Funding Bill Gets Clause on Embryo Patents
Ban Inserted Into Appropriations Measure Stirs Political, Philosophical Debate

By Rick Weiss
Washington Post Staff Writer

Monday, November 17, 2003; Page A04

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 over 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 believed 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 anti-corporate advocates who contend that patenting cloned human embryos and related products is inherently unethical and would turn human life itself into just another commodity. "If patents on human embryos are allowed, then biotech companies will market babies with certain traits just like Perdue markets chicken or Ford markets sport-utility vehicles," Lori B. Andrews, a law professor at Chicago-Kent College of Law, editorialized recently in the Chicago Tribune.

Both sides agree that the issue raises profound questions about when human life begins and how the products of life may be commercialized. Unexpectedly, and, some say, inappropriately, it now appears that 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. David Joseph Weldon (R-Fla.) 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 that 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 believed to hold great potential for treating degenerative diseases.

Brownback's language seeks to make clear that 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 still 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 smokescreen for its true goal: to keep open the option of patenting embryos.

Company representatives have largely sidestepped that question, though some, including Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), have made statements suggesting they do not want to rule out the possibility of patents on certain human embryos or similar cellular creations that have been engineered to serve as sources of medicines or therapeutic stem cells.

Others have argued similarly that it would be wrong to completely close the door to such patents because it is too soon to know what kinds of acceptable goods may come from such research, including novel medicines or perhaps even healthier babies.

At a minimum, representatives of the biotechnology industry say, it would be wrong to rush through legislation dealing with such a complicated political, economic and ethical question.

"We would object to changes in patent law done through the appropriations process," said Michael J. Werner, vice president for bioethics at BIO. Werner emphasized that the industry remains opposed to patents on humans, but he declined to define what he meant by "human."

Werner said he had not seen Brownback's specific wording, but he expressed concerns that the language may intentionally or inadvertently encompass -- and hence stymie -- rapidly evolving technologies that involve the use of embryos or embryonic cells. A spokesman for BIO added that he anticipated a loud outcry from patient advocacy groups when word of the pending Hill action gets out.

But supporters of the Weldon and Brownback approach, including leaders from some religious organizations and antiabortion groups, say the patenting of human embryos would represent an offensive and unacceptable level of commodification of human life.

"The biotech industry has disseminated these imaginative and expansive claims about the Weldon amendment," said Douglas Johnson, legislative director of the National Right to Life Committee. "I think this puts the spotlight on the real issue: The biotechnology industry is lobbying to keep the legal door open for patenting cloned or genetically modified human embryos to ensure the payment of royalties for each embryo created or sold under license. All of that is essential for making human embryo farms and fetus farms profitable."

Few scientists have ventured into the ethically treacherous terrain of creating genetically modified embryos -- though a few have reported doing simple cellular and genetic manipulations on embryos of the sort that could, under some interpretations of current law, be eligible for patents. But the history of patents on life forms makes it difficult to predict whether a scientist seeking such a patent might prevail. Although the patent office has generally been disinclined to grant such patents, the courts have leaned in favor. The one time the Supreme Court weighed in, in a 5 to 4 decision in 1980, it said patents could be issued on "anything under the sun made by the hand of man."

Since then, many life-form patents have been issued on everything from a mouse engineered to get breast cancer to human cell lines. In 1987, Donald J. Quigg, then commissioner of patents and trademarks, wrote in a memo: "A claim directed to or including within its scope a human being will not be considered to be patentable subject matter."

That, however, is as far as the office has gone, leaving room for confusion in the young but burgeoning field of human embryo research. Patent office officials have repeatedly asked Congress for legislative guidance.

President Bush has not addressed the patenting issue directly, and it is not clear how actively the White House will engage the new debate. Bush struggled for months to come up with a policy he announced two years ago that sought to balance the interest of federally funded researchers in having access to embryonic stem cells and opponents' desire to prevent such experiments.

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