Companion bills introduced Wednesday in the U.S. House ofRepresentatives and Senate would create clear rules forgranting biotechnology process patents.

Since 1985, when the court ruling in In re: Durden establishedthat biotechnology processes are not non-obvious, companieshave had to seek process patents by arguing uniqueness, whichinvolves differentiating a particular process from all others.

Although the Durden ruling is notorious, a series of confusingand inconsistent court cases have plagued the industry, withequally confusing procedures facing companies that seekprocess patents, according to Rep. Rick Boucher, D-Va. Heauthored the legislation introduced in the House.

Companies that patent a host cell face problems if a foreigncompany produces the end product overseas and markets it inthe U.S. Amgen Inc. (NASDAQ:AMGN) of Thousand Oaks, Calif.,entered a patent dispute with Chugai Pharmaceutical of Japanover the Japanese company's attempt to sell an anti-anemiaEPO (erythropoietin) product in the U.S., Boucher said.

The bill would allow a company to block the sale of animported product that infringes on the U.S. patent.

Boucher is on the House Judiciary Committee and was asked bybiotech companies to sponsor this legislation, which is limitedto biotechnology processes.

A similar bill unanimously passed the Senate last year, and aversion identical to the House bill was introduced Wednesdayin the Senate by Sen. Dennis DeConcini, D-Arizona and Sen.Orrin Hatch, R-Utah. DeConcini chairs the Senate Patents,Copyrights and Trademarks subcommittee.

The legislation is supported by the pharmaceutical andbiotechnology industries as well as universities.

"America's biotechnology industry is a clear leader over itscounterparts in Japan and Europe, and one of the keyingredients to maintaining this lead is an adequate andeffective system of intellectual property protection," Bouchersaid. "However, deficiencies in current patent law threaten thelong-term viability of the industry in our country. Our measureis an important step toward increasing Americancompetitiveness, promoting industrial innovation andenhancing fair trade."

Having the proper protections in place should contribute to thebalance of trade, he said.

-- Nancy Garcia Associate Editor

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

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