10 October 2016Biotechnology

A woolly debate: the rights and wrongs of cloning

“Should life be patented?” asks Paul Chapman, head of Avidity’s life sciences team, relaying the concern of the UK public and intellectual property officials when the creators of Dolly the Sheep sought to patent their experiment.

Chapman says: “This was in the mid-1990s, a period when the whole issue of the patenting of biotech inventions was very much a hot topic.”

He explains that the cloning, by the scientists Sir Ian Wilmut and Keith Campbell, was an idea had been worked on for a while by the time Dolly became a reality in 1996.

“No-one had ever successfully cloned animals before, so it was very interesting and caused a big stir with the fact that patents were being filed on these techniques.”

Dolly was a female sheep and the first mammal cloned from an adult somatic cell by using the process of nuclear transfer.

It was cloned by Wilmut, Campbell and colleagues at the Roslin Institute, part of the University of Edinburgh, Scotland, and the work was financed for agricultural reasons.

Dolly was born on July 5, 1996 and died from a progressive lung disease shortly before turning seven years old.

The cloned sheep caused people to question the IP laws. With innovation taking a big leap, the issue of what could be patented was put into the spotlight.

As explained by Chapman, patent law was in a position where it had to adapt in order to cope with new technologies—the law had not been able to allow the patenting of animals or cloning before then. The most common type of patenting was of inventions such as machinery.

The experimental method for creating Dolly, and the sheep itself, were successfully patented in the UK, although questions of ethics regarding the patenting of life were still being asked.

Chapman says: “Morals have always been part of the process of patenting in Europe, and an ethical standard had already been established by the EPO with regard to patenting animals. The arrival of Dolly, however, provoked further debate because of the nature of cloning and issues surrounding the process, and in particular, looking at the potential application of the techniques to humans.”

In 1998, the EU harmonised the patent law relating to biotechnological inventions in member countries. This was to clarify which inventions are patentable on ethical grounds, in order to give legal certainty to organisations in the sector for attracting the considerable investment that is needed for innovation. By January 2007, all the 27 EU member states had implemented the directive (98/44/EC).

The 1990s became a defining time for patentability of life. Since Dolly was born, the guidelines have become clearer and many questions regarding the matter have been answered.

Chapman explains: “You can’t process the cloning of human beings or processes of processing genetic identity of human beings. Further, you can’t use human embryos for industrial or commercial purposes.”

Mighty mouse

The question of ethics when patenting also related to the suffering of the animals. As explained by Chapman, the benefits of a process had to outweigh the suffering of the animal. An example would be the ‘oncomouse’ case from Harvard University in the early 1980s, which was allowable because, although the mouse suffered, the benefits of the experiment outweighed the suffering due to medical benefits to human beings.

The oncomouse was among the first transgenic animals to be produced. Animals which are transgenic have DNA from other species artificially introduced into their genome. In this case, researchers at Harvard produced a genetically modified mouse that was highly likely to get cancer, by introducing an oncogene that can trigger growth of tumours. The mouse was developed for potentially beneficial applications such as medical research, enhanced food production, and the production of proteins or organs.

The case raised general ethical issues regarding transgenic technology itself, whether patents should be granted at all for animal or animal varieties, as well as the moral implications in relation to the suffering caused to the transgenic animal.

Despite the directive and guidelines for patentability in the EU, the Dolly case coincided with a huge debate in Europe about patenting of life and genes. It began to raise questions around the guidelines of what was and was not patentable.

Chapman explains: “The difficulty with the framework is that it is interpreted by national courts. This had led to some divergence across the EU in terms of what is allowable. So it is not a unified code—it is a framework.”

He adds: “The European Patent Office operates this framework within the rules of their prosecution, but once it gets into litigation, there are clear divergences across Europe.”

In the UK, methods of cloning Dolly are patentable, including the product of the process. This is because in the EU the product is seen as part of the process of cloning and is therefore allowable. In this case, the creators sought to patent both the process and the cloned sheep itself.

"Despite the directive and guidelines for patentability in the EU, the Dolly case coincided with a huge debate in Europe about patenting of life and genes."

Alasdair Poore, a partner in Mills & Reeve’s technology and commerce team, tells LSIPR that the Dolly case brought up political as well as ethical questions.

“Dolly the Sheep had a quite a significant consequence from a political point of view.

“It’s one of the particular cases where it has resulted with IP getting a much higher public profile, and you see that quite widely, in the sense that it’s quite a successful journalistic tagline that people have patented or are claiming ownership to life.”

As explained by Poore, from that point of view, the case has raised the profile of cloning and at the same time forced politicians and IP practitioners to appreciate that there is a political and public profile to patents, which was previously paid less attention to.

Poore argues that patent attorneys have to pay attention to the political context in which patents were granted.

Chapman adds: “Dolly the Sheep became very famous as it was a very exciting innovation. It was a very significant innovation for Britain, as it was seen to be leading the way.”

Around the world

Although there was a general optimistic outlook on the Dolly case in Britain, the acceptance of the patent remained a question elsewhere.

Chapman says: “In other countries, this case was very controversial and it was therefore difficult to get it patented around the world.”

In the US for instance, the process of cloning is patentable, but the product, such as the sheep, is not.

He adds: “Ultimately in the US, it has been struck down, but that has more to do with the current way that the US looks at biotech inventions. The picture is not very favourable in the US at the moment.”

The cloning of Dolly became even more controversial as the public began to question whether the cloning of human beings would eventually become a possibility.

Answers were needed so the UN General Assembly produced its Declaration on Human Cloning. The declaration, which was made public in 2005, prohibits all forms of human cloning “inasmuch as they are incompatible with human dignity and the protection of human life”.

The declaration prohibits therapeutic cloning, as well as reproductive cloning. This means cloning of human cells for use in medicine and transplants is prohibited, along with the creation of a genetic duplicate of a human being.

Advancements in human cloning have not materialised in the same way as those for animals, and undoubtedly continue to prove controversial in the patent arena.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk