When is a patent not a patent?

Introduction

When I set out on these series of talks many years ago now, the opening instalment was called "The Age of Reason". The meaning behind the title was that a body of talented and experienced Patent Court Judges would bring reason and predictability to the patents system which would work for the benefit of all parties.

Last year, with some irony, I entitled the talk "The Perfection of Reason?" My view then was that, in fact, nothing had happened in the intervening years to suggest that "reason" had been brought to the system, and instead we had a brand of "judicial consumerism" which seemed to start from the prejudice that intellectual property was bad for the markets, and needed to be restrained and controlled. It may be that the Judges have delivered predictability, but what is predictable is that patentees will get a hard time in the English Courts.

I am afraid, as we will see, that little has changed this year. Indeed, I believe that the trends I have been highlighting have reached new high watermarks during 2007, with potentially damaging consequences for the UK as a venue both for patenting, and for patent enforcement.

I will adopt my usual format of dealing first with infringement issues, followed by validity, and finally technical procedural matters in the Patents Courts.

Infringement issues

Construction

It should not come as much of a surprise that the issue of construction is rarely considered in a detailed legal context in the Courts at present. Since the Amgen decision, and its refinement in various subsequent decisions, in particular the Mayne Pharma case, the Judges have been digesting and applying the new rules, without necessarily specifically referring to judicial authority.

The gist of the Amgen agenda, as perfected in Mayne Pharma, was that the Courts should read the words on the page, and unless there is any particular reason to go behind those words, it needs little help with their meaning. It can look to the specification and the drawings to resolve ambiguity, and if still in difficulty, can look at the overall context. However, armed with the full lexicon of the English language, those drafting patents should be assumed to have said what they mean. There is, according to current authorities, certainly nothing in the nature of a doctrine of equivalents.

An illustration of that came this year in the case of LB Europe v Smurfit. This was a case heard by Roger Wyand QC as a Deputy High Court Judge. It concerned tamper proof taps on wine boxes. The need behind the invention was driven by a previous French wine taxation system, and the solution reached was that there should be a tearable device on the box which bore the taxing certificate, and which prevented liquid from being dispensed without the device being damaged. Having considered the nature of the invention and described it in some detail, the Judge repeated the lengthy formula set out by Lord Justice Jacob in the Mayne Pharma case, which was derived in turn from the House of Lords decision in Amgen. He then went on to construe the claim on the basis of the ordinary words on the page, saying that he had no difficulty doing so. Perhaps the clearest illustration of the manner of reasoning is found in paragraph 52 of the judgment where the Judge says:

"Applying these principles of construction [the Mayne Pharma principles] I have no difficulty in reading integers (B), (C) and (D) of the claim as being fulfilled by the elastic sealing membrane acting on the piston in the manner of a spring in resisting movement of the piston. It is apparent when one tries to open the claimant's tap that the elastic membrane does "load" the piston in that there is resistance from the membrane to any, even slight, movement of the piston. In the context, the reference to the piston acting on the elastic membrane is satisfied by the fact that the piston pulls the membrane out of the outlet hole when it is pulled up."

With apologies for dipping into the detail of a case in that way, I think that it illustrates the manner of judicial construction following Amgen. The old "Improver" questions appeared to have been put to bed, even though the door was left open in Amgen for them to be used. This is common to all the cases which I have read this year where construction has been an issue. There is simply no new law on the matter – it is being dealt with as a question of fact in each case.

It may be recalled that sub-paragraph (i) of the Mayne Pharma formulation states "it further follows that there is no general doctrine of the equivalents". I wonder how long that will last? The Courts have made much of the importance of Article 69 of the European Patent Convention, and in particular the Protocol on its interpretation.

It may be recalled that when the formulation questions originally devised in the Catnic case and confirmed in Improver, were considered to be "old act" law, the judicial approach was simply to re-title them as "the Protocol questions" to indicate that they were the proper means of complying with the requirements of the Protocol on the Interpretation of Article 69.

Now, the Protocol has been rewritten and the new version is due to come into effect in December this year. The main body of the old paragraph has remained intact, subject to some relatively semantic alterations (e.g. "patentee" replaced by "patent proprietor"), but the interesting step is the addition of a new Article 2 heading "Equivalents" which reads: "For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims".

I have already heard that those reluctant to consider any change claim that this has no real meaning, and takes the law no further forward. It should lead, they say, to no significant alteration in the manner in which patents are construed. Lord Hoffman presaged this approach in Amgen.

That would be a strange position to adopt. We are told in Amgen that "plain words should have a plain meaning". Here, there has been a change – a new paragraph has been inserted, and the word "equivalents" has been included. When the changes were being discussed as long ago as the year 2000, the UK delegation said: "It was an interesting proposal which consisted of a radical change to the legal position in the United Kingdom and still required in-depth examination and consultation of the interest groups involved".

The official paper goes on to say: "The Office compared the legal position in the United Kingdom with the proposed arrangement. UK law did not apply the classical doctrine of equivalents, instead dealing with the issues of equivalence by applying the principle of "purposive construction" developed in the House of Lords "Catnic" decision."

The Improver case was widely discussed in the 2000 Diplomatic Conference, as the English method of construction had led to a different result being achieved in the United Kingdom to that which occurred in Germany. The Swiss delegation to the conference said of the Improver case that it was "a striking demonstration of how equivalents were treated differently in individual contracting states". It went on to say that there was an urgent need for legislation and supported the basic proposal which has now come to pass in the revised Protocol to Article 69.

Those seeking to resist change will undoubtedly point to the fact that the final version is watered down from the original. There was, in the first draft, an explanation of what the new paragraph was stated to mean which said: "A means shall generally be considered as equivalent if it would be obvious to a person skilled in the art that using such means would achieve substantially the same result as that achieved through the means specified in the claim".

Whether the end result is wider or narrower may be a matter for construction in due course. In a special edition of the Official Journal in 2003, the following was stated by way of explanation: "The changes to Article 69 European Patent Convention (EPC) are likewise purely clarificatory and editorial. The same is true of the addition made to the Protocol on the Interpretation of Article 69 EPC as part of the revision. In one form or another, patent practice in all the contracting states has long accepted that equivalents should be taken into account in determining the extent of protection of the European patent. The Protocol's new Article 2 neither gives a binding definition of equivalents nor specifies exactly how they are to be taken into account. The new provision is thus intended not to change the existing legal situation but to formalise the elements underlying it."

Back in 2000 the UK delegation to the Diplomatic Conference did not think that was the case. Further, it is hardly true to say of the United Kingdom that it has "long accepted that equivalents should be taken into account". In the Amgen case back in 2004 Lord Hoffmann said: "If literalism stands in the way of construing patent claims so as to give fair protection to the patentee, there are two things that you can do. One is to adhere to literalism in construing the claims and evolve a doctrine which supplements the claims by extending protection to equivalents. That is what the Americans have done. The other is to abandon literalism. That is what the House of Lords did in the Catnic case…the solution… was to adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming".

Lord Hoffmann described the American-style doctrine of equivalents as "born of despair". It is hard to see how this strong position against the consideration of equivalents can be squared with the amendment to the Protocol on the Interpretation of Article 69. I look forward with great interest to how Judges will deal with this issue in the next 12 months.

Remedies - injunctions

Injunctions in patent cases are relatively rare. In Sevier v Polska Kitchin J granted an injunction to Sevier after they discovered that KRKA had obtained a marketing authorisation for a generic form of drug under the Mutual Recognition Procedure with Hungary as a reference state. Sevier applied for an injunction, and KRKA counterclaimed for summary judgment alleging that the patent was invalid.

Interestingly the Judge adopted the position of seeking to assure himself that there was a serious issue to be tried. The trend in recent years has been a return to the old judicial approach to injunctions, namely that, providing there was a prima facie case, the balance of commercial convenience would dictate whether the injunction should be granted. However, it has long been the case in patent cases that the best chance of success would be to demonstrate to the Judge that there was more than a prima facie case, and indeed, that there was a serious issue.

In this case, there was the added complication that KRKA alleged that it itself had a serious chance of success in its allegation that the patent was invalid. Interestingly the Judge considered the submission, and agreed that the argument was a powerful base for attacking validity.

However, he was not persuaded that Sevier's case was without merit, and noted that: "If I do not grant the injunction sought, there is a very substantial risk that Sevier will suffer severe damage through price erosion and that such damage is likely to continue long after trial, even if Sevier prevails".

