UK Patent Office practice notice on patenting inventions involving human embryonic stem cells

London, 11 April 2003

The Patent Office today published a Practice Notice clarifying the UK's position on inventions involving human embryonic stem cells.

The Patent Office considers that, on balance, the commercial exploitation of inventions concerning certain types of human embryonic stem cells (pluripotent cells) would not be contrary to public policy or morality in the United Kingdom and so they should not be excluded from patentability.

Human embryonic pluripotent stem cells do not have the potential to develop into an entire human body. A number of reports from UK political, medical and scientific bodies 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.

The Patent Office will:

- not grant patents for processes of obtaining stem cells from human embryos. According to the Patents Act 1977, as amended, uses of human embryos for industrial or commercial purposes are not patentable inventions.

- not grant patents for human totipotent cells. Human totipotent cells have the potential to develop into an entire human body, and the human body at the various stages of its formation and development is excluded from patentability by the Patents Act 1977, as amended.

- grant patents for inventions involving human embryonic pluripotent stem cells provided they satisfy the normal requirements for patentability.

Patents provide an incentive to innovation. Without the protection provided by patents, industry and other inventors might not undertake the risk, investment and necessary research to make the advances that we hope for in this area such as improved healthcare products.

The framework for patenting of biotechnical inventions is set out by an EU Directive, and has been implemented into UK law by amending the Patents Act 1977.

The Directive does not explicitly address the patentability of inventions involving human embryonic stem cells. The Practice Notice sets out the new approach to the patentability of such inventions.

This approach though, as with all other Practice Notices published by the Patent Office, is subject to modification in the light of judgments from the courts.

Biotechnological inventions are judged against the normal patentability requirements of being novel, non-obvious and industrially applicable. Provided they can meet these requirements and are not excluded, for example, on moral grounds, a patent can be granted.

Notes for editors

1. The Practice Notice is available from the Patent Office website at http://www.patent.gov.uk/patent/notices/ practice/stemcells.htm

2. The EU Directive on the legal protection of biotechnical inventions can be found at http://europa.eu.int/smartapi/cgi/sga_do c?smartapi!celexapi!prod!CELEXnumdoc&lg= EN&numdoc=31998L0044&model=guichett and the amendments made to the Patents Act 1977 can be found at http://www.hmso.gov.uk/si/si2000/2000203 7.htm

3. Recent reports that have examined the issue of embryonic stem cell research include:

- "Stem cell research: medical progress with responsibility", the Donaldson Committee report, 16 August 2000, http://www.doh.gov.uk/cegc/

- "Stem cell research and therapeutic cloning: an update", the Royal Society, November 2000, http://www.royalsoc.ac.uk/policy/index.h tml

- "Stem cell therapy: the ethical issues, Nuffield Council on Bioethics", 14 November 2001, http://www.nuffieldbioethics.org/publica tions/pp_0000000007.asp

- "Report of the House of Lords Select Committee on stem cell research", 13 February 2002, http://www.publications.parliament.uk/pa /ld/ldstem.htm

Department of Trade and Industry, Press Release No. P/2003/253