September 22, 2011

Patent Reform Bill Prohibits Patenting of Human Organisms

A provision in the new America Invents Act (AIA) will expressly prohibit the Patent and Trademark Office from issuing any patents on human organism.  The language in Section 33 of the new act is quite sparse: "Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism."  The origin of this provision is found in the Weldon amendment to the patent bill, which has described as necessary by pro-life groups in order to block the patenting of human embryos or genetically engineered humans.  The provision is unusual in its simple declaration of a class of null patents, in that it does not take the more logical route of formally excluding such "inventions" from the classes of patentable subject matter in 35 U.S.C. 101.   However, the PTO does instruct examiners that such patent applications are to be rejected under the formal Section 101 and the new AIA provision. The PTO has previously declared in 1987 that genetically engineered humans are not eligible for patenting; almost 10 years later, when challenged with a 1998 patent application that claimed a human chimera, the PTO rejected the application: "It is the position of the PTO that inventions directed to human/non-human chimera could, under certain circumstances, not be patentable because, among other things, they would fail to meet the public policy and morality aspects of the utility requirement."  In summary, the unusual evocation of a morality requirement in U.S. patent law, the existence of the 13th Amendment which forbids ownership of other humans, and PTO actions to date all counsel that any attempts to patent a human organism - embryo; genetically engineered - will fail, and would have failed even without the recent legislation.

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