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Thursday, 26 June 2008

EPO hears WARF arguments

Yesterday the European Patent Office (EPO) heard oral submissions on the application of Wisconsin Alumni Research Foundation (WARF) for a European patent that relates to human embryonic stem cells. All in all, some 126 submissions were received from interested parties, including the United Kingdom Intellectual Patent Office (UK-IPO) -- which observes that there is no consensus within European Patent Convention Contracting States concerning the public policy issues which WARF’s application raises.

The IPKat has received a press statement from Scotland-based IP practice Shepherd and Wedderburn, which endorses the UK-IPO’s position that it is for Contracting States and not the EPO to determine acts which they consider to be immoral. Says the statement:

"The issues raised by bioscience are within the margin of appreciation of Contracting States. It is unfair to WARF that the moral acceptability of its purported innovation will be decided upon by the EPO, based on its perception of what may be acceptable across the breadth of Contracting States".
The firm predicts that the EPO is likely to move cautiously [the IPKat says, that's no surprise if you consider its movements over the past 30 years], concerned not to be seen as pushing potentially unwanted technical innovation on to the more conservative Contracting States. This caution, concerning issues of public policy which ought rightly to be decided at Contracting State level, may have unintended consequences. The firm's conclusion is that the imposition of moral criteria upon patent application decisions in the stem cells field may well drive investment from Europe to jurisdictions where patent criteria will be decided upon solely on the basis of merit [the IPKat has never understood why this should make any difference: wherever the R&D cash is spent, the results will be either patentable or non-patentable in the same markets -- and even the absence of patent protection has never stopped people commercialising their products if they see a profit ahead. Can someone assist him?].

The IPKat awaits further developments with bated breath.

20 comments:

athurgood said...

The EPO decided that a transgenic animal could be patentable provided that the benefit to society outweighe d the suffering to the animal (T19/90 ), and they did the same with transgenic plants that may cover plant varieties, so it is not strictly true to say that the EPO has neither shifted rapidly, nor pushed potentially unwanted technical innovation on to the more conservative contracting states. The EPO has always done this, and not just in the life sciences - IT is another example. These decisions have always led to a complete lack of harmonisation in the EPC contracting states and in the EU in general.

Other examples that spring to mind:
- 2nd Medical Use or Swiss claims
- diagnostic and surgical methods

In a sense, the EPO has been a motor for change, forcing governments and the courts to tackle thorny questions that might otherwise have been pushed under the carpet. The fact that the governments then actually do nothing about it is part and parcel of political life, but this is where the current EPC falls down, because if individual governments can decide what is patentable and what is not, then what is the point of having any sort of common agreement in the first place ?

Anonymous said...

I agree with the previous posting. There are also areas where a concensus on morality exclusions has been reached. One example is the area of anti-personnel mines. The Ottawa treaty has been signed and ratified by most of the EPC states. This treaty bans the production, distribution and use of anti-personnel mines.

The EPO takes this as a clear sign that the interpretation of the morality exclusion generally applies to these products in the EPC states and as such will not grant patents for them (see the EPO Guidelines C-IV, 4.1). This treaty gave a clear sign of the pervading legal view of the immoral nature of these products and its general recognition in the EPC states.

In the area of biotechnology there is less concensus between and also within the EPC states. One view is that the morality exclusion exists (Art.53(a) EPC), but it only really exists to remove extreme cases from patentability. It would certainyl be inappropriate to use patent law to regulate the biotechnology industry. The EU reached agreement on the patent-biotechnology directive, which the EPO then adopted into its regulatory provisions (Rules 26-29 EPC). The directive (and by derivation the above EPC regulations) was a political compromise and so is difficult to interpret, which is why we find the issues which they regulate before the Enlarged Board of Appeal.

Mad_as_a_hatter

Anonymous said...

"it is for Contracting States and not the EPO to determine acts which they consider to be immoral."
Yes, and as soon as the EPO decides that something is moral, I am sure the same firm will be chastising any differing contracting states to fall into line and accept the EPO's judgment for the good of patent harmony in Europe (and the good of their client).

Anonymous said...

"... a concensus on morality exclusions has been reached. One example is the area of anti-personnel mines."

There are arguments that the banning of the use of anti-personnel mines is deeply immoral because the weapon allows relatively poor communities to protect themselves. Without them they are easy prey. See Sudan.

Anonymous said...

Jeremy, could you back up your assertion

'The firm predicts that the EPO is likely to move cautiously [the IPKat says, that's no surprise if you consider its movements over the past 30 years],'

As the first couple of posters have noted, the Boards of Appeal have set the pace on many issues, rather than being 'cautious'. The exclusions under Art 52(2), (3) are another example.

If you think the EBA has a track record of being cautious, perhaps you could explain why in a little more detail? For example, do you consider the House of Lords or Court of Appeal or the German BGH to be less cautious, and if so on what basis?