He accepted that KRKA might also suffer unquantifiable lost because of the difficulty in establishing the extent of sales they would have made if the injunction were granted. He concluded: "However it seems to me that the difficulty of assessing this loss and its extent are far outweighed by the potential damage to Sevier".

Accordingly, he granted the injunction with the usual protection in terms of a cross-undertaking in damages.

It is as well for KRKA that such a cross-undertaking was obtained because, perhaps unsurprisingly, the patent was subsequently revoked in its entirety by Pumfrey J with all the consequences that follow from such a decision.

Many people appear to live in fear of patent injunctions in the United Kingdom, and perhaps this case is a warning to both sides in any potential dispute. Injunctions, it seems, are still available but with the English Court's track record for upholding patents, a patent owner would be well advised to consider very seriously the risks posed by the cross-undertaking in damages.

Damages

There are rarely very many cases on damages, and this year was no exception. The only significant development came in the long-running saga of Unilin v Berry. It may be recalled that Unilin had sued Berry in the Patents County Court in relation to snap together fibreboard flooring. Judge Fysh held the patent valid and infringed, and the decision was upheld by the Court of Appeal. A petition for leave to appeal to the House of Lords was dismissed. When Unilin applied for directions for the damages enquiry, Berry said those proceedings should be stayed, along with the assessment of all cost orders, pending the outcome of the opposition hearing in the European Patent Office – a process which was continuing. It argued that the patent may yet be revoked or limited in such a way that the products held to be infringing would not be covered by the patent.

Judge Fysh said that Unilin's entitlement to financial relief and costs was not res judicata but refused a stay in respect of the damages and cost issues on other grounds. Both parties applied to the Court of Appeal. Berry appealed against the refusal of the stay, and Unilin expressed concern on the Judge's finding in relation to res judicata, worrying that if the European Patent Office subsequently found the patent to be invalid or limited it would not be entitled to the money it had been awarded by the English Courts.

The Court of Appeal found that Judge Fysh had not erred in principle in refusing a stay, such a decision being down to matters of discretion, and consequently not something they could overturn. However, in relation to the other issue, they said that the defendants were estopped from challenging Unilin's entitlement to an account of profits whatever the result in the European Patent Office.

Article 68 of the European Patent Convention states that where a patent is revoked in opposition proceedings it shall be considered to have been invalid "as from the outset". On the face of it, this would seem to mean that there would be no basis on which a judgment and infringement proceedings could be maintained and enforced once a patent had been revoked.

However, the Court of Appeal thought differently. Citing Article 64 of the EPC under which National Courts are given authority as regards procedure, the Court of Appeal concluded that infringement is a matter for national law. Lord Justice Jacob said that once the cause of action for infringement is given, it is as a matter of English law merged into the judgment, and the owner of the patent becomes entitled to a new piece of property, namely the judgment. The Court accordingly concluded that there was nothing in the EPC to suggest that revocation should take away this property right. Lord Justice Jacob said: "I am not sorry to reach that conclusion. It means that businessmen in this country know that they can use the rather speedy court system here to get a conclusion one way or the other. If the patent is revoked, the way is cleared; if it is upheld and held infringed then compensation will be payable for past acts. And an injunction will run unless there is a later revocation by the European Patent Office (EPO). Subject to that last point, the effect of all this is that one does not have to wait to find out who has won until the slowest horse in the race gets there."

This is an interesting conclusion. He appears to concede that an injunction preventing infringement of a patent would end with the revocation of that patent by the EPO. How can that position be reconciled with the general principle that the right to the judgment is a new piece of property? The judgment surely includes the ruling on an injunction and the ruling on damages and costs?

I am afraid that the desire to provide certainty for "businessmen" gives rise to a very unsatisfactory outcome based much more on policy than justice. It is not difficult to see the problems faced if, for example, the enforcement of a damages or costs award were stated to be subject to the outcome of the European opposition which may take seven years or more to be achieved. However, the idea that the party should have to pay substantial damages in relation to the "infringement" of a patent which in law was deemed never to have existed, is a very strange state of affairs, brought about in part by the massive discrepancy in efficiency between the English Courts and the European Patent Office. At the end of last year's paper, I criticised a situation where a legal system allows procedure to take precedence over justice. With some hesitation, I suspect we are in the same place here.

Costs

Over recent years there has been a move towards an "issues-based" approach to costs. This, in part at least, appears to be the result of a desire by the Courts to deter the taking of "bad points" in patent cases. This year has seen something of a fight back.

In Actavis v Merck the claimant had won its case for invalidity of a patent on the basis of the method of treatment issue, but had lost on obviousness. The claimant contended that it had won the case and that it had not been unreasonable or improper for it to have brought the case regarding obviousness. The defendant in turn submitted that the claimant should cover all the costs incurred in connection with the obviousness issue.

The defendant sought to rely on the recent authorities, and in particular quoted Lord Justice Jacob in SKB v Apotex where he said: "An issue by issue approach is therefore one that should be applied so far as it reasonably can. On the other hand such an approach is not the be all and end all. Whether or not it was reasonable for a party to raise, pursue or contest a particular allegation remains a relevant factor to be taken into account as part of the conduct of the parties."

In the same case, Lord Justice Arden had started from the opposite presumption, saying: "The Court is always very reluctant to award costs on an issues basis".

In the Actavis case, Warren J concluded: "If there exist two really distinct issues where one has been lost and one won, it might be appropriate to see the issues as separate from a costs perspective. None the less, an issues based order is to be avoided with the same result roughly being achieved by the percentage reduction. That is in contrast with the position where the winner under the old practice took all as a general rule subject to exceptions".

What the Judge appears to be striving to do is to achieve a middle ground. Rather than have a "winner takes all system" he suggests that the question of issues on which the successful party has lost should be dealt with merely by a "finger in the wind" assessment on a percentage basis, rather than dissecting the costs of each individual issue on its own.

The Judge concluded: "It is clear of course that cost issues are heavily fact-based and all at the discretion of the Court. It is also clear that the Civil Procedure Rules represent a significant shift in approach, but having said that, the starting point, I am sorry to repeat, remains that the winner gets his costs even when there have been issues on which he loses. That must be the correct starting point, particularly in relation to a defendant who is a person brought to the Court unwillingly, who is introduced into litigation which he did not wish to be involved in and defends himself and raises all proper points in his defence, although he must act reasonably and proportionally."

The Judge went on to award the claimant 75% of its costs after assessment concluding "there is I am afraid little science in this and some might say no art either".

However, the award of costs is very much at the discretion of the Court, and such a finding is virtually unassailable. Similar issues arose this year in the case of Generics v Lundbeck. In this case Lundbeck held the patent for an anti-depressant drug. Actions for revocation were brought by the claimants. The actions failed on obviousness and lack of novelty, but succeeded on insufficiency in relation to two out of three claims attacked. The costs totalled over £3 million, and Lundbeck submitted that it should be awarded 75% of the costs having succeeded on two of the three issues, and in relation to one of the three claims.

The Court thought otherwise. Although both parties had achieved a measure of success, the claimants were seen as having succeeded in having the main patent claims revoked which meant that they were now free to make the drug in question, provided they avoided one claim. Kitchin J heard the case and said that his first job was to establish who could properly be described as the successful party. He said that it was not open to the claimants to say that claim 6 was of no interest to them as they had chosen to attack it for what they thought were no doubt well-thought out reasons. However, he went on to conclude: "Nevertheless, I believe that to treat these proceedings as, so to speak, a "draw" would not be a fair reflection of the reality. [The claimants] have succeeded in having the main product claims revoked. As a result they are free to make and sell [the drug] provided they do not use the particular method the subject of claim 6".

The Judge then conducted a fairly detailed consideration of the issues, how they had gone, and what had been decided. In the end, he thought that a fair result would be achieved by ordering Lundbeck to pay the claimants 60% of their costs, and for the claimants to pay Lundbeck 40% of its costs in relation to the issues upon which it was successful. He was happy to make a general ruling that such costs should be considered to be two-thirds of their costs as a whole.

This result is somewhere in between the "issues based" approach and that favoured by Warren J in the Actavis case. If there is a discernable trend emerging here, it is a preference for percentages over issues. The Courts have the discretion to make the decision, and appear keen not to become immersed in too much detail.

Defences

I have always taken a particular interest in the concept of the "Euro defence".It emerged briefly again this year in the case of Sandisk v Philips. The issue in this case was whether the manner in which the defendants had enforced and licensed their patents amounted to a breach of the provisions of the Competition Act 1998 and/or Articles 81 and 82 of the EC Treaty. There was also an issue over whether the Court had jurisdiction to hear the complaint or grant relief.

