Statutory guidance

Inventions involving human embryonic stem cells: 25 March 2015

Published 25 March 2015

This notice replaces and updates the guidance given in the Office’s previous Practice Notices dated 3 February 2009, 17 May 2012, and 27 June 2014.

1. Background

European Directive 98/44/EC (“the Directive”) on the patentability of biotechnological inventions was implemented into UK law by virtue of amendments to the Patents Act 1977 (“the Act”). Any interpretation of the Directive by the Court of Justice of the European Union (“CJEU”) is therefore binding on the UK.

In C-34/10 (“Brüstle”), the CJEU ruled on the interpretation of Article 6(2)(c) of the Directive. This Article excludes from patentability uses of human embryos for industrial or commercial purposes. Paragraph 3(d) of Schedule A2 to the Act corresponds to Article 6(2)(c) of the Directive.

2. Definition of the term “human embryo”

The CJEU ruled in Brüstle 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”. The CJEU held that the term “human embryo” included:

• any human ovum after fertilisation, 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

In C-364/13 (“International Stem Cell Corporation”), the CJEU has further clarified the definition of the term “embryo” for the purposes of Article 6(2)(c) of the Directive, by ruling that:

an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’ within the meaning of that provision [i.e. Article 6(2)(c) of the Directive], if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being.

3. Scope of the exclusion

In light of the aforementioned decisions, the Office’s practice for inventions involving human embryonic stem cells is as follows, with the term “human embryo” interpreted in accordance with those decisions:

(i) Processes for obtaining stem cells from human embryos

According to paragraph 3(d) of Schedule A2 to the Act, uses of human embryos for industrial or commercial purposes are not patentable inventions. On this basis, the Office will not grant patents for processes of obtaining stem cells from human embryos.

(ii) Human totipotent cells

Human totipotent cells have the potential to develop into an entire human body. In view of this potential, such cells are not patentable because the human body at the various stages of its formation and development is excluded from patentability by paragraph 3(a) of Schedule A2 to the Act. The Office will therefore not grant patents for human totipotent cells.

(iii) Inventions requiring the destruction of human embryos

In Brüstle, 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, 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 to the Act. 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.

(iv) Human stem cells not derived from human embryos

Patents for inventions concerning human stem cells that are not derived from human embryos, such as induced pluripotent cells and adult stem cells, will be granted provided that they satisfy the normal requirements for patentability.

(v) Inventions for therapeutic or diagnostic purposes

The CJEU judgment in Brüstle 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.

Further details of the Office’s practice in relation to inventions involving human embryonic stem cells can be found in the Office’s ‘Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the Intellectual Property Office’.

4. Enquiries

If you have any enquiries about this Practice Notice, please contact:

Dr Philip Mountjoy
Intellectual Property Office
Concept House
Cardiff Road
Newport
South Wales
NP10 8QQ
United Kingdom
Tel: +44(0)16 3381 4355

Julyan Elbro
Divisional Director, Patent Examination
Intellectual Property Office