Inventions involving human embryonic stem cells
Advances in stem cell technology have triggered 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 has arisen 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 what will be the 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.
(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. Moreover, 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 has 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 is ready to grant patents for inventions involving such cells provided they satisfy the normal requirements for patentability.
A
Brimelow
Comptroller-General of Patents, Designs and Trade Marks
April
2003
If you have any enquiries about this Practice Notice, please contact:
Rowena Dinham
Concept House
Cardiff Road
Newport
South
Wales
NP10
8QQ
United Kingdom
Tel:
+44(0)1633 814995
Fax: +44(0)1633 814491
Footnote
- "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.
