WASHINGTON -- The National Institutes of Health will notappeal the U.S. Patent and Trademark Office's (PTO) rejection ofthe agency's application to patent 2,421 gene sequencefragments. The agency also will withdraw another patentapplication claiming 4,448 sequences, as well as correspondingforeign applications.
The decision to drop the claims was made by NIH DirectorHarold Varmus just before the Feb. 10 deadline to appealrejection expired. "I do not believe that patenting at this stagepromotes technology development, and it may impede moreimportant research collaborations here and internationally,"said Varmus.
"I think it's a wise decision," said James Watson, director ofCold Spring Harbor Laboratories, who shared the Nobel prizefor DNA structure. "I didn't know of a single scientist whoapproved of the (patents). I think it was a potentially greatthreat to the biotechnology world," he told BioWorld.
Watson left NIH because of conflict over this matter withformer NIH Director Bernadine Healy.
"I'm very pleased to hear it," Brian Richards, chairman ofBritish Biotechnology Group plc, told BioWorld upon beinginformed of the news. "(Varmus) is a very sensible chap."
The patents could have caused great confusion, Watson said. "Ifyou were even able to patent a full-length gene, you (could) beblocked by someone who didn't know what they had done."
Patents of unknown fragments could have flooded the patentoffice, Richards told BioWorld. "If it had been considered ...important to patent incomplete sequences, there would be atremendous rush on making claims from a whole variety oftissues from a whole variety of organisms, which would createa great morass of uninterpretable information in the patentoffice," he said.
"I have notified science leaders in other countries about theNIH decision and have initiated discussions that I hope willlead to international consensus on this issue," said Varmus.
Richards indicated that the United Kingdom would be happy tofollow NIH's lead. "There was a defensive set of applicationsmade by our Medical Research Council," he told BioWorld."They were made purely because of the Craig Venterapplications. Right now the MRC, and the U.K. generally, hasbeen taking stock of its position and was moving toward thatwhich most pharmaceutical companies would considerappropriate, and that is that filing patents on gene sequencesshould only be made where there are clear indications ofusefulness of those sequences."
In a memo released Sept. 28, 1992, the Senior Advisory GroupBiotechnology (SAGB), the European biotechnology tradeassociation, stated that applications to patent gene sequencesshould be judged "... on the normal basis of industrialapplicability, novelty and inventive step."
According to SAGB, "because the subject matter is genome-based does not imply that a different set of criteria (from otherscientific and technical research) should be used. There is clearneed for international harmonization on these views as amatter of urgency, particularly between the United States,Japan and the EC."
"There are also additional questions as to whether a nationalinstitution such as the NIH or MRC should apply for patents forresults which have been obtained from publicly fundedresearch," said SAGB.
The NIH patent applications were filed to protect the sequenceswhile the PTO determined whether such sequences would bepatentable. Concurrently, NIH published the sequences andmade the DNA clones available to the research community.
NIH first filed on June 20, 1991. On Aug. 10, 1993, the PTOissued a final examiner's action rejecting the claims.
The patent applications were initiated by former NIH patentlawyer Reid Adler of the Office of Technology Transfer, and"Bernadine learned about it and decided to support him,"Watson told BioWorld. "Id like to forget about it."
The decision will have no impact on patent law, Don Silvert, apartner at Leydig, Voit, & Mayer told BioWorld.02149GENE FRAGMENTS
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.