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Tuesday, 18 October 2011

Stem cells and Patentability: the Brüstle decision issues

Update: the Decision, which was not yet available when this post was written, is now available here. And we Anglophones can rejoice for once as it's available in English.
 
A press release has issued from the Court of Justice of the EU (CJEU). The Court has this morning issued its decision in Brüstle v Greenpeace  (C-34/10). The IPKat reported earlier on the background to the referral, the referred questions,and then on the Advocate-General's Opinion.

Rather than repeat the questions verbatim (which you find in the links above), below you will find the IPKat's attempt to summarise the issues and then the questions and answers given by the Court. The technical explanation is given with all due apologies to those who are specialists in the field and who can tell a pluripotent stem cell apart from a totipotent one even when riding past at dusk on a galloping horse.


Background - the Directive

Good for what ails ya, like a patent medicine of old.
Stem cell research involves making use of embryonic cells. The Biotechnology Directive (98/44/EC) rules out patentability for certain inventions, including "uses of human embryos for industrial or commercial purposes". Given the ethical, moral, philosophical and religious differences of opinion on when human life can be said to begin, the legislators shied away from the politically loaded question of what exactly constitutes a human embryo, and left the term undefined. It was left to the Court to answer a series of questions on the meaning of "human embryo", therefore.

The referral came in a case where Greenpeace applied to revoke a patent held by Mr Brüstle, who had invented a way to produce, from embryonic stem cells, specialised cells for treating neurological diseases such as Parkinson's, starting with embryonic stem cells.

The early stages of development 
The IPKat has gathered that the very early development of a human embryo involves the following notable stages:
Top: development from fertilized egg to blastocyst
Bottom: illustrating how the pluripotent cells differentiate into organs

Illustration: Mike Jones
  1. The first few days after fertilisation: a few cells are present, each of which has the capacity to develop into a complete human being. Each cell has within it the full capacity for subsequent division, then for specialisation, which will ultimately lead to the birth of a human being. These cells are known as "totipotent cells".
  2. About five days after fertilisation: as growth continues, the cells develop into a ball called a blastocyst, composed not of totipotent cells, but of "pluripotent cells", which mark the start of diversification, gradually developing into specialised cells forming organs and structures of the body. These cells no longer have the individual ability to develop into a human being alone. They are the stem cells from which Mr Brüstle worked. Removal of these stem cells may damage or destroy the blastocyst, presumably depending on how this is done.
  3. About 72 hours later, implantation into the uterus occurs, which has been argued as marking an important milestone in whether or not pregnancy is likely to continue successfully.
Totipotent cells can also be produced artificially using cloning methods, such as the process which resulted in Dolly the sheep, i.e. transferring the nucleus of a mature human cell into an unfertilised ovum, or by parthenogenesis, i.e. stimulating an unfertilised ovum to begin dividing and developing.


Question 1: What is meant by "human embryo" within the context of the Directive?
The first question posed to the Court asked for a definition of what the term "human embryo" covered: did it include the ovum from initial fertilisation or was some later stage of development required? It also sought clarification on whether it included cells produced by the artificial methods, and specifically asked about whether the term covered pluripotent stem cells removed from the blastocyst.

The Court pointed out that firstly that it was not called upon to broach questions of a medical or ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the Directive.

Because the legislature intended to exclude any possibility of patentability where respect for human dignity could be affected, it follows, in the view of the Court, that the concept of ‘human embryo’ must be understood in a wide sense. Accordingly, the Court considers that 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. The term "human embryo" also covers those artificially stimulated or manipulated (but unfertilised) cells which are capable of commencing the process of development of a human being.

As regards pluripotent stem cells obtained from a human embryo at the blastocyst stage, – those which are concerned by the invention covered in Mr Brüstle’s patent – the Court found that it is for the referring court to ascertain, in the light of scientific developments, whether they are capable of commencing the process of development of a human being and, therefore, are included within the concept of ‘human embryo’.

This last point is perhaps mildly surprising, if only because the Advocate General had gone further in his Opinion to the Court: he had advocated that pluripotent embryonic stem cells not be regarded as "human embryos" because they do not in themselves have the capacity to develop into a human being, but that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, whether its destruction or its modification.

Question 2: What was meant by the expression 'uses of human embryos for industrial or commercial purposes'.
This question focused on whether there was a distinction between using embryos for scientific research and using them in a purely commercial process.

The Court has held that the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and cannot therefore avoid exclusion from patentability. Consequently, the Court concludes that scientific research entailing the use of human embryos cannot access the protection of patent law.

There is one qualification, however, which is based on a Recital in the Directive. The patentability of uses of human embryos for industrial or commercial purposes is not prohibited under the Directive where it concerns the use for therapeutic or diagnostic purposes which are applied to the human embryo and which are useful to it – for example to correct a malformation and improve the chances of life.

Question 3: Patentability where the patent is silent on using human embryos but they are nevertheless required
The situation addressed in this question is where, for example in producing Mr Brüstle's neurological precursor cells, the patent does not mention the use of human embryos in its teaching, but there is a supposition that firstly, stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell entails the destruction of that embryo.

Because not excluding such an invention from patentability would allow a patent applicant to avoid the non-patentability by skillful drafting of the claim, the Court has held that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in the Brüstle case, does not refer to the use of human embryos.


