Anna Dannreuther; all views are the author’s own

The Court of Justice of the European Union (CJEU) recently clarified its stance on biotechnology patents in the International Stem Cell Corporation case, modifying its earlier decision in Brüstle. The court now emphasizes the “inherent capacity” of a non-fertilized human egg stimulated by parthenogenesis to become a human being as the defining factor for it to be considered a “human embryo” and thus ineligible for patenting under the Biotechnology Directive. Previously, in Brüstle, the court considered such an egg a “human embryo” if it showed the ability to initiate the human development process.

Background

This case delves into the patentability of living organisms under the Biotechnology Directive 98/44. The directive seeks to balance the promotion of biotechnological advancement through patents with the protection of human dignity and integrity. While the directive generally handles biotechnological inventions like other scientific inventions seeking patents, it prohibits patenting certain processes for ethical reasons. Beyond a general ban on inventions contradicting public order or morality, the directive specifically forbids patenting processes involving human cloning, germline modification, and the use of human embryos for industrial or commercial purposes.

The 2011 Brüstle case presented the CJEU with the opportunity to define a “human embryo.” The case involved a German neurobiologist with a patent for producing neural precursor cells from human embryonic stem cells (a potentially confusing term as it’s used even when the cells aren’t derived from human embryos). He argued his methods offered significant therapeutic potential for neurological diseases. Greenpeace contested the patent’s validity, citing the use of human embryos in the process. The referring court sought clarification from the CJEU regarding the concept of a “human embryo” under the Directive. The CJEU concluded:

“any human ovum after fertilisation… and any non-fertilised human ovum whose division and further developments have been stimulated by parthenogenesis constitute a ‘human embryo’.” [para 38]

The court justified the unpatentability of both fertilized and non-fertilized eggs based on their shared capability, similar to embryos created through fertilization, to “commence the process of development of a human being” [para 36].

In the current case, International Stem Cell Corporation aims to patent in the UK a process for the “parthenogenetic activation of oocytes for the production of human embryonic stem cells.” This process essentially involves “activating” a human egg through chemical and electrical techniques. The activated egg can develop to the blastocyst stage (approximately 200-300 cells) but cannot progress further due to the absence of paternal DNA required for extra-embryonic material (placenta) formation. This process falls under the third category deemed unpatentable in Brüstle due to the creation of a “human embryo.”

Henry Carr QC, acting as Deputy Judge of the High Court, questioned the validity of the Court’s Brüstle interpretation, given current scientific understanding suggesting that parthenotes cannot develop into human beings. He referred a question to the CJEU on this point, strongly suggesting the Court should exclude this specific process from the “human embryo” definition. In his judgment, he notes:

“Stem cells have the potential to revolutionise the treatment of human disease because of their capacity to differentiate into almost any type of adult cell. The recitals to the Biotech Directive express two competing policy considerations. On the one hand, the research in the field of biotechnology is to be encouraged by means of the patent system, and on the other hand, that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person…The Biotech Directive is to be interpreted in a way that balances these competing policy considerations.”

Judgment

The CJEU clarifies that the Brüstle principle hinges on an unfertilized human egg stimulated by parthenogenesis (a parthenote) possessing the “inherent capacity of developing into a human being” to be classified as a “human embryo.” [para 28] Echoing the Advocate General’s Opinion, the court highlights that the focus should be on the parthenote’s potential to fully develop into a human being rather than its capacity to simply begin this process. The national courts are left to ascertain whether a specific parthenote has this capacity [paras. 36–38].

The court does not explicitly justify this shift in emphasis. It does, however, acknowledge discrepancies in the scientific information presented in the current case and in Brüstle. The current case suggests parthenotes cannot develop into humans, while information in Brüstle indicated they could [paras. 31, 33]. This seems to be a factor in the “foregoing considerations” mentioned in paragraph 38, which informs the Court’s judgment. The court did not address the possibility of genetically manipulating the parthenote to enable full-term development, as International Stem Cell Corporation had revised their applications to exclude the introduction of additional genetic material.

Comments

The court’s decision is generally positive. It refines the Brüstle ruling, so parthenotes are not automatically categorized as “human embryos” and thus excluded from patenting. This paves the way for patenting biological research using alternative methods for deriving embryonic stem cells. However, two points of contention arise.

First, as noted by the Advocate General in paragraph 43 of his Opinion, Member States retain the right to prohibit the patentability of parthenotes based on Article 6(1) of the Directive, citing public order or morality. While this shift from outright exclusion to Member State determination might be welcomed by countries with stricter biological protection stances (like Poland, which intervened to argue for excluding parthenotes from patentability to safeguard human dignity), it introduces risks. As the patentability of parthenotes now hinges solely on individual Member States’ cultural norms, “patent tourism” could emerge. Parthenote stem cell researchers might gravitate towards jurisdictions receptive to their practices and avoid less welcoming ones. This could impact the freedom of establishment and the free movement of services, disadvantaging researchers in less permissive jurisdictions. While this risk exists for all biotechnological processes, the reclassification of parthenotes could exacerbate inconsistencies in their treatment across Member States.

Second, the judgment lacks a clear discussion on the developmental stage at which an organism is considered a human being and thus excluded from the “human embryo” definition. The court defers to national courts to determine whether a parthenote has the “inherent capacity to develop into a human being.” This lack of guidance is unhelpful, as national courts must now decide both if the parthenote possesses this capacity and, if not, whether it should be excluded from patenting based on morality and/or public order. This places a significant burden on national courts, which could benefit from further guidance on the principle. Additionally, the principles derived from these cases are complex. Given that Brüstle still considers fertilized human eggs as “human embryos,” should national courts assume that parthenotes, lacking the capacity to form extra-embryonic tissue and differing in this way from fertilized eggs, do not constitute human beings? What if parthenotes capable of producing extra-embryonic tissue were created? Would the case law suggest that these parthenotes have the potential to develop into a human being? While seemingly straightforward, explicit clarification from the court would be beneficial.

Clarification on the patentability of parthenotes potentially subject to future genetic manipulation would also be beneficial.

Conclusion

Currently, patenting parthenotes is no longer strictly prohibited based on their classification as “human embryos” under Brüstle. However, their patentability rests entirely with individual Member States, based either on grounds of public order or morality, or on whether the Member State defines them as “human embryos” under the revised definition. Clearer guidance for national courts on what constitutes “development into a human being” would have strengthened the judgment.

Photo credit: Daily Telegraph