essentially the same in both statutes.

However, we took the opportunity

occasioned by the passage of the Sunshine Act to change the standard language used by NIH in citing exemption 4. In so doing, we shifted to the current format to clarify the grounds on which meetings could be closed. In making this language change, no substantive shift from the prior practice was intended.

In fact, NIH's operating instructions to its Committee Management Officers, as revised in light of the Sunshine Act, continue to provide that exemption 4 is not to be used in situations when it is evident in advance that information covered by the exemption will not come up for

discussion.

Mr. Chairman, that concludes my statement. I would be pleased to respond to any questions or comments you may have.

Thank you for the opportunity to testify before your Subcommittee on
June 26 concerning NIH patent policies.

I have reviewed the transcript of the hearing, and an edited version is attached. At the time of the hearing, I left two items with the Subcommittee for the record:

1. A list of inventions involving recombinant DNA techniques made with the help of HEW funds; and

2. The DNA Patent Decision Document, the supporting analysis, and all of the comments received from the public.

During the hearing, you asked for copies of the comments of the various Federal agencies on the DNA Patent Decision Document. All of the written comments received from other Federal agencies, including those of the Department of Justice, are attached. Also during the hearing, your staff assistant, Mr. Gerald Sturges, asked if the University of California (UC) has any patent related petitions pending review in DHEW. UC has one petition on file under the deferred determination policy, asking the Department to grant UC rights in an invention made with HEW financial assistance. This invention is not related to recombinant DNA but is for Azetomycins, a new drug. UC also has on file a petition to enter into

an Institutional Patent Agreement (IPA) with the Department.

After the hearing, Mr. Sturges asked my staff to provide for the record a clarification of the number of institutions having IPA's with HEW. We have double checked the list and, as stated in my testimony, 72 institutions have IPA's with HEW. A copy of the list is enclosed.

Sincerely yours,

Enclosures

CC:

Mr. William B. Cherkasky

Donald S. Fredrickson, M.D.
Director

INSTITUTIONS HAVING INSTITUTIONAL PATENT AGREEMENTS

WITH

THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
DECEMBER 7, 1977

1. 11/13/70

2/20/74

Alabama, University of

American Dental Assn.

Health Foundation

Alton Ochsner Medical Foundation

Boston University, The Trustees of
California Institute of Technology
Cancer Research, Institute for

Case Western Reserve University

Children's Hospital and Research Foundation
Colorado, Board of Regents of the University of
Colorado State University

Community Blood Council of Greater New York, Inc.

12/1/68 Cornell University

2. 4/18/75

3.

4.

12/31/69
11/5/76

5.

12/ 1/68

6.

8/16/73

11.

12.

13.

14.

12/ 1/68

15.

7/ 5/72

16.

3/26/70

George Wasghington University
Georgia, University of

Harbor General Hospital, Attending Staff Association of
Harvard University

Illinois, University of

IIT Research Institute

Indianapolis Center for Advanced Research, Inc.

Indiana University - Indiana University Foundation
Iowa, University of

Iowa State University

Jackson Laboratory

Joslin Diabetes Foundation, Inc.

Division of Kaiser Foundation Hospitals

29. 12/1/68 Kansas, University of and University of Kansas Medical Center 4/21/70 Maryland, University of

Michigan, The Regents of the University of
Michigan State University

36. 11/26/73 Michigan Technological University

12/1/68 Minnesota, University of

Mississippi, University of (Oxford Campus)
Missouri, University of

Mount Sinai Hospital, and Mount Sinai School of Medicine

of the City University of New York

New Hampshire, University of

New York, City University of

43. 1/ 2/69 New York, State University of and The Research Foundation

12/1/68 Ohio State University, and The Ohio State University
Research Foundation

Oregon Research Institute

5/28/69 Pennsylvania, University of

10/15/70 Pennsylvania St. te University,

46.

47.

11/26/73

48.

49.

50.

12/ 1/68

11/15/74

59.

12/7/71

Princeton University

Providence Medical Center

Purdue University and Purdue Research Foundation
Research Triangle Institute

Rochester, University of

Rockefeller University

11/5/76 Rush-Presbyterian-St. Luke's Medical Center
1/9/70 Rutgers University

Salk Institute

Southern California, University of

Sloan-Kettering Institute for Cancer Research
SRI International

Stanford University

12/10/68 Utah, University of

Washington State University

3/26/75 Washington University (St. Louis)

12/1/68 Wisconsin, The Regents of the University of
6/ 6/69 Wistar Institute

8/9/73 Worcester Foundation for Experimental Biology

Chairman NELSON. Our next witness is Dr. Jordan Baruch, Assistant Secretary of Commerce for Science and Technology, appearing for Dr. Frank Press, the President's science adviser.

[The information follows:]

EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY

WASHINGTON, D.C. 20500

June 22, 1978

Dear Senator Nelson:

I am writing with regard to your request that I appear before the Monopoly and Anticompetitive Activities Subcommittee to testify on the history, legal basis, and implications of Institutional Patent Agreements as an implement of government patent policy. As discussed with your staff, I believe I can be most effectively represented at this time by Dr. Jordan Baruch, the Assistant Secretary of Commerce for Science and Technology. Dr. Baruch is Chairman of the Subcommittee on Intellectual Property and Information of the Federal Coordinating Council for Science, Engineering, and Technology (FCCSET), my interagency policy committee for Federal research and development and its management.

As I am sure you realize, the development of the optional policy for the allocation of patent rights arising from Federally sponsored R&D is exceptionally difficult. The issue does not lend itself to simple solutions and the views of knowledgeable and reasonable people differ. The Administration therefore has not yet taken a position on the issue. However, Dr. Baruch's FCCSET subcommittee is looking carefully into the matter in order to develop a balanced policy for consideration by the Administration. The FCCSET subcommittee includes the principal R&D agencies as well as others who have a perspective on the issue, such as the Department of Justice. In his testimony Dr. Baruch will describe the subcommittee's views of the various issues and the questions that must be resolved before there is a restructuring of current Federal patent policy for its sponsored research and development.

I greatly appreciate your continuing interest in this matter and your willingness to have Dr. Baruch appear for me.