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Reviewed 5 December 2012

Inventions involving human embryonic stem cells

The practice disclosed in this notice has been updated, please see Inventions involving human embryonic stem cells (17 May 2012) for more details.

Advances in stem cell technology raise questions about the patentability of:

  • stem cells which have been isolated from human embryos, and
  • processes involving these cells

Uncertainty about what can be patented in this field may arise because the Patents Act 1977, as amended to implement Directive 98/44/EC on the legal protection of biotechnological inventions, does not directly address the patentability of human embryonic stem cells

This Notice sets out the Intellectual Property Office’s general practice on the patentability of inventions involving such stem cells, although each case will be treated on its own merits in the light of all the relevant circumstances. Moreover, the Office's practice is subject to any future guidance from the UK courts.

This Notice supersedes a previous Notice of the same title issued in April 2003. It reflects an update in the Office's practice to take account of the recent WARF decision External Link from the European Patent Office Enlarged Board of Appeal (EBoA), which has addressed the patentabilty of human embryonic stem cell cultures. The EBoA held as unpatentable those products (namely, human embryonic stem cell cultures) which at the filing date of the patent application in question could only be obtained from a method which involved the destruction of human embryos. However, the EBoA concluded that the decision “is not concerned with the patentability in general of inventions relating to human stem cells or human stem cell cultures.”

The Office has reconsidered its practice in this area in light of this decision.

(i) Processes for obtaining stem cells from human embryos

According to Paragraph 3(d) of Schedule A2 to the Patents Act 1977 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 Patents Act 1977. The Office will therefore not grant patents for human totipotent cells.

(iii) Human embryonic pluripotent stem cells

Human embryonic pluripotent stem cells, which arise from further division of totipotent cells, do not have the potential to develop into an entire human body, and can be grown in culture and the cell lines stored in cell banks. Although there is some opposition in the United Kingdom to research involving embryonic stem cells, a number of reports from influential UK political, medical and scientific bodies [1] in recent years have emphasised the enormous potential of stem cell research, including embryonic stem cell research, to deliver new treatments for a wide range of serious diseases. This indicates that on balance the commercial exploitation of inventions concerning human embryonic pluripotent stem cells would not be contrary to public policy or morality in the United Kingdom. Thus, the Office will continue to grant patents for inventions involving such cells provided they satisfy the normal requirements for patentability and provided that, at the filing or priority date, the invention could be obtained by means other than the destruction of human embryos.

Enquiries

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

Rowena Dinham

Intellectual Property Office
Concept House
Cardiff Road
Newport
South Wales
NP10 8QQ
United Kingdom

Tel:  +44 (0) 1633 814995
Fax: +44 (0) 1633 814491

Sean Dennehey
Director of Patents
Intellectual Property Office

3 February 2009

Footnote

1. "Stem cell research: medical progress with responsibility", the Donaldson Committee report, 16 August 2000, "Stem cell research and therapeutic cloning: an update", The Royal Society, November 2000, "Stem cell therapy: the ethical issues", Nuffield Council on Bioethics, 14 November 2001, "Report of the House of Lords Select Committee on stem cell research", 13 February 2002.