[Congressional Record (Bound Edition), Volume 149 (2003), Part 20]
[Extensions of Remarks]
[Pages 27387-27388]
[From the U.S. Government Publishing Office, www.gpo.gov]




                            PATENT AMENDMENT

                                 ______
                                 

                            HON. DAVE WELDON

                               of florida

                    in the house of representatives

                      Wednesday, November 5, 2003

  Mr. WELDON of Florida. Mr. Speaker, this summer I introduced an 
amendment that provides congressional support for the current federal 
policy against patenting humans. It was approved by the House of 
Representatives without objection on July 22, 2003 as Sec. 801 of the 
Commerce/Justice/State appropriations bill.
  Since that time, the Biotechnology Industry Organization (BIO) has 
launched a lobbying campaign against the amendment, and has now 
enlisted the political aid of the broader ``Coalition for the 
Advancement of Medical Research'' (CAMR), an umbrella organization of 
groups supporting human cloning for research purposes.
  BIO and CAMR claim to support the current policy of the U.S. Patent 
and Trademark Office (USPTO) against patenting human beings. However, 
they oppose this amendment, saying it would have a far broader scope--
potentially prohibiting patents on stem cell lines, procedures for 
creating human embryos, prosthetic devices, and in short almost any 
drug or product that might be used in or for human beings.
  The absurdity of these claims is apparent when one compares the 
language of the amendment with the language of the current USPTO policy 
that these groups claim to support.
  The House-approved amendment reads:
  ``None of the funds appropriated or otherwise made available under 
this Act may be used to issue patents on claims directed to or 
encompassing a human organism.''
  The current USPTO policy is set forth in two internal documents:
  U.S. Patent and Trademark Office, ``Notice: Animals--Patentability,'' 
1077 Official Gazette U.S. Pat. and Trademark Off. 8 (April 21, 1987):
  ``The Patent and Trademark Office now considers non-naturally 
occurring non-human multicellular living organisms, including animals, 
to be patentable subject matter within the scope of 35 U.S.C. 101. . . 
. A claim directed to or including within its scope a human being will 
not be considered patentable subject matter under 35 U.S.C. 101. The 
grant of a limited, but exclusive property right in a human being is 
prohibited by the Constitution. Accordingly, it is suggested that any 
claim directed to a non-plant multicellular organism which would 
include a human being within its scope include the limitation `non-
human' to avoid this ground of rejection.''
  (This notice responded to the Supreme Court's 1980 decision in 
Chakrabarty concluding that a modified ``microorganism,'' a bacterium, 
could be patented, and a subsequent decision by the USPTO's own Board 
of Appeals in Ex parte Allen that a multicellular organism such as a 
modified oyster is therefore patentable as well. The USPTO sought to 
ensure that these policy conclusions would not be misconstrued as 
allowing a patent on a human organism.)
  U.S. Patent and Trademark Office, Manual of Patent Examining 
Procedure (Revised February 2003), Sec. 2105: ``Patentable Subject 
Matter--Living Subject Matter'':
  ``If the broadest reasonable interpretation of the claimed invention 
as a whole encompasses a human being, then a rejection under 35 U.S.C. 
101 must be made indicating that the claimed invention is directed to 
nonstatutory subject matter.''
  In other words, the USPTO clearly distinguishes between organisms 
that are nonhuman and therefore are patentable and those organisms that 
are human and therefore not patentable subject matter.
  As a USPTO official testified recently to the President's Council on 
Bioethics:
  ``When a patent claim includes or covers a human being, the USPTO 
rejects the claim on the grounds that it is directed to non-statutory 
subject matter. When examining a patent application, a patent examiner 
must construe the claim presented as broadly as is reasonable in light 
of the application's specification. If the examiner determines that a 
claim is directed to a human being at any stage of development as a 
product, the examiner rejects the claims on the grounds that it 
includes non-statutory subject matter and provides the applicant with 
an explanation. The examiner will typically advise the applicant that a 
claim amendment adding the qualifier, non-human, is needed, pursuant to 
the instructions of MPEP 2105. The MPEP does not expressly address 
claims directed to a human embryo. In practice, examiners treat such 
claims as directed to a human being and reject the claims as directed 
