On August 24, 2004, the United States Patent Office (USPTO) issued US Patent No 6,781,030, entitled "Methods for cloning mammals using telophase oocytes" which includes claims directed to methods for cloning "mammals". Although the USPTO has long issued patents on transgenic mammals and the methods for producing these, the issuance of this patent is noteworthy, following as it does with the recent enactment of the "Weldon amendment" which was an attempt to bar the USPTO from issuing patents on human organisms. In 2003, Representative David Weldon inserted a provision in a Congressional spending bill which provided that "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 use of the term "human organism" caused much controversy at the time. Opponents of the provision were concerned that it would prohibit the patenting of human-derived biotechnology inventions such as stem cells. Weldon later elaborated on the scope of his amendment: "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 though in vitro fertilization, somatic cell nuclear transfer, or parthogenesis; drugs or devices (including prosthetic devices) which may be used in or on human organisms." [Emphasis added by the Editor] The Consolidated Appropriations Act, 2004, H.R. 2673, Sec. 634 (the Congressional spending bill including the Weldon amendment) was first passed by both the House and Senate, and later signed by President Bush on December 23, 2003. In Canada, higher life forms such as transgenic mice and methods of medical treatment are not patentable subject matter, whereas modified genes and cells are. Stem cell research is regulated in Canada by the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, and the Assisted Human Reproduction Act, which was assented to last March. To read the patent, visit: http://makeashorterlink.com/?I4A925749. To read Representative Weldon's December 8, 2003 remarks, see: http://www.aipla.org/html/reports/2004/Weldon2.pdf. To review Canada's Assisted Human Reproduction Act, visit: http://laws.justice.gc.ca/en/a-13.4/2294.html. Summary by: Lenni Carreiro

E-TIPS® ISSUE

04 09 15

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