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A recent decision blocking the patenting of inventions which involve the destruction of human embryos is causing heated debate in the life sciences fraternity. Martin Hyden and Rosemarie Lee report

The patentability of human embryonic stem cells (hESCs) is a subject that has been taxing patent authorities and practitioners around the world for some time, raising difficult legal and ethical questions. While the issue has arisen in a number of cases in the past, the recent application for patent protection of inventions involving hESCs by the Wisconsin Alumni Research Foundation (WARF) has provided a focus for discussion, highlighting the different views on the subject, both within Europe and elsewhere.

What are stem cells?

To understand why this is such a vexed question, it is necessary to understand what makes stem cells in general, and hESCs in particular, so interesting. Stem cells are animal cells that remain undifferentiated (i.e. not developed into a cell of a particular organ or structure in the body), even after many cell-division cycles. They only differentiate into mature cells of a particular type after exposure to appropriate conditions. There are two broad types of human stem cells: hESCs, found in blastocysts (formed just before the embryonic stage) or embryos; and human adult stem cells (hASCs), found in adult tissue. hESCs can be ‘totipotent’, with the potential to develop into all cell types of a human being, including placental cells; or ‘pluripotent’, which means they can develop into a number of cell types, but not placental cells.

Controversial medical advances

The potential for hESC-derived treatments to provide advances in the medical world has been widely reported. It is this potential that brings stem cell technology and patenting into the limelight. There are two main aspects of hESCs that cause the related technologies to be placed under scrutiny. The first is that the conventional technique to obtain hESCs involves destruction of an early-stage embryo, raising the question of destruction of life. The second is the potential for hESCs to develop into all human cell types, raising the question of artificially creating life or cloning.

Patents in the European Union

Because of these (and other) concerns, the European Commission (EC) issued a directive in 1998 regarding patenting in the field of biotechnology (Directive 98/44/EC), which sets out classes of biotechnology invention that can and cannot be patented. This directive is binding on member states of the European Union (EU), each of which is empowered to grant patents in its own territory. The directive does not specify hESCs as a class of inventions to be excluded, but includes broader definitions that can be interpreted to include hESCs in certain cases.

Somewhat confusingly, patents can also be obtained in individual member states through the European Patent Convention (EPC). Patents granted under the EPC are done so by the European Patent Office (EPO). The EPO is an organ of the European Patent Organisation, whose members include not only member states of the EU, but also of other, non-EU, European countries. The EPO is not subject to the directives of the EC, but it has modified its rules to be essentially consistent with the 98/44/EC directive, thus avoiding potential conflict between the two systems.

The two main restrictions of the European Patent Convention relating to the patenting of hECSCs are:

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