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Clarification of the UK Patent Office’s position on the patentability of inventions involving human embryonic stem cells

Clarification of the UK Patent Office’s position on the patentability of inventions involving human embryonic stem cells

23/06/03

The patentability of inventions involving human embryonic stem cells has been a controversial issue for many years. One case which attracted considerable publicity was a European patent application (the ‘Edinburgh’ application) directed to a method isolating embryonic stem cells from more differentiated cells in a cell culture. This application was opposed by 14 parties on the basis that such technology was immoral. Amongst the opponents were the governments of three European states. In the opposition proceedings, the patent was limited to exclude human cells, and was allowed to remain in force. Nevertheless, when the patent was originally granted in 1999, there was an enormous amount of public debate on the patentability of stem cell technology.

Although no such cases have arisen at the United Kingdom Patent Office, there has been uncertainty as the Patents Act 1977 does not explicitly discuss the patentability of stem cell technology.

To address this issue, the UK Patent Office has released a notice that will endeavour to clarify which facets of this controversial scientific field are patentable. The fundamental points of the notice are as follows:

Processes for obtaining stem cells from human embryos: - Unpatentable.

Paragraph 3(d) of Schedule A2 of the Patents Act 1977 states that the use of human embryos for industrial or commercial purposes is not patentable. The UK Patent Office will therefore not grant patents directed to processes of obtaining stem cells from human embryos.

Processes involving human totipotent cells: – Unpatentable

Human totipotent cells have the potential to develop into an entire human body. Such cells are therefore unpatentable, as paragraph 3(a) of Schedule A2 of the Patents Act 1977 excludes from patentability the human body at the various stages of its formation and development.

Processes involving human embryonic pluripotent stem cells: - Patentable

Human embryonic pluripotent stem cells do not have the potential to develop into an entire human body. Although there is opposition to embryonic stem cell research, this is outweighed by the enormous potential of stem cell research to deliver treatments for a wide range of diseases. Accordingly, as commercial exploitation of patents of these types of processes is not contrary to public policy or morality, the Patent Office will grant patents for inventions involving such cells, provided they satisfy the normal requirements for patentability.

If you would like any further information regarding the patentability of this type of technology, or any queries in general, please do not hesitate to contact us.