[Congressional Record (Bound Edition), Volume 149 (2003), Part 22]
[Extensions of Remarks]
[Pages 31004-31005]
[From the U.S. Government Publishing Office, www.gpo.gov]




 AMENDMENT TO SUPPORT CURRENT U.S. PATENT AND TRADEMARK OFFICE POLICY 
                   AGAINST PATENTING HUMAN ORGANISMS

                                 ______
                                 

                            HON. DAVE WELDON

                               of florida

                    in the house of representatives

                       Friday, November 21, 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.

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