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Saturday, 29 October 2011

Brüstle: what will happen next?

"Phew", said the IPKat, "for
one dreadful moment I thought
I'd have to write this myself ...!
Earlier this month the IPKat reported on the keenly-awaited ruling of the Court of Justice of the European Union in Case C-34/10 Brüstle v Greenpeace, in which the Court ruled, in interpreting the provisions of the biotech Directive (98/44), that a process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. The IPKat's original post attracted quite a bit of comment, which is not surprising if one considers both the high level of human interest in the case and its consequences for investment in a very sensitive sector.

The IPKat has since received these thoughts from Dr Philip Webber (Dehns), which he is happy to share with his readers:
"Following the issuing of the recent stem cells decision from the CJEU (Brüstle v Greenpeace, C-34/10), opinions are still sharply divided as to the correctness of the decision. While it has been welcomed by Greenpeace and some church groups, many scientists have expressed deep concern about the effect that this decision may have on the stem cell industry within Europe. There are also questions about how wide the effect of the decision will be and what the European Paten Office (EPO) will do in response. 
Since the background to the referral and some comments on the answers given by the CJEU have already been posted by the IPKat, that material will not be reproduced here. The following thoughts will concentrate on the possible repercussions of the decision within Europe. A small amount of background is, however, appropriate. 
While the decision has provided some useful clarification on what is a "human embryo" (as least as far as patent law is concerned), the main impact of the decision stems from the comments made by the CJEU judges on the morality of stem cell-based inventions. 
It will be recalled that, for many years, the Patent Office Examiners in Europe had very little guidance on what inventions were immoral, until in 1998 the European Commission passed a directive on the patenting of biotechnological inventions (the Biotech Directive). This directive confirmed that isolated genes and cells were patentable, but it also included – for the first time – a list of inventions which were said to be immoral, hence unpatentable. This list included “uses of human embryos for industrial or commercial purposes”.When the directive was passed, stem cell technology was in its infancy and the directive did not directly address the patentability – or morality – of human stem cell based inventions. In order to harmonise its practice with the Biotech Directive, the EPO incorporated the main provisions of the Biotech Directive into the EPO rules in 1999. 
In 2008 the EPO applied this “uses of human embryos” rule when it judged the morality of a patent held by Wisconsin Alumni Research Foundation (WARF) which related to pluripotent stem cells. In that case the EPO ruled that, although the claims of the patent did not specifically cover “uses of embryos” at the filing date of the patent application, human embryos had to be destroyed in order to produce the claimed pluripotent stem cells.  Accordingly the invention could not have been put into practice at that time in a moral manner. For that reason, the WARF patent application was rejected under the morality exclusion. Subsequently, however, it has been the practice of the EPO to allow patents on stem cell inventions under circumstances where the inventions can be put into practice at the filing date without requiring the destruction of human embryos, for example if the inventions are based on human stem cells which have been grown in the laboratory (i.e. established cell lines). In particular, the EPO has established that human embryonic stem cell lines were readily available at least by May 2003; patent applications based on such material and filed after this date have generally not been deemed to be immoral. 
Given that the questions which were referred to the CJEU were largely similar to those addressed by the EPO in the WARF decision (G2/06), many expected the Advocate General to take a line in Brüstle which was similar to that taken by the Enlarged Board. However, an early indication that the European Court was going to depart from the WARF decision was provided by the Advocate General in March 2011 (noted briefly by the IPKat here). He hinted strongly that the full history of the invention needed to be taken into account when considering its morality -- not just whether the invention could be put into practice in a moral manner at the filing date of the patent. It was these comments that sent shockwaves through the European stem cell industry, with letters of concern being published in Nature and the major UK papers. 
The decision of the CJEU has confirmed and clarified the comments made by the Advocate General. Essentially, the judges of the CJEU have followed the ethical line taken by the Advocate General, and they have made the point absolutely clear, stating that the full history of the invention must be considered when deciding upon the morality of that invention -
"The fact that destruction may occur at a stage long before the implementation of the invention ... is ... irrelevant". 
Hence all inventions which require or have required in their past the destruction of a human embryo are now deemed to be immoral, and thus unpatentable, by the CJEU. 
European patents which cover such inventions will still remain in force until they are challenged, but they will become essentially unenforceable. Patentees will have to take decisions on whether such patents still have any residual value or whether they should simply be allowed to lapse due to non-payment of renewal fees. 

The decision will have binding effect on the courts of the EU member states but the EPO (which is not an EU institution) will have to decide whether to change its practice in light of the CJEU's decision. Implementation of the decision would not require either a change to the Articles or to the Rules of the European Patent Convention (EPC), so it could technically be implemented merely at the Directorate level. 

More mischievous patent attorneys will be starting to consider what patents in other areas of technology might be vulnerable as a result of this decision. Does the use of slave labour to mine metals such as tin, tantalum, tungsten and gold for the mobile phone industry mean that mobile phone patents are immoral? 
Moral compass
On a practical level, the decision has been welcomed by Greenpeace and some church groups, who have hailed the application of a moral compass to this area of technology. In contrast, many scientists have expressed dismay about the potential effect that this decision will have on European stem cell companies. They are particularly concerned about the detrimental effect that this decision may have on investment in stem cell companies. In particular, if investors cannot obtain patent protection for such inventions in Europe, are they still going to invest in European stem cell companies? The decision should not affect the ability of such companies to obtain patents in the US and elsewhere, but in the absence of European patents, will investment dry up? Or will such companies be driven out of Europe? 
The irony of the situation is that the original intention of the Biotech Directive was to protect biotech inventions and to promote investment in this area in Europe, whereas the application of the Biotech Directive by the CJEU in this case could well lead to the destruction of a significant part of the European stem cell industry".

