Directive 2004/48/EC On the Enforcement of Intellectual Property Rights Contributions from industry and judiciary Issues for Industry David Rosenberg GlaxoSmithKline David is the Vice President of Corporate Intellectual Property Policy and he has responsibility for managing the development of the company’s position on IP policy issues. He represents GSK’s position on various industry bodies. He joined the company and has been with them since 2000, after spending 15 years in the IP group at Clifford Chance doing IP litigation. David Rosenberg: I think this has been fascinating so far hearing experiences from different countries around the EU as to how the Directive has and has not been implemented. Without wishing to criticise, it is a bit of a shame there is nobody speaking from Eastern Europe because, of course, for many of the Eastern European countries for whom IP is relatively new the Enforcement Directive would be particularly relevant. I think it would be really, really interesting to hear the experiences from Eastern European countries. My remarks will be brief and I am only going to address three topics. Firstly, I am going to make some general remarks about the context and political background to the Enforcement Directive; secondly, some comments on how important I think the Directive is likely to be in practice; and three, some remarks about the future. I ought to stress, particularly as I gather everything is being recorded, that I am speaking in my personal capacity and not necessarily expressing the views of GlaxoSmithKline. Let us look at the context in which the Directive was drawn up. As we all know, in the mid-1990s we saw the TRIPS agreement, which I think for all sorts of reasons may prove to be the high point in international IP protection. The enthusiasm was high, everybody thought IP was a great thing, that we would see wonderful IP rights and enforcement throughout the world. It is not quite how it has worked out. At the end of the 20th century and at the beginning, the first few years of the 21st century I think it is fair to say we have seen increasing pressure on the intellectual property system both internationally and in the EU. We had various developing countries, including important developing countries, missing TRIPS implementation deadlines in important respects. We had, as I know all too well, the debate around the relevance of patents to access to medicines in the developing world, claims that patents were impeding access, killing people, GlaxoSmithKline were referred to as GSK meaning global serial killers. You may think that is funny; it is not funny at all if you are the company. We had the case that the pharmaceutical industry not very cleverly brought against Nelson Mandela in South Africa and for a change, and for the wrong reasons, patents actually became front-page news in the newspapers, at least in the British newspapers. Whoever thought that would happen? In the South African case we had patents front-page news and to an extent we are seeing it in the newspapers even today. I do not know how many of you have been reading the press reports about compulsory licensing in Thailand, about the case Novartis have brought against a particular provision of the Indian Patents Act. Again, the patent system is actually up there in real newspapers. We have seen news about Developing countries missing deadlines, the access to medicines crisis, we saw increasing levels of counterfeiting and piracy fuelled largely by digital technology, we saw complete chaos in the EU over the Computer Implemented Inventions Directive, death threats to MEPs about patent laws. Please, what is going on? Then we saw the absolute inability of the Member States in the Community to do anything about Compat after 35 years for reasons which again had nothing to do with the patents system whatsoever, entirely nationalistic reasons around languages, etc., understandable at one level but complete chaos from an industrial policy perspective. Against that background I think it was very, very, very important that the Enforcement Directive was passed in the first place. It was important that the EU send a message that it was important to have proper enforcement of IP. That was a big political message. It was also important, I think, because it showed that the EU at least sometimes can do something sensible on IP. We have not seen very much good come out of the EU on IP for about 10 or 15 years and it was a very important political message. Let us now look at some more of the background and how the background to the Directive has impacted on what it actually says. If you look at the traveux preparatoire and the recitals, you will see that there were three real objectives: one, approximation of remedies around the EU; two, implementation of TRIPS; three, and most importantly I think, the prevention of counterfeiting and piracy. All those, I think, have had some input into what is actually in the Directive and it is noticeable that the Directive has certain elements which are TRIPS-plus, in other words, elements that are not actually required by TRIPS. The power to seize documents relating to infringement as well as infringing products is probably a TRIPSplus measure. The right to information regarding distribution networks, outside counterfeiting and piracy, remember, is also a TRIPS-plus measure. The right to seize bank accounts on certain occasions and the very important thing, the only thing that is taken from British law, obviously, is payment of the other side’s legal costs if you lose. All those are additional to what TRIPS requires and I think industry as a whole would regard these as best practice additions and very, very welcome. There are some slightly odd things given that this was essentially an anticounterfeiting and piracy measure. The fact that it was anti-counterfeiting and piracy probably explains why in the initial drafts there were proposals for criminal remedies. That makes sense for counterfeiting and piracy; it does not necessarily make sense for other things but I will come back to that briefly later. If it is anti-counterfeiting and piracy, why does it include patents? I think it is a jolly good idea that patents are included in this but for an anticounterfeiting and piracy measure it is a bit odd that it should include patents. Equally, if it is about counterfeiting and piracy why does it apply to parallel traded goods that come in from outside the EU which infringe IP? They may be IP infringements but they are genuine goods, they are the originator’s goods and it is slightly odd that an anticounterfeiting and piracy measure should deal with parallel traded good. Again, I think the reason for this is largely political. At the time people were talking about this