[Congressional Record Volume 157, Number 91 (Thursday, June 23, 2011)]
[Extensions of Remarks]
[Pages E1177-E1180]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
AMERICA INVENTS ACT
______
speech of
HON. CHRISTOPHER H. SMITH
of new jersey
in the house of representatives
Wednesday, June 22, 2011
The House in Committee of the Whole House on the State of
the Union had under consideration the bill (H.R. 1249) to
amend title 35, United States Code, to provide for patent
reform:
Mr. SMITH of New Jersey. Madam Chair, for over two decades, USPTO has
had an internal policy that human beings at any stage of development
are not patentable subject matter under 35 U.S.C. Section 101. I
commend Chairman Lamar Smith for including in the manager's amendment
to H.R. 1249, the America Invents Act, a provision that will codify an
existing pro-life policy rider included in the CJS Appropriations bill
since FY2004. This amendment, commonly known as the Weldon amendment,
ensures the U.S. Patent and Trade Office, USPTO, does not issue patents
that are directed to or encompassing a human organism.
Codifying the Weldon amendment simply continues to put the weight of
law behind the USPTO policy.
This amendment and USPTO policy reflect a commonsense understanding
that no member of the human species is an ``invention,'' or property to
be licensed for financial gain. Patents on human organisms commodify
life and allow profiteers to financially gain from the biology and life
of another human person.
Codifying a ban on patenting of humans would not violate
international obligations under the TRIPs agreement with the WTO, in
which member countries can exclude from patentability subject matter to
prevent commercial exploitation which is ``necessary to protect ordre
public or morality, [and] to protect human, animal or plant life.''
(The Agreement on Trade-Related Aspects of Intellectual Property
Rights, Article 27, Section 5).
[[Page E1178]]
Even the European Union prevents patents on human embryos on the
basis of morality and public order without conflicting with the TRIPs
agreement. (See Guidelines for Substantive Examination. European Patent
Office. Part C, Chapter IV, Section 4.5, iii (Rule 28c))
4.5 Biotechnological inventions
In the area of biotechnological inventions, the following
list of exceptions to patentability under Art. 53(a) is laid
down in Rule 28. The list is illustrative and non-exhaustive
and is to be seen as giving concrete form to the concept of
``ordre public'' and ``morality'' in this technical field.
Under Art. 53(a), in conjunction with Rule 28, European
patents are not to be granted in respect of biotechnological
inventions which concern:
(iii) uses of human embryos for industrial or commercial
purposes; The exclusion of the uses of human embryos for
industrial or commercial purposes does not affect inventions
for therapeutic or diagnostic purposes which are applied to
the human embryo and are useful to it (EU Dir.98/44/EC, rec.
42).
I also submit into the Record items from previous debate on the
Weldon amendment that will add further clarification to the intent of
this important provision.
Speech of Hon. Dave Weldon of Florida in the House of Representatives,
July 22, 2003
H. Admt. 286
Departments of Commerce, Justice, and State, the Judiciary,
and Related Agencies Appropriations Act, 2004--(House of
Representatives--July 22, 2003)
Amendment Offered by Mr. Weldon of Florida
Mr. WELDON of Florida. Mr. Chairman, I offer an amendment.
The CHAIRMAN pro tempore. The Clerk will designate the
amendment.
The text of the amendment is as follows:
Amendment offered by Mr. Weldon of Florida:
None of the funds appropriated or otherwise made available
under by the act may be used to issue patents on claims
directed to or encompassing a human organism.
Mr. WELDON of Florida. Mr. Chairman, technology proceeds at
a rapid rate, bringing great benefits to humankind from
treatments of disease to greater wealth and greater knowledge
of our world. However, sometimes technology can be used to
undermine what is meant to be human, including the
exploitation of human nature for the purpose of financial
gain.
Several weeks ago, at a meeting of the European Society of
Human Reproduction and Embryology in Madrid, Spain, it was
reported that scientists had created the first male-female
hybrid human embryos. The researchers transplanted cells from
male embryos into female embryos and allowed them to grow for
6 days. This research was universally condemned as
unnecessary and unethical.
Reuters reported that one member of the European Society
condemned this research, saying there are very good reasons
why this type of research is generally rejected by the
international research community. Furthermore, the scientists
who created these she-male embryos reportedly want to patent
this research.
It is important that we, as a civilized society, draw the
line where some rogue scientists fail to exercise restraint.
Just because something can be done does not mean that it
should be done. A patent on such human organisms would last
for 20 years. We should not allow such researchers to gain
financially by granting them an exclusive right to practice
such ghoulish research.
Long-standing American patent and trademark policy states
that human beings at any stage of development are not
patentable, subject to matters under 35 U.S.C. section 101.
