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Margo A. Bagley teaches at Emory University School of Law. A fuller discussion of this topic appears in her article, “Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law,” 45 Wm. & Mary L. Rev. 469. In the Feb. 13 issue of Science, South Korean researchers fanned the flames of the cloning-research controversy by announcing that they had successfully created cloned human embryos and harvested their stem cells, destroying the embryos in the process. In response, cloning opponents renewed the contention that it is immoral to create human life just to destroy it, and cloning proponents countered that it would be immoral not to allow potentially life-saving research to move forward. But while the debate over the research rages, not much is being said about patents. Patent rights can be extremely lucrative and provide significant incentives both for inventors to create patentable innovations and for investors to fund such research. Consequently, focusing solely on the controversial activity, and ignoring the patent incentive, seems an incomplete approach. For good or ill, the U.S. patent statute is not designed to consider the morality of an invention in the patentability determination. A person is entitled to a patent unless the invention fails to meet one of the statutory requirements such as utility or novelty. None of the requirements considers morality concerns. As a result, patent applicants (i.e., scientists) are deciding the subject-matter limits of patents by the contents of the applications they file in the U.S. Patent and Trademark Office (PTO). Not surprisingly, once controversial patents issue, it becomes more difficult to engage in ex post policy discussions concerning whether such inventions should receive the federal government’s patent imprimatur. The PTO has long maintained a policy of denying patents on claims “encompassing a human.” This policy relies on a judicially created moral-utility doctrine that allowed the PTO and courts to deny patents on morally controversial inventions (such as gambling machines) for much of the 19th and early 20th centuries. But over time, courts became less comfortable making ad hoc morality decisions with no statutory authority and eventually gutted the doctrine by holding that if an invention had at least one beneficial purpose, it could be patented. In interpreting the current patent statute, the U.S. Supreme Court held in Diamond v. Chakrabarty (1980) that “anything under the sun that is made by man,” living or nonliving, is eligible for patent protection, and has declared itself to be “without competence” to consider the moral implications of this expansive definition. Misguided amendment Thus, recent PTO statements of its policy against granting patents on humans have created the incorrect impression for Congress and the public that the PTO can lawfully reject patent applications based on morality concerns. Indeed, the inclusion of the Weldon Amendment (H.R. 2673) in the 2004 consolidated appropriations bill suggests that Congress is still laboring under this misapprehension. The amendment is styled as a “clarification” of the PTO policy against granting patents on humans, and bars the PTO from using appropriated funds to issue patents encompassing a human organism. But the Weldon Amendment does not amend the patent statute, fails to define “human” or “encompassing a human” and expires in one year. The amendment may have seemed necessary because several patents have issued, quietly and perhaps accidentally, from the PTO that encompass humans, either explicitly or implicitly, despite the PTO policy. Explicitly, because they claim a mammal or organism not limited to the nonhuman variety; implicitly, because they claim a method of cloning humans (owners of method patents are allowed to prevent the importation of “products,” such as cloned human embryos, produced by the patented process). Other morally controversial patent applications, concerning human-animal, mixed species chimera and mammalian fetuses, are also pending in the PTO. If Congress, representing the U.S. public, really is concerned about patents on humans or other controversial subject matter, it needs to do more than vaguely and temporarily “bless” an outdated PTO policy that contradicts the patent statute. Instead, Congress must take the time to clarify the extent to which moral issues should be considered in patentability determinations, if at all. After really studying the matter, if Congress believes that there are some inventions no one should “own,” then it owes it to the public and to patent applicants to set the limits. Otherwise (after one year, at least), there will be no limits at all.

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