The relationship between the National Institutes of Health, theworld's largest biomedical research organization, and the U.S.biotechnology industry is changing as the NIH adopts a morebusinesslike attitude.

Since assuming her post in April, NIH Director Bernadine Healyhas attempted to move the organization's 14,000 employeesaway from the "ivory tower" and toward a more assertivemarketing model for transferring its technology.

Healy's increased emphasis on protecting the government'sintellectual property rights and marketing its inventions toindustry will probably speed the commercialization of itsdiscoveries, according to NIH officials. They reason that patentprotection will be more attractive for the licensees and helpstimulate demand to commercialize NIH technology.

At the same time, the new climate has raised conflicts with thebiotechnology industry that remain to be resolved in 1992.Several NIH initiatives during the year will directly affect theindustry, including a final decision on the appropriateness ofgovernment patenting of cDNA genetic codes and promulgationof new conflict-of-interest rules governing the relationshipsbetween NIH employees and grant recipients with privateindustry.

Healy has initiated a fresh version of the conflict-of-interestguidelines after earlier proposed guidelines were assailed fromall sides.

An initial version, unveiled late in 1989, succumbed to protestsfrom researchers and biotech companies, who objected toproposals for strict rules preventing federally fundedresearchers or their families from holding stock in companieswith which they collaborate. Louis Sullivan, Health and HumanServices secretary, ordered a rewrite to provide looserguidelines for researchers working in preclinical stages ofproduct development.

Subsequent proposals were attacked in Congress for being tooweak to prevent federally funded scientists from being swayedby consulting fees and stock offers.

George Galasso, associate director for extramural affairs at NIH,who is writing the current draft of the proposed rules, toldBioWorld he expected the guidelines to be released during1992.

The NIH's decision to apply for patent protection for more than300 partially sequenced cDNA fragments, announced inOctober, stimulated controversy in scientific and industrycircles. Critics contend that the NIH acted prematurely bypatenting sequences that it had not explored to determinepotential action or utility.

Reid Adler, head of NIH's Office of Technology Transfer, toldBioWorld that NIH filed the application to stimulate a broaddiscussion of the merits of patenting early research from theHuman Genome Project.

Adler noted that publishing information about the cDNAsequences before filing a patent application would have putthem in the public domain, precluding patent protection. "Notfiling would have been a policy by default," he said.

The application preserved NIH's option to pursue patents, saidAdler, although it has not yet made its decision.

Adler said NIH is engaged in discussions with industryassociations, major companies and government scientists on thebest ways to transfer genome-related discoveries to industry.He said the government might institute "some kind of licensingsystem that would be an incentive to product development."

NIH's increased emphasis on technology transfer is reflected ina substantial increase in 1992 staffing of the Office ofTechnology Transfer, according to Adler. The office will doublethe size of its patent group to 12 full-time staff and augmentthe licensing group by adding five or six staffers to the currentfour.

The NIH will conduct more sophisticated analyses of its newinventions in 1992 to target marketing to companies that mighthave an interest in evaluating or developing particulartechnologies, Adler said.

He said the Office of Technology Transfer also plans to upgradeits information services to make information about newtechnologies more accessible. It will improve its electronicbulletin board to make it easier to use and will publish the fulltext of NIH patent applications for clients who have signednon-disclosure agreements.

NIH inventions are grouped in 18 portfolios, includinginfectious disease, AIDS-related inventions, cancertherapeutics, and research tools (including expression vectors).Adler speculated that areas of NIH research that may exciteparticular interest in the biotechnology industry in 1992include immunotoxin research; antibodies linked to growthfactors or to toxins that might target anti-cancer agents totumors; DNA technologies, including antisense and triple helix;research on transgenics as disease models and sources ofprotein products; and research on central nervous systemactive compounds.

During 1992, the NIH also will be reviewing its modelCooperative Research and Development Agreement (CRADA),the vehicle for most collaborations between NIH and privateindustry, Adler said. A separate model CRADA for clinicalresearch might be adopted, he said.

-- Steve Usdin BioWorld Washington Bureau

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