Though current policy would not issue patents on human
embryos, Congress has remained silent on this subject. Though
this amendment would not actually ban this practice, it is
about time that Congress should simply reaffirm current U.S.
patent policy and ensure there is not financial gain or
ownership of human beings by those who engage in these
activities.
This amendment simply mirrors the current patent policy
concerning patenting humans. The Patent Office has, since
1980, issued hundreds of patents on living subject matter,
from microorganisms to nonhuman animals. It does not issue
patents on human beings nor should it. Congress should
reaffirm this policy, and this amendment simply accomplishes
this by restricting funds for issuing patents on human
embryos, human organisms.
Congress should speak out, and I encourage my colleagues to
support this amendment.
I would like to add, Mr. Chairman, that this has no bearing
on stem cell research or patenting genes, it only affects
patenting human organisms, human embryos, human fetuses or
human beings.
Mr. OBEY. Mr. Chairman, will the gentleman yield?
Mr. WELDON of Florida. I yield to the gentleman from
Wisconsin.
Mr. OBEY. Mr. Chairman, I thank the gentleman for yielding
to me.
I think I heard the gentleman say this, but I want it
repeated again so it is clear. Is the gentleman saying that
this amendment would not interfere in any way with any
existing patents with respect to stem cells?
Mr. WELDON of Florida. Reclaiming my time, Mr. Chairman, I
would respond that, no, it would not. And I recognize that
there are many institutions, particularly in Wisconsin, that
have extensive patents on human genes, human stem cells. This
would not affect any of those current existing patents.
The Patent Office policy is not to issue these patents, and
there never has been one. The Congress has been silent on
this issue. I am trying to put us on record that we support
the Patent Office in this position that human life in any
form should not be patentable.
Mr. OBEY. I appreciate the gentleman's clarification.
Mr. WELDON of Florida. Mr. Chairman, I yield back the
balance of my time.
The CHAIRMAN pro tempore (Mr. Terry). The question is on
the amendment offered by the gentleman from Florida (Mr.
Weldon). The amendment was agreed to.
____
Speech of 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, nonhuman, 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
[[Page E1179]]
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.
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.
____
Speech of Hon. Dave Weldon of Florida in the House of Representatives
Friday, November 21, 2003
Amendment to Support Current U.S. Patent and Trademark Office Policy
Against Patenting Human Organisms--(Extensions of Remarks--November 22,
2003).
Mr. WELDON of Florida. Mr. Speaker, this summer I
introduced an amendment that provides congressional support
for the current U.S. Patent and Trademark Office policy
against patenting human organisms, including human embryos
and fetuses. This amendment was approved by the House of
Representatives with bipartisan support on July 22, 2003, as
Sec. 801 of the Commerce/Justice/State appropriations bill.
On November 5th of this year, I submitted to the
Congressional Record an analysis of my amendment that offers
a more complete elaboration of what I stated on July 22nd,
namely, that this amendment ``has no bearing on stem cell
research or patenting genes, it only affects patenting human
organisms, human embryos, human fetuses or human beings.''
However, some have continued to misrepresent my amendment
by claiming it would also prohibit patent claims directed to
methods to produce human organisms. Moreover, some
incorrectly claim that my amendment would prohibit patents on
claims directed to subject matter other than human organisms.
This is simply untrue.
What I want to point out is that the U.S. Patent Office has
already issued patents on genes, stem cells, animals with
human genes, and a host of non-biologic products used by
humans, but it has not issued patents on claims directed to
human organisms, including human embryos and fetuses. My
amendment would not affect the former, but would simply
affirm the latter. This position is reaffirmed in the
following U.S. Patent Office letter of November 20, 2003.
I submit to the Record a letter from James Rogan,
Undersecretary and Director of the U.S. Patent office, that
supports the enactment of my amendment because it ``is fully
consistent with our policy.''
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.
____
Speech of Hon. Dave Weldon of Florida in the House of Representatives
Monday, December 8, 2003
Conference Report on H.R. 2673, Consolidated Appropriations Act, 2004--
(House of Representatives--December 8, 2003)
Mr. WELDON of Florida. Mr. Speaker, on July 22, 2003, I
introduced an amendment to provide congressional support for
the current U.S. Patent and Trademark Office (USPTO) policy
and practice against approving patent claims directed to
human organisms, including human embryos and human fetuses.
The House of Representatives approved the amendment without
objection on July 22, 2003, as section 801 of the Fiscal Year
2004 Commerce/Justice/State Appropriations Bill. The
amendment, now included in the Omnibus appropriations bill as
section 634 of H.R. 2673, reads as follows: ``None of the
funds appropriated or otherwise made available
[[Page E1180]]
under this Act may be used to issue patents on claims
directed to or encompassing a human organism.''
The current Patent Office policy is that ``non-human
organisms, including animals'' are patentable subject matter
under 35 U.S.C. 101, but that human organisms, including
human embryos and human fetuses, are not patentable.