The patentees owned patents relating to MP3 technology. One of the defendants, acting on behalf of the others, had intensively licensed the patents, arguing that four of them were essential for the manufacture or sale of MP3 players in the European Union in accordance with agreed standards. Border Detention Orders were made against Sandisk products, and seizures were made from an exhibition in Germany.

Sandisk commenced proceedings before the Patents Court challenging the validity of the patents, seeking declarations in relation to essentiality and non-infringement, and alleging abuse of a dominant position in a number of ways.

The validity and essentiality issues are scheduled for hearing next year. In the 2007 case, the Court was asked to consider the manner in which the defendants dealt collectively, the fact that their licences tied essential and non-essential patents together, an alleged demand for excessive royalties, and the fact that the licence appeared to extend beyond the expiry of the essential patent. Sandisk further alleged that the defendants had mis-used the patents system to acquire and maintain a collectively dominant position and brought harassing and vexatious actions.

For the purposes of the application, the defendants did not challenge the allegation of market share, or the general identification of the market.

There were a number of jurisdictional points, on the basis that none of the defendants were domiciled in England and Wales, nor was the claimant. However, in relation to the general issue of whether or not its patent enforcement activities constituted abusive conduct, the Judge concluded: "Where there is no dispute that the patents had been granted to the patentee, it seems to me that the enforcement action can be considered to be merely harassing in the sense explained [in this case] if the patent is obviously not infringed or if the patent is invalid and in either case the patentee either knows or believes that to be the case. It might be argued that reduplication of patent proceedings takes on a harassing aspect, but for the reasons I have endeavoured to explain, enforcement must proceed if it proceeds at all, on a country by country basis."

He concluded that the Sandisk position was "unarguably bad" and accordingly the defence based on European anti-trust law failed.

I suspect we have not heard the last of this case, and this issue. The question of essentiality in patent cases is becoming more and more topical, with many cases scheduled over the next 12 months. Further, there is a suggestion that the European Commission is beginning to take seriously allegations of the misuse of "patent clusters" as a means of confusion and monopolising a section of the market. I anticipate there will be more to report on these issues in the years to come.

Validity

Insufficiency

There is rarely much law on this area, and this year is no particular exception.

In European Central Bank v Document Security Systems the patent in suit was directed to making documents that would produce moiré patterns using scanning type copying devices in order to add security to bank notes. The patent was found invalid for added matter, but the question of its sufficiency was considered. The only legal point of interest was the reiteration that, in seeking to make the patent work for the purposes of an insufficiency argument, the skilled person "must seek success". Whilst not being required to carry out any prolonged research, enquiry, or experiment, he may need to carry out "ordinary methods of trial and error, which involve no inventive step and generally are necessary in applying a particular discovery to produce a practical result".

The Court concluded that in each case it would be a question of fact depending on the nature of the invention and the extent of the steps required. In this case, the allegation fell on the evidence.

I have already referred to the case of Generics v Lundbeck in the context of costs. That costs award arose out of the findings of Mr Justice Kitchin in the main case. The patent in suit concerned an anti-depressant drug called Escitalopram, the world's top selling branded anti-depressant at the date of judgment. The allegations of anticipation and obviousness failed, but the two key claims in the patent, claims 1 and 3, were both found invalid for insufficiency.

Kitchin J held: "I accept that if a patentee describes a new and non-obvious compound which has a beneficial effect and describes a way by which it can be made then he is entitled to a patent for the compound… others might find different ways of producing it, but this does not render the original patent insufficient because in each case they are making use of the technical contribution – the knowledge that they are making a new and useful compound."

However, he said that was not the case with this set of facts. He said: "The inventive step taken by the inventors of the patent was not deciding to separate the enantiomers of citalopram, but finding a way it could be done. The technical contribution they made was the discovery that the diol intermediate could be resolved and then the enantiomers of the diol converted into the enantiomers of citalopram whilst preserving their stereochemistry."

He concluded: "The first person to find a way of achieving an obviously desirable goal is not permitted to monopolise every other way of doing so".

There is a consistent logic to that approach. If you discover the compound, then you have a patent which protects you against any other means of arriving at that compound.

If however you discover only a method for producing the compound, then you cannot expect that protection to extend to every other method of arriving at the same result.

The saga of Halliburton v Smith has been going on for some time. It reached the Court of Appeal at the very end of 2006 with the key question being whether the patent in suit was invalid for insufficiency. At first instance that patent was held to be invalid for insufficiency on the basis that the methods in effect require the development of a full computerised model, and that this was too much to ask the skilled person to do. The parties settled the case and on the basis of the terms of the settlement, the patentee sought to have the patent restored. The Controller General objected, and there was a preliminary issue which I reported last year as to whether or not the matter should proceed to a hearing.

The hearing duly took place before the Court of Appeal and the appellant argued that there was sufficient teaching in the specification of the patent, alongside an academic paper which, it argued, was incorporated through a cross-reference. The appellant further argued that where implementation of an invention required work, it did not matter how much work was required, provided the work was "routine".

The Appeal was duly rejected.

At first instance Pumfrey J had concluded that the sufficiency of a specification is a question of fact in each case and there is not general rule. He said that: "Although statements like "you may not set a man a problem and call it a specification" or "the skilled person must be enable to perform the invention without prolonged research, enquiry and experiment" give a flavour of the problem they do not really help."

The word "routine" was discussed, and the old judgment of Mentor v Hollister was raised, in particular where Lloyd LJ said "a phrase like "routine trials" introduces a positive concept, easily understood and applied".

There was an unsurprising reiteration of the usual principles of insufficiency when Lord Justice Jacob said: "Patents are meant to teach people how to do things. If what is "taught" involves just too much to be reasonable allowing for all the circumstances including the nature of the art, then the patent cannot be regarded as an enabling disclosure. That is the basic concept behind the requirement of sufficiency and one that lies at the heart of patent law".

Lord Justice Jacob approved the European Patent Office test of "undue effort" for testing sufficiency. He said: "It is another way of applying the very words of the objection which emphasise the question is one of degree ("clearly enough and completely enough")".

The usual warning was given in relation to appeals on the issues of insufficiency, with the quote from Lord Hoffmann which is generally being wheeled out again: "The need for appellate caution in reversing the Judge's evaluation of the facts is based upon much more solid grounds than professional courtesy. It is because specified findings of fact, even by the most meticulous Judge, are inherently an incomplete statement of the impression which was made upon him by the primary evidence. His expressed findings are always surrounded by a penumbra of imprecision as to emphasis, relative weight, minor qualification and nuance, of which time and language do not merit exact expression, but which may play an important part in the Judge's overall evaluation".

It is hardly surprising that in the circumstances the Court upheld the judgment concluding: "Overall therefore on the specific embodiment the position is this: that the patent requires work going beyond the agony of the work required to produce an original scientific paper worthy of publication after peer review, sets the impossible but "very important" task of calculating the bit/cone speed ratio, and is founded on a wrong assumption about the relationship between depth of penetration and force. It is hardly surprising the Judge found it insufficient".

With regard to the argument that all was explained by a learned paper incorporated by cross reference, the problem appeared to be that it was not in fact referred to in the body of the patent at all. There is a minor reference to the paper in relation to a different issue to that for which reliance was subsequently sought, but the patent actually went out of its way to identify three publications to be incorporated by reference, and the paper in question was not one of them. The Court concluded: "If necessary information is not actually in the patent, then the skilled person must be given a clear unambiguous direction of where to get it. He cannot be expected to find such a direction buried in acknowledgements of the prior art."

Anticipation

Anticipation seems to be diminishing in judicial importance each year, with fewer and fewer cases dependent upon it as an issue. More often than not, it appears to arise in pharmaceutical cases concerning second medical use, and that was the scenario in Actavis v Merck, a case already considered in relation to costs.

The big question was whether a patent concerning the use of an existing drug in low doses should be revoked on the basis that the only novelty was in a different dosing regimen. Merck owned a patent on a drug which was an enzyme inhibitor. It marketed the drug under the name "Propecia" for the treatment of androgenic alopecia, including male pattern baldness. Merck also owned an earlier patent for the same drug used for treatment of a different condition with a conventional dose of 5"mg daily. The earlier patent disclosed the use of the drug to treat alopecia, but referred to a much higher dose than that later referred to in the contested patent. Actavis contended that the earlier patent had already disclosed the therapeutic application of the drug and novelty could not reside in a new dosing regimen for the treatment of the same disorder.

Inevitably the case of Bristol Myers Squibb v Baker Norton was referred to. In that case Lord Justice Aldous had described the claim as "an unsuccessful attempt to monopolise the new method of treatment by drafting it along the lines of the Swiss type claim."

