Patent rules force stem-cell research to seek alternatives

THE European system prohibits the patenting of inventions deemed to be "immoral" or "unethical". As such, the moral and ethical debate surrounding the patentability of stem cells derived from human embryos – and the processes making use of these cells – is heated.

There are implications for institutions that fund research into human embryonic stem cells and those that carry out research in this area. The University of Edinburgh's recently opened Medical Research Council Centre for Regenerative Medicine will be watching developments closely.

The European Patent Office (EPO) has finally refused to grant a patent for stem cells that necessarily involved the destruction of a human embryo. This has left open the question of whether human stem cells will be patentable if they derive from a method that does not involve human embryo destruction.

The European Patent Convention (EPC) is the overriding source of patent law for each of the 31 European states, including the UK. Inventions which are contrary to morality are prohibited by the EPC.

In 1999, The University of Edinburgh was granted a patent that broadly included the use of mammalian stem cells, but opposition to this led to the clarification by the EPO that the patent would not include human stem cells.

The most recent case before the EPO confirmed this approach. The case, concerning a patent application by the Wisconsin Alumni Research Foundation, involved cells being taken from an embryo and induced to multiply in vitro – outside the human body.

The question of whether human embryonic stem cells were patentable, when made by a process that unavoidably destroyed the embryo, was referred to the EPO's highest adjudicating authority, the Enlarged Board of Appeal.

The board found that products made in this manner were not patentable. The board also ruled that, while technology now allows for this process without the destruction of human embryos, the legal decision relates to the original 1995 application and the technologies available at that time.

This most recent case will mean institutions – like those in Scotland, which have a strong presence in the stem-cell research sector – will need to seek alternative methods of human embryonic stem-cell production and recent developments now make this possible.

Scientists at the Medical Research Council Centre for Regenerative Medicine are developing ways to mend damaged bones and cartilage using a patient's own stem cells. They are also looking at ways liver disease could be treated using embryonic stem cells to reduce the need for transplants. Another team is looking to develop novel therapeutic strategies for multiple sclerosis using both adult and embryonic stem cells in combination with nerve regeneration.

The Roslin Institute has also been granted a licence for research involving stem-cell products derived from human embryos. Stem-cell research is currently focused on the differentiation of human embryonic stem cells into specific lineages, development of methods of gene targeting and elucidation of intercellular signalling to allow human embryonic stem cells to grow indefinitely in the laboratory.

It was clear from previous decisions that non-embryonic stem cells are patentable, such as adult stem cells and cord blood stem cells. It also seemed that human embryonic stem cells derived from foetal cells following a termination of pregnancy are patentable.

This recent decision leaves open the possibility for researchers to obtain patent protection for inventions which describe a method of producing human embryonic stem cells that does not involve the destruction of a human embryo.

With advancing technologies available for stem-cell research, it is hoped that the decision will help attract further funding for research in this area and ultimately the progression to commercial application of that technology.

&#149 Philippa Montgomerie is an IP specialist and associate with law firm DLA Piper

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