Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

NIH CRADA PARTICIPANTS WOULD BE ABLE TO SHIELD RESEARCH DATA as trade secrets under a policy change the National Institutes of Health is considering, NIH Associate Director for Intramural Affairs Philip Chen told the House Science/Research and Technology Subcommittee May 3. Although 1989 amendments to the Federal Technology Transfer Act (FTTA) allow federal labs to designate results of Cooperative Research and Development Agreements (CRADA) research as trade secrets, the NIH has prohibited researchers from keeping data secret. NIH has argued that its policy on CRADAs is "consistent with its mission to develop and disseminate new knowledge." Chen testified that NIH is considering a policy that would allow industry to protect trade secret information in "appropriate circumstances, such as where the commercial value of protecting certain data might greatly outweigh the benefit of providing the research community with that information." The NIH official also chairs the NIH/Alcohol, Drug Abuse and Mental Health Administration Patent Policy Board. The subcommittee hearing, chaired by Rep. Valentine (D-N.C.), was held to review the progress made by federal agencies in implementing the technology transfer act, enacted in 1986. The act directs federal laboratories to enter into CRADAs with private firms, universities and state and local governments. Examples of current CRADAs at NIH include a collaboration with the Gaithersburg, Md.-based biotech firm Genetic Therapy, Inc. to develop cancer gene therapy, and work with the Worcester, Mass. firm Transgenic Sciences to develop a transgenic rabbit for use in AIDS studies. NIH has had 130 CRADAs. Chen also outlined current NIH efforts to implement the FTTA. After reorganizing the NIH Office of Technology Transfer, NIH is holding monthly "Technology Management Team Meetings" in which scientists and administrators discuss licensing for individual intramural inventions and attempt to "package" related inventions in commercially useful groups. The office is also developing an electronic bulletin board to provide information on Public Health Service technology transfer rules and full-text files of patent applications. The bulletin board is expected to be in operation by this summer, Chen said.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts