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[What appears below is the text of a letter sent by the head of the U.S.
Patent and Trademark Office to key members of the Senate and House
Appropriations committees on November 20, 2003, endorsing enactment of the
Weldon Amendment. The Weldon Amendment, strongly backed by NRLC, prohibits
patents from being issued on any "human organism." On January 23, 2004, the
Weldon Amendment became law as part of an omnibus appropriations bill.]
U.S. PATENT AND TRADEMARK OFFICE
November 20, 2003
Hon. Ted Stevens
Chairman
Committee on Appropriations
U.S. Senate
Washington, DC.
Dear Mr. Chairman:
Thank you for the opportunity to present the Administration's position on
the Weldon amendment adopted by the House during consideration of H.R. 2799,
the Commerce-Justice-State Appropriations bill FY 2004, and the effect it
would have on the United States Patent and Trademark Office (USPTO) policy
on patenting living subject matter. For the reasons outlined below, we view
the Weldon amendment as fully consistent with USPTO's policy on the
non-patentability of human life-forms.
The Weldon Amendment would prohibit the U.S. Patent and Trademark Office
from issuing any patent "on claims directed to or encompassing a human
organism." The USPTO understands the Weldon Amendment to provide unequivocal
congressional backing for the long-standing USPTO policy of refusing to
grant any patent containing a claim that encompasses any member of the
species Homo sapiens at any stage of development. It has long been USPTO
practice to reject any claim in a patent application that encompasses a
human life-form at any stage of development, including a human embryo or
human fetus; hence claims directed to living "organisms" are to be rejected
unless they include the adjective "nonhuman."
The USPTO´s policy of rejecting patent application claims that encompass
human lifeforms, which the Weldon Amendment elevates to an unequivocal
congressional prohibition, applies regardless of the manner and mechanism
used to bring a human organism into existence (e.g., somatic cell nuclear
transfer, in vitro fertilization, parthenogenesis). If a patent examiner
determines that a claim is directed to a human life-form at any stage of
development, the claim is rejected as non-statutory subject matter and will
not be issued in a patent as such.
As indicated in Representative Weldon's remarks in the Congressional Record
of November 5, 2003. the referenced language precludes the patenting of
human organisms, including human embryos. He further indicated that the
amendment has "exactly the same scope as the current USPTO policy," which
assures that any claim that can be broadly construed as a human being,
including a human embryo or fetus, is not patentable subject matter.
Therefore, our understanding of the plain language of the Weldon Amendment
is fully consistent with the detailed statements that the author of the
amendment, Representative Weldon, has made in the Congressional Record
regarding the meaning and intent of his amendment.
Given that the scope of Representative Weldon's amendment does not alter the
USPTO policy on the non-patentability of human life-forms at any stage of
development and is fully consistent with our policy, we support its
enactment.
With best personal regards, I remain
Sincerely,
James E. Rogan
Under Secretary and Director |
