The UK Intellectual Property Office (UK IPO) issued a notice in February, clarifying its position on inventions involving human embryonic stem cells. The notice explains the UK IPO's updated practice in this area further to the November 2008 decision from the European Patent Office Enlarged Board of Appeal (EBoA) on the WARF/Thomson stem cell application and replaces a previous note on the same subject issued in April 2003.
The EBoA's decision held that any products (i.e. human embryonic stem cell cultures), which at the filing date of a patent application could only be obtained from a method involving the destruction of human embryos, are not patentable. However, the EBoA noted that the decision "is not concerned with the patentability in general of inventions relating to human stem cells or human stem cell culture".
The UK IPO has reconsidered its practice in this area in light of the decision and in the new notice, sets out a summary of its approach to considering patent applications for:
- processes for obtaining stem cells from human embryos;
- human totipotent cells; and
- human embryonic pluripotent stem cells.
Processes for obtaining stem cells from human embryos
The UK IPO states that it will not grant patents for processes for obtaining stem cells from human embryos. This is in accordance with Paragraph 3(d) of Schedule 12 of the Patents Act 1977, which provides that uses of human embryos for industrial or commercial purposes are not patentable inventions.
Human totipotent cells
Human totipotent cells are cells which have the potential to develop into an entire human body. The UK IPO note states that the UK IPO will also not grant patents for human totipotent cells, because such cells are not patentable under Paragraph 3(a) of Schedule A2 to the Patents act 1977, which excludes the human body (at the various stages of its formation and development) from patentability.
Human embryonic pluripotent stem cells
Human embryonic pluripotent stem cells are created when totipotent cells divide. Pluripotent cells no longer have the potential to develop into an entire human body. Pluripotent stem cells can give rise to any foetal or adult cell type, but cannot develop into a foetus or adult human because they do not have the potential to contribute to extraembryonic tissue, such as the placenta. Crucially pluripotent cells can be grown in culture and the cell lines can be stored in cell banks. The UK IPO note says that the UK IPO will grant patents for inventions involving human embryonic pluripotent stem cells provided that (i) the usual requirements for patentability are met and (ii) that at the priority date for the application, it is possible to achieve the invention without the destruction of human embryos. This second proviso echoes the essence of the WARF decision.
In its discussion of the patentability of inventions involving human embryonic pluripotent stem cells, the UK IPO notice mentions the opposition from some fronts in the UK to research involving human embryonic stem cells of any sort. However, it concludes that on balance, taking into account reports from "a number of influential UK political, medical and scientific bodies", inventions involving human embryonic pluripotent stem cells would not be contrary to morality or public policy in the UK.