to non-statutory subject matter.'' (Testimony of Karen Hauda on behalf 
of USPTO to the President's Council on Bioethics, June 20, 2002, http:/
/bioethicsprint.bioethics.gov/transcripts/jun02/june2I session5.html)
  Current USTPO policy, then, is that any claim that can reasonably be 
interpreted as ``directed to'' or ``encompassing'' a human being, and 
any claim reaching beyond ``nonhuman'' organisms to cover human 
organisms (including human embryos), must be rejected. My amendment 
simply restates this policy, providing congressional support so that 
federal courts will not invalidate the USPTO policy as going beyond the 
policy of Congress (as they invalidated the earlier USPTO policy 
against patenting living organisms in general).
  Literally the only difference between my amendment and some of these 
USPTO documents is that the amendment uses the term ``human organism,'' 
while the USPTO usually speaks of the non-patentability of (anything 
that can be broadly construed as) a ``human being.'' But ``human 
organism'' is more politically neutral and more precise, having a long 
history of clear interpretation in federal law.
  Since 1996, Congress has annually approved a rider to the Labor/HHS 
appropriations bill that prohibits federal funding of research in which 
human embryos are created or destroyed--and this rider defines a human 
embryo as a ``human organism'' not already protected by older federal 
regulations on fetal research. In December 1998 testimony before the 
Senate Appropriations Subcommittee on Labor/HHS/Education, a wide array 
of expert witnesses--including NIH Director Harold Varmus and the head 
of a leading company in BIO--testified that this rider does not forbid 
funding research on embryonic stem cells, because a human embryo is an 
``organism'' but a stem cell clearly is not (see S. Hrg. 105-939, 
December 2, 1998). That same conclusion was later reached by HHS 
general counsel Harriet Rabb, in arguing that the Clinton 
administration's guidelines on stem cell research were in accord with 
statutory law; this same legal opinion was accepted by the Bush 
administration when it issued its more limited guidelines for funding 
stem cell research (Legal memorandum of HHS general counsel Harriet S. 
Rabb, ``Federal Funding for Research Involving Human Pluripotent Stem 
Cells,'' January 15, 1999). To argue now that a ban on patenting 
``human organisms'' somehow bans patenting of stem cells or stem cell 
lines would run counter to five years of legal history, and would 
undermine the legal validity of any federal funding for embryonic stem 
cell research.
  BIO also claims that the amendment raises new and difficult questions 
about ``mixing'' animal and human species. What about an animal that is 
modified to include a few human genes so it can produce a human protein 
or antibody? What about a human/animal ``chimera'' (an embryo that is 
half human, half animal)? The fact is, these questions are not new. The 
USPTO has already granted patents on the former (see U.S. patent nos. 
5,625,126 and 5,602,306). It has also thus far rejected patents on the 
latter, the half-human embryo (see Biotechnology Law Report, July-
August 1998, p. 256), because the latter can broadly but reasonably be 
construed as a human organism. The Weldon amendment does nothing to 
change this, but leaves the USPTO free to address new or borderline 
issues on the same case-by-case basis as it already does.
  In short, my amendment has exactly the same scope as the current 
USPTO policy, and cannot be charged with the radical expansions of 
policy that BIO and its allies claim. In reality, BIO opposes this 
amendment because it opposes the current USPTO policy as well, and has 
a better chance of nullifying this policy in court (or having courts 
reinterpret it into uselessness) if it lacks explicit support in 
statutory law.
  This goal is apparent from BIO's own ``fact sheet'' opposing the 
amendment (see www.bio.org/ip/cloningfactsheet.asp). There BIO argues 
that human beings should be patentable, if they arise from anything 
other than ``conventional reproduction'' or have any ``physical 
characteristics resulting from human intervention.'' In other words, 
humans should be seen as ``inventions'' and thus be patentable on 
exactly the same grounds as animals are now.
  The logic of this argument reaches beyond the human embryo, because 
an embryo who resulted from reproductive technology or received any 
physical or genetic modification presumably remains just as invented 
throughout his or her existence, no matter what stage of development he 
or she reaches.

[[Page 27388]]

  BIO's stated support for reducing members of the human species to 
patentable commodities makes the passage of my amendment more urgently 
necessary than ever.

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