In response to an overwhelming number of genetic sequences thatneed to be examined for patent claims, the U.S. Patent andTrademark Office (PTO) said late Wednesday that applicants formultisequence gene patents must limit their claims to 10 independentand distinct nucleotide sequences for each application. Currently,genetic sequence patents contain as many as thousands of sequencesthat each must be examined for patentability.

"This move is simply an administrative decision to deal with thebacklog," said Richard Schwartz. "Otherwise, these patents would sitaround without being examined because we simply lack theresources."

As a user-fee funded operation that receives no taxpayer dollars, thePTO has received an estimated $350,000 from 350 genetic sequencepatent applications to evaluate 500,000 individual sequences. Thosefunds don't come close to covering the costs of paying examiners andsearching data bases to see if the sequence is novel and patentable.Schwartz noted that "we estimate it would take $9 million to dealwith these cases."

In addition to providing more funds to the PTO, the move is likely toforce applicants to focus on their most promising sequences creatinga "self-selection" that may speed the patent examination said patentattorney Charles Lipsey, of Finnegan, Henderson, Farabow, Garrett& Dunner in Washington.

The PTO held public hearings in April in San Diego and Arlington,Va., and had conversations with members of the biotechnologyindustry before coming to this decision.

"This move is very encouraging," said William Haseltine, chairmanand CEO of Human Genome Sciences Inc. (HGS) in Rockville, Md."It should allow for careful evaluations of these patents. We don't seethis as negative in any way."

Haseltine noted that, for HGS, the change could mean having 10,000sequences examined might cost his company $1 million, but thatfigure was "certainly not outside the realm of possibilities." He alsopointed out that the move will result in patents actually beingexamined rather than gathering dust because PTO has insufficientresources.

"This is a reasonable response," Haseltine said. "It allows us tomaintain protection of the partial sequence patents and pursue thosethat we think are worth an additional investment." n

-- Lisa Seachrist Washington Editor

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

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