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Embryonic stem cells update

Non-binding opinion marks a step towards patent harmonisation across Europe

Stem cellThe patentability of stems cells is a controversial subject and an area of law that is evolving rapidly. On March 10, 2011, Advocate General Bot gave his non-binding opinion (C-34/10 Oliver Brüstle v Greenpeace) on the patentability of embryonic stem cells, which, if followed by the Court of Justice of the European Union, will set minimum harmonisation requirements throughout Europe.

Definition
A stem cell is a special type of cell that, under the appropriate conditions, has the ability to replicate quickly, producing identical copies. They can be grown to large numbers in culture and then manipulated to differentiate into specific cell types for onward application.

As a result, stem cells have a wide range of uses in medical research from regenerative and therapeutic medicine to drug discovery and toxicology. One common use is to transplant these specific cell types into patients to replace damaged or diseased cells of the same type, restoring function. In the future, it may even be possible to grow organs from stem cells for transplantation into patients. However, stem cells cannot develop into a full human being nor are they classified as 'embryos'.

Generally speaking there are two types of stem cell: embryonic and post-embryonic. Embryonic stem cells are obtained from the inner cell mass of a blastocyst and are able to differentiate into any type of cell (they are pluripotent).

As embryonic stem cells are obtained from a blastocyst their derivation typically involves the destruction of human embryos. Post-embryonic stem cells derive from cells that have already developed past their embryonic state and, importantly, their creation does not result in embryo destruction. Unlike embryonic stem cells, they are restricted in their ability to differentiate to their tissue of origin (they are multipotent).

The development of stem cell technology is heavily regulated and it takes a significant amount of time and money to create a usable product. Research and development have to be carried out at an early stage: stem cells with the necessary characteristics must be derived, produced, isolated and stored in sufficient number and quality for onward clinical application without degradation. Thereafter, clinical trials and strict testing are necessary to ensure safety and efficacy. Patent protection allows companies (and their sponsors) to recoup some of these costs. However, there has been much debate as to whether stem cells and processes that use stem cells should be afforded protection.

Patent protection
For many years European patent law has made it clear that one cannot patent the 'human body' (including at various stages of formation) or the 'use of human embryos for industrial or commercial purposes'. However, historically these prohibitions have been interpreted differently by Member States regarding patenting stem cells.

The Advocate General's opinion makes it clear that totipotent cells, those which appear in the first few days of human development after fusion of the gametes, are excluded from patentability. The Advocate General's reasoning was that totipotent cells represent the first stage of the human body and as such must be legally classified as embryos, therefore the patentability of such must be excluded. Likewise, the blastocyst stage of development, by which time a four- to six-day-old embryo has been formed consisting of a ball of about 100 cells, must also be excluded from patentability.

When considering embryonic stem cells, although the Advocate General appreciated that embryonic stem cells were not 'embryos' nor could they develop into a human being (they are not totipotent), he made it clear that their origin could not be ignored. He stated that embryonic stem cells, or processes that use embryonic stem cells, should only be patentable if the stem cells were not obtained to the detriment of an embryo, be that its destruction or its modification. 

Although not specifically mentioned by the Advocate General, it seems reasonable that as the derivation of post-embryonic stem cells does not involve the use or destruction of human embryos, they, as well as uses thereof, should be afforded patent protection. 

Impact
If the Advocate General's opinion is followed it will harmonise the law in this area across all of Europe. However, this is not as pioneering as it first appears. The European Patent Office has already reached the same conclusion following its decision in Wisconsin Alumni Research Foundation (WARF) patent application (the WARF decision effectively prevented embryonic stem cell related patent applications being made through the administratively efficient route of the European Patent Office as their creation would inevitably result in the destruction of a human embryo).

However, unlike a ruling from the European court, the WARF decision is not binding on national IP offices and nothing prevented applicants simply applying at a national level in the pro-patentability jurisdictions. However, France, the UK, Germany and Spain have already introduced national law prohibitions on the patentability of embryonic stem cells and so any ruling of the European court will simply pull all Member States into line. The real danger of any such ruling is that stem cell researchers could migrate to jurisdictions outside the EU where patent protection is more favourable.

Rob Jacob

The Author
Rob Jacob
is an associate at Stephenson Harwood





6th July 2011

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