Otherwise, your comment looks like a random unsubstantiated potshot at the EPO.

Jeremy said...

My goodness -- I only said the EPO was cautious, as is evidenced by its thorough and patient approach towards the analysis and resolution of the problems it deals with. I didn't accuse the organisation of being (i) slow or (ii) unoriginal in its thinking. I used to think the word 'cautious' was a compliment - the opposite of 'rash' or 'imprudent' [and indeed 'incautious']. Has it now become a term of opprobrium?

Anonymous said...

Jeremy

While of course it does not matter where you invent something, you can still patent it where you like, the poor psycology is still there: "don't like patents = don't like innovation", which may mean no grants, difficulties with planning, best engineers probably going elsewhere, no culture of patenting, so inventions not protected, and so on, none of which may be true but it is not a good start. This analysis does get repeated. A moral ban is an even worse message: "Dear Mr Mayor, I would like to set up an immoral business in your city, will you please help."

Jeremy said...

I remain unconvinced. In the days when it was still seriously thought by some that software patents were not available in Europe, there was still plenty of software-related R&D going on, wasn't there? The big problem with Europe was that it was too linguistically, financially and culturally fragmented to be an effective home market in the way the US was.

IP Mouse said...

Dear Jeremy
may I correct you in that it was not the EPO hearing oral submission on the WARF application but the Enlarged Board of Appeal hearing both WARF representatives and the President of the EPO (see the earlier entry by David). It cannot be emphasised enough that “the Enlarged Board of Appeal” is not the same as “the EPO”, although there still is the unfortunate organisational incorporation. As you further may be aware of, the deciding Board has two external members, national judges from Italy and Romania, and they certainly would not like any implication of being under control of the EPO, which they, being as independent as the other members of the Board, certainly are not.

Philip Grubb said...

I agree with the views of Shepherd & Wedderburn. It is absurd that something should be regarded as immoral and thus unpatentable when it is perfectly legal in many nember states. Of course the problem arises from the Biotech Patenting Directive, which listed certain subjects as excluded from
patentability just because they were the hot issues of 1999. Unfortunately these have since been carved in stone in the Implementing Regulations of the
EPC. There is also a regrettable tendency to use Art. 53(a) to punish the inventor for some allegedly immoral act he committed before the invention was even made, rather than to concentrate on the effects of commercial
exploitation of the invention. If indeed the invention can now be
commercially exploited without using human embryos, why should Art. 53(a)apply? This should be an exception to the general rule that everything must be assessed as of the filing date.

The fact that the EPO is situated in one of the most Catholic
areas of Europe may have something to do with it. The position of the Church is clear:

"Touch not the embryonic cell
For if you do, you'll go to Hell
Forget your scientific goal
Each stem cell has a tiny soul."

Anonymous said...

"If indeed the invention can now be commercially exploited without using human embryos, why should Art. 53(a)apply? This should be an exception to the general rule that everything must be assessed as of the filing date."

So companies should be stimulated to file patents on products that cannot (yet) morally be exploited, because you never know where technology will be once the Nth divisional gets to the appeal stage?

Then better get rid of Art. 53(a) altogether. It doesn't make sense to me to make patentability dependent on the duration of the prosecution. If a claim is allowable in the 19th year after filing, it should also be allowable in the 2nd year after filing and vice versa.

In my view the point of Art. 53(a) is NOT to prevent the commercial exploitation of immoral inventions (after all, granting a patent will prevent commercial exploitation by all but the inventor!), but to prevent patent law to be a stimulus for immoral research. Preventing immoral acts is a matter for national law.

David said...

IMHO, A53(a) is completely pointless, generating only heat and no light whatsoever. Getting a patent on something has very little to do with being able to commercially exploit it. Just ask any pharmaceutical company. The landmine issue is always wheeled out in these cases as a good example, but I fail to see why getting a patent on an improved landmine has anything to do with the moral issue of using them.

In the words of the GLC, "guns don't kill people, rappers do; call the police, whoo whoo whoo".

twr57 said...

Philip Grubb's IP verses are much appreciated, both for content and technical skill. This one draws two comments. The first is a suggested amendment: the last line could (without affecting the scansion) more accurately read:

"Each tiny stem cell has a soul".

The Catholic Church has no position on the size of souls (or on other irrelevant attributes, such as age or colour).
A second criticism might query 'scientific goal' (though here it is more difficult to suggest an amendment that scans). Clearly the work on human embryos is undertaken from a mixture of motives (like almost everything else in life): including scientific curiosity, desire to prevent suffering, to enhance a professional reputation and in hope of commercial gain. But from what motive is it patented?

One might also doubt the extent of the Catholic Church's influence in Bavaria (let alone in the EPO...).

