Summary Minutes of Meeting
March 29, 1977

National Institutes of Health
Bethesda, Maryland

The sixth meeting of the Interagency Committee took place on March 29
at the National Institutes of Health. The meeting was chaired by
Dr. Donald S. Fredrickson, Director of the NIH. The two agenda items
considered were: (a) the Commerce Department Order providing for the
accelerated processing of patent applications for inventions related
to recombinant DNA activities and (b) Committee review of the draft
legislation prepared by the Office of the General Counsel, DHEW.

REVIEW OF COMMERCE DEPARTMENT ORDER ON
ACCELERATED PROCESSING OF PATENT APPLICATIONS

The Department of Commerce Order providing for accelerated processing of patent applications for recombinant DNA inventions was suspended on March 9 (except for applications relating to safety of research in this field) so that the Interagency Committee could consider recommendations concerning research in this field by the private sector. The Committee review of the Order and the explanatory documents prepared by the Commerce Department centered on the following issues:

1. The Accelerated Processing of Patent Applications

Dr. Betsy Ancker-Johnson, the Commerce Department representative, explained that the acceleration of the patent process will result in earlier disclosure of the information included in the patent application. She

emphasized that the manner in which the review of the application would be

conducted is not affected, but that this review would commence

approximately six months sooner than the average review. She noted that precedents for such an acceleration exist for inventions in the fields of energy and environmental protection and that the Order requires research inventions receiving accelerated processing to adhere to the standards established by the NIH Guidelines.

Committee reactions to the Order were solicited and it was noted, for example, that environmental groups would prefer that the technology transfer from research to commercial application not proceed as quickly as in other areas because of the potential risks posed to public health and the environment. Dr. Ancker-Johnson replied that the Order requires research inventions receiving accelerated processing to adhere to the safety assessments and standards required by the NIH Guidelines.

Dr. Ancker-Johnson explained that the Order requires foreign inventors to adhere either to the Guidelines or to standards which are equivalent to the Guidelines. It was noted that this might provoke protests from these inventors and that most western European countries were following the United Kingdom Guidelines, which are comparable, but not identical, to the NIH Guidelines. Dr. Ancker-Johnson responded that foreign inventors could still file patent applications through the normal process if they could not or would not abide by the NIH Guidelines or their equivalent.

Dr. Ancker-Johnson further explained that the implementation of the provisions of the Order regarding the Guidelines are self-executing; that is, the accuracy of statements by the inventor will be relied on by the Commerce Department, but misrepresentations may imperil patent rights if

challenged by another party, and misrepresentations are also subject to

criminal penalties under United States law.

3. Exemptions from Adherence to the NIH Guidelines for Proprietary Information on Patent Rights

Dr. Ancker-Johnson stated that the inventor defines that which is pro

prietary or patentable, but the Patent Office would review such statements in light of the NIH standards. The initial determination for exemption would, however, lie with the inventor. Dr. Fredrickson expressed concern that, in light of NIH standards and procedures promoting maximum disclosure, these exemptions may significantly limit the applicability of the NIH

Guidelines.

Committee Advice

In stating their views on the Order, Committee members agreed that their views relate only to the health and safety aspects of the Order.

The majority of Committee members were favorably disposed to the reinstatement of the Commerce Department Order because: (1) accelerated processing involves no change in patent procedures that appears to be inimical to the public good; (2) it motivates compliance with the safety standards of the NIH Guidelines by non-governmentally funded domestic investigators during the period while national legislation is being considered; and (3) it encourages compliance with a set of recognized safety standards by foreign investigators who may not yet be subject to comparable standards in their

own countries.

Representatives from the following agencies so recommended:

VA, NRC, NSF, NASA, ERDA, FDA, CDC, DOD, Commerce, and USDA.