## Facts

- A German patent was granted to Dr. Oliver Brüstle for isolated and purified neural precursor cells derived from human embryonic stem cells, related production processes, and therapeutic uses for neurological diseases.
- Greenpeace e.V. filed an action in German courts seeking annulment of the patent on morality grounds tied to the use of human embryos.
- The German Federal Patent Court invalidated the patent insofar as it covered processes for obtaining precursor cells from human embryonic stem cells.
- On appeal, the German Federal Court of Justice referred questions to the Court of Justice of the European Union (Grand Chamber) for a preliminary ruling interpreting Directive 98/44/EC, including the meaning of “human embryo” and the scope of the exclusion for “uses of human embryos for industrial or commercial purposes.”

## Issues

1. How should “human embryo” be defined for purposes of the patentability exclusion in Directive 98/44/EC Article 6(2)(c), including whether it covers entities beyond a fertilized ovum.
2. Whether a process is excluded from patentability when it involves removal of a stem cell from a blastocyst-stage embryo in a way that destroys the embryo.
3. Whether the exclusion for “uses of human embryos for industrial or commercial purposes” extends to scientific research uses and to inventions whose implementation presupposes prior destruction or use of embryos as base material.

## Decision

- The court held that “human embryo” is an autonomous concept of EU law requiring uniform interpretation across Member States.
- The term “human embryo” must be interpreted broadly to include:
  - any fertilized human ovum capable of commencing the development of a human being; and
  - certain non-fertilized human ova that have been manipulated (including somatic cell nuclear transfer and parthenogenesis) where they are capable of commencing such development.
- A process that entails destruction of a human embryo (including removal of a stem cell at the blastocyst stage that destroys the embryo) is excluded from patentability.
- The exclusion applies even if the patent claims do not expressly mention embryos, where the invention requires prior destruction of embryos or their use as base material.
- Therapeutic or diagnostic uses applied to the embryo and useful to it are not excluded; use of embryos for scientific research is excluded when tied to industrial or commercial exploitation.
- Applying these rules, inventions like Brüstle’s—dependent on embryonic stem cells obtained by destroying embryos—fell within the exclusion from patentability.

## Legal Principles

- Patent-law morality exclusions in Directive 98/44/EC Article 6(2)(c) require a uniform EU-wide definition of “human embryo.”
- “Human embryo” includes biological entities capable of commencing the developmental process of a human being, not limited to a fertilized ovum.
- Inventions are unpatentable where their implementation requires destruction of human embryos or use of human embryos as starting material, regardless of how the claims are drafted.
- The phrase “uses of human embryos for industrial or commercial purposes” is interpreted broadly and can cover research uses linked to industrial or commercial exploitation.
- A narrow exception permits patentability for therapeutic or diagnostic uses that are applied to, and beneficial for, the human embryo itself.

## Conclusion

The court adopted a broad, uniform EU definition of “human embryo” and held that patent protection is unavailable for inventions whose execution presupposes the destruction of human embryos or their use as base material, while leaving room only for patents on therapeutic or diagnostic applications that benefit the embryo.


Brüstle v. Greenpeace e.V., Case C-34/10 (C.J.E.U. 2011)