European Union: EPO Practice - Patenting Human Embryonic Stem Cells in Europe

The patentability of biotechnological inventions in the European Union is governed by European Directive 98/44/EC (the "Biotech Directive").  One effect of the Biotech Directive is to prohibit patents on the use of human embryos for commercial or industrial purposes. 

This issue commonly arises in the field of human embryonic stem cells.  Embryonic stem cells are derived from early stage embryos, and the original methods for obtaining such cells involved destroying the embryo.  The European Patent Office (EPO) interprets the Biotech Directive as meaning that a patent may not be granted to any product or method that requires the destruction of a human embryo.  This has been further clarified by recent decisions of the EPO and the Court of Justice of the European Union (CJEU), which have considered what is meant by the term "embryo" in this context, and how this prohibition should be applied in the context of downstream products and processes. 

Definition of an "Embryo"

In a 2011 decision (Case C-34/10, Oliver Brüstle v. Greenpeace eV), the CJEU held that the term "embryo" should be interpreted broadly to cover all stages of human development after fertilization of a human egg, and also to cover all similar cells that are "capable of commencing the process of development of a human being."  This meant that a wide variety of cell types fell within the exclusion from patentability.

However, in December 2014, the CJEU was asked to consider this issue again, this time in the particular context of parthenogenetically activated human oocytes, i.e., human egg cells that had been chemically activated but that had not actually been fertilized.

In their 2011 decision, the CJEU specifically stated that this type of activated oocyte should be included in the definition of an embryo because these cells are "capable of starting" the process of development into a human being.

However, in their 2014 decision (Case C-364/13, Int'l Stem Cell Corp. v. Comptroller General of Patents, Designs and Trade Marks), the CJEU reviewed new technical information and came to a different conclusion.  They held that a human embryo should only cover cells that have the inherent capacity to develop into a human being.  The term "embryo" therefore does not cover all cells that are capable of starting to develop into a human being, only those that have the capacity to fully develop into a human being. 

Based on the evidence presented to the court in this case, it seems that parthenogenetically activated human oocytes will now be patentable in Europe.  It is also possible that some other cell types, which would have been excluded from patentability under the CJEU's 2011 decision, may now be patentable if it can be shown that they are not capable of fully developing into a human being.

Effect on Downstream Products and Processes

Prior to the CJEU's 2011 decision, the EPO had taken the view that the exclusion provided by the Biotech Directive would not apply if it was possible to obtain suitable human embryonic stem cells from a commercially available cell line.  For example, if human embryonic stem cells could be purchased from such a cell line at the priority/filing date of the patent, then any downstream methods, uses, or products derived from them could be patented.

However, in its 2011 decision (Case C-34/10, Oliver Brüstle v. Greenpeace eV), the CJEU also concluded that the "use of a human embryo" in the Biotech Directive does not have to be part of the invention that is claimed.  If a human embryo was destroyed at any earlier stage, even if that destruction occurred long before the implementation of the invention, then the invention cannot be patented.  This means that, for example, new uses of a commercially available human embryonic stem cell line may not be patentable, if that cell line was originally produced by a method that involved destroying a human embryo.  The effects of the Biotech Directive therefore apply not only to human embryos and their direct uses, but also to all downstream methods and products that derive from them.

This approach is now followed by the EPO.  For example, in decision T1441/13, issued in September 2014, the EPO's Board of Appeal refused an application directed to a method of producing differentiated cells from primate pluripotent stem cells, such as human embryonic stem cells.  The claimed method did not indicate the source of the cells, but the Board of Appeal concluded that the known and practiced method of obtaining human embryonic stem cells at the filing date of the patent application required the destruction of human embryos.

The Board also concluded that the first public disclosure of a method by which human embryonic stem cells could be obtained without destroying a human embryo was published by Chung et al. ("Chung") in January 2008.  In practice, therefore, claims relating to human embryonic stem cells may be allowed by the EPO if they have a priority/filing date of January 2008 or later, as they can rely on Chung's nondestructive methods of obtaining cells from human embryos.  However, if the patent application relates to particular human embryonic stem cells that could not be obtained using Chung's method, such as particular cell lines that are known to have been produced by a destructive method, such an argument is unlikely to succeed. 

If European patent claims encompass both destructive and nondestructive methods, it may be necessary to disclaim any products, methods, or uses that required the destruction of a human embryo.  The Board also made it clear that such a disclaimer can only be used in cases where nondestructive methods were available at the filing date.  In cases filed prior to January 2008, such a disclaimer cannot be used because suitable nondestructive methods were not available.

Conclusion

This is an area of law that is likely to keep developing as companies try to test the boundaries of the exclusion and to identify what inventions they can protect using the patent system in Europe. 

For example, the EPO's current use of a January 2008 cut-off date is based on the assumption that no earlier methods were available for obtaining human embryonic stem cells without destroying an embryo.  However, as the case law develops, earlier publications may become relevant.  For example, we must wait to see whether interested parties can establish a date earlier than January 2008 for the availability of stem cells produced from parthenogenetically activated oocytes.

This means is that there is likely to be uncertainty for companies working in this area for some time to come.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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