Directive, talking about protecting IP generally and particularly protecting patents, was not a good thing, but talking about combating counterfeiting and piracy gave some legitimacy to some of the broader aspects of what actually became the Directive. I personally find that quite interesting. How important is it actually going to be in practice? I think we have heard today that it has clearly improved some national laws although some countries almost certainly still need to implement parts of it. We do see remedies and enforcement measures that are available in law that did not used to be, and that has to be a good thing. In theory, the aim of this, and let us go back, is to “approximate legislative systems” – and I quote from the Directive, Article 10 – “to ensure a high equivalent and homogenous level of protection.” I think that is where it is going to fail in its objective. There are a number of difficulties. For example, some of the remedies depend on proof of intent. I am a common lawyer, and I do not quite understand how you prove intent in civil law systems where you do not have disclosure and do not have crossexamination, and I particularly do not understand how we are going to prove intent in genuine commercial conflicts, not counterfeiting and piracy, that is easy - you copy something, you sell it as something else, that is easy. In a genuine dispute about whether something is patent infringing or not what does “intent” mean and how are you ever going to prove it, and to have remedies depend on the existence of intent I think is slightly odd and will probably have the effect, actually, of lowering remedies rather than increasing them. It is nothing about aggravated damages or bad behaviour but remedies may be reduced for innocent behaviour. Equally, on the injunction section there is a provision that says, if damages are inadequate and there is innocent infringement and it would cause disproportionate harm there may be no injunction. I understand much of that, that is the “what happens if there is a tiny patent infringing bit in a major computer mainframe”, that is the sort of thing the US is looking at, at the moment. I understand that that is an issue but I do not understand why intent to infringe should come into that at all. I think that is going to cause some complexities. In terms of approximation of laws, Recital 7 specifically refers to major disparities in calculating damages. Article 3 says, “remedies will be effective, proportionate, and dissuasive”, so pretty impressive stuff until you look at what the damages provisions actually say. The damages provisions in Article 13 give no practical guidance whatsoever as to how damages shall be assessed in the Member States and, as we have already seen, there are significant differences between the Member States. British law does it properly, German law ignores the issue; it is too difficult. There is no guidance at all as to how damages should be calculated and I think it gets worse than that because it says, “in appropriate cases” whatever that may be “a lump sum can be awarded, for example, royalties.” So what is “appropriate”? If you look at Article 26 it says, “it may be appropriate where it is difficult to determine the amount of damages”. Well, frankly, in IP cases determining damages is difficult and if royalties or a small lump sum are acceptable this will not be dissuasive or effective. I think there is a real possibility that although it talks about effective and dissuasive it is going to be meaningless and that provision, in particular, I suspect is a sop, as we British call it, a concession to the Germans because the Germans do not like difficult questions on damages. Frankly, we would say: “too bad, that is what courts are there for”. The courts are there to make difficult decisions and if every time it is difficult they say, “You can have a little lump sum,” it is not going to be effective, proportionate, and dissuasive. The biggest difficulty I see with this Directive is that, although it says these remedies will be available, it is impossible at this stage to say how they are going to be applied on a day-to-day basis in different Member States in practice. It says, “You, the courts, will have the power to give remedy A, remedy B, or remedy C,” but it does not say at all when you should do so. So, until practice develops we are going to have no idea as practitioners what you can get from which courts, different courts will develop in different ways, some courts will give interlocutory or interim injunctions in certain cases, some courts will not. All the forum shopping we see now is going to be there despite the Directive. I know, for example, of a particular patent case, not one we are involved in but a pharmaceutical patent case, where you have the same infringing products and you have the same patent in six different jurisdictions, applications for preliminary relief were made in Belgium, Italy, Sweden, Germany, France, and the Netherlands. The injunction was granted in Belgium, Italy, and Sweden; it was denied in Germany, the Netherlands, and France. Why? There is no good reason if we are really approximating. The answer is that we are not really approximating, we are providing for the availability of remedies rather than any sort of approximation as to how they are granted in practice. I do not think the Enforcement Directive will make a blind bit of difference to that. I do not see that there is any real prospect of harmonisation on availability of interim remedies, or indeed on damages at the moment. I do not see there is a real prospect of the ECJ helping at all, or the courts applying remedies consistently in the Member States. So, going back to my question about how important this is going to be, it was an important political step, it should improve availability of remedies but it is not even fully implemented yet, and we just have to wait and see how it actually applies in practice. Let me make a few remarks about the future so it will be connected to what I have already said. Let me start with a new point which I will call, Enforcement Directive Number 2, which the EU is now calling a Criminal Sanctions Directive. Please keep this in mind and look at what is going on. Criminal sanctions were dropped from the first Directive probably on the basis there were doubts as to Community competence to legislate in the criminal field. In a recent ECJ case 176/03, the Commission now takes the view that they have competence to legislate in the criminal field. I think that is actually very doubtful and I gather it is incredibly controversial and I am not sure they do. So, as you all probably know, we now have a proposal for a new directive on criminal penalties. That has some real difficulties in it, too. The