WASHINGTON -- The National Institutes of Health's applicationfor a patent on partially sequenced DNA fragments reflects theincreasingly aggressive posture the NIH is taking towardgovernment-derived intellectual property and transferringtechnology to private industry.

NIH has filed a patent application for about 340 partialcomplementary DNA (cDNA) sequences obtained by Dr. CraigVenter of the Institute for Neurological Diseases and Stroke,and intends to file on an additional 1,500 sequences. Thefiling, coming before NIH investigators have identified theactivity or utility of the sequences, has aroused controversy inacademic, industrial and legal circles.

Articles last week in both Nature and Science presented viewsof several distinguished scientists who warned that researchinto genetic function would be stifled by a patent.

Some executives and scientists also predicted that an NIHpatent would trigger an expensive and inefficient rush topatent preliminary research, clogging the already burdenedPatent and Trademark Office.

The NIH touched off another patent dispute in May when itclaimed that its scientists should have been named as co-inventors of Burroughs Wellcome Co.'s AIDS drug, AZT. At thetime, Reid Adler, head of NIH's Office of Technology Transfer,said that the case was the first, but probably not the last,time the NIH would have a dispute with industry overintellectual property rights.

At that time, Adler said the AZT case reflected "NIH'sobligations to assess its intellectual property rights thatarise in the course of its ongoing research programs."

Michael Odza, publisher of the Technology Access newsletter,said the cDNA move is based on NIH's increasing efforts toleverage its technology. "This is part of a larger trend. NIH hasstaffed up, brought in people from industry with experience incommercial development."

Lita Nelsen, associate director of the Office of TechnologyLicensing at the Massachusetts Institute of Technology, said,"NIH is trying to be more effective in using intellectualproperty to induce development in the same way that theuniversities, at least in theory, ought to be doing theirlicensing."

NIH filed the application to stimulate discussion of the meritsof such a policy, according to Adler. "There has not been a finalpolicy determination to seek protection on these kinds ofinventions, but rather to preserve the option to do so," he said.Publishing the cDNA sequences before filing a patentapplication would have put them in the public domain, Adlersaid.

"Publishing the partial cDNA sequences without filing a patentapplication might have rendered unpatentable the full codingsequence that you can find with the partial sequence, as wellas recombinant expression vectors that contain that codingsequence," he said. "Now we have an opportunity to elicit somefeedback from the research community and industry."

The NIH soon will publish a formal request for comments in theFederal Register and has scheduled a Nov. 14 session on theissue at a technology transfer forum at its Bethesdaheadquarters.

Adler said the NIH wants to ensure maximum transfer of itstechnology to the public, and that patenting the cDNAsequences might be the best way to do it.

Several industry executives and patent attorneys disputed thetheory, saying such wide patents would discourage commercialdevelopment of the sequenced genes.

"The blanket patenting of sequences just because they arethere is taking things too far," said Alan Smith, senior vicepresident for research at Genzyme Corp. "It is a disincentive toinvention."

If the patent is issued, said Bruce Eisen, chief patent counselat Genetics Institute Inc., "I would be against it because therewould be comparatively little incentive for companies to comeforward and develop" the genes.

Nevertheless, said Eisen, "I think a public service has beendone by raising the issue now. It is something of a tempest in ateapot because I don't think it will get through the PatentOffice. "


The National Institutes of Health's action to patent cDNAsequences "is a smart move on their part, but it is self-limiting," according to Iver Cooper, a Washington-basedattorney with Browdy & Neimark who specializes inbiotechnology.

Cooper told BioWorld that issue of an NIH patent faces threehurdles.

Utility: Under patent law, it isn't sufficient to say an inventionis useful in research, said Cooper. It must have a morecommercial use.

The NIH could discover uses for some of the genes during thepatent examination process, which typically takes more thantwo years. "They may be hoping that a generalized statement ofutility in the application, coupled with later proof of utility,might be sufficient to satisfy the Patent Office that theapplication satisfies the utility requirements," Cooper said. Hepredicted such a strategy would have limited chance ofsuccess.

Obviousness: Scientists who oppose the patent argue that it isvery easy to isolate the cDNA copies of the genes. "If that istrue, it is natural for the Patent Office to ask, 'Does it reallyrequire more than ordinary skill in the art to isolate thesegenes?' If it is really a routine effort, then it is, 'Sorry,Charley. Come back when you have a use for the gene,' " Coopersaid.

Procedure: It is possible that the Patent Office will require aseparate application for each of the more than 300 sequences,Cooper said.

Even if the NIH gets the patent, it might be a "one-time coup,"according to Cooper. The isolation of partial sequences of cDNAwould become "prior art," and no longer patentable.

Reid Adler, head of the NIH's Office of Technology Transfer,countered that the sequences were derived using new, "non-obvious" technologies, and that although there isn't a greatdeal of information about the genes, there are some knownuses, such as probes to distinguish between human and non-human tissue.

He also said that "half of the sequences have some sort ofhomology to genes that have been identified in other (non-human) organisms. It is not too early for companies to considerdeveloping therapeutic products based on some of thesequences, and the patent might be a powerful incentive." --Steve Usdin

-- Steve Usdin BioWorld Washington Bureau

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