On September 2, 2003, the Biotechnology Industry Organization (BIO) issued
what it called a "cloning factsheet," this being a document expressing
objections to the Weldon Amendment, a measure under consideration in
Congress that would prohibit the U.S. Patent Office from issuing patents on
human embryos. The entire factsheet is posted
here.
What follows is footnote no. 1
in the factsheet:
Four categories of inventions can be claimed: "a new and useful process,
machine, manufacture or composition of matter." Any new and useful
improvement to any of those may also be patented. The courts and the PTO
[Patent and Trademark Office] have determined that multicellular living
organisms, including animals, are patentable. In general, however, courts
have interpreted the patent statute to deny protection for claims directed
to "products of nature." Only things that have been specifically altered in
their physical makeup through human intervention, and as a result differ
from the corresponding products in their natural states, may be the subject
of a U.S. patent claim. For example, a bacterium discovered in the wild may
not be patented as a "thing," but a purified composition containing the
bacterium in a form distinct from how it is found in nature may be patented.
Similarly, an animal or human produced by conventional reproduction -- with
no intervention by an "inventor" -- would not qualify as a patentable
"manufacture" because it is a product of nature. Living organisms that
possess physical characteristics resulting from human intervention qualify
for protection because such living organisms are no longer "products of
nature."
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