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March 2, 1978

Dr. Robert M. Rosenzweig
Vice President for Public Affairs
Stanford University
Stanford, California 94.305

Dear Dr. Rosenzweig:

Shortly after the release of the NIH Guidelines on Recombinant DNA Research in June 1976, you sent me a letter requesting that the National Institutes of Health review DHEW policies relating to the patenting of recombinant DNA research inventions. As you know, your letter prompted NIH to review current DHEW patent regulations governing existing institutional patent agreements and to consider how recombinant DNA research inventions should be handled under the terms of those agreements. Over the summer and fall of 1976, NIH solicited comments from a broad range of individuals and institutions on this matter.

An analysis of the comments received on the question of patenting recombinant DNA inventions was completed in December 1976, and was referred for review to the Federal Interagency Committee on Recombinant DNA Research. As you know, this Committee was convened by the Secretary of HEW, with the approval of the President, to address the extension of NIH Guidelines beyond NIH to the public and private Sector S.

In an interim report to the Secretary in March 1977, the Committee recommended that legislation be developed to govern the conduct of recombinant DNA activities nationally. On the basis of those recommendations, an Administration bill was drafted and was introduced in Congress by Senator Edward M. Kennedy and Representative Paul G. Rogers. Congressional hearings were held, but no bills were enacted in the past session. It appears, however, that new bills will be considered shortly by the relevant congressional committees.

The Committee reviewed NIH patent policies with respect to recombinant DNA research in May, and the Public Health Service and the Office of the General Counsel completed a review of the report in December. The report, enclosed, provides an analysis of all comments received on this matter and of the Interagency Committee review of patent policy. On the basis of the findings contained in the report and my discussions with Dr. Julius Richmond, the Assistant Secretary for Health, and Peter Libassi, General Counsel for the Department, it is my recommendation that at least for the present, recombinant DNA research inventions developed under DHEW-NIH support should continue to be administered within current DHEW patent


agreements with the universities. Each agreement, however, will be amended to permit the institution to grant a license under patents secured on any such invention only if the licensee provides assurance of compliance with the physical and biological containment standards set forth in the Guidelines in any production or use of recombinant DNA molecules under the license. In my view, the requirements set for NIH grantees and contractors will thus be honored by licensees as well.

Accordingly, Stanford may proceed to file recombinant DNA research patent applications. You should know that Federal patent policies are under extensive review by the Executive Branch and the Congress, and that this may lead to actions affecting the administration of institutional patent agreements generally and other conditions for recombinant DNA research inventions specifically. For the present, however, recombinant DNA research inventions should not be handled differently under current institutional patent agreements, except for the requirement that licencees agree to comply with containment standards set forth in the NIH Guidelines.

I regret the long period of time required to review patent policies involving recombinant DNA research, but the complexity of the issues necessitated an extended analysis. Your letter stimulated a thorough and much needed policy review. I appreciate your interest and patience.

Sincerely yours,

Donald S. Fredrickson, M.D.


An Analysis by the Director,
National Institutes of Health,
November 1977

I. Introduction

The need for the Department of Health, Education, and Welfare (DHEW) to establish a policy on the patenting of DHEW-supported inventions involving the use of recombinant DNA molecules has occasioned efforts to achieve a consensus of views from the public and private sectors. An account of these efforts, with relevant background and analysis, is presented here.

On June 23, 1976, the National Institutes of Health (NIH) released guidelines to govern the conduct of NIH-supported research on recombinant DNA molecules. In this research, "genes"--that is, deoxyribonucleic acid (DNA) molecules--from virtually any living organism can be transferred to single cells from certain completely unrelated organisms. These experiments depend on the ability to join genetic material of different sources and then to propagate the resulting hybrid elements in single bacterial and animal cells. The NIH Guidelines establish carefully controlled conditions for the conduct of experiments involving the insertion of such recombinant genes into organisms such as bacteria.

The guidelines were developed by a scientific advisory committee created by NIH in response to requests by many scientists engaged in this field of research. These scientists had previously called for

a moratorium on certain kinds of experiments while appropriate guidelines

were devised. In December 1975 the NIH Recombinant DNA Advisory Committee

proposed guidelines to the Director of NIH which were reviewed at a public hearing in February 1976. As released on June 23, 1976, these guidelines had been revised in light of a number of suggestions presented by the public commentators. Accompanying the release was a Director's Decision document addressing the issues raised at the public hearing and in subsequent correspondence.

The NIH Guidelines were published in the Federal Register on July 7, 1976, for further public comment. In response to suggestions of public commentators, NIH also undertook an environmental impact assessment of recombinant DNA research and filed a Draft Environmental Impact Statement in the Federal Register on September 9, also for public comment.

In June, shortly before the release of the Guidelines, Dr. Robert M. Rosenzweig, Vice President for Public Affairs at Stanford University, sent me a letter asking NIH to review DHEW policies relating to the patenting of recombinant DNA research inventions. Dr. Rosenzweig noted that both Stanford and the University of California were applying for patent protection for recombinant DNA research inventions developed by their investigators under NIH support. However, in view of the intense public interest in this research generally, the two universities felt the need for a formal advisory opinion by NIH on the patenting of recombinant DNA inventions developed under NIH grants or contracts. A number of other universities indicated similar interest in obtaining the official views of NIH.

Prior to making an official pronouncement of DHEW-NIH policy with

respect to patenting of recombinant DNA research inventions, NIH decided

to solicit comments from a broad range of individuals and institutions.

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