By Lisa Seachrist

Washington Editor

WASHINGTON — Biomedical research, from the outset, has been a collaborative enterprise. However, in the age of biotechnology and the billion-dollar molecule, collaborations increasingly come with strings attached.

Plasmids, cell lines, laboratory animals, and databases are not only tools for conducting research; they represent the valuable intellectual property of the parties producing them, whether from academia or industry. The transfer of that property is accomplished through procedures that go far beyond a simple purchase — or, as it was in days gone by, a handshake.

Protecting intellectual property can translate into promises of royalties down the line, restrictions on publications in the near term, and grantings of first-refusal rights when research enters the clinical development arena.

As the landscape for biomedical research has become more difficult to navigate, the perception has grown that academic researchers are finding the terms associated with conducting research have become more and more onerous and, at times, prohibitive.

In response to that perception, Harold Varmus, director of the National Institutes of Health (NIH) has convened a Working Group on Intellectual Property Restrictions on Access to and Use of Research Tools in Biomedical Research to assess the nature and the extent of the problem.

"Everybody is more attuned to the fact that what they produce may have value down the line," said Rebecca Eisenberg, professor of law at the University of Michigan Law School, in Ann Arbor, and chairwoman of the NIH working group. "As a result, everybody is more alert about the need to protect intellectual property." This charged atmosphere leads to "conflicts between the several different competing interests at stake."

Eisenberg said the working group has received input from approximately 20 universities so far. From the university perspective, Eisenberg notes, the greatest problems are confidentiality, publication restrictions and conflicting obligations.

Obtaining the necessary research tools can be a difficult problem for university scientists, because the institutions where they are working aren't "rolling in dough," Eisenberg said. As a result, tools are often offered for free with a royalty agreement attached.

"It doesn't take too many half [percent] and one percent royalties to have promised away a lot of your rights to intellectual property," she said.

Committed Royalties Could Inhibit Licensing

With too much profit going into royalties to other entities, a university may find that it can't interest a pharmaceutical firm in licensing the property for clinical development.

In addition, when several different providers of research tools request exclusive licensing rights to any developments of the research, a researcher cannot conduct such research. He can't logically fulfill the agreements because two different entities can't be granted those rights, said working group member Steve Holtzman, CFO of Millennium Pharmaceuticals Inc., of Cambridge, Mass.

"There are three levels of rights grants that a provider may ask for from a researcher," Holtzman said. "There are the rights to any modifications or improvements to the tool, the rights to new uses for a tool — for example, a cytokine may be useful for rheumatoid arthritis as well as another inflammatory condition — and finally the rights to any new invention discovered using the tool. The question is, 'Is the last level overreaching?'"

While the working group has a good sense of the issues from the university perspective, the group has heard relatively little from the biotech and pharmaceutical industries.

Holtzman said a number of biotech companies are not in the business of selling their research tools, so a royalty agreement is a logical way of profiting from them.

"What is emerging is that it is a problem that doesn't affect solely academic researchers," Holtzman said. "Transferring research tools between universities and between companies is also difficult. I would like to encourage the members of industry to provide feedback to the working group. It's not just a university problem, and it would be inappropriate for the situation to be represented as industry is the bad guy."

BIO To Distribute Survey

The working group has already begun reaching out to industry by developing a questionnaire that will be distributed by the Biotechnology Industry Organization.

"We are trying to find out how important these rights are to the company and how much they gain from them," Eisenberg said. "And we want to know what kinds of problems they encounter when they license research from universities."

In addition to the questionnaire, the working group has a web page where scientists can post messages to a message board or privately e-mail suggestions and concerns to the working group. The web address for the working group is http://www.nih.gov/welcome/forum.

"This is not an easy situation to resolve," Eisenberg said. "We need to be sure that we are hearing more than one side of the story." *

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