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New NIH Rules Promote Sharing of Tools

The National Institutes of Health (NIH) last week released controversial new guidelines that set ground rules for sharing research tools. The goal is to increase access to new materials for biomedical researchers, while not preventing inventors and entrepreneurs from withholding their products from scientists.

NIH director Harold Varmus, who next month takes up his new job as president of the Memorial Sloan-Kettering Cancer Center in New York City, is a longtime advocate of improving access to research tools, particularly transgenic mice. In 1997, he commissioned a review of federal patent law and urged his advisers to find ways to take lawyers out of the picture. Last year, the group proposed ways to encourage materials sharing, and Varmus asked the NIH Office of Technology Transfer to develop new guidelines based on those proposals. Last week Varmus authorized the release of the guidelines on the NIH Web site.

NIH lays out four principles for handling such research tools:

  1. Scientists who receive federal funds must avoid signing agreements that stifle academic communication. Any materials transfer agreements that impose "excessive" editorial control or might delay publication by more than 60 days are "unacceptable."
  2. Scientists should not seek or agree to exclusive licenses on "research tools," which are defined as inventions whose "primary usefulness" is "discovery" and not a product to be approved by the Food and Drug Administration.
  3. Academic scientists should "minimize administrative impediments" on materials exchanges by refusing "unacceptable conditions." For example, NIH says, scientists should avoid using materials linked to "reach-through" legal provisions claiming broad rights to all future discoveries that might be linked to use of the materials.
  4. Be nice. Academic institutions should be as flexible in dealing with others (including companies) as they would have others be with them.

University licensing officials generally support the goals, if not every detail, of the new policy. Implementing the policy may be difficult, warns Joyce Brinton, director of Harvard University's technology licensing office. "Unless the for-profit sector is willing to lessen its demands" for control over research tools, Brinton wrote to NIH earlier this year, NIH's objectives "will not be met."