Bio-Tech Genl, Genentech Patent Trial Begins
NEW YORK -- Continuing a lengthy battle to get its growth-hormone product on the market, Bio-Technology General Inc. (BTGC) argued in court Monday that competitor Genentech Inc.'s (DNA) patent on the drug isn't valid.
Bio-Technology General received Food and Drug Administration approval to market its drug, Bio-Tropin, in 1995. The small biotech firm hasn't been able to launch the drug in the U.S., however, because of a patent-infringement lawsuit brought by market leader Genentech.
The drug, which treats children with short stature, is similar to ones that have been sold by Genentech and Eli Lilly & Co. (LLY) for several years. Novo-Nordisk A/S (NVO) also markets a product under a licensing agreement with Genentech.
Genentech won a court order in December 1995 barring Bio-Technology General from selling the product in the U.S. While Bio-Technology General has been able to sell the drug overseas, sales have brought in only about $17.3 million annually; in contrast, Genentech's annual sales in the U.S. for its growth-hormone products top $214 million.
In opening statements Monday, Bio-Technology General attorney Rich Delucia told a Manhattan federal jury that Genentech "rushed" its patent in the late 1970s and failed to provide complete information about growth-hormone development.
Delucia asked the jury to find Genentech's patent invalid, noting that only a court can reverse a decision made by the patent office.
Genentech is scheduled to give opening statements Tuesday. Marie Kennedy, a Genentech spokeswoman, said the trial concerns only one of the company's many patents related to growth-hormone products. A jury deeming that the patent in question is invalid would pave the way for another competitor to enter the marketplace, but not directly harm Genentech's business, she said.
"It wouldn't impact us in any way in terms of payments of royalties or other payments," she said. "It would just give Bio-Technology General the right to launch their product in the marketplace."
The trial is expected to last about a week.
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