In the Brüstle judgment, handed down on 18 October 2011, the Court of Justice of the European Union (CJEU) ruled on the interpretation of the Biotechnology Directive with respect to the patentability of human embryonic stem cells. The CJEU ruled that any invention which requires the destruction of a human embryo was not patentable. This includes an invention whose implementation requires the use of an embryonic stem cell line, the establishment of which originally required the destruction of a human embryo. This judgment went one stage further than the interpretation by the European Patent Office (EPO) of the Enlarged Board of Appeal’s decision in the WARF case. The EPO had interpreted the WARF decision to mean that inventions which relied on embryonic stem cell lines are patentable; as long as the applications were filed after such stem cell lines were available. The EPO made this interpretation despite the fact that the embryonic stem cell lines themselves were derived from the destruction of an embryo.
Both the EPO and the United Kingdom Intellectual Property Office (UK IPO) have now issued revised examination guidelines in light of the Brüstle judgment. The UK IPO is bound by the judgment of the CJEU in Brüstle but strictly speaking the EPO is not. However, in practice it would be illogical for the EPO to grant patents which were then not valid in the EU Member States and therefore it was most likely that the EPO would revise its guidelines in light of the Brüstle judgment.
The EPO Guidelines are relatively brief. They state that a claim directed to a product which at the time of filing of the application could only be obtained by the destruction of a human embryo is excluded from patentability. They also state that the point in time at which such destruction takes place is irrelevant. The guidelines state that when examining subject matter relating to human embryonic stem cells, the entire teaching of the application and the relevant disclosure in the description have to be taken into account to establish whether the products are exclusively obtained by the use, involving the destruction, of a human embryo.
It is clear that destruction of a human embryo or use of a cell line derived from destruction of a human embryo is a bar to patentability. However, the brevity of the EPO Guidelines leaves some uncertainty as to the EPO’s practice in relation to stem cells which hopefully will become clearer as individual cases are examined. For example, the patentability of induced pluripotent stem cells (iPS cells) is not discussed in the guidelines. As adult cells which have been de-differentiated to stem cells one would expect iPS cells to be patentable since the technology does not require the destruction of human embryos. Nevertheless, the guidelines make no reference to iPS cells so that some uncertainty regarding their patentability remains in place.
UK IPO Guidelines
The UK IPO guidelines provide a little more guidance on the patentability of human embryonic stem cells. In its revised guidelines, the UK IPO has repeated its previous position that human totipotent cells, which have the potential to develop into the entire human body, are not patentable. Moreover, methods for culturing or propagating such totipotent stem cells are not patentable. Following the Brüstle judgment, the UK IPO guidelines also state that an invention which requires the use of cells that originate from a process that requires the destruction of a human embryo is not patentable irrespective of whether the claims refer to the use of human embryos. Such an invention is not patentable irrespective of when the destruction took place and the guidelines specifically state that where the invention uses an embryonic stem cell line which was derived from the destruction of a human embryo the invention is not patentable.
In contrast to the EPO guidelines, the UK IPO guidelines do refer to iPS cells. They state that iPS cells which are obtained from the de-differentiation of adult stem cells by the forced expression of certain genes are clearly not obtained from a human embryo. The guidelines state that iPS cells cannot go on to form a human being and are not subject to the same exclusion as to patentability.
It will be interesting to see how the patentability of stem cell inventions develops, for example with respect to iPS cells. Although the UK IPO have given some guidance with respect to iPS cells further questions are likely to arise. For example, it is theoretically possible to de-differentiate an adult cell to a sufficiently immature phenotype that it could give rise to any tissue of the human body and therefore theoretically a human being. The UK IPO seems likely to take the view that such a cell is not patentable, either considering it to be a totipotent cell or a cell capable of forming a human being.
The Brüstle judgment has significantly restricted what is patentable with respect to human embryonic stem cells. However, the emergence of newer technologies, such as iPS cells and human embryonic stem cells derived from umbilical cord blood, should give stem cell companies opportunities to protect their intellectual property. The stem cell research industry will be keeping a close eye on how EPO and UK IPO practice develops.
For more information, contact Simon Bradbury or your usual Appleyard Lees advisor.
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