IV. All agencies voiced support for DHEW's policies governing believe that recombinant DNA research inventions should be handled Summary Review and Analysis From all the comments received, there was general support for Institutional Patent Agreements between the DHEW and grantee institutions. The agreements allow, through appropriate conditions, the disposition of inventions as a result of Department-supported research. Under the terms, there is a careful delineation of the rights and duties of grantees and of the Department. Detailed conditions are set forth for institutions to grant exclusive and nonexclusive licenses, and a set of conditions for the distribution of royalties is included. the agreement upon 30 days notice. Either party may terminate Under the terms of the agreement, institutions must grant the Government a royalty-free nonexclusive license, under which any grantee or contractor of the Government operates. Under patent law, the use of patents for research purposes is not an infringement, and anyone may use the invention in research without paying royalties. In sum, DHEW Institutional Patent Agreements are perceived to strike a fair and equitable balance between public rights and private interests. A number of commentators disagreed with the action of Stanford and the University of California in seeking to patent such inventions. Specifically, several commentators believed that those universities were ill-advised to seek patents when contributions to research advancement in this area were shared by a number of institutions and investigators. These are important considerations in the determination of patent rights. However, the appropriate forums for adjudicating rights to patent inventions are the U.S. Patent and Trademark Office and the courts. The Patent Office reviews all patent applications to determine whether the claims for the new inventions are attributable solely to the claimant. The NIH recognizes its responsibility to provide the Patent Office with all relevant research information on recombinant DNA, in order that review of claims can proceed with full knowledge of prior research results in this area. The commentators did not believe patents to be an impediment to the free flow of information. There may be special problems posed by the Freedom of Information Act which will influence the administration of patents in the future. For the present, however, it would appear that the Act and the patent agreement do not necessarily conflict. The commentators supported the IPAs and urged that recombinant DNA research inventions not be excluded from them. All com When the Guidelines were released in June, a key public issue was their extension to the rest of the public and private sectors. mentators whose views were solicited in 1976 agreed that there must be standards to govern the conduct of recombinant DNA research and that the NIH Guidelines could provide the standards for such research nationally. They were divided, however, on whether to achieve that goal through the use of patent agreements. Several commentators recommended Federal action to ensure uniform standards with appropriate monitoring. They noted that the implementation of the NIH Guidelines through licenses granted under patents is awkward at best and would be only a temporary solution. The Interagency Committee members voiced strong support for Department policies governing Institutional Patent Agreements, and all except representatives of the Department of Justice believe that recombinant DNA research inventions should be considered within the existing terms of the Institutional Patent Agreement. It should be noted that the Justice Department opinions rested heavily on a draft bill orginally proposed by Senator Kennedy for the regulation of recombinant DNA research activities. Specifically, Justice referred to the patent sections of this draft bill that were based on the concept of Government ownership of recombinant DNA research inventions. In subsequent versions of Senator Kennedy's bill, however, all sections related to patents were eliminated. The perceived need for extension of the Guidelines generated support among the commentators in the summer and fall of 1976 for the use of patents as a means of obtaining compliance. Legislation to ensure uniform standards and regulations nationally for all recombinant DNA activities in both the public and private sectors was considered in the First Session, 95th Congress. In the current session, legislation once again is being considered. Use of the Institutional Patent Agreement as a means of obtaining compliance with the NIH guidelines is not an adequate substitute for legislation. However, in the absence of legislation, a condition in the IPAs to require assurances of compliance with the safety standards in the NIH guidelines is warranted. This leaves the residual question whether the subject of the patentable processes (recombinant DNA techniques) is of such a peculiar nature that financial return to the inventors should be denied. This argument, too, had few advocates among the commentators. There are no compelling economic, social, or moral reasons to distinguish these inventions from others involving biological substances or processes that have been patented, even when partially or wholly developed with public funds. Such inventions include vaccines for rubella and rabies, treatments for herpes infections of the eye, treatments for uremia, and prostaglandins--compounds that may have a number of possible medical uses. The argument that commercial development based on patent protection has or will assure maximum benefits of these inventions to the public applies as well to the putative benefits of recombinant DNA inventions. It is recognized that Federal patent policies are under extensive review by the Executive Branch and the Congress. This may lead to actions that could affect the administration of Institutional Patent Agreements generally and the conditions for recombinant DNA research inventions specifically. It is recommended, however, that recombinant DNA research inventions developed under DHEW-NIH support should, at least for the present, continue to be administered within current DHEW patent agreements with the universities. But each agreement should be amended to ensure that the licensees will comply with the physical and biological containment standards set forth in the Guidelines in any production or use of recombinant DNA molecules under the license. If legislation is passed, these safety standards will be mandated by the law for all who conduct or support recombinant DNA research. |