WASHINGTON -- The brouhaha continues over the NationalInstitutes of Health's (NIH) effort to patent roughly 2,500predominantly useless fragments of genes of unknownfunction.

After the U.S. Patent and Trademark Office (PTO) rejected theinitial application on Aug. 20, Michael Astrue, general counselof the Department of Health and Human Services, ordered NIHChief Bernadine Healy not to file a new application and torefrain from releasing information on the matter. However,Healy testified about the PTO decision in a congressionalhearing on Sept. 22.

Whether NIH will reapply for the patents remains uncertain.The fact that the application was initially rejected has littlebearing since most applications are initially rejected, saidRobert P. Merges, a specialist in patent law and a professor atThe Boston University School of Law.

Also, Astrue is leaving HHS on Nov. 6 to enter private practice,and it is not clear who will become responsible for directingNIH regarding this patent application. Although Astrue said theCouncil on Competitiveness will take responsibility, the councilsaid it will not.

Some opponents to granting the patents, including theIndustrial Biotechnology Association, regard the application forthe patents favorably because they think it could help clarifypatent law.

The purpose of filing for the patents, said a member of Sen.Pete Dominici's, R-N.M., staff, was not to grab the patent rights,but "to keep NIH in the game" and force the patent office toclarify the law. Healy told Congress in September that NIHwould agree not to enforce such patents if they are grantedexcept in exceptional cases, such as to combat rare diseases.

Astrue, however, claimed Healy wants the patents for NIH sobadly that she would take the matter all the way to federalcourt.

Internationally, the U.S.'s partners in the international genomepatenting effort are staunchly opposed to the NIH's patentingproposal, said Sir Walter Bodmer, director general of theImperial Cancer Research Fund in the United Kingdom andpresident of the Human Genome Organization, an internationalbody of scientists working on mapping the human genome.

"The French are opposed, the Japanese are opposed," and, saidBodmer, his own organization is opposed. "The (British) MedicalResearch Council filed for similar patents," he said, "but saidthat they would withdraw the applications if NIH withdrew itsapplications."

The NIH's patenting effort "is at odds with the logic of thegenome sequencing project," said Merges. Allowing patenting ofgene fragments indiscriminately would decentralize this highlycoordinated effort.

Another danger of allowing patenting to go forward, saidMerges, "is that someone who wants to develop a gene wouldhave to get a license from each holder of a gene fragmentpatent. There could be 200 fragment claims on one singlegene."

Still worse, he said: "Picture scientists leaning over the benchand discussing the fine points of utility doctrine. What a wasteof time."

But Merges said the institutions should take their own course,and he doubts whether the PTO would accept the patents.

To which Astrue responded, "You shouldn't wait untilsomething becomes a problem before you do something aboutit."

In the event that PTO allows the gene fragments to bepatented, Steve Lawton of Hogan and Hartson, a Washingtonlaw firm, has floated legislation that would allow those seekingto patent genes to ignore patents on their fragments. If thepatenting goes forward, Congress may consider the legislationnext year.

Also, the congressional Office of Technology Assessment hasbegun investigating the issue and will hold a symposium onDec. 4.

-- David C. Holzman Special to BioWorld

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