The International Trade Commission (ITC) decided not to reviewGenentech Inc.'s human growth hormone patent claims against Bio-Technology General Corp. and Novo Nordisk A/S, clearing the wayfor the two companies to sell their products in the U.S. after they getFDA approval.
The ITC's action this week let stand an administrative law judge'sruling in November that dismissed South San Francisco-basedGenentech's patent infringement case against Bio-TechnologyGeneral, of Iselin, N.J., and Denmark-based Novo Nordisk. Thejudge said Genentech patents were infringed, but threw out thecomplaint because Genentech delayed in providing certaindocuments.
Genentech said it may challenge the ITC decision in U.S. AppealsCourt. The company last December filed a patent infringement suitin federal district court in Delaware against Bio-Technology Generaland Novo Nordisk.
And both Bio-Technology General and Novo Nordisk have filedsuits in federal district court in New York seeking declarations thattheir products do not infringe Genentech's patents related torecombinant human growth hormone.
The court battles could take years to be resolved, but in themeantime if Bio-Technology General and Novo Nordisk get FDAapproval of their growth hormone products, the ITC decision allowsthem to sell the drugs in the U.S.
Both companies market their growth hormones outside the U.S. andhave filed for FDA approvals. Bio-Technology General's product issold under the name BioTropin and Novo Nordisk's growth hormoneis called Norditropin.
Genentech's Protoprin was the first recombinant human growthhormone on the market in 1985. Eli Lilly & Co., of Indianapolis, isthe only other company with FDA approval of a human growthhormone product. Lilly's Humatrope was approved in 1987.
Genentech and Lilly settled their disputes over growth hormone andother product patents earlier this year when Lilly agreed to payGenentech $145 million. Some of the growth hormone patents in thatdispute are involved in Genentech's battles with Bio-TechnologyGeneral and Novo Nordisk.
The U.S. market for growth hormone is between $300 million and$400 million annually.
Bio-Technology General's spokeswoman, Leah Berkovitz, said if thecompany gets FDA approval this year and manages to grab even aminimal share of the U.S. market, the revenues would be enough topush Bio-Technology General into its first year of profitability.
Genentech's stock (NYSE:GNE) closed Wednesday at $45.37, up 12cents. Bio-Technology General (NASDAQ: BTGC) was $2.25, down9 cents. n
-- Charles Craig
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