an interpretation is consistent with sound public policy, with Congressional intent, and with Constitutional directives.

ARGUMENT

I. An Investigator's Ideas and Creative Work Are Valuable

A. TO THE INVESTIGATOR BECAUSE:

The advancement, remuneration, professional recognition, and personal satisfaction of a scientist depend upon the soundness of his ideas and the skill with which the scientist applies them to a research problem. The problems selected by applicants in seeking Federal research support and the results of the research (in terms of contribution to science, recognition of the effort as an original product, being the first to publish the research findings, and the like) are thus of substantial "proprietary" interest to him and are traditionally treated in this regard by the scientific community and by the Federal granting authorities, regardless of the locus of research.

B. TO SOCIETY AT LARGE FOR THEIR CONTRIBUTION TO THE RESOLUTION OF PROBLEMS OF PUBLIC SIGNIFICANCE BECAUSE:

1. They illuminate our understanding of human problems. Federal agencies support academic research

'One member of an NIH initial review group (Dr. Walter Eckhart of the Salk Institute) characterized the importance of an application to an applicant as follows: the 4 to 5 hours a primary reviewer may spend studying an application "is done not so much. because of a sense of responsibility or what the other members may think of your presentation, but because one knows that for the applicant it's a matter of life or death". Quoted in Wade, "Peer Review System: How to Hand Out Money Fairly", 179 Science (No. 4069) 158, 159 (1973).

because of public recognition of the contributions such research may make to the solution of human problems. For example, the Department of Health, Education, and Welfare is authorized to "encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and [to] promote the coordination of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control and prevention of physical and mental diseases and impairments of man. . ." 42 U.S.C. § 241. Specifically, the Department of Health, Education, and Welfare is authorized to make "grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects." 42 U.S.C. § 241 (c).

The recognized preeminence of the United States in the field of biomedical research, the scientific capabilities of modern medicine, the advances made in alleviating or ameliorating previously devastating disease problems testify to the success of this approach. The continual increase in appropriations for the programs of the National Institutes of Health, testify to the Congressional and public support of this as an appropriate public policy.

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2. They are a source of innovations resulting in useful products.

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"From 1969 through the fall of 1974 estimates of the Department show that the intellectual property rights to 329 innovations either generated, en

" NIH appropriations have increased from $34.8 million in 1950 to over $2.5 billion in 1977. Basic Data Relating to the National Institutes of Health, DHEW Publication No. (NIH) 77-1261, 1977, Table 12.

hanced, or corroborated in the performance of Department [of Health Education and Welfare]funded research were under control of university patent-management offices...

996

These innovations included drugs and therapeutic agents which promise great benefit in improving health and improving the quality of life of mankind.

II. An Investigator's Ideas, Properly Developed, Often Are Transformed Into Commercially Valuable Property.

It is clear from the preceding quotation that an investigator's ideas and research efforts often result in patentable innovations. It should also be apparent that when this work has matured from a concept to a patented innovation it is transformed into identifiable “intellectual property" and its owner acquires substantial protection under U.S. patent and property laws. Furthermore, an idea or innovation may be commercially valuable, even absent the protections of a patent, if it is managed in a manner suitable to acquiring and preserving the character of a trade secret.

Patented innovations are of little direct concern in this case because of their protection in law. Of direct and substantial concern to amicus, however, are those inchoate forms of intellectual property represented by an innovation which may be patentable, but is not yet at a stage where it can be patented, and those insights which may form the basis for a commercially valuable trade secret. The possibility of obtaining a patent is jeopardized and, in some cases foreclosed, by uncondi

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Report of the President's Biomedical Research Panel-Disclosure of Research Information, at 15. DHEW Publication No. (OS) 76-513, June 30, 1976.

tioned disclosure prior to the filing of the patent application. A trade secret loses its value upon disclosure to the public.

Patent laws of both the United States and foreign countries are drafted against the interest of those parties making or permitting publication of their innovation prior to the filing of a patent application. In the United States, publication of an unpatented invention initiates a one-year statutory period for filing a patent application on the innovation or valid patent protection is precluded. In most foreign countries valid protection is precluded if a patent application had not been filed prior to the date on which the information was first disclosed.

Within the patent laws, publication has been broadly defined as any unconditional disclosure by its owner of information on an innovation of interest. For example, even a thesis available on the shelves of a university library but not necessarily reviewed by any researcher has been deemed in the context of the patent laws, to be a publication of the innovation disclosed therein."

III. Exemption 4 of the FOIA Is of Crucial Significance in the Protection of an Investigator's Ideas.

A. PREMATURE DISCLOSURE DIMINISHES AN INVESTIGATOR'S STOCK-IN-TRADE.

Traditionally, Federal granting agencies have recognized and protected a scientist's proprietary inter

'Hamilton Laboratories v. Massengill, 111 F. 2d 584, 45 U.S.P.Q. 594 (6th Cir. 1940); Indiana General Corp. v. Lockheed Aircraft Corp., 249 F. Supp. 809, 148 U.S.P.Q. 312 (S.D. Cal. 1966); Gulliksen v. Halberg, 75 U.S.P.Q. 252 (Bd. App. 1937); Ex parte Hershberger, 96 U.S.P.Q. 54 (Bd. App. 1952).

est in his work. Applications submitted for funding and the research protocols they contained have been withheld from disclosure under the authority of Exemption 4. It was clearly recognized that making the preliminary research, research designs and protocols public at the time of application would violate the proprietary rights of applicants and greatly enhance the danger that the applicant's ideas (his stock-in-trade) will be appropriated by others. Another researcher might modify the original proposal, be awarded the grant and be the first to publish findings thereby not only causing loss of the research opportunity and grant to the initial applicant but also crediting the subsequent applicant with the idea.

These concerns of the research scientist are very real and highly important, and preoccupy them constantly. The essence of this concern was expressed by Dr. James Dewey Watson, Nobel laureate and Professor of Molecular Biology, Harvard University, when he candidly said that "we [scientists] all know too well that the types of jobs we eventually get are very much dependent upon how much we produce. There is little enthusiasm for those who always come in second." Professor Watson, in observing that "success in generating new ideas usually being more than the simple combination of native intelligence and a good measure of luck", pointed out that "(a)ll too often science resembles playing poker for very high stakes, where re

8 Watson, "The Sharing of Unpublished Information," second Frank Nelson Doubleday Lecture for 1973-74, at the National Museum of History and Technology, January 29, 1974, prepared remarks at 4.