Therefore, any claim directed to a living organism must
include the qualification ``non-human'' to avoid rejection.
This amendment provides unequivocal congressional support for
this current practice of the U.S. patent office.
House and Senate appropriators agreed on report language in
the manager's statement on section 634. The statement reads:
``The conferees have included a provision prohibiting funds
to process patents of human organisms. The conferees concur
with the intent of this provision as expressed in the
colloquy between the provision's sponsor in the House and the
ranking minority member of the House Committee on
Appropriations as occurred on July 22, 2003, with respect to
any existing patents on stem cells.''
The manager's statement refers to my discussion with
Chairman David Obey, when I explained that the amendment
``only affects patenting human organisms, human embryos,
human fetuses or human beings.'' In response to Chairman
Obey's inquiry, I pointed out that there are existing patents
on stem cells, and that this amendment would not affect such
patents.
Here I wish to elaborate further on the exact scope of this
amendment. The amendment applies to patents on claims
directed to or encompassing a human organism at any stage of
development, including a human embryo, fetus, infant, child,
adolescent, or adult, regardless of whether the organism was
produced by technological methods (including, but not limited
to, in vitro fertilization, somatic cell nuclear transfer, or
parthenogenesis). This amendment applies to patents on human
organisms regardless of where the organism is located,
including, but not limited to, a laboratory or a human,
animal, or artificial uterus.
Some have questioned whether the term ``organism'' could
include ``stem cells''. The answer is no. While stem cells
can be found in human organisms (at every stage of
development), they are not themselves human organisms. This
was considered the ``key question'' by Senator Harkin at a
December 2, 1998 hearing before the Senate Appropriations
Subcommittee on Labor, Health and Human Services and
Education regarding embryonic stem cell research. Dr. Harold
Varmus, then director of the NIH testified ``that pulripotent
stem cells are not organisms and are not embryos. . . .
``Senator Harkin noted: ``I asked all of the scientists who
were here before the question of whether or not these stem
cells are organisms. And I believe the record will show they
all said no, it is not an organism.'' Dr. Thomas Okarma of
the Geron Corporation stated: ``My view is that these cells
are clearly not organisms . . . in fact as we have said, are
not the cellular equivalent of an embryo.'' Dr. Arthur Caplan
agreed with this distinction, saying that a stem cell is
``absolutely not an organism.'' There was a unanimous
consensus on this point at the 1998 hearing, among witnesses
who disagreed on many other moral and policy issues related
to stem cell research.
The term ``human organism'' includes an organism of the
human species that incorporates one or more genes taken from
a nonhuman organism. It includes a human-animal hybrid
organism (such as a human-animal hybrid organism formed by
fertilizing a nonhuman egg with human sperm or a human egg
with non-human sperm, or by combining a comparable number of
cells taken respectively from human and non-human embryos).
However, it does not include a non-human organism
incorporating one or more genes taken from a human organism
(such as a transgenic plant or animal). In this respect, as
well, my amendment simply provides congressional support for
the Patent Office's current policy and practice.
This amendment should not be construed to affect claims
directed to or encompassing subject matter other than human
organisms, including but not limited to claims directed to or
encompassing the following: cells, tissues, organs, or other
bodily components that are not themselves human organisms
(including, but not limited to, stem cells, stem cell lines,
genes, and living or synthetic organs); hormones, proteins or
other substances produced by human organisms; methods for
creating, modifying, or treating human organisms, including
but not limited to methods for creating human embryos through
in vitro fertilization, somatic cell nuclear transfer, or
parthenogensis; drugs or devices (including prosthetic
devices) which may be used in or on human organisms.
Jamed Rogan, undersecretary of the U.S. Patent and
Trademark Office, has stated in a November 20, 2003, letter
to Senate appropriators: ``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 . . .
including a human embryo or human fetus. . . . 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).'' Undersecretary Rogan
concludes: ``Given that the scope of Representative Weldon's
amendment . . . is full consistent with our policy, we
support its enactment.''
The advance of biotechnology provides enormous potential
for developing innovative science and therapies for a host of
medical needs. However, it is inappropriate to turn nascent
individuals of the human species into profitable commodities
to be owned, licensed, marketed and sold.
Congressional action is needed not to change the Patent
Office's current policy and practice, but precisely to uphold
it against any threat of legal challenge. A previous Patent
Office policy against patenting living organisms in general
was invalidated by the U.S. Supreme Court in 1980, on the
grounds that the policy has no explicit support from
Congress. In an age when the irresponsible use of
biotechnology threatens to make humans themselves into items
of property, of manufacture and commerce, Congress cannot let
this happen again in the case of human organisms.
I urge my colleagues to support this Omnibus in defense of
this important provision against human patenting.
____________________