To try and overcome that, Merck cited a number of EPO decisions and proposed that an important gap had opened between the EPO jurisprudence on second medical use and the approach of the English Courts as evidenced in the Bristol Myers case.

Warren J felt that he was indeed bound by the Bristol Myers decision, a Court of Appeal case, and that it was not open to Merck to argue that there had been a sufficient change to alter the approach of the English Courts at this level. The particular quote which he deployed from the Bristol Myers case came from the judgment of Lord Justice Buxton where he said: "The novelty of the second medical use, on which patentability rests, must therefore be found in applications that are new… the novelty cannot apply in the method of use, but in the new therapeutic purpose for which the substance is used."

Warren J concluded: "It may be novel to use it in the small dosage which it is now apparent can result in successful treatment, rather than the much larger doses mentioned in [the previous patent]. But this is simply a different dosing regime and is thus precisely the same as the situation in Bristol Myers."

All current cases about Anticipation take place in the shadow of the 2005 decision of the House of Lords in Synthon v SmithKline Beecham. In the case of European Central Bank v Document Security Systems Lord Hoffmann was quoted by way of explanation in the passage where he said: "The matter relied upon as prior art must disclose the subject matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question of whether performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing… it follows that, whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so."

That appears to be the uncontested position in relation to anticipation, subject to the (in my view unnecessary) complication regarding the supposedly different concepts of "disclosure" and "enablement".

These issues were considered this year in the case of Merz v Allergan. This case concerned the use of botulism toxins in medicine for use in pain relief related to inappropriate muscle activity or contracture. Allergan marketed its drug under the "Botox" brand name and it was a leading treatment for torticollis, a condition characterised by involuntary turning of the head and muscular pain. Once again the patent was drafted in the "Swiss" form. The case was heard by Mr Justice Kitchin who commented: "In the present case there are two allegations: prior use and prior disclosure. They were both considered by the House of Lords in Merrill Dow v Norton. The approach to be adopted in relation to each of them is, in substance, the same. It is important that the outset to have in mind is that an invention is a piece of information and making matter available to the public within the meaning of the Patents Act therefore requires the communication of information… the key question is therefore whether the prior act or disclosure relied upon conveyed sufficient information which would have enabled anyone to work the invention."

Kitchin J reconfirmed the Synthon v SmithKline Beecham position saying: "The House emphasised that to make good its case Synthon had to make good two points. The first was that its application disclosed the invention the subject matter of the later claim – the requirement of disclosure. The second was that an ordinary skilled man would be able to perform the disclosed invention if he attempted to do so using the disclosed matter and the common general knowledge – the requirement of enablement. These are distinct concepts, each of which has to be satisfied and each of which has its own rules."

Kitchin J explained his view of the discrepancy saying: "As to disclosure…the prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the later patent. In the case of a prior use, this is unlikely to be an issue – either it was or was not within the scope of the later monopoly. In the case of a disclosure however, it is not enough that infringement is a possible or even likely consequence of performing the matter the subject of the prior disclosure. It must be necessarily entailed."

In relation to the question of enablement, he said that a disclosure will be enabling if the person skilled in the art would have been able to discover its composition or internal structure and reproduce it without undue burden.

There is one comment of considerable importance in this judgment where Kitchin J says: "There is one further point I would mention at this stage. A product forms part of the state of the art if it was available to the public and a person skilled in the art would have been able to reproduce it, irrespective of whether or not he would have been motivated to do so."

Accordingly, prior use can invalidate a patent where the skilled person could have examined it or conducted tests to find out how it worked, whether or not in fact they would have been motivated to do so. He describes this as a "bright line" test – avoiding subjectivity and most questions of degree (save, of course, for undue burden).

I have previously made it quite clear that I do not believe the House of Lords has it right over the question of enabling disclosure. I can see no reason why they should be treated as separate concepts. The requirement in the act is for "enabling disclosure – a simple single concept". I must confess to being a little concerned by the "bright line" test applied. In addition to his other many attributes, it appears that the skilled person is now obliged to pick up and look at everything he sees with intellectual curiosity.

Added matter

In European Central Bank v Document Security Systems there was an allegation that a key integer in the claim ("overlaying a grid") was not disclosed in the application either expressly or implicitly.

Giving judgment, Kitchin J inserted the usual quote on this matter from the 1991 case of Bonzel v Intervention Limited where Aldous J (as he then was) said that the question about this matter must be made on a comparison of two documents read through the eyes of the skilled addressee. The two documents in question are the application and the patent granted, and the question to be asked is whether any subject matter relevant to the invention has been added, whether by addition or deletion.

Clear and unambiguous disclosure is required in the application to provide a proper basis for a claim.

Kitchin J said: "This comparison is a strict one. Subject matter will be added unless it is clearly and unambiguously disclosed in the application as filed". He then carried out a meticulous comparison of the publications and concluded that the application did not clearly and unambiguously disclose the integer in question. He said that it may well have been obvious, but that is not the test.

The difference is the same as that between an allegation of anticipation and one of obviousness. For anticipation to succeed there must have been clear and unambiguous direction, and that is also the proper test to apply when assessing added matter.

In the case of Merz v Allergan Kitchin J elaborated further on his theme. He said: "It is the Court which must carry out the comparison, but it must do so through the eyes of the skilled person. Matter is not added if the patent includes matters which the skilled addressee would take for granted on reading the earlier application."

Obviousness

It should come as no surprise to anyone that the vast preponderance of this year's cases deal with the question of obviousness. I am going to pick the highlights, rather than wade through each individual case, as there is relatively little "new law". However, the Pozzoli case does contain a reformulation of the Windsurfing test and as such is interesting in itself.

This was a Court of Appeal decision in relation to the case regarding CD containers. The initial decision by Lewison J was that the patent was invalid for obviousness. Lord Justice Jacob first set out the famous Windsurfing formulation and said that he felt it needed a minor restatement by way of elaboration. The result came out as follows:

1. "Identify the notional "person skilled in the art";
2. Identify the relevant common general knowledge of that person;
3. Identify the inventive concept of the claim in question or if that cannot be readily done construe it;
4. Identify what, if any, differences exist between the matter cited as forming part of the "state of art" and the inventive concept of the claim or the claim as construed;
5. Viewed without any knowledge of the alleged invention as claimed, do those differences consist of steps which would have been obvious to the person skilled in the art or do they require any degree of invention?"

The principal alteration is to change the running order of the questions; in his view, you should adopt the mantle of the skilled person (with the relevant common general knowledge) first, then consider the inventive concept. There is a logic to this, though whether this will make any difference in many cases remains to be seen.

This was a case where, at first instance, an argument run by the patentee was that there were technical prejudices against taking the step claimed to be inventive, and that meant it was not obvious. This gave rise to the Pilgrims Progress references concerning "lions in the path" and whether they were a real or imagined threat. Lewison J adopted this reasoning saying that where the prejudice was shown to have been mistaken, then the patent contributes to the art, but: "If on the other hand the perceived technical problem exists in the same form both before and after the claimed invention, then the prejudice has not been overcome at all. In such circumstances overcoming the prejudice cannot be part of the inventive concept, although the technical means for dealing with the perceived problem can be."

Lord Justice Jacob said he would not analyse things that way. He said there was an intellectual oddity about anti-obviousness arguments based on technical prejudice: "It is this: a prejudice can only come into play once you have had the idea. You cannot reject an idea as technically unfeasible and impractical unless you have had it first. And if you have had it first, how can the idea be anything other than old or obvious? Yet when a patent demonstrates that an established prejudice is unfounded – that what was considered unfeasible does in fact work, it would be contrary to the point of the patent system to hold the disclosure unpatentable."

He went on to explain: "Patentability is justified because the prior idea which was thought not to work must, as a piece of prior art, be taken as it would be understood by the person skilled in the art. He will read it with the prejudice of such a person. That which forms part of the state of the art really consists of two things in combination, the idea and the prejudice that it would not work or be impractical. A patentee who contributes something new by showing that, contrary to the mistake of prejudice, the idea will work or is practical has shown something new. He has shown that an apparent "lion in the path" is merely a paper tiger. Then his contribution is novel and non-obvious and he deserves his patent."

I will restrain, for the time being only, from any comment on the use of the word "deserves"!

