Stem cells have the advantage that they can differentiate into a wide range of specialised cell types and have the ability to self-replicate. Stem cell research is a rapidly developing area, providing tools that may be used in the repair or replacement of tissues. Such research has great potential to medicine and may provide significant advancement in the treatment of a variety of conditions and diseases. However, stem cell research often involves the use of human embryos and as such has raised moral and ethical questions.
When we last wrote on this subject in Spring 2009 edition of this newsletter , we mentioned that new methods have been developed for the production of stem cell lines (‘induced pluripotent stem cells') that do not require the use of human embryos but involve inducing adult cells to revert back to the pluripotent state and we wrote that questions remained open over whether human embryonic stem cells (hESCs) prepared using methods in which the embryos remain viable would be allowable.
hESC lines were good enough
Research has allowed for the production of hESC lines which are a suitable starting point for many inventions in this field. Such cell lines are considered to have been available from May 2003. Since the WARF (Wisconsin Alumni Research Foundation) decision (G2/06) of 2008 the UKIPO position allowed for inventions that could have been performed using a deposited stem cell line. Accordingly, patent applications filed after May 2003, were generally considered free from the exclusion because destruction of a human embryo was not necessary as part of the invention.
Since then, the CJEU has had cause to consider the matter in case C-34/10. Its decision issued in October 2011.
The CJEU concluded that a human embryo includes an ovum (whether resulting from fertilisation or otherwise) but left open for future consideration in the light of scientific developments the question of whether a single stem cell obtained from a human embryonic blastocyst might also constitute an embryo within the meaning of Directive 98/44/EC of the European Parliament and of the Council.
The exclusion is now broader
Subsequent to that decision, the EPO has issued a new Guideline on the subject and the UKIPO has issued a practice note. These broaden the exclusion to patentability.
The EPO will not grant claims to inventions that necessarily involve the destruction of human embryos. This position has been encoded in new Guideline G-II, 5.3(iii):
A claim directed to a product, which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability under Rule 28(c), even if said method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant.
Examiners are required to consider the entire teaching to establish whether products such as stem cell cultures are obtained exclusively by the use, involving the destruction, of a human embryo.
The UKIPO position is similar. It will not grant claims for inventions relating to stem cells (including hESC lines) that have involved the destruction of a human embryo. Taken literally, this would seem to hinge on a more factual question of what eventually happened to the embryo from which the hESC lines were derived. In practice, the position is probably the same as the EPO position, viz. does the specification describe an acceptable way of obtaining the invention?
There will be many patent applications granted or under examination that were considered acceptable prior to the CJEU decision but relied on hESC lines for sufficiency of disclosure. The validity of these will now be in grave doubt.
No change for inventions for therapeutic or diagnostic purposes
The exclusion of the uses of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it. This is clear from the Directive and is repeated in the new Guideline and the UKIPO practice note.
Our advice for applicants is unchanged
- Where possible, applications should include a sufficient disclosure of at least one method by which the stem cells involved in the application can be produced without using human embryos.
- If the invention necessarily involves the use of human embryos, where possible applicants should provide a disclosure of a method of production that does not involve the destruction of those human embryos.
One-Minute Tutorial on Stem Cells
Totipotent cells - these are cells which have the potential to develop into an entire human body. They can develop into any organ of the body, including a placenta. Hence, they can develop into a foetus.
Pluripotent cells - these are cells which have been produced by further division of human totipotent cells and which do not have the potential to develop into an entire human body. They cannot , for example, develop into placenta cells, so they cannot develop into a foetus. Nevertheless, their capacity to develop into many other organs (if not all other organs) makes them as interesting to research as totipotent cells.
Induced pluripotent cells are pluripotent cells which are artificially produced from an adult cell by the forced expression of certain genes.
A blastocyst is a ball of cells formed early in the process of embryonic development. As the blastocyst develops, a stage is reached at which cells in the centre are no longer able to form a placenta. They are no longer totipotent and are merely pluripotent.
We are informed by the European Human Embryonic Stem Cell Registry (hESCreg) that extraction of pluripotent stem cells from a blastocyst that has actually proceeded to develop to a live birth of an infant is, at the time of going to press, a possibility that has been described only in theory. It would be a brave mother who would permit such a procedure.