House and Senate negotiators on Thursday reached an agreement on language in House and Senate versions of the Commerce, Justice and State Department appropriations bill that would prohibit the U.S. Patent and Trademark Office from issuing patents on "human organisms," such as genetically engineered embryos, the AP/Washington Post reports (AP/Washington Post, 11/25). The House in July -- with no public hearings and little debate -- passed by voice vote an amendment, sponsored by Rep. David Weldon (R-Fla.), to its version of the appropriations bill (HR 2799) that would bar patent claims on the human organism, a move that biotechnology companies say is a back-door attempt to stop research using embryonic stem cells. Sen. Sam Brownback (R-Kan.) earlier this month quietly added legislative language to the Senate version of the appropriations bill (S 1585) in order to make clear that the ban on patents on human organisms would not extend to stem cells (Kaiser Daily Reproductive Health Report, 11/18). The compromise provision would ban patents for genetically engineered human embryos, fetuses and human beings but would not affect patents on genes, cells, tissue and other biological products, the AP/Post reports. Weldon said that the language agreed upon by House and Senate negotiators includes a provision that makes it clear that the patent ban on human organisms would not interfere with stem cell research, according to the AP/Post. The provision also would not prohibit scientists from obtaining patents for the procedures or methods of creating a biological product. Weldon said that the amendment allows USPTO to address "new or borderline issues," such as allowing patents in cases where scientists use a few human genes to modify an animal so that it produces a human protein or antibody, according to the AP/Post.

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USPTO Director James Rogan said that the provision is "fully consistent with USPTO's policy on the non-patentability of human life forms" (AP/Washington Post, 11/25). Although the USPTO since 1987 has had a policy to reject any patent application including within its scope a human being, many legal experts say that the legal grounds for such a policy may be shaky in light of a 1980 Supreme Court ruling requiring a patent for a bacterium genetically engineered to eat oil spills. In that case, the court said that because the bacterium had been engineered by humans and was not found in nature, it qualified for a patent. However, the law is murky on whether human embryos can be patented, and USPTO officials have suggested that legislation may be needed to ensure that its position of denying patents on human organisms is not overturned by the courts (Kaiser Daily Reproductive Health Report, 11/18). Michael Werner, chief of policy for the Biotechnology Industry Organization, which earlier had opposed the provision, on Thursday said that although he had not seen the bill, he had heard that it appeared to be "compatible with the goals of the biotech industry," adding, "Our companies are interested in being able to do stem cell research, regenerative medicine and the development of treatments for diseases -- not in getting patents on embryos." The appropriations bill that includes the provision is part of the a package of unfinished spending bills that Congress is expected to approve and send to President Bush next week, according to the AP/Post (AP/Washington Post, 11/25).