A ban on the issuing of U.S. patents on human embryos was enacted into law today – the culmination of an eight-year effort in which National Right to Life played a key role.
The pro-life policy was enacted as part of a bill called the "America Invents Act" (H.R. 1249). The bill, which runs 58 pages in its final form, makes numerous changes to the laws that govern the granting of patents in the United States, which is a function of the U.S. Patents and Trademarks Office (USPTO), part of the Department of Commerce.
A patent is a government-conferred property right that gives an inventor exclusive rights to manufacture or use his invention for a defined period, usually 20 years. The patent holder can license others to employ his patent for a fee, called a royalty.
Early in the year, when it became clear that Congress was likely to take up sweeping revision of the patent laws, NRLC insisted on inclusion of language to codify (make permanent) a previously enacted temporary prohibition on any patents being issued on human embryos.
Subsequently, the NRLC-backed language was added to the bill, with the support of House Judiciary Committee Chairman Lamar Smith (R-Tx.), House Speaker John Boehner (R-Ohio), House Majority Leader Eric Cantor (R-Va.), Congressman Chris Smith (R-NJ), and other key lawmakers. Both the House and Senate subsequently approved the broader bill without separate votes on the NRLC-backed provision. President Obama signed the bill into law today.
The key language, as it appears in Section 33 of the enacted measure, reads as follows: "Notwithstanding any other provision of this title, no patent may issue on a claim directed to or encompassing a human organism."
A similar prohibition was originally proposed by former Congressman Dave Weldon (R-Fl.) in 2003, with the strong support of NRLC, as a amendment to the annual appropriations bill that funds the USPTO. The House adopted the Weldon provision on July 22, 2003. There followed a four-month struggle, in which the powerful Biotechnology Industry Organization (BIO) lobbied strenuously against enactment of the ban.
NRLC fought hard for the Weldon language, arguing that it was one necessary bulwark against the plans of some biotechnology organizations to create an industry based on the creation and manipulation of human embryos. NRLC and other backers of the Weldon language cited statements by some researchers that they wanted to patent and market human embryos with certain genetic profiles as "models" for studying certain diseases.
Furthermore, in a letter to key members of Congress dated September 11, 2003, then-BIO President Carl B. Feldbaum objected to the Weldon language on grounds that it "would preclude the U.S. Patent and Trademark Office (PTO) from granting patents on an organism of human species at any stage of development produced by any method [or] a living organism made by human cloning . . ." In a memo, BIO argued that a "genetically modified embryo" should be patentable, since it reflected "human intervention."
NRLC Legislative Director Douglas Johnson said at the time, "The BIO memo and letter fully demonstrated the need for the Weldon Amendment. BIO's theory of patent law would allow patents to protect what President Bush has called 'human embryo farms.'"
NRLC and its allies ultimately prevailed, and the Weldon ban was enacted as part of a broad government funding bill in early 2004. A detailed account of the 2003-2004 fight is found at www.nrlc.org/killing_embryos/Human_Patenting/Weldonamendmentsurvives.html.
Because the Weldon provision was attached to a one-year appropriations bill, it has been necessary to renew it for each subsequent fiscal year. While NRLC and other pro-life forces have been successful in fending off attempts to weaken or repeal the annual bans, the long-term goal – now realized – was to codify the ban into permanent law.
Commenting on enactment of the permanent ban today, NRLC's Douglas Johnson commented, "This law recognizes that human life is not a commodity, and that a member of the human family can never be regarded as a mere invention, or as 'intellectual property.'"
Richard Doerflinger, associate director of the United States Conference of Catholic Bishops' Secretariat of Pro-Life Activities, commented, "Unethical researchers and biotechnology companies are willing not only to create and destroy embryonic human beings for research purposes, but even to patent these fellow humans so they can license, market, buy, and sell them as mere commodities. By prohibiting patents on human organisms, Congress has helped prevent such gross abuses and has taken some of the profit motive out of the drive for human cloning.'
The substantive scope of the Weldon language was explained by then-USPTO Director James Rogan in a letter dated November 20, 2003, as follows: "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. . . . [which] 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)."
