CONGRESS TO TACKLE HUMAN-EMBRYO PATENTS
Rick Weiss, the Washington PostTHE ORLANDO SENTINEL
WASHINGTON -- Legislative language quietly submitted Friday for incorporation into a huge appropriations bill could push Congress to abruptly confront this week the contentious question of whether the government should issue patents on human embryos or medical products that come from them.
As a result, what had been a simmering congressional debate about a seemingly arcane detail of patent law is poised to boil over into a political and philosophical battle.
Patents have long been allowed on gene-altered animals and human cells cultured in the laboratory. Until now, however, the legal landscape has been foggy on whether the tiny balls of cells that constitute the earliest stages of human development can be patented by scientists or companies that have manipulated them in novel ways.
The U.S. Patent and Trademark Office has long said it will not issue a patent on a "human being." To do so, some argue, would violate the 13th Amendment prohibiting slavery. But the patent office has not addressed the issue of exactly when a developing embryo or fetus becomes a human being and whether its policy against patenting humans reaches back before birth.
Now that essential question, which has long been at the core of the abortion debate, is being raised in intellectual-property law. At issue is the submission of Republican "clarifying language" for a Senate appropriations bill that would ban patents on human embryos, codifying a national policy for the first time. Senate leaders indicated they will push to complete action on the spending bill this week.
On one side of the emerging controversy are medical researchers and representatives of the biotechnology industry, who say conservatives are trying to carve out an overly broad ban on the patenting of potentially curative human-cell lines and other embryo products as part of a larger agenda to give embryos full human rights. If that effort is successful, these scientists warn, companies will refuse to invest in what is widely thought to be one of the most promising avenues of medical research, and the field will wither.
On the other side are religious conservatives and some liberal anticorporate advocates who contend that patenting cloned human embryos and related products is inherently unethical and would turn human life itself into a commodity.
Both sides agree the issue raises profound questions about when human life begins and how the products of life may be commercialized. It now appears those questions are to be dealt with by Congress for the first time in the relative obscurity of an appropriations bill for the Commerce, Justice and State departments.
Sen. Sam Brownback, R-Kan., added the language to clarify wording in a controversial House-passed measure, his office said.
The House measure, which was introduced by Rep. Dave Weldon, R-Palm Bay, and passed by voice vote in July, would ban patents on "human organisms." Weldon has said the bill's aim is simply to ban the patenting of human embryos, fetuses and adults. But industry officials have expressed fears the word "organisms" would ban patents not only on embryos but also on related processes and on products derived from embryos, including embryonic stem cells, which are thought to hold great potential for treating degenerative diseases.
Brownback's language seeks to make clear the Weldon ban would not preclude patents on cell lines and other products. It reads in part: "Nothing in this section shall be construed to affect claims directed to or encompassing 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)."
His wording also states that unique processes devised by scientists to create these products would be eligible for patents.
If Brownback's clarification survives Hill deliberations, it would mark the first time Congress had codified any aspect of the human patenting issue.
The question now facing the biotechnology industry is whether it can live with such a ban or whether, as conservatives have said, the industry's expressed fears about the Weldon bill were a smoke screen for its true goal: to keep open the option of patenting embryos.
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Sam Brownback