7 comments:

Anonymous said...

I am sure I am missing something, but I would like someone to explain the following statement, which is often made when discussing patent policy, but which never made much sense to me: "In particular, if investors cannot obtain patent protection for such inventions in Europe, are they still going to invest in European stem cell companies?"

Why does this disproportionately affect European companies? US companies will not be able to get patent protection in Europe either, and European companies will still be able to get patent protection (assuming it is still available) in the US. European companies are neither uniquely advantaged nor disadvantaged. Conversely, companies may base themselves in Europe to avoid the threat of infringment actions (ignoring the research exemption for now), whilst still being able to use patent protection in overseas markets.

TJ said...

@Anonymous 11:35am You seems to be missing the fact that, for most companies, their home market is their most important. This is for all sorts of reasons: better in tune with local market trends; easier relations with suppliers and distributers (same language, same time zone, etc.); no exposure to currency fluctuations; etc. So Europe is likely to be a proportionately less important market for a US company than it is for a European company.

Adrian Howes said...

Rhetorically (as you are no doubt a busy man), I am curious as to why everyone thinks the consequences of the CJEU's decision will drive research and investment away from Europe to the detriment of Europe.

Surely the opposite would be the case. No patent coverage in Europe would give free rein to any company wanting to conduct research in Europe on stem cell technology to do so without fear of patent protection. Also, no doubt, whatever equivalent to a generics industry that forms out this research and commercialisation of this technology will set up shop in Europe, and conduct whatever necessary clinical trials etc here in preparation for selling to the rest of the world once patent protection in those countries expires.

For the consumer in Europe it would also lead to cheaper therapies as they would not be paying towards the licence fees of these drugs and will benefit from a competitive market. Arguably this might also increase the number of non-Europeans coming to Europe to seek treatment here, and consequently lead to Europe becoming the centre of both stem cell research and treatment around the world.

This is of course providing the effect of the CJEU's decision does not encourage other countries to ban stem cell related patents and as such there will still be money to be made from it elsewhere.

Therefore the only downside to the decision would seem to be a reduced pot of funds globally to conduct future research. On the other hand the upsides for Europe are likely to be 1) an increase in the number of organisations conducting stem cell research here (especially with no shortage of skilled labour); 2) an increase in generic-types conduction clinical trials; and 3) the place to come to be treated.

It seems to me that the effect of the CJEU's decision will benefit Europe massively and of course have the presumably unintended consequence of ensuring significantly more destruction of human embryos in Europe than anywhere else, which I fear was not quite what its so-called "moral" judgment was intended to achieve.

Anonymous said...

Am I missing something or is there a bigger question here: The CJEU is expressing a view on what counts as a human embryo (albeit in the context of a fairly specific question): surely that should not be a matter for a few judges to decide on - it is a question on which there should be a public debate (and on which there are likely to be different answers in different Member States). I know that the CJEU purported not to be broaching "questions of a medical or ethical nature", in effect, what they have done is to decide on a moral question.

Also these are questions on which individuals have strong personal opinions, often faith-based, which could colour any jusgement: What are the religious leanings of the Judges and AG?

Is there a knock-on effect for, for example, IVF or abortion? I believe there is a similar question being raised in Mississippi (and that both the Republican and Democrat prosective governers there are in favour) - causing some concern; and plans for the same issue to be raised in other states too.

Or am I wrong?

Anonymous said...

The Alliance of German Scientific Organizations seems to be making a similar point:

http://www.nature.com/news/german-science-organizations-slam-european-court-over-stem-cell-ruling-1.9606?WT.ec_id=NEWS-20111213

Anonymous said...

Patents are important for the market for the product, so previous commentators are correct that the EU will still be a good place to do research. The need to 'patent in the home market' argument is old and false for such biotech industries.

It was and still is true of the garden shed brigade and those firms (eg mechanical, engineering) who are still focussed on their home nation and not the broader international markets. [The EU is still NOT considered a single market by many firms for various reasons as localism may always rule (I did order a take-away from France once, but the winter channel crossing resulted in the delivery of a frozen meal).

The question of defining an embryo is a red-herring argument by those supportive if such patenting. An overly legal and technical interpretation would be counter to the intention to disallow patents in this area. The moral disagreement with abortion is not over the specific number of weeks when technically a foetus can survive on its own (many teenagers could not survive without parental assitance) and the same applies to patenting of embryos. The issue over the establishment of a legal right to life is also a red herring in the embryo-patenting discussion

I support the exclusion from patentability, but can still consider this case on its merits. The fact is that at the priority date of the invention, it could not be repeated without the destruction of a human 'embryo'. It is arguably the case that because of this exclusion and also the USA's previous attitude to such research has led to the development of alternative sources of stem cells.

It is now time for the Biotech patent industry to "get over it" and be grateful that they received an early Christmas present from the Supreme Court, which gave them a lower hurdle for industrial application than anyone could have imagined, and of which other industries can only dream.

My perpetual motion patent application was rejected even though it has use in the research of perpetual motion machines, in addition to its secondary use as a doorstop.

Anonymous said...

ps. Re Nature article.

The ECJ did not determine the patenting of embryo-related inventions to be immoral, but applied the Biotechnology Directive which placed a legal restriction on such patenting because it was believed that within the EU, it would be considered immoral. Odd how this German scientific community would have liked the ECJ to have miscronstrued EU law just because it suits their own self interest. Not very European!

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