76 
The two-day meeting that began at the Institutes here today is considering a 
set of proposed revisions in the guidelines first published in the summer of 1976 
to govern Federal grantees involved in gene-splicing studies. 
Opening today’s session, Dr. Donald S. Frederiekson. director of the agency, 
described the issue of guideline revision as “a matter of considerable national and 
even international interest.” 
RELAXING "thE RTJLES 
In some respects the proposed revisions, first made public this fall relaxed the 
rules, removing some experiments from coverage by the guidelines and changing 
safety requirements for others. The revisions have been made by a special com- 
mittee established by the Institutes on the basis .of data that have accumulated 
in recent years concerning the research. 
Ohe document made public concerning the revisions said that the guidelines 
continued to be deliberately restrictive with the intent of erring on the side of 
caution, although “everything we have learned tends to diminish our estimate of 
the risk” involving the major atea of experiment in which the proposed revisions 
offer some relaxation. 
Some speakers today criticized the proposed relaxations for being unjustified 
and criticized the procedures ol revision for not including sufficient contribution 
from critics or allowing enough time for a study of the documents. 
One invited speaker from Europe, on the other hand, said that some features 
of the guidelines were much too stringent t This view is held by some American 
scientists and contested by others. 
[From the Wall Street Journal, Jan. 26, 1978] 
Politics and People 
(By Alan L. Otten) 
Patenting life 
Washington — A tiny number of government officials, lawyers and scientists 
have begun wrestling with a huge legal problem : Should forms of life be patented? 
Ultimately, the Supreme Court or Congress may have to provide the answer. 
It’s another area where rapidly expanding scientific knowledge is creating tricky 
new ethical, legal and social quandaries. 
The question immediately at stake is whether patents should be granted for 
microorganisms, those minute living and reproducing bacteria, viruses and other 
organisms. In one case, an appellate court has already answered in the affirmative, 
and a second case is waiting decisipn. 
Many experts believe the issue will remain narrowly focused on microorganisms 
in food, drug, chemical and similar products, and that the courts can be counted oh 
to avoid any science fiction horror extensions of patentability. At least a few others, 
though, contend the principle affirmed by the court could easily be applied in far- 
out and scary directions; to patent products of recombinant DNA technology, 
cloning, cell fusion and other genetic engineering, perhaps organic modification of 
animals or eveh humans. 
The patent law, dating back to the earliest days of the republic, authorizes 
patent protection for the invention or discovery of “any new and useful process, 
machine, manufacture or composition of matter.” The idea, of course^ is to encour- 
age research and invention by guaranteeing a temporary monopoly on the product. 
A 1930 law extended coverage to certain “asexually reproduced” new plant 
varieties. 
It’s long been assumed that the processes for producing a particular micro- 
organism and the methods for using it could be patented, but the question of 
patenting the organism itself — without doubt, a form of life — hadn’t been seri- 
ously addressed until recently. Then Uphojn Co. sought a patent for a micro- 
organism it had isolated from a soil sample and produced in a biologically pure 
culture, useful for preparing the antibiotic lincomycin. 
A government patent examiner ruled the microorganism a “product of nature” 
and therefore not entitled to patent protection. A three-man appeals board within 
the Patent and Trademark Office also refused the patent* by a two-to-one vote, 
but the majority gave a different reason: A microorganism is “a living organism” 
and Congress never meant living things to be patentable. 
Upjohn appealed to the Court of Customs and Patent Appeals, and a three-to- 
two vote last fall overturned the board and authorized granting the patent. The 
majority, which included a judge from another appellate court sitting in for an 
[Appendix B — 125] 
