In a recent commentary, Baker Institute science and technology policy experts described two international court cases that aimed to define “research” — and that ultimately arrived at two different answers.
“What makes this interesting is that the courts’ definition of ‘research’ was based on politics — what the court wanted the end result to be,” said Kirstin Matthews, the institute’s fellow in science and technology policy. To reach a decision prohibiting human embryonic stem cell (hESC) patents, the EU court ruled that “research” occurs in a continuum. To reach a decision supporting federal funding of stem cell research, the U.S. court ruled that “research” involves a specific project.
In the U.S. case, Sherley v. Sebelius, the plaintiffs claimed that a Department of Health and Human Services (DHHS) policy allowing federal funding for hESC research violated federal law. The plaintiffs argued that the policy conflicted with the Dickey-Wicker Amendment, which prohibits federal funding of research involving the destruction of a human embryo. In its ruling, the U.S. Court of Appeals defined “research” as a specific project. Research utilizing existing hESC lines was viewed differently from research that included the creation of novel hESC lines (a process that requires the destruction of a human embryo and is not eligible for federal funding). This ruling upheld the Obama administration’s 2009 stem cell policy.
In the EU case Brüstle v. Greenpeace, Greenpeace sued scientist Oliver Brüstle over his patent that proposed the use of hESCs to generate nerve cells. The EU Biotechnology Directive specifically bans the patenting of the human body and “uses of human embryos for industrial or commercial purposes.” The EU court defined “research” as an entire series of related projects. Since the patent involved hESCs, it was revoked despite the fact that it did not include the creation of hESCs. As a result, any technologies that use hESCs or their products cannot be patented in the European Union.
Both cases were extremely disruptive to stem cell research. While the ruling in the US was favorable to stem cell research, a temporary injunction was placed on approximately $123 million worth of hESC research funded by the National Institutes of Health while lawyers appealed the decision. In the EU, the ruling against patenting of hESC-related technology sent shockwaves through the biotechnology industry. But with the complex nature of the research, some researchers argued that patenting might not be as necessary as it is in other fields. Many biotechnologies require specific cells, conditions, and techniques that can be controlled without patenting.
While the long-term effects of the court rulings remain to be seen, the cases ultimately demonstrated that ambiguous science policies make research an easy target for lawsuits. Furthermore, the courts’ definitions of “research” appeared to be influenced by the political climate of the day. Stem cell polices must be straightforward and supported by the public to prevent the courts from making scientific decisions and hindering advancements in research.
The article “Defining ‘Research’ in the US and EU: Contrast of Sherley v. Sebelius and Brüstle v. Greenpeace Rulings” by Maude Rowland Cuchiara, James Lawford Davies. and Kirstin R.W. Matthews was published online in the July 2013 issue of Stem Cell Reviews and Reports. Matthews is a fellow for science and technology policy at Rice University’s Baker Institute and a lecturer in natural sciences and sociology; Cuchiara is a Baker Institute faculty scholar; and Davies is a British lawyer.
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Dec. 1, 2013, 4:31 p.m.