In Actavis v Merck Warren J considered the question of obviousness. This is the case regarding the treatment for alopecia where the patent was found invalid as merely setting out a new treatment regimen. The Judge however felt, for the purposes of a possible appeal, that it was important to consider the question of obviousness. He summarised the issues which had been put forward by Counsel and said there was much common ground. It appeared that both barristers accepted:

1. Obviousness is a question of fact and the primary evidence is that of properly qualified experts. All other evidence is secondary.
2. The primary function of experts is to educate the Court in technology – they come as teachers, as makers of the mantle for the Court to don.
3. Whether or not the invention is obvious involves taking into account a number of factors, the attributes and common general knowledge of the skilled person, and difference between what is claimed and the prior art, and whether there is a motive provided or hinted by the prior art and so on.
4. The skilled person is deemed to look at the readily publicly available documents, however obscure they may be, and he is deemed to be interested in the prior art, even if a real worker in the field would not be.

He went on to confirm the usual view that the skilled addressee can, and in many cases will, be a team and that in those cases, the skilled addressee processes the accumulated common general knowledge of each of the members of the team.

Finally, in relation to common general knowledge, he describes it as the background knowledge of the notional man against which the prior art must be considered. It is not limited to material he has memorised and has at the front of his mind but includes all material in the field he is working in which he knows exists. What is more, it is not permissible for the skilled person just to link one piece of prior art with another unless to do so would in itself be uninventive. A mosaic is permissible, but it must be one which the skilled person can put together with no invention.

He gives an interesting consideration of the question of whether obviousness need be technical or commercial. He comments: "Patents are granted for technical advances, not for appreciating that a technically obvious development can be exploited commercially. It is not necessary that the hypothetical technician must be taken as applying his mind to the commercial consequences which might follow if the step or process in question were found in practice to achieve or assist the objective which he had in view."

Warren J manages to quote Aristotle in relation to the link between testosterone and hair growth, commenting "the congenital growth of hair never falls out, for a eunuch never goes bald"!

The upshot of his detailed consideration of a large volume of prior art was that the patent was not obvious, but, as we have already seen, it had already been dispatched under the Bristol Myers principle. In Ferag v Muller Martini the Court of Appeal came to consider the question of whether a patent for a paper cutter was obvious. At first instance, Lewison J had found the patent both invalid and not infringed.

The patent related to a method of shear cutting. It identified the main problem relating to current machines was that they were either too slow when compared to the printing process or not of sufficiently high quality. The solution was to have a shear cut where two knife parts moved independently of each other, one fixed relative to the material being cut and the other being brought temporarily into a clear defined cutting engagement. This allowed the signatures to be cut at a sufficiently high quality and speed.

Describing the patent in suit, Lord Justice Jacob said: "A masterpiece of draftsmanship this is not."

It was a patent translated from German, which gave its own difficulties, but he said that with knowledge of the common general knowledge firmly in mind, it was possible to make sense of it. The Judge had adopted the Windsurfing approach, and the Court of Appeal duly approved it. With no further elaboration on the law, the Court of Appeal launched into a dissection of the product, the patent, and the prior art, and concluded that the Judge was wrong, and the patent was both valid and infringed. That in itself makes this case noteworthy.

In Generics v Lundbeck the case concerned an anti-depressant drug. What was said in the case was routine, but it is worth reflecting briefly on the question of commercial success.

Kitchin J agreed that commercial success "can support a case of inventiveness". In this case, the argument was one of "long felt want", that is to say a known problem in need of a solution. Having achieved that solution it was alleged that the invention had achieved striking commercial success. However, Kitchin J warns himself:"Although these are essential elements of the argument they must be approached with some caution; The commercial success may be attributable to factors other than the invention, for example effective advertising, better workmanship or more attractive presentation. Or it may be that those in the field are not aware of the prior art said to render the invention obvious or were unable to exploit any developments of it. Careful consideration must be given to all the circumstances."

Lundbeck argued that the success of the drug was due to its superior therapeutic qualities; in particular its greater efficacy and that more patients responded to treatment.

Kitchin J said: "But none of this is disclosed in the patent. For the reasons I have given I do not believe it is permissible for Lundbeck to rely in support of inventiveness upon the technical merit of discoveries about the surprising efficacy of [the drug] which it had not made at the date of the patent. Likewise it seems to me that commercial success which is attributable to these discoveries cannot be supportive of inventiveness either."

I wonder if I am alone in not understanding this argument. The fact that Lundbeck themselves did not realise the advantages which would render the product so efficacious, does not in itself mean that to discover it was not inventive. The fact is that the product did turn out to be a substantial commercial success, and consequently if the development had been obvious it should surely have been found before? There is, to me, no logic in the position adopted by Kitchin J.

He was more easily persuaded by arguments that Lundbeck's sales representatives focused on this particular product, it being their best drug, and this was the cause of its commercial success, rather than its efficacy. The fact that they could presumably only sell something which was in itself successful and efficacious does not appear to have weighed with the Judge. I will return to the issue of the Court's prejudice against commercial success below.

The case of Nichia v Argos is very important. The case actually deals with the question of disclosure of documents, and in particular, whether when a patent in suit is alleged to be invalid for obviousness, without any plea of commercial success or long felt want, the Court should order disclosure of documents relating to the making of the invention.

In this instance Pumfrey J had refused a request for disclosure. Argos appealed. The principal judgment in the Court of Appeal came from Lord Justice Jacob and I will return to that in a moment. However, it is worth noting that Lord Justice Pill referred to the manner in which Pumfrey J dismissed the application.

He said: "My disagreement with the Judge is that, with respect, he did not attempt to consider the needs of the case but dispensed with disclosure as a matter of principle stating: "I have waited nine years actually to do this"."

How interesting, enlightening, and worrying that our most experienced Patents Court Judge, now on his way to the Court of Appeal, should take such a view of the question of disclosure in patent litigation.

Lord Justice Jacob took the opportunity to reiterate many principles of the basic law of obviousness. He set out and approved his own restatement of the Windsurfing test from the Pozzoli case, going on to say: "For present purposes what matters is that this basic formulation does not involve expressly what the inventor actually did or thought. Nor for that matter what his opponent did or thought. The inventor may have thought that what he did was little short of, or actually, a work of genius – that he was a latter day Edison. He may be able to show that he struggled manfully for many years before conquering the problem. On the other hand he may have said "I think what I did was dead easy, but given how soft Patent Offices sometimes can be, I'll give it a go". No matter what it was the test is not what he did or thought but whether a step would have been obvious to the man skilled in the art."

He went on to say: "It is quite possible that what the inventor did was, given his particular circumstances, actually very very clever, yet his patent be held invalid for obviousness. A clear example would be where the prior art relied upon was published shortly before the priority date and was only trivially different from what was claimed. If the inventor did not know of this, what he did could well be clever, yet his invention is obvious."

None of the above is terribly controversial, even if I think there are some hints in the language concerning Lord Justice Jacob's view of the patent system. Where he gets a little more controversial is when he says: "A patent is a public document. Any member of the public ought in principle to be able to make his own assessment of not only what the monopoly actually is, but whether that monopoly is valid. Obviousness is an objective question. If it depends on the private evidence or documents of the patentee (or of anyone else) the purely objective nature of the question will be impaired."

I find it hard to believe that anyone could seriously believe that a member of the public, reading a patent from the Patent Office website, should be able to make his or her own assessment of not only the extent of the monopoly (that should be the case), but whether that monopoly is valid. I find that a flimsy basis for argument. Lord Justice Jacob then goes through the various authorities which are often cited against the deployment of commercial success as an argument, in particular Mölnlycke v Proctor & Gamble. That is the case where the Vice Chancellor said that "secondary evidence…has its place and the importance or weight to be attached to it will vary from case to case. However, such evidence must be kept firmly in its place."

It has become practice down the years to adopt the mantra referred to by Lord Justice Jacob as emanating from John Whitford QC in around 1967 when he said "never call the inventor". I do not agree with this in all cases. The purpose of the expert witness is to educate the Court – "they come as teachers". However, why should the inventor not help to educate the Court in the relevant art? It is all too easy for Judges to adopt a prejudice born of their own views, and "judicial notice". The inventor might prove invaluable in overcoming such prejudices.

Dealing with the disclosure issue, Lord Justice Jacob comments that patent actions range in their commercial importance from those worth billions of pounds, to modest disputes between smallish companies. He said that proportionality requires the procedure to be tailored to the size of the dispute. He said: "I think the time has now come to hold that proportionality requires that normally such disclosure should not be ordered. Only in the largest kind of case, where the legal costs, although very substantial, form a small proportion of what is at stake, does what is involved by disclosure of this sort of material become proportionate. It is no good having the overriding objective, the specific requirements of dealing with a case in ways which are proportionate and a specific power to dispense with standard disclosure otherwise. You need millions at stake before the costs of hundreds and thousands on an issue which is only "secondary" and which must be "firmly kept in its place" are warranted."

