In the US and in most Asian countries, all stem cells and their uses are patentable, whilst in Europe the situation is much less clear. While patent protection for adult stem cells rarely presents any problems, the situation is complex with respect to hES cells because they are still mainly derived from human embryos. This has also resulted in restrictions on hES cell research funding.
Europe's stance on hES cell patentabilityAccording to the European Patent Convention (EPC), it is not possible to patent the human body at the various stages of its formation and development, or the simple discovery of one of its elements, including the sequence or partial sequence of a gene.1 Nonetheless, an element isolated from the human body or otherwise produced by means of a technical process may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
Of particular relevance is the provision in the EPC excluding from patentability inventions that are contrary to public order or morality. Specific guidance on the exact meaning of this in respect of biotechnological inventions is provided and the EPC explicitly states that it is not possible to patent:
It is the explicit exclusion from patentability of uses of human embryos for industrial or commercial purposes that has created the most controversy surrounding hES cells and their patentability on the grounds of public order and morality. While it is clear that patents covering methods that generate stem cells or stem cell lines through the use (i.e., destruction) of human embryos cannot be granted, the legislation is unclear on whether a stem cell itself, which has been generated by a method that destroys embryos, is excluded from patentability.
The Enlarged Board of Appeal of the EPO recently had an opportunity to provide general guidance in this area in the Wisconsin Alumni Research Foundation (WARF) application,2 which sought to patent primate embryonic stem cells. It chose not to do so and instead, the Enlarged Board of Appeal stressed that its decision did not concern the general question of hES cell patentability. However, it ruled that the patenting of inventions relating to hES cells is prohibited if they can only be obtained by the destruction of human embryos. This is irrespective of whether the method involving the destruction forms part of the patent claims.
This decision is unsatisfactory because although it has not resulted in the prohibition of patents relating to hES cells, it provides no guidance on any circumstances in which hES cells will be patentable.