12:00 AM
Jun 21, 1993
 |  BioCentury  |  Regulation

NIH analysis of Scripps-Sandoz

Following is a nearly complete text of a June 11, 1993, letter from NIH Legal Advisor Robert Lanman to Douglas Bingham, general counsel of The Scripps Research Institute. Text from the institute's short reply is included. In some cases, very long paragraphs in the original have been divided for readability.

Dear Mr. Bingham:

At our April 13 meeting, we agreed to provide you with specific written comments on the Scripps/Sandoz research agreement. As we explained at that time, NIH is concerned that the agreement unduly restricts scientific research supported by the Government, appears to be contrary to the letter and spirit of the Bayh-Dole Act (35 U.S.C. §§ 200-211) and may impinge unreasonably upon scientific freedom because of its coverage of potentially all Government-funded inventions made by Scripps' employees, and because of the degree of control that Sandoz is given over the research and patenting activities of the Scripps Research Institute. The potential twenty-year duration of the agreement exacerbates those concerns.

As stated in 35 U.S.C. § 200, the objectives of the Bayh-Dole Act are to (a) promote use of inventions arising from federally funded research; (b) encourage maximum participation of small business firms in federally supported research; (c) promote collaboration between commercial concerns and nonprofit organizations; (d) ensure that inventions made by nonprofit organizations and small business firms are used to promote free competition and enterprise; (e) promote the commercialization and public availability of inventions made in the United States by United States industry and labor; (f) ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against any nonuse or unreasonable use of inventions; and (g) minimize the costs of administering patent policies.

Guidance on these objectives and other aspects of the Bayh-Dole Act is provided in the Department of Commerce regulations at 37 CFR Part 401. Provisions of the Scripps/Sandoz agreement that appear to be inconsistent with these statutory and regulatory provisions are discussed below.

1. Broad Scope of Research Covered by the Agreement

Under the agreement, Sandoz will provide Scripps "General Funding" which can be used at the discretion of Scripps to support the direct and indirect cost of "General Funding Research." This would include all research, regardless of the funding source, undertaken by Scripps during Phase II, except "Excluded Research," i.e., specifically identified ongoing research projects with third parties, and "Specific...

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