first Directive is aimed at counterfeiting and piracy, but the penalties are actually quite small in comparison to the money that can be made from counterfeiting and piracy. They need to be bumped up. Probably with my British hat on, I am extremely concerned about the Community saying to me that we have to have criminal penalties for patent infringement. I think it is an appalling piece of legislation that I know is in place in most Member States. I know it is not used in very many but I think it is a very, very, very bad idea indeed to have criminal penalties for patent infringement because it has the real prospect of stifling competition. To close, I see big problems arising from the fact that the Directive requires remedies to be available but gives no practical guidance as to how or when they should be applied. That will lead to lack of harmonisation. How is that going to be dealt with in practice? The EPLA, if it happens, might actually impact on patent enforcement because we will have, if you like, central litigation in patents but that is not going to help on copyright, trade marks, and designs, we are still going to have different courts applying the remedies in different ways. I do not think we can expect very much help from the ECJ. There may or may not be references to the ECJ on the meaning of the Directive. It is quite difficult to work out what those references could actually be given the very vague nature of the Directive. Even if there are references to the ECJ, if we look at what the ECJ has done recently in the IP field on parallel trade, re-boxing, re-packaging, trade mark directive, I think it is fair to say that most of the judgments serve to confuse people rather more than they clarify the position. Anything that comes from the ECJ may be less than entirely helpful, as it turns out. Because as I said we have no guidance we may find courts in one member state granting or refusing remedies in cases where an entirely opposite result is achieved in different Member States and I am not sure what can be done about that. In theory, if a particular court did not give remedies on a regular basis I suppose enforcement proceedings could be brought by the Commission but it is awfully difficult again on the basis of the Directive itself to see how you would actually do that. The whole point is you have to have it in the law but it does not say anything about when you should exercise it. To conclude, I do think the Directive is a very good idea but I think it may prove to be of limited practical value. I think we are going to have to wait and see. In April 2009 the Commission is supposed to start preparing a review of the effectiveness of the implementation so perhaps I could suggest to UNION that in about another two years’ time we should have another session, possibly with the Commission here, to see how this is actually going in practice. Mike Nicholls: I am interested in what you think about this good faith or bad faith infringement. If you set out to make a product which is as close as possible to a competitor’s but which avoids the patent, are you acting in bad faith or are you acting in good faith in trying very hard not to infringe? Is it a similar position or do you think it will be similar to the position in the States on wilful infringement where my understanding is that if you have an opinion from a patent attorney saying that you do not infringe that is at least some defence? David Rosenberg: Let me try and answer your second question first, is it going to be like the position in the United States, I hope not, but it is possible. Answering your first question, does getting as close as possible to the infringement whilst trying to avoid infringement, is that good faith or bad faith, I do not know. If you go to a patent attorney who says it is 50:50 or it is 75:25 is that good faith or bad faith? In my view, as a matter of policy if you are genuinely trying to get as close as possible and trying to avoid infringement that should be good faith. The IP system is supposed to encourage people to use what is out there and get as close as possible as you can. It gives you a certain defined boundary, and it is very difficult to define what that boundary is, but I do not think that should be bad faith infringement. I do not know how it is going to work. I have a real problem with words like “intentional infringement” particularly when you are talking about the meaning of the word “intentional” across 27 different members states all of whom will have (a) a slightly different word for it and (b) a different meaning ascribed to that word. Roy Marsh: I am a British patent attorney based in Munich. I wonder whether for a user of a patent system such as your employer we are actually in Europe not far short of a perfect system for you to use, if we can deal with all the small details. What I have in mind is with England common law jurisdiction and the rest of Continental Europe running on a completely different civil law jurisdiction you can pick the legal system that suits your purposes. You could run an action in Germany on Monday, run a different action in London on Tuesday, and get the facts out in London on Tuesday with experiments, discovery, cross-examination of the experts, a lengthy written reasoned decision in England quickly, and then use it in all the other jurisdictions in Europe for the rest of your programme of enforcement. That seems likely in theory but maybe it does not work out like that in practice for a real corporate user of a system. What I have in mind is that Germany and England, completely poles apart on the enforcement side, and may be for a sophisticated user such as your employer it is actually an advantage to have those two completely different systems. David Rosenberg: That is an extremely interesting question to which I do not have a good answer. I think there is a lot in it so let me try a slightly flippant answer. I think that would be the case if UK courts ever enforced patents these days. The way it is going at the moment, every time we sue in the UK court we end up with a bad decision so that is not the sort of influence we want to have in the rest of Europe. That is a slightly flippant answer to a much more serious question and I think, yes, there is a lot to it. I personally think there is a lot of value for all sorts of reasons in the different systems in different Member States. I have huge issues both in principle and in practice with things like EPLA, not because I am a little Englander but because I do think there are values to each of the cultural approaches to these things. It would be inappropriate of me for all sorts of reasons to comment on what our strategies are or might be but obviously there is a lot to that as a proposition.