THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS An Analysis by the Director, Contents I. II. III. Introduction. . Review of Issues and Comments Received in the Patenting Interagency Committee IV. Summary Review and Analysis APPENDICES. THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS DEVELOPED UNDER DHEW SUPPORT: 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 The se acid (DNA) molecules--from virtually any living organism can be transferred to single cells from certain completely unrelated organisms. 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 2 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. 3 Appendix I lists all individuals and groups whose views were solicited in the drafting of the present analysis. A copy of the letter soliciting their comments is also attached. All correspondence from the commentators will be published in the second of a series of volumes that document the public policy issues and the proceedings relating to NIH decisions on recombinant DNA research. A review and analysis of comments received on the question of patenting recombinant DNA inventions was completed in December 1976 and referred to the Federal Interagency Committee on Recombinant DNA Research for their attention. Following the Committee review, the report was considered by the DHEW Office of the General Counsel, the Public Health Service, and the National Institutes of Health. The review, together with a brief report on related activities of the Interagency Committee, appears below. II. Review of Issues and Comments Received in the Patenting of Recom binant DNA Inventions A. Department of Health, Education, and Welfare Patent Policies First, the Department may enter into an Institutional Patent Agreement (IPA) with a university or other nonprofit organization that has instituted mechanisms for administering patents on inventions (see Appendix II). The IPA provides the institution the first option to own all inventions made in performance of Department grants or contracts, subject to a number of conditions deemed necessary to protect the public interest. Some of the more important conditions are 32-634 O 78 51 (1) a royalty-free license permitting the Government and those functioning under Government direction to use the invention, (2) a limit on the term of any exclusive license granted (3) authority to withdraw specified grants from the Institutional Patent Agreements, (4) a right of the Department to regain ownership if the institution breaches the terms of the IPA or fails to take effective steps to commercialize the invention, and (5) a right to disclose the invention to the public after a U.S. patent application has been filed. Stanford and the University of California each hold one of the 72 IPAs now being administered by the Department. For those institutions that have not entered into a patent agreement with the Department, determination of ownership is deferred until an invention has been made, at which time an institution may petition the Department for ownership of the invention. In the past, approximately 90 percent of all such petitions have been granted on the basis of a satisfactory plan proposed by the institution for development or licensing. The IPA provides a mechanism to facilitate the conversion of new knowledge from the research laboratory to marketable products, by assuring that the institution where the discovery is made can grant licenses for continued development of inventions generated with Department support. The Department Patent Branch reports that 167 patent |