## Facts

- A biotechnology company filed two UK patent applications covering methods and products for producing human pluripotent stem cells from parthenogenetically activated unfertilised human oocytes (parthenotes).
- The inventions relied on parthenotes modified so they lacked the inherent capacity to develop into a human being; due to genomic imprinting, they could undergo limited development but could not develop to term.
- The UK Patent Office rejected the applications as unpatentable, treating the inventions as involving “uses of human embryos for industrial or commercial purposes” under national law implementing Directive 98/44/EC.
- The rejection relied on an earlier CJEU interpretation that treated certain parthenogenetically activated ova as “human embryos” when they are capable of commencing the developmental process of a human being.
- On appeal, the UK High Court accepted as a factual premise that the parthenotes at issue were incapable, given current scientific knowledge, of developing into a human being and referred a question to the CJEU for interpretation of EU law.

## Issues

1. Whether unfertilised human ova stimulated by parthenogenesis, which are incapable (given current scientific knowledge) of developing into a human being, fall within “human embryos” under Directive 98/44/EC’s patentability exclusion.
2. How to apply the criterion “capable of commencing the process of development of a human being” to parthenotes that can divide but cannot develop into a human being.

## Decision

- The CJEU held that a parthenote is not a “human embryo” for purposes of the Directive’s exclusion if, in light of current scientific knowledge, it does not have the inherent capacity to develop into a human being.
- The Court clarified that the relevant capacity is the inherent ability to develop into a human being, not merely the ability to initiate cell division or limited development.
- The Court left to the referring national court the factual determination whether the parthenotes described in the applications lacked that inherent developmental capacity.
- The case returned to the national court to apply the clarified EU-law test; other possible patentability objections under morality/ordre public were not resolved by the ruling.

## Legal Principles

- “Human embryo” in Directive 98/44/EC is an autonomous EU-law concept requiring uniform interpretation across Member States.
- An organism constitutes a “human embryo” only if it has the inherent capacity to develop into a human being, assessed in light of current scientific knowledge.
- The phrase “capable of commencing the process of development of a human being” refers to initiating a developmental process that can lead to a human being, not mere cellular division.
- The Directive’s exclusion for “uses of human embryos for industrial or commercial purposes” is construed narrowly and should not extend to entities lacking inherent capacity to develop into a human being.
- Scientific capability is a factual matter for national courts to assess, applying the legal test articulated by the CJEU; the classification may change if scientific developments alter inherent capacities.

## Conclusion

The CJEU limited the embryo-based patent exclusion by holding that parthenotes are outside “human embryo” when they lack, given current science, the inherent capacity to develop into a human being, and it directed national courts to apply this capacity-based test to the facts.


Int’l Stem Cell Corp. v. Comptroller Gen. of Patents, Designs & Trade Marks, Case C-364/13 (C.J.E.U. 2014)