What does this decision to ban patenting of embryo stem cells mean?

Posted on October 19, 2011 by

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The European Court of Justice made a decision yesterday which effectively bans the patenting of scientific techniques involving embryonic stem cells, even if the technique itself does not directly destroy an embryo but at some stage in the process has involved the use of an embryo.

This has no effect on us doing research using embryos or cells derived from embryos in the UK – this is still allowed, strictly regulated through UK law. But there is ongoing discussion over the impact this decision will have on investment in stem cell research in the UK.

Stem cell research has the potential to revolutionise how many serious conditions and diseases are treated. Researchers are worried that without the ability to patent their findings to ensure a financial return they will struggle to get funding from the private sector. Medical research charities fund a lot of research involving embryonic stem cells so they are concerned too, not only where their rights to the research they fund will stand but also the impact on their ability to attract pharmaceutical companies to co-fund research with them – collaborations which a lot of research depends on.

Background

There has been an ongoing court case in Germany over a patent on a technique involving cells derived from embryonic stem cells.

The patent, owned by Professor Oliver Brüstle, uses a cell line descending from cells taken from a blastocyst (a collection of cells formed 5-6 days post fertilisation) which goes on to develop into a human

European patent law bans the patenting of techniques that involve the use of human embryos. There was question over whether this blastocyst is defined in law as a “human embryo”. If a blastocyst is defined as a “human embryo” then Professor Brustle’s cell line could not be patented under the European ban.

The case was referred to the European Court of Justice to define what a “human embryo” is – as no such definition currently exists in EU law – and whether the European law to ban patents of techniques involving the destruction of human embryos applies to this case.

The Advocate General, Yves Bot, gave his preliminary opinion in March that such patents should not be allowed because they involve the destruction of a human embryo. This opinion was not binding – it went on to be considered by 13 judges in the Grand Chamber of the European Court.

It is this decision of the European Court of Justice’s Grand Chamber which is important for UK law.

The ruling released on the 18th October 2011 is the final judgment of the Grand Chamber (made up of 13 Judges). There’s also an easier to digest press release here.

What did the Judge’s say?

They ruled that a “human embryo” is anything that can develop into a human being

any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’… if that fertilisation is such as to commence the process of development of a human being’.

This can mean fertilised eggs (fertilized naturally or by IVF) or eggs which have been injected with another cell’s nucleus (which is a bit like fertilisation).

As the Grand Chamber does not rule on individual cases the German court must now decide whether the blastocyst required for Oliver Brüstle’s technique is capable of developing into a human being. It is likely that the German court will decide against Professor Brüstle, concluding that the blastocyst – which is part of the progression from a fertilised egg to a fully formed human being – comes under this definition of “human embryo” and so banning the patenting of his cell line.

The Court also ruled that there is no special case for scientific research, it should be treated in the same way as industrial and commercial use. Therefore the patent laws prohibit the patenting of techniques which involve the destruction of human embryos for use in scientific research.

Lastly, the Court ruled that any technology involving stem cells is only patentable if the cells were obtained through a process that did not require the destruction of a human embryo at any stage. Professor Brüstle’s patent had, by clever drafting, avoided mentioning the destruction of an embryo – however, it is a necessary prerequisite for the technology

What does this mean for us?

Current UK legislation strictly regulates the use of embryos in research, individually licensing the use of an embryo for research up to14 days after fertilization. This EU definition of a human embryo as “anything that can develop into a human being” will not effect UK regulation but it will be used in patent law. This combined with the Court’s other two rulings appears to prohibit the patenting of all techniques which have involved embryonic stem cells at some stage for use in scientific research.

This means that we can still do research involving embryonic stem cells in the UK but we cannot patent these discoveries – basically the next step in taking these discoveries to the marketplace to develop them into medicines. Patenting new techniques is how money is made from discoveries and many funders won’t be attracted to invest if they can’t make money out of their investment.

However this patent ban will not affect all the stem cell research going on in the UK. Only a small part of which uses stem cells derived from embryos. Much stem cell research, including that using induced pluripotent stem cells (adult cells that have been genetically reprogrammed to act like embryonic stem cells) will still be patentable.

This could act as a disincentive to investors choosing where to fund research; they may choose to do their research outside the EU where these rules do not apply and they would be able to patent their discoveries.

But Lawford Davies Denoon – a law firm specialized in life sciences – is quoted in several places today suggesting that the impact on UK science might not be so big. Alex Denoon said:

This is an unwelcome judgement, but I think the practical ramifications will be limited. I suspect that inventors and patent attorneys will find ways around some of this.. …it will be possible to obtain these kinds of patents in other countries such as the US, and further it will be virtually impossible for a competitor to obtain approval for a ‘generic’ version of an approved embryonic stem cell therapy.

What now?

We are still working out what the impacts are going to be for UK research. It is going to take time to unpick but funders and investors will be looking at what this means and taking it into account when they decide where to invest. Places like the US, where the ban on federal funding of stem cell research has been lifted by Obama, may be an increasingly attractive option for investment.

The UK government will be concerned about this because as highlighted in the recent stocktake on regenerative medicine we are very good at stem cell research. Healthcare and the life sciences is one of the growth areas the government identified in its recent plan for growth and is keen to foster.

Posted in: Policy