However, Lord Justice Jacob was overruled by a combination of Lord Justice Rix and Lord Justice Pill, both of whom said that the obligations for standard disclosure applied in patent actions every bit as much as in other cases. Whilst both Judges acknowledge Lord Justice Jacob's experience in the field of intellectual property disputes, they conclude that, whilst there may be cases where disclosure may be severely limited, or refused altogether, consideration should be given to the needs of the particular case. In this case, they felt that it was justified, and Lord Justice Jacob suffered the rare experience of being overruled.

All of which brings me to the leading case this year on the question of obviousness, namely the Court of Appeal hearing in Conor v Angiotech. This was the case which I last year described as "the high watermark" in obviousness in the United Kingdom. That was following a judgment by Pumfrey J in which various clear indicators demonstrated that there was a significant judicial prejudice at work.

As an aside it is perhaps worth noting that in the 10 years that Mr Justice Pumfrey sat in the Patents Court, my researchers can only find four instances of him finding a patent valid and infringed!

Conor v Angiotech concerned medical stents. The gist of the invention was the finding that, by inserting taxol in the polymer coating of a stent with slow eluting qualities, the stent could be delivered through blood vessels to the point of treatment, and a slow low dose of taxol applied, without the unpleasant side effects which normally accompany that particular drug, however efficacious it may be.

Applying Windsurfing, the inventive concept was held to be: "A stent coated with a polymer containing taxol such that it is suitable to prevent or treat stenosis after insertion."

The "obvious to try" issue raised its head and the Court of Appeal confirmed its previous finding in St. Gobain v Fusion Provida where it said: "The obvious to try test really only works where it is more or less self evident that what is being tested ought to work".

What followed was somewhat extraordinary. It had been argued before the Court of Appeal that the Australian approach was the right approach to adopt. Lord Justice Jacob acknowledged that the Australian Courts are taking "a very pr- patent view of obviousness" and went on to say: "…whether, if that is so, it is good for the Australian economy is not my concern."

Further Lord Justice Jacob, upholding the original finding of obviousness said: "I think this decision is not only sound, but accords with rational patent policy. I have already said that the information in the patent actually adds nothing to the knowledge of the skilled man. So the patentee has done nothing by his disclosure to deserve a monopoly."

What these various passages tell us is extremely informative concerning the Courts' thinking in the United Kingdom. When Lord Justice Jacob says that the good of the Australian economy "is not my concern" he is absolutely right. Nor is the good of the English economy. That is a matter for the legislator and the executive. He further gives himself away with reference to a "rational patent law policy", and the concept of whether or not the patentee "deserves" a monopoly. These issues are really not the concern of the Judge. The Court of Appeal might do well to remind itself of the fundamentals of the English constitution. There is a division of powers – Parliament makes laws, the Courts apply them. It is not for the Courts to decide what is beneficial to the country's economy, or indeed what its patent policy should be. Its place is to consider the words of the statutes and apply them in accordance with their normal meaning.

It might be worth considering what the word "obvious" actually means. Its Latin root is the expression "ob via" meaning "an obstruction in the way of". That has found its way into the English speaking world with a number of different nuances, that they have a common theme. A selection of dictionary definitions reveals obvious described as meaning "easily seen", "easily discovered", "clearly or plainly evident", "recognised", "quite apparent", and "plain to see".

The emphases employed are interesting. "Easily seen"; "quite apparent"; "plain to see".

To be obvious, something must be right in your way – it must not be something you have to look for.

This is the approach of the Australian Courts, and to some extent of other European Courts. It is worth noting that, virtually at the same time as the Court of Appeal was confirming the invalidation of the patent in the Conor v Angiotech case, the Dutch Court was upholding it. The facts were identical to those in the United Kingdom, but the Dutch Court applied the "problem/solution" approach. Explaining the difference in outcome, the Dutch Court said: "To that extent the Court differs from the opinion of the English Court…which invalidated the patent for lack of inventive step by reason of a different application of the law. In fact the English Court examined – to put it briefly – the question of whether the average skilled person would consider to try taxol and next answered it in the positive. Contrary to this Court, the English Court did not get to the question of whether there was a reason or not to choose precisely taxol from the suggested alternatives of the state of the art."

This is the old "would/could" dilemma. The English Courts say that if the skilled person could do something, then that is enough. The Dutch, in common with the Americans, look for motivation and ask whether the skilled person would do something. The latter approach seems to me to be more appropriate, fairer to the patentee, and indeed more consistent with the real meaning of the word "obvious". As we have seen, the literal meaning of the word is such that it must be problematic as to whether the skilled person should be required to make any enquiry, or whether the answer should be right in front of them, albeit at least one step away to avoid colliding with the law of anticipation.

Something has to change. The current position is untenable and the English Courts are clearly out of step with the rest of Europe, North America, and Australia.

Procedure and other issues

Entitlement

For whatever reason, this remains a popular topic of litigation in the Courts.

The case of Liffe v Pavel Pinkava is a rare example of a case under section 39, dealing with the extent of an employee's duties.

Dr Pinkava devised a system and related inventions permitting the trading on an electronic exchange of various financial instruments not previously so traded. He subsequently filed four applications for US patents. At first instance, the Judge found that the patents belonged to Liffe because Dr Pinkava was employed by Liffe and the inventions arose out of duty specifically assigned to him in circumstances such that the inventions were reasonably expected to result.

Dr Pinkava appealed.

Section 39 of the Patents Act 1977 says that, as a matter of course, an invention made by an employee shall belong to the employer provided it was made in the course of his normal duties or in duties specifically assigned to him in circumstances where an invention might reasonably be expected to result from the carrying out of his duties.

At first instance, Kitchin J had held that the inventions were not made in the course of normal duties, but were in the course of specifically assigned duties.

To cut a long story short, the Court of Appeal found that in fact the inventions had been made in the course of his normal duties, which had merely evolved over time. The principal judgment was given by the Chancellor who said: "The suggestion that what is "normal" is to be ascertained by reference to some other standard such as "ordinary", "day-to-day" or "primary" must also, in my view, be rejected. Parliament has chosen the word "normal". It is not for the Courts to substitute for that ordinary English word some other test which may or may not be quite the same."

He went on to say that it is not in doubt that the duties of an employee may evolve in the course of time.

In relation to the question of whether an invention may reasonably be expected to arise, he said: "The second submission for Counsel for Dr Pinkava was that in ascertaining whether an invention might reasonably be expected to result from the carrying out by an employee of his duties, the qualities of the particular employee, whether positive or negative, are not relevant. I would reject this submission. The statutory test is an objective one but it is to be applied to the circumstances of the particular case."

He went on to say: "It would be inconsistent with that test to assume that Dr Pinkava's duties were carried out, not by him, but by some notional employee of reasonable or average ability. And how would such an employee be ascertained?"

Although the overall judgment was agreed by all parties, Lord Justice Jacob disagreed on one key issue. He said: "Where I differ from the Chancellor is in thinking that the particular attributes of the individual employee are a relevant circumstance. I cannot accept that, given all other factors being equal (contract terms, nature of job and so on), there can be a difference as to ownership depending on whether the individual employee is thick or brilliant. Why should an unimaginative employee get the invention because no one expected him to come up with anything, whereas an Edison in exactly the same situation has to hand it to his employer? I do not think Parliament intended an enquiry into the inventiveness of the individual employee or what, if anything, the employer knew about that."

Whilst I cannot help but find some irony in reading Lord Justice Jacob speculating into what Parliament actually meant by words used, on this matter he must be right. With his customary ability to reduce the complex to the absurdly simple, the example he gives demonstrates quite clearly why the Chancellor's conclusion is plainly wrong.
In Luxim v Ceravision the question was the jurisdiction of the Comptroller. In particular, the issue was whether a hearing officer of the Comptroller General of the UK Intellectual Property Office was incorrect to refuse a request by one party to decline to deal with entitlement proceedings in favour of the High Court. The matter was heard by Mr Justice Warren.

The Comptroller submitted that, by statute, Parliament had intended primary jurisdiction on entitlement issues to rest with the Comptroller and that the discretion to decline to deal should be exercised sparingly. He contended that if he was to decline to deal with any difficult or complex case, he would be abdicating the responsibility given to the Office. Instead, he argued that only "highly complex" cases should reach the High Court.

