA at Toyobo's plant in Katata, Japan. It is believed to be the first seizure by Japanese authorities to protect a biotechnology patent. A decision in the main action is expected from the court on Wednesday (10/30). The written preliminary injunction affirms Genentech's patent claims brought in the suit.

"We are pleased with the Osaka court's forceful action in protecting our intellectual property rights in this case," said G. Kirk Raab, president and chief executive officer. "If this type of fair treatment is displayed in similar cases and throughout the appeals process, then Japan will indeed be signaling the worldwide biotechnology industry that meaningful protection, backed by strong remedies, is honored in Japan."

Following the court's action, Genentech's product is currently the only recombinant t-PA sold in Japan. Genentech has two licensees in Japan, Mitsubishi Kasei Corp, which markets the product under the trade name GRTPATM, and Kyowa Hakko Co. Ltd., which uses the trade name ActivacinTM. Additionally, Mitsubishi has a co-marketing partner for GRTPA, Tanabe Seiyaku of Osaka.

The products ordered removed from the market were sold by Toyobo and its marketing partner, Daiichi Pharmaceuticals, under license from Genzyme Corp. Genentech's and Toyobo's products were approved earlier this year in Japan and launched on May 24, when they were listed on the National Health Insurance (NHI) price list, the last step in Japan before a product is marketed. The NHI set the price for t-PA at approximately $2,250 U.S. (Y315,000) for a 40 mg. dose.

Under Japanese law, appeals of district court patent rulings are possible and would usually take at least two years, during which time the infringing products could not be sold. However, the prevailing parties must post a bond to cover damages for lost sales if the patent ruling is eventually reversed.

A third t-PA product, not approved for marketing in Japan, is the subject of a patent suit still pending in Japan. In 1989, Genentech brought suit in Osaka District Court against Sumitomo Pharmaceutical Co., Ltd., a licensee of the Wellcome Foundation.

Genentech, which has marketed t-PA under the brand name Activase? in the United States since its approval in 1987, manufactures bulk t-PA product at its South San Francisco, Calif. plant and ships it to Japan where its licensees perform final manufacturing and packaging.

Genentech, Inc. is a biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant medical needs.

# # #