Honolulu mice highlight cloning issues in Europe

HONOLULU MICE HIGHLIGHT CLONING ISSUES IN EUROPE

This article originally appeared in Patent World Issue #105, September 1998

Last month the media introduced us to the 'Honolulu mice'. These little rodents are famous because they have been generated by a method known as 'somatic cell nuclear transfer', otherwise known as cloning. This technique involves harvesting an egg from the ovaries of a female mammal and replacing its nucleus with the genetic material from a donor cell which is somatic - ie contains the full chromosomal complement for that mammal rather than just half, as would be the case for a sperm or for an egg. Once the transfer of the genetic material is complete, the egg develops into an embryo, which is implanted into the uterus of a 'foster mother'. The resultant offspring is a clone of the mammal from which the donor cell is derived.

The Honolulu mice came hot on the heels of Dolly, the cloned sheep, who made her debut in Scotland last year. Dolly was produced using essentially the same principle as the mice, although there was some variation in the actual experimental procedure used by the two groups. What is remarkable about both Dolly and the mice is that the donor cell came from an adult animal, whereas it has always been assumed that for the technique to work the donor cell would have to come from an embryo.

The latest cloning development brings the possibility of cloning a human being one step closer and the debate as to whether this would ever be ethical will be raging for many years to come. That notwithstanding, the ability to clone other mammals is a breakthrough of considerable commercial potential. For example, it could allow the generation, very quickly, of large numbers of identical livestock genetically modified to resist certain diseases or to produce useful pharmaceuticals in their milk.

Having regard to the potential usefulness of the technique, it is not surprising that both the Roslin Institute, who produced Dolly, and the University of Hawaii, the home of the mice, have applied for patents to protect their technology. Neither party has a patent right granted yet, but it is a measure of the expectations that both have already concluded lucrative licensing deals. This is in spite of the fact that for a number of years now, there has been great uncertainty as to what patent protection will be available in Europe for technologies involving the genetic engineering of animals and plants.

A major step forward came in May this year when the European Parliament finally adopted the European Commission's Directive on the Legal Protection of Biotechnological Inventions. Once in force this should harmonise the law in all the countries of the European Union (EU). The Directive confirms the patentability of technical methods such as cloning for producing animals, although not for producing human beings, so long as the method is not likely to cause the animal suffering.

Patent protection for animals per se will also be available, although the distinguishing characteristic of the animal must be one which is not just applicable to a single variety. Of course a patentable invention must also be novel and inventive, criteria which a cloned animal itself could find hard to satisfy, it being by its very nature identical to something which already existed. Nevertheless, the final adoption of the Biotechnology Directive is good news for the cloners because it makes the pursuance of patent rights in EU countries a worthwhile exercise.

There is just one dark cloud on the horizon. The European Patent Office (EPO), which is not an EU organisation and therefore not bound by the Directive, has not yet finally decided whether plants and animals which are the products of genetic engineering should be patentable, although it is currently granting patents for methods of producing such animals. Article 53(b) of the European Patent Convention specifically excludes the patenting of 'plant and animal varieties' and unlike the European Parliament, the EPO has not yet been able to conclude that an invention, the technical feasibility of which is not confined to a single variety, should fall outside this exclusion.

A final resolution of the issue has been sought from the Enlarged Board of Appeal of the EPO [1] and a decision is eagerly awaited. The Board has been asked to consider not only whether Article 53(b) prohibits the patenting of

genetically engineered plants per se but also whether it prohibits methods of making them. Any decision is likely to be held applicable to animals as well. The passing of the Biotechnology Directive is a powerful incentive for the Enlarged Board of Appeal to decide in favour of patenting genetically modified animals and methods of making them. To do otherwise would only encourage inventors such as Dolly's to file for patents at the national Patent Offices of the EU states where the Directive is in force and to bypass the EPO altogether.

Whatever the final decision it is to be expected that patent rights of some description will eventually be issued in Europe in respect of cloning technology. Such patents will then pose interesting challenges for patent lawyers with regard to their enforcement.

Claire Baldock, Boult Wade Tennant, London

Notes [1.] T1054/96 Novartis AG.