Mr Justice Warren allowed the appeal and said that this case involved matters which would more properly be determined by the Court. In particular, there were non-patent legal issues at large in this case, including possible statute barring under Californian law, and these would ordinarily be regarded as the province of the Judge. He declined to lay down any criteria, but noted guidance available in the Patents Hearing Manual. He concluded that the correct test was not that the matter or question must be highly complex, and nor should the jurisdiction be exercised cautiously or sparingly.

He said that although statute conferred initial jurisdiction on the Comptroller, this was not intended to carry a predisposition to retain cases within the Office. The Judge said that the Comptroller's role as arbiter of the forum was to decide whether it appeared to him that the question was more properly to be determined by a Court. Only an appearance to him was necessary; he did not have to be incapable of resolving the issues nor to be able to say with certainty that the question was more properly to be determined by a Court.

Last year I referred at length to the extraordinary case of Cinpres v Melea. That was a case which was started in the Patent Office, but turned into a massive fight on contested evidence. The Patent Office Hearing Officer, incapable of dealing properly with the evidence, made a simplistic judgment, wholly incorrect as it turned out, which was ultimately upheld by the Court of Appeal on procedural grounds. If ever there was an object lesson in why all difficult entitlement cases (in my view all entitlement cases) should be heard by the High Court, that was it.

Mr Justice Warren was necessarily diplomatic in giving his judgment, but the message is clear. Only the most basic cases should remain in the Patent Office.

Finally, and hot of the press, the House of Lords has delivered its view on entitlement in the case of Yeda v Rhone Poulenc. This case had been through Lewison J at first instance and then the Court of Appeal, both of which ruled that amendments to the case originally filed were not allowable because they post-dated the expiry of the two year limitation period for entitlement cases in Section 37 of the Patents Act 1977. The argument was that the amendments, one of which was to introduce a cause of action to meet the requirements of the Markem case were time barred . This was the decision of the court of Appeal which ruled that merely claiming inventorship was not sufficient to support an entitlement claim, and some other cause of action like breach of contract or breach of confidence was required. The other amendment sought was to move from a claim of joint ownership to a claim for sole ownership. Lord Justice Jacob ruled in the Court of Appeal that such a change meant that what was happening was effectively a new claim which was being brought outside the limitation period.

The House of Lords upheld the appeal and over-ruled the Court of Appeal on both counts. It found that the change from a claim for joint to sole ownership was not a new claim, but merely an adjustment to the general claim asserting title. It found that the mischief addressed by the two year limitation period was to prevent "stale claims" not to prevent legitimate amendment to existing claims.

The more radical finding was that the Court of Appeal had been completely wrong in the Markem case and that there was no requirement for a separate cause of action based on contract or confidentiality. The reasoning arises from the fact that the entitlement regime is strictly statutory, and exists in the context of a "first to file" patent system. Lord Hoffman said: "Section 7(2) and the definition in Section 7(3) are in my opinion an exhaustive code for determining who is entitled to the grant of a patent. That is made clear by the words 'and to no other person'. In saying that the patent may be granted 'primarily' to the inventor section7(2) emphasises that a patent may be granted only to the inventor or someone claiming through him"

The Markem decision was a classic piece of judicial law-making the like of which I have identified elsewhere. The House of Lords' decision rectifies a straightforward error and restores the sensible position. The Patents Act is where we look for the law on entitlement and we do not need to delve into the realms of other tortious remedies to justify a claim. This sort of decision makes you wish more cases went as far as the House of Lords.

Patentable subject matter

Last year this was very much "the big issue" with numerous cases. It was perhaps inevitable that there would be fewer this year, though there have still been enough. However, for the definitive comment on the subject, one barely need look any further than the joint cases of Aerotel and Macrossan. It pays to go back to the legislation. Article 52 of the European Patent Convention specifically excludes from the category of patentable subject matter "schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers". That wording could barely be much clearer. As Lord Justice Jacob said: "The provisions about what are not to be "regarded as inventions" are not easy. Over the years there has been and continues to be much debate about them and about decisions on them given by National Courts and the Boards of Appeal of the EPO. They form the basis of a distinct industry of conferences and are the foundation of a plethora of academic theses and publications. There has also been much political debate too: some urging removal or reduction of the categories, others their retention or enlargement. With the political debate we have no concern – it is our job to interpret them as they stand."

More irony?

Lord Justice Jacob comments that there is no evident underlying purpose behind the provisions as a group. Categories are there, but there is nothing to tell you one way or the other whether they should be read widely or narrowly. He comments that they form a disparate group with no common overarching concept, and that some categories are given protection by other intellectual property laws. Artistic creations and computer programs have protection under the law of copyright.

He said that there is or may be overlap between some of the exclusions themselves and between them and the overall requirement that an invention be "susceptible of industrial application".

Apparently the traveaux preparatoires to the European Patent Convention do not provide a lot of help. All that emerges is that the various categories are the result of compromises and distinct discussions about each of them. This at least confirms that no overarching principle was intended.

Lord Justice Jacob goes on to consider the position outside Europe. The history of the US legislation starts with the Patent Act of 1792 authored by Thomas Jefferson who took the view that "ingenuity should receive a liberal encouragement". Subsequent patent statutes employed the same broad language, and this was left intact as recently as 1952. The committee reports accompanying that act inform us that congress intended statutory subject matter to "include anything under the sun that is made by man".

There has been further pressure arising from TRIPS. The treaty does not have the same explicit categories of non-invention, saying instead that patents shall be available "for any inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application".

Lord Justice Jacob also commented that there had also been substantial pressure from potential patentees themselves on patent offices around the world.

He concludes that "just as with arms, merely because people want them is not sufficient reason for giving them".

His reason for saying this is perhaps more clearly illustrated in the next passage when he says: "Despite the fact that such patents have been granted for some time in the US, it is far from certain whether they have been what Sellars and Yeatman would have called "a Good Thing". The patent system is there to provide a research and investment incentive but it has a price. That price (what economists call transaction costs) is paid in a host of ways: the costs of patenting, the impediment to competition, the compliance cost of ensuring non-infringement, the cost of uncertainty, litigation costs and so on."

He goes on to comment that there is no hard empirical data showing that the liberalisation of what is patentable in the USA has resulted in a greater rate of innovation or investment in the excluded categories.

This is something of a give-away as far as Lord Justice Jacob's attitude towards patents is concerned. I have long suspected that he thinks this way, but taking this quote alongside the passage I have already mentioned from Conor v Angiotech, it is quite clear that Lord Justice Jacob has taken it upon himself to be the economic arbiter of good practice in relation to the patent system in the United Kingdom.

The upshot of all this is a four stage test set out by the Court of Appeal, and now adopted in a number of subsequent decisions. The test goes like this:

1. Properly construe the claim (i.e. decide what the monopoly is);
2. Identify the actual contribution (i.e. decide what the inventors have really added to human knowledge);
3. Ask whether it falls solely within the excluded subject matter (i.e. does the contribution consist of excluded matter "as such");
4. Check whether the actual or alleged contribution is actually technical in nature (the Court of Appeal noted that this step "may not be necessary because the third step should have covered this").

Applying the test to Aerotel, the Court accordingly held that the system as a whole was new, that the contribution was a new system, and in particular a new combination of hardware, that the claim was for more than just a method of doing business as such, and that the system was clearly technical in nature. Accordingly, the patent was upheld. In relation to Mr Macrossan's patent, the opposite was found.

Lord Justice Jacob quoted with approval from the judgment of Mr Justice Kitchin in the case of Crawford's application when he said: "At the heart of all these decisions is the consistent principle that an inventor must make a contribution to the art (that is to say the invention must be new and not obvious) and that contribution must be of a technical nature (susceptible of industrial application) and not within one of the areas excluded by Article 52(2)."

The issue which is vitally important to recall in dealing with these cases is that the question of patentability arises in relation to the patent before it is granted. Accordingly, none of the usual grounds for invalidating a patent are relevant. The only question is whether or not the application is legitimately susceptible to patenting within the meaning of Article 52 of the European Patent Convention. Too many cases appear to become confused on this issue.

The new Aerotel formulation was endorsed and supported by Mr Justice Pumfrey in the case of Cappellini's application and in the case of IGT v The Comptroller of Patents .

For the time being the Courts seemed to have found their preferred method of dealing with these cases, but as we have seen in the past, these multipart formulations become the subject of very detailed consideration and analysis, and I would be surprised if this one were still standing in five years' time.