Conclusion
The Court's Decision will perhaps disappoint those Member States which sought to leave it to individual countries to decide on the definition of "human embryo", or those who wished for a more liberal regime (such as requiring implantation as a precondition for a human embryo to exist).

However, there is no real surprise here, given that the Advocate General's Opinion has largely been followed, although the Court declined to state as a general rule that pluripotent cells are not regarded as human embryos. In order not to be regarded as a human embryo, a cell (or collection of cells) must not be capable of subsequent development into a human being.

The IPKat leaves it to readers to decide whether the patenting regime which will result from this ruling is a good one. No doubt opinions will vary ...

10 comments:

Anonymous said...

Given that the social mores of the various Member States vary widely it is rather disappointing that we are being lumbered with a centralised edict on morality.

It is difficult, for me at least, to see why the EU needs to be meddling in such questions in the first place. Is this really something that they have to take control of in order to ensure the maintenance of the internal market?

Anonymous said...

I am sure the IPKat will be relieved to see that the decision of the Court is available in English.

Dagvokat said...

http://www.europeanvoice.com/article/imported/the-ethics-of-stem-cell-research/71680.aspx

Norman said...

I must say that this whole exclusion looks to me like free-riding in the guise of morality, as the result is that member states will have the benefit of such inventions without paying the price. Art 53(a) of the Convention on the Grant of European Patents, quoted by the Court, provides that “European patents shall not be granted in respect of inventions the commercial exploitation of which would be contrary to "ordre public" or morality.” If this is the ultimate basis for the exclusion from patentability, then it seems to me that practicing the invention, not merely patenting it, is equally immoral. For consistency the member states should therefore also prohibit the use of the invention for treating Parkinson’s disease. Unless the member states are willing to do that, the exclusion from patentability strikes me as hypocritical.

Anonymous said...

Norman, it's usually possible to find a low motive for a decision you don't like. Personally, I never find such arguments very satisfactory.

Most patent attorneys agree that morality is not a good basis for Patent Offices to reject patents. The argument is a largely pragmatic one. Patent examiners are not experts in morality - and views about what is moral differ somewhat between countries as well as changing over time (certainly during the lifetime of a patent).

But what is true of patent examiners is not necessarily true of everyone. The Court is there to interpret EU law. This is made by EU organs, including the European Parliament. Not everyone is convinced that these organs have complete legitimacy, but they clearly have a better right to lay down standards of morality than do Patent Offices. The Court, at least, must accept the legitimacy of the laws so made. That being so, the current decision (discouraging though it may be to scientists, investors and those fervently hoping for cures for serious diseases) is a perfectly reasonable and proper interpretation of EU Directive 98/44.

Anonymous said...

Speaking as a non-religious patent attorney, the issue for me is the use of human embryos in research and/or industry. I personally find this immoral and a line must be drawn that shall not be crossed.

As for patenting inventions that rely on the use of embryos, I have no moral problem, provided the application is theoretical. The inherent problem is obviously the requirement for enablement that cannot be met without the experimental work and resultant data.

The issue of the exclusion to patenting is not, therefore, one of morality itself, but is merely sensible to mirror the perceived (by the EU) immorality of the commercial exploitation.

The ban should also be seen as an opportunity to find non-human-embryonic methods for stem cell production, that can be patented and the commercial explotation thereof protected.

If we are going to discuss hypocrisy, can we have the views of those, such as Norman, that are not happy with this particular decision on Article 7(b) of the directive?

"processes for modifying the germ line genetic identity of human beings"

Just imagine a world of clones without Parkinson's or other terrible diseases. It's about drawing a line.

Anonymous said...

The way I see it, we now have a CJEU ruling that is fairly in line with the EPO (especially WARF/stem cells). The problem remains, of course, that the European and US patent laws do not converge on this matter... Any thoughts on that?

Anonymous said...

Norman, consistency might require member states to prohibit the COMMERCIAL use of the invention for treating Parkinson’s disease. There is no reason why universities and state institutions could not develop and provide such treatments on a non-commercial basis (albeit without the aid of the patent system).

Anonymous said...

The key reasoning of the judgment is FAULTY. When extending the commercial or industrial use clause to research and patenting research the Court simply forgot that the commercial or industrial use clause was there in the first place because it was found to be contrary to a COMMON European ethical principles on non-commodification and non-instrumentalisation. By making the irresponsible logical link the ECJ seems to suggest that human embryonic research and patenting the results of human embryonic research automatically violates those principles arising from human dignity. This I think needs proving (a difficult proof indeed), and it needs to be stablished that it is a requirement common to the WHOLE of Europe. If only the Court would learned the Directive properly ....

Anonymous said...

I don't agree. Your view as to what the 'commercial and industrial' limitation is doing there and how it is to be interpreted seems to me entirely unpersuasive. I see the Directive as laying down 'morality' in this area (because the legislators were not ready to leave such important questions to Patent Offices or even Courts). They may not have got this right (some of us think there are even higher authorities than the European Parliament) but they were entitled to try, and the Court is obliged to respect their efforts and not ignore them. I have been asking for at least a decade what sense the limitation made, given that all rational patents are taken out for commercial advantage: and the view of the Court about this seems entirely reasonable.

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