Inventions involving human embryonic stem cells: 27 June 2014 (archived version)
Published 27 June 2014
© Crown copyright 2014
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1. Archived version
Please note this version is no longer current practice see updated version.
2. Background
The Court of Justice of the European Union (“CJEU”) recently delivered its judgment in case C-34/10, where it ruled on the interpretation of Article 6(2)(c) of European Directive 98/44/EC (“the Directive”) on the patentability of biotechnological inventions. This Article excludes from patentability uses of human embryos for industrial or commercial purposes.
The Directive has been implemented into UK law by virtue of amendments to the Patents Act 1977. Paragraph 3(d) of Schedule A2 to that Act corresponds to Article 6(2)(c) of the Directive. Any interpretation of the Directive by the CJEU is therefore binding on the UK.
3. Definition of the term “embryo”
The CJEU ruled that, for the purposes of Article 6(2)(c), the term “human embryo” must be interpreted broadly to include any organism that is “capable of commencing the process of development of a human being”. This includes:
A human ovum as soon as fertilised, if that fertilisation is such as to commence the process of development of a human being; A non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, insofar as it is capable of commencing the process of development of a human being; A non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis, insofar as it is capable of commencing the process of development of a human being.
4. Scope of the exclusion
The CJEU ruled that use of human embryos within the meaning of Article 6(2)(c) of the Directive occurs if the implementation of the invention requires the destruction of human embryos, even if the claims of the patent do not refer to the use of human embryos. The CJEU also ruled that the destruction may occur at any stage, including long before the implementation of the invention. Thus, the Office practice will now recognise that where the implementation of an invention requires the use of cells that originate from a process which requires the destruction of a human embryo, the invention is not patentable according to paragraph 3(d) of Schedule A2. For example, where the implementation of the invention requires the use of a human embryonic stem cell line the establishment of which originally required the destruction of a human embryo, the invention is not patentable.
The practice of the Office in relation to human stem cells that are not derived from human embryos, such as induced pluripotent cells and adult stem cells, is unchanged. Patents for inventions concerning such cells will be granted provided that they satisfy the normal requirements for patentability.
The CJEU judgment confirmed that inventions that are for therapeutic or diagnostic purposes that are applied to and useful to the human embryo are not excluded from patentability. The Office will continue to grant patents for such inventions provided they meet the other legal requirements.
5. Enquiries
If you have any enquiries about this Practice Notice, please contact:
Philip Mountjoy
Intellectual Property Office
Concept House
Cardiff Road
Newport
South Wales
NP10 8QQ
United Kingdom
Tel: +44(0)16 3381 4355
Fax: +44(0)16 3381 4491
Sean Dennehey
Director of Patents
Intellectual Property Office