Stealth Stipulation Shadows Stem Cell Research

A mid the flurry that followed the United States Congressional winter 2003 recess, the presidential primaries, and the debate over this year's budget, lawmakers gave final approval to 30 words that could have far-reaching consequences for the scientific community. With few hearings, and scant review or debate, Congress sanctioned a plan that forbids the US Patent and Trade Office (PTO) to issue patents on human organisms.1 While seemingly innocuous – after all, the federal government has long had a policy of forbidding patents on human beings – the nuances of the legislation have researchers concerned that it could be used to prevent research on human cell lines and other embryo products that hold promise for curing and treating disease. The wording in the Bill is "None of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism.""The legislative language is not as clear as [some people] would like to think it is," says Sean Tipton, vice president of communications at the Coalition for the Advancement of Medical Research (CAMR), which represents scientific societies, universities, and patient groups. "The language is still somewhat ambiguous as to what exactly is prohibited. Embryos? Or the products that come from embryos? If it's products, then it clearly will impact embryonic stem cell research." STATUS QUO OR NO? Supporters of the provision – which was placed in a congressional spending bill that the House passed in July 2003, the Senate passed in January 2004, and President Bush was expected to sign soon – say it merely codifies what has long been the practice at the US Patent and Trade Office (PTO). "Technology proceeds at a rapid rate, bringing great benefits to humankind, from treatments of disease to greater wealth and greater knowledge of our world," says Rep. David Weldon, the Florida Republican who wrote the provision. "However, sometimes technology can be used to undermine what is meant to be human, including the exploitation of human nature for the purpose of financial gain." In the past, the office has issued patents on genes, stem cells, animals with human genes, and nonbiologic products used by humans. It has never issued a patent on claims directed to human organisms, including fetuses and human embryos. When arguing for his plan on the House floor, Weldon assured skeptical lawmakers that his plan would reaffirm that policy, but would not interfere with existing patents with respect to stem cells. "I recognize that there are many institutions... that have extensive patents on human genes [and] human stem cells," Weldon says. "This would not affect any of those current, existing patents." After close questioning by law-makers, Weldon also insisted that the term "organism" does not include "stem cells" – for the purposes of existing or future patents. James Rogan, former director of the PTO, wrote Congress, expressing his support for the Weldon and assuring lawmakers it was "fully consistent our policy... on the non-patentability of human life forms at any state of development." A MATTER OF INTERPRETATION Research groups point out that they, too, object to the patenting of human beings. But they note that the Weldon plan does not refer organisms." Because the language does not define "human organism," they say, it could be interpreted by some to forbid the patenting of many human-derived biotechnology inventions, thus impeding the development of new and potentially lifesaving products. "We certainly can't say we support this proposal," says Michael Werner, chief of policy at the Washington-based Biotechnology Industry Organization (BIO). "There may be situations that involve embryonic material that are not human beings, and we don't want this language interpreted so broadly that those things are covered." Says Tipton: "It's possible that an ambitious US attorney could try to use [the provision] to go after a clinic or research firm that was trying to advance [a disease cure]." Among the biotechnology inventions placed in jeopardy, argue researchers, are stem cells and stem cell production methods; all cell and tissue therapy products and methods, including techniques for making replacement tissue and organs; gene patents; transgenic animals capable of making human proteins; and methods for inducing production of an exogenous protein by humans – such as gene therapy. The provision could, contends CAMR, cripple medical research that uses somatic cell nuclear transfer – more commonly called therapeutic cloning – to help find cures for deadly diseases. "This provision is just a hasty, back-door attempt to stifle therapeutic cloning research," says Michael Manganiello, president of CAMR, which has led efforts to support federal funding of embryonic stem cell research and to prevent a ban on therapeutic cloning. QUIET FIAT Researchers and lawmakers also object to the manner in which Wel-don put his plan into law. Because the congressman put it into a so-called "omnibus spending bill," there was little in the way of committee hearings or debate that typically accompany such a controversial measure. Congressional rules require lawmakers to approve spending bills in their entirety, without picking and choosing provisions they like or dislike; the only way to object to the Weldon plan was to vote against the entire spending plan. Such a vote was politically unpalatable to several in Congress who feared it might cost them support back home, where voters were already concerned that Congress was late passing a 2004 budget. "The Senate had absolutely no discussion of this provision. There was no debate on the floor; neither the Senate nor the House had any hearings on this very complex subject," says CAMR's Manganiello. "Indeed, we fear many members were denied the opportunity to fully grasp the impact of this." Researchers claim the Weldon plan is part of a larger agenda by religious conservatives and anti-abortion groups to give embryos full human rights. Religious leaders have indeed weighed in. Cardinal William Keeler, archbishop of Baltimore and chairman of the Pro-Life Committee for the US Conference of Catholic Bishops, urged political leaders to support Weldon's plan. "Tragically, some researchers want to patent and market human embryos with certain genetic profiles as models for studying diseases with genetic roots," Keeler wrote to Senate Majority Leader Bill Frist (R-Tenn). "Their project may well succeed, unless Congress provides clear and explicit support for the [Weldon] policy against patenting human embryos." Douglas Johnson, legislative director of the National Right to Life Committee, argues that Weldon's provision was necessary to prevent courts from trying to overturn the PTO policy banning patents on human beings. "There are a lot of people who believe that at such a time that some biotech firm would file such a patent [on a human organism] and be denied, they would go to court and the courts would likely rule there was no legal basis for denying the patent," Johnson says. "Now, if there were such a case, the courts would rule that Congress has spoken to the issue clearly." Moreover, Johnson contends that the provision is necessary because some researchers have an agenda they don't want to discuss openly. He notes that Sen. Sam Brownback (R-Kansas) tried to address researchers' concerns by spelling out that the Weldon plan would not prevent patents on stem cells, tissues, genes, hormones, and other things that researchers say they are concerned about. BIO rejected Brownback's offer, Johnson says. "They saw that the Brownback amendment would blow away their smokescreens and put a spotlight on the real basis for BIO's opposition to the Weldon amendment – the desire to keep the legal door open to obtaining patents on human embryos," Johnson says. "They wanted to conceal that issue under this blizzard of bogus claims." The Weldon plan, say Tipton and others, could have a chilling effect on future research funding. The threat that patents on certain stem cell processes might be denied could remove the economic incentive to conduct stem cell and therapeutic cloning research, drying up investment in such efforts. "People may not seek to translate basic research into clinical applications," Tipton says. "And it sends a negative signal to talented young scientists... saying [that] if you go into this field, it's a field fraught with political peril." BIO notes that it takes 10 to 12 years and about $800 million (US) to bring a biotechnology product into the market, and investors need assurances that their investment will pay off. "Without patent protection on products developed through biotechnology, investors would not put money into inventions that cannot be protected by the patenting system," states a BIO analysis of the Weldon plan. Unavailable would be "treatments for tissue regeneration for burn victims, bone marrow regeneration after chemotherapy, growth hormone deficiency, and some conditions for which lifesaving biotechnology therapeutics would not be available," according to the analysis. Because Congress must approve spending bills each year, Weldon will have to include his provision again in the 2005 budget, a process likely to get underway by year's end. CAMR, BIO, and others plan to launch an aggressive effort to prevent its inclusion next time. "We are hopeful that our reading of [Weldon's plan] essentially affirms [the PTO] policy," Werner says. "But if it doesn't, we will have even more concerns. "When it comes up again, I think there will be efforts by the research community to stop it." Dana Wilkie dwilkie@copleydc.com is a writer in Washington, DC.

Stealth Stipulation Shadows Stem Cell Research

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March 2004

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