But David is clearly right about Article 53a. These questions are not for Patent Offices. In USA, for example, the Office is willing to patent all life-forms "except human beings". This means that, sooner or later, it will have to decide what a human being is.

Anonymous said...

As was clear from my earlier comment in response to Philip Grubb, I fully agree that there's no point to Art. 53(a) EPC _as far as preventing immoral exploitation_ is concerned. There is simply no way that NOT granting a patent will prevent that same immoral exploitation (at least once the invention has been made).

However, art. 53(a) EPC is there and presumably for a reason. Does it not make sense that its ratio is to prevent the promise of a patent right to be a stimulus for reasearch into "immoral inventions"?

The promise of a monopoly is meant as a stimulus to improve things, right? (If you deny, then what's the point of patent law?) Do we need to stimulate people to improve landmines?

I'm not saying Art. 53(a) is an essential cornerstone of patent law, but IMHO the article is not without any point.

Anonymous said...

re anon. june 28.

It depende on how you interpret "improve". A bigger bang for your buck or a self destructing system which neutralises the mine shortly after deployment to minimize civilian casualties. On the battleground, mines are laid to form a protective screen and are a defensive measure rather than offensive. Of course, it could be argued that a system which minimises "collateral damage" should be available to all and therefore patent protection is not desirable.

Anonymous said...

"It depende on how you interpret "improve"."

Yes, but isn't that the same as saying that the immorality of the commercial exploitation of mines depends on your point of view?

So while you have a point, I don't think it detracts from my argument. What I basically mean is that "the commercial exploitation of X is immoral" appears to be sufficient justification for holding that "the inventor of X should not be rewarded for his research with a monopoly". Or maybe you can turn this around and consider the grant of a patent to be a reward that is moral in essence.

Anonymous said...

As I see it, the problem with the morality exclusion is that the consideration of whether an invention is moral or immoral is always going to be subjective. Anti-personnel land mines can be seen as being "good" for the soldiers using them in that they are better protected from attack but "bad" because of the risk of innocent casualties. It is the same with stem cell issues and the like - one side considers that research should not be impeded because of the potential for developing medical cures and the other side objects to performing experiments on potential (or actual) humans. While the law makers can decide that certain acts should be prohibited, the patent offices are not the correct bodies to make a decision as to what is or is not immoral.

Anonymous said...

With regard to Art.53(a) exclusions, it is entirely true that this can be seen as a subjective analysis and depends on an individual level to a certain degree on a person's cultural, political, religious and philosophical outlook.

However, this provision is only applied where there is a legislative consensus in the EPC states as to what constitutes an immoral commerical activity and it does not depend on the approach in any one particular EPC state or region (including the Bundesland of Bavaria).

In the case of biotechnology and anti-personnel mines (note that anti-vehicle mines are not excluded) this legislative consensus exists in the form of the the Biotechnology patenting directive and the Ottawa treaty respectively and exists at a supra-national level. This means that a public debate has occurred and a consensus reached whereby all interested parties have been heard(including those who want no limitations on patentbility in these areas and those who want to ban all patenting in these areas). After this debate a common position was reached and then laid down in treaty/ written agreement.

An activity or product which would be illegal or highly controlled in certain member states but not others, such as gambling, private ownership of firearms etc, is not so excluded, because there is no consensus.

I also agree with the posting above, the article exists for a reason. There is no point having this provision and simply ignoring it, since this would mean that we are subverting the democratic process, by ignoring the will of the legislator (which in the case of the EPC consists of democratically elected EPC governments, who drew up and then ratified the Convention). Who are we to ignore a legal provision which they instituted? To do so is ultra vires, it is for the users of the system to interpret the provision, not to ignore it.

Mad_as_a_hatter

twr57 said...

That the legislators thought there was a good reason for the provision doesn't mean that they were right. We aren't entitled to ignore it: we are entitled to say it makes little sense. And if the sense isn't self-evident, then the provision is quite likely to receive a minimalist interpretation. That's not anti-democratic.

The fact remains that there are very few inventions that are intrinsically immoral (ignoring, for the moment, any minor disagreements we may have about what's moral and what isn't). Most of the time, what makes the difference is how the invention is applied in practice.

Anonymous said...

Did anyone notice that the appellant in the WARF case before the Enlarged Board has requested to refer two questions to the ECJ?

I suppose the EBA has no power (nor obligation) under Art. 234 EC-Treaty to refer questions to the ECJ, as it is strictly speaking not interpreting EC law.

On the other hand it is interpreting provisions that were copied and pasted from EC law and that do apply in member states, and in some ways the EBA (together with the Boards) is a final arbitrator of those provisions.

In my opinion there is at least some doubt on whether a referral to the ECJ is possible. Since Art. 234, if it applies, gives an obligation to refer, the EBA should IMO make a referral and let the ECJ decide on the admissibility. Interesting!

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