Defining “Research” in the US and EU: Contrast of Sherley v. Sebelius and Brüstle v. Greenpeace Rulings

• Published in: Stem cell reviews Vol. 9; no. 6; pp. 743 - 751
• Main Authors: Cuchiara, Maude L., Lawford Davies, James, Matthews, Kirstin R. W.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.12.2013; Springer Nature B.V
• Subjects: Biomedical and Life Sciences; Biomedical Engineering and Bioengineering; Cell Biology; Commerce; Embryonic Stem Cells - cytology; European Union; Humans; Legislation as Topic; Life Sciences; Patents as Topic - legislation & jurisprudence; Public Policy; Regenerative Medicine/Tissue Engineering; Stem Cell Research - economics; Stem Cell Research - legislation & jurisprudence; Stem Cells; United States; United States; Policy; Patent; Sherley v. Sebelius; Brustle v. Greenpeace; Court case
• ISSN: 1550-8943; 2629-3269; 1558-6804; 2629-3277
• DOI: 10.1007/s12015-013-9462-3

In 2011, courts in both the United States and European Union handed down decisions related to human embryonic stem cell (hESC) research. In both cases, the definition of research was challenged – but the two courts reached different opinions. In the US case, Sherley v. Sebelius , research was defined as a specific project. The US District Court of Appeals did not link research utilizing existing hESC lines to the act of destroying a human embryo in order to create the line, which is not eligible for federal funding. In contrast, the Court of Justice of the European Union in the Brüstle v. Greenpeace case determined inventions related to hESCs were unpatentable since they resulted from research that involved the destruction of human embryos. In this article, we will compare and contrast these two court cases, the politics related to the rulings, and their impacts. We find that these cases significantly impacted current research and have the potential to negatively impact future stem cell research and development. However, the long-term effects of the cases remain to be seen, and there is a chance that these cases could actually strengthen this area of science. Ultimately, we feel that stem cell polices must be straightforward and supported by the public to prevent courts and judges from making decisions on science, which are disruptive to the progression of research.