93 
Thank you for allowing NRDC this opportunity to supplement its testimony 
before your committee. 
Sincerely, 
Mabcia J. Cleveland. 
Enclosure. 
45 Rockefeller Plaza, 
New York, y.Y., November 29, 1377. 
Marcia Cleveland, Esq., 
Natural Resources Defense Council, Inc., 
122 Eust 42nd Street, New York, N.Y. 
Dear Marcia: You have asked us to explain how certain provisions of the 
patent laws of the United States and other countries may affect proposed legis- 
lation relating to recombinant DXA research. The specific area of interest is 
the relationship between, on the one hand, disclosure requirements needed to 
implement a regulatory program for assuring the health and environmental 
safety of recombinant DXA research and, on the other hand, the waiver-by- 
publication provisions common in national patent systems. This topic is large, 
and our response is not exhaustive. We hope, however, that it may be a useful 
first effort. 
The United States Patent Act provides, in Title 35, United States Code, Section 
102(b), that a person shall not be entitled to a patent for an invention if 
(a) the invention was.. . . described in a printed publication in this or a for- 
eign country or in public use or on sale in this country, more than one year 
prior to the date of application for patent in the United States. 
The “date of application for patent in the United States” is the date on which 
the inventor, or the assignee of the inventor, submirs to the Patent and Trade- 
mark Office the written description of the invention that is known as the patent 
application. In the normal course of events, that date precedes by about two 
years the date a patent would ultimately issue for that invention. 
Therefore, once an invention has been described in a printed publication, 
placed in public use or offered for sale, a one-year countdown begins. At the end 
of that year, patent rights to the invention in the United States are irretrievably 
lost, unless a patent application has already been submitted. 
The terms “printed publication”, “public use” and “on sale” are, of course, 
the operational terms in Section 102(b), the terms whose meaning often deter- 
mines whether a patent that was issued by the Patent and Trademark Office is 
valid or invalid. An extensive body of decisional law has grown up around those 
terms. For present purposes there are two significant facts about that body of 
case law: first, the precise meaning of each of those terms in Section 102(b) is 
not fixed ; and second, those terms cause patent owners a great deal of concern. 
The uncertain scope of the terms used in Section 102(b) leads patent owners 
to act cautiously when they realize that they are skirting the periphery of 
one of those forbidden acts. This tendency toward caution is encouraged by 
the fact that, in litigation, alleged infringers regularly claim that the patented 
invention was in use, on sale or described in a printed publication sufficiently 
early to destroy the validity of the patent. Pre-trial discovery on the issue can 
be extensive. 
Moreover, the one-year “grace period” included in United States law is not 
found in the patent laws of all other countries. Several countries, including 
Italy, France, the Netherlands, Norway, Spain. Sweden and Uruguay, do not 
give any grace period for acts like those listed in Section 102(b), no matter 
where in the world those acts occur. In France, for example, no patent may 
be obtained if the invention “has been made available to the public. by written 
or oral description; by use or by any other means prior to the. date of filing 
of the patent application. . . .” French Patent Law, Article 8. 
Since patent applications must be filed in every country in which patent pro- 
tection is sought, the more severe foreign requirements respecting prior dis- 
closure, use or sale often become controlling. That is. a United States company 
interested in obtaining worldwide patent coverage on an invention will file a 
patent application in at least one country before making any publication of the 
invention. (An international convention adhered to by most countries allows 
subsequent patent applications filed up to a year later in signatory countries 
to relate back to the filing date of that first application ) . 
For these reasons, patent-oriented entities involved in recombinant DNA 
research will be uneasy about disclosing information relating to that research 
[Appendix B — 352] 
