[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.

                          ____________________