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BIOETHICS

European Court Decision has Big Implications for Stem Cell Research

Brüstle v. Greenpeace, decided by the Court of Justice of the European Union, or CJEU, on October 18, 2011, changes the landscape of patent law in the European Union. Brüstle was referred from the Bundesgerichtshof, Germany’s Federal Court of Justice, to the CJEU for guidance on the meaning of “human embryo” in Directive 98/44/EC on the legal protection of biotechnological inventions (hereinafter Directive).

The CJEU ruling held that all processes, excluding those applied for the benefit of the embryo itself, requiring the prior destruction of human embryos, or their prior use as base material, cannot enjoy patent protection. This holding applies even if—as is the case with Oliver Brüstle’s patent on neuronal precursor cells generated from human embryonic stem cells, or hESCs—the patent application describing the process does not explicitly refer to the use of hESCs. CJEU decisions are binding on all EU member states. There is no avenue for appeal.

As expected, immediate responses to the ruling were negative. Research on hESCs, like all scientific research, relies on funding. Despite the growing promise of therapeutic treatments with hESCs, funding is not easy to obtain. Without the promise of patent protections, opponents of Brüstle contend, where is the incentive for investors to fund hESC research in the European Union?

This particularly affects academic institutions and smaller research companies, both of which do not generally take their research to the market themselves, but instead rely on securing licensing deals from investors after reaching the proof-of-concept stage. Moreover, hESC researchers are perplexed by the funding paradox Brüstle begets. It seems odd, researchers aver, that Brüstle allows funded research on established cell lines, but will not reward their ultimate efforts with patent protection. Some have even questioned whether, absent such protections, researchers will relocate to the United States and Asia, where patent protection is available, thus creating a European “brain drain.”

Many, however, argue that funding worries have been exaggerated. Chiefly, Brüstle only affects hESC patents obtained in EU member states, so EU researchers can simply apply for patents in the United States or Asia, where similar restrictions do not exist. As opponents note, however, some researchers may be unwilling to apply for patents abroad because they would have to disclose information that could otherwise be kept as trade secrets in the European Union. Importantly, Brüstle does not affect patents on related hESC technologies. Consequently, researchers may still obtain patents in the European Union for, for instance, mechanisms or devices for delivering cells. By shifting the focus to related technologies, researchers may still be able to secure investor funding for their efforts, despite Brüstle’s effects. Some have even suggested that Brüstle might actually accelerate hESC research because the ruling eliminates potential worries over unintentionally infringing on other researchers’ patents.

While these practical concerns are important, the enduring worry with Brüstle is its affect on moral issues surrounding stem cell research. In interpreting the meaning of “human embryo” in the Directive, the CJEU relied on the Directive’s legislative intent of preventing patentability where respect for human dignity could be harmed. The CJEU, therefore, adopted a wide definition of “human embryo,” which includes: 1) any fertilized human ovum; 2) any nonfertilized human ovum into which the cell nucleus from a mature human cell has been transplanted; and 3) any nonfertilized human ovum whose division and further development have been stimulated by parthenogenesis, i.e., the process by which an oocyte develops into an embryo without being fertilized by a spermatozoon.

There are two problems here. First, although the CJEU stressed that it must only offer a legal interpretation of the Directive, not broach ethical questions, it has unwittingly weighed in on the moral debate. Conservatives, progressives, and transhumanists have widely divergent viewpoints on the concept of human dignity. The Directive seems to embody a conservative approach to patentability of biotechnology. By blindly relying on the Directive’s approach, the CJEU has implicitly adopted this stance in Brüstle. Second, by adopting a particular stance on human dignity, the CJEU has undercut its efforts toward uniformity in the European Union. Member states do not all share the same cultural and religious values and, hence, do not share the same stance on human dignity. How can uniformity be maintained when Brüstle places the CJEU on one side of the debate?

The second issue in Brüstle is whether the challenged patent violates the Directive, which bars the patenting of an invention where its commercial exploitation is contrary to morality or ordre public (public policy). This, roughly, is the commodification argument, which comprised Greenpeace’s primary challenge to Dr. Brüstle’s patent. The CJEU noted that the aim of scientific research is distinguishable from industrial or commercial purposes. Because granting a patent by definition entails industrial or commercial application, however, the use of human embryos for purposes of research that constitutes the subject matter of a patent application cannot, the CJEU held, be separated from industrial and commercial use.

Entertaining the commodification argument, however, is worrisome because the argument is not well defined. An appeal to commodification is often used for its rhetorical force, rather than for sound reasoning. Most people likely oppose commodifying humans, but the argument itself rarely goes beyond this initial appeal. The CJEU conflates hESC research with commercial intentions in a way that plays on this rhetorical force. This issue is emblematic of the ambiguity that plagues Brüstle. Not only is “commodification” employed vaguely in the ruling, but we are also left uncertain of the meaning of other terms, such as “human dignity” and “morality,” upon which the CJEU relies. This confusion is highlighted by some researchers, who do not understand how the CJEU can deem their research immoral when member states’ governments do not. Moreover, embracing a consequentialist viewpoint on morality, some have questioned how their research can be immoral when it has such promising therapeutic possibilities.

Brüstle, ultimately, is worrisome because this ambiguity comes with a lack of future guidance, both legally and ethically. Stem cell research is a rapidly changing field, particularly considering recent advancements with induced pluripotent stem cells, or iPSCs. The CJEU’s definition of “human embryo” begs the question: Will iPSCs have the same fate as hESCs under EU patent law? Ethics has always had trouble pacing scientific discovery. The law, too, suffers from similar difficulties. Brüstle only further muddies the waters.

Nicholas J. Diamond, a lawyer by training, is currently finishing graduate work in bioethics at the University of Pennsylvania.

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