Appeals and stays

The most substantive reconsideration of the issue of whether litigation should be stayed pending the outcome of European opposition proceedings took place this year in the case of Glaxo v Genentech. The case was heard before Mr Justice Lewison, who set the background by referring to the judgment of Lord Justice Aldous in Kimberly Clarke v Proctor & Gamble where he said:

"It is not sensible for a Court in this country to allow proceedings to be heard in this country which duplicate those in the EPO unless justice requires that to happen."
This has given rise to the statement that was amplified by Mr Justice Laddie in Hunt Technology v Don & Low where he said: "There is a presumption in favour of a stay. However, that does not mean, as at times appear to be suggested on this application, that this is a difficult presumption for a party resisting a stay to overcome… absent any other consideration a stay is the appropriate course to adopt. But when there are other considerations it is for the Court to weigh up the pros and cons and see where the justice of the situation lies."

This position was reiterated by Lord Justice Jacob in Unilin v Berry where he said: "Of course in principle the preferred option is to stay UK proceedings if there are corresponding EPO proceedings. And it may in some circumstances be the case that an interim injunction could serve to hold the fort while these proceed. But all must depend on the circumstances and particularly the timing."

So the conclusion we are led to adopt is that there is a presumption in favour of staying UK proceedings to abide the outcome of European Patent Office opposition proceedings, but that the presumption can be set aside if there are sound commercial or other pressing reasons to do so.

Lewison J set out a series of reasons why patent litigation should be treated differently to other litigation when it comes to the question of a stay pending parallel proceedings.
He pointed out that patents have territorial application and that a patent in the same terms may be granted in several states worldwide. However, the causes of action are not the same in relation to each of those states, as the law may be subtly different, or the patent slightly differently worded. This makes a difference as between patent cases and general breach of contract cases where more than one National Court may have jurisdiction over precisely the same dispute.

He said that it was inherent in the legal structure that established the European Patent Office that proceedings may take place in the EPO itself and in National Courts, and consequently it was necessary to make suitable provision for that. He pointed out that the EPO had no power to deal with questions of infringement, so where infringement is alleged and the claim is met by a counterclaim for revocation, either both claim and counterclaim must be stayed or both must be allowed to proceed. He commented that "anything else would be grossly unfair".

He pointed out that a decision by the EPO is not necessarily final anyway. It is final if it revokes the patent but if it does not, it is still open to Courts to revoke patents on the basis of different prior art, or different legal considerations.

Finally, he pointed out that patents involve monopolies, and the common law has traditionally been cautious about upholding monopolies. Accordingly there is a public interest in ensuring that invalid monopolies are declared to be such as soon as possible.

It was argued in the Glaxo case that there was a difference between cases where infringement was an issue, and those where the UK proceedings were purely an application for revocation. The Judge rejected that argument, saying that it set the bar too high and was not consistent with the way in which patent cases have developed. The Judge said that whilst the absence of infringement proceedings is a relevant consideration, he did not consider that it was decisive.

Lewison J considered the factors in favour of a stay including the avoidance of duplication, the likelihood that significant additional costs might be incurred, the possibility that the claims might be amended during the opposition process in the EPO, and the willingness of the parties to provide undertakings.

On the latter point, he considered that the undertakings offered by Genentech in this case were not sufficient, and represented little more than "cold comfort". Referring to the previous case of Unisantis v X-ray Optical Systems, he said that he had granted a stay in that case and what had tipped the balance for him was that the offered undertakings removed the risk of taking the competitor off the market at some later date. He said that no such undertakings had been offered in this case, and accordingly they were not influential.

He went on to consider the relevant factors which might militate against a stay. Delay was the most obvious, and the inherent uncertainty in knowing when EPO proceedings would be resolved. The effect of any delay had to be considered. In this case, GSK was undertaking substantial clinical trials. The phase 2 trials were almost complete, and the cost of the phase 3 trials was likely to be between US$50 and US$100 million. He was unhappy about the uncertainty occasioned by a stay in this case and quoted Lord Justice Jacob who had said in another case "business needs to know where it stands".

Finally, he commented on the "spin-off value" of having UK proceedings conducted swiftly. He quoted Laddie J in Unilin v Frisa when he commented that:
"Judgments obtained from this Court on issues of infringement and validity have in the past, at least on occasions, helped to inform the parties so as to enable them to resolve their disputes on a worldwide basis earlier rather than later."

His conclusion was that the proceedings should be allowed to go on to trial without a stay, but invited the Court of Appeal to examine the current practice to see whether it is justified given that patent cases seem to be out of line with more usual commercial cases. It will be interesting to see whether this invitation is adopted.

In GlaxoSmithKline v Sanofi there was another application by a defendant to stay revocation proceedings pending the outcome of EPO opposition proceedings.

The patent, for a vaccine against the bacteria that causes a range of diseases including pneumonia and meningitis, was granted in October 2004 and is in force in 17 European States. Glaxo commenced revocation proceedings before the UK Courts in May 2006, and had also opposed the European patent before the EPO.

This case was heard by Mr Justice Kitchin who set out the various factors which he thought appropriate. In favour of a stay he listed the avoidance of the duplication of proceedings, the risk of amendment by the EPO, and the possible substantial delay in EPO proceedings. He listened with interest to evidence given on behalf of GSK by a patent attorney from its in-house department who went through the procedure and indicated that a final decision on an appeal from the EPO could be delayed until the second half of 2011.

Undertakings were offered by Sanofi including undertakings not to sue GSK during the period of the stay nor to seek any financial relief other than damages. It also agreed not to seek any injunctive relief, and agreed to prosecute the EPO proceedings diligently.

Sanofi argued that GSK's business was of such a size that it couldn't be said that damages at any level would impact on its commercial plans. In this case, the maximum damages payable could only be some £4.5 million.

GSK disputed this, saying that its product was a substantially better one and would achieve high sales. It expressed concern that it could only proceed on the basis that it was incurring a real risk of running up a substantial liability. Sanofi argued that GSK had already spent very substantial sums developing the vaccine with the issue of the patent unresolved.

The Judge referred to the potential benefit of the proceedings being brought in the United Kingdom, and then turned to proportionality. He said: "It is certainly true that patent proceedings in this country are frequently very expensive. However I think that GSK submits with some justification that even if damages are restricted in the light of the undertakings offered by Sanofi, the sums at stake are still significant and even though they do not dwarf the potential costs of a trial and appeal, they nevertheless do justify the bringing of proceedings. Further, both sides are clearly in a position to pay any costs liability which may arise."

Having weighed everything up, the Judge decided that this was not an appropriate case for a stay.

Finally, under this heading, in Research in Motion v Vista, Mr Justice Patten joined the fray. Vista applied for a stay of the revocation action pending the outcome of EPO opposition proceedings. There was evidence that the opposing proceedings would not be concluded for at least another four to five years. The defendant offered a full set of undertakings not to seek injunctive relief, damages or an account of profits for the duration of the stay and afterwards.

Patten J said there was a danger of over-defining the relevant test. He said it is a discretionary power which should be exercised to achieve a just and proportionate resolution of the dispute between the parties. He felt that the need for a speedy resolution of the validity of UK patents in a jurisdiction which is a major market outweighed the mere cost savings involved in staying the proceedings. Accordingly, he refused the stay, saying that both parties could easily meet the costs, there was precedent of value in a recent UK judgment, and there was need for commercial certainty when the patent in suit is in a highly competitive field. He said the undertakings offered would not remove the commercial uncertainty caused by having to wait four to five years until an EPO opposition was concluded. Finally, he said that there was a public interest in removing an invalid patent from the Register as quickly as possible.

It is hard from those three cases to notice that there is a "presumption in favour of a stay". I am slightly dubious about the particular value of a UK judgment(!), and I wonder what lies behind the "public interest" in removing an invalid patent. Surely a patent is presumed to be valid until it is found to be otherwise? If so, is this an appropriate starting point for refusing a stay?

I think it is safer to assume that there is no presumption in favour of a stay at all. Hopefully this matter will be resolved by the Court of Appeal before too long. At the time of going to press with this paper the Court of Appeal decision in the Genentech case is expected any time.

Procedure

There was one major procedural case of interest this year. In Arrow v Merck the question arose as to whether the UK Court had jurisdiction to grant a declaration that the claimant's own product was obvious over the prior art at the time of the priority date. This effectively amounts to seeking a declaration that there is a Gillette defence, before the trial has taken place.

Mr Justice Kitchin, who heard the case, summarised the issue as follows: "Where one person holds over another a threat of patent infringement proceedings on the basis of division or applications, whether this Court should necessarily refuse to allow the person so threatened to seek a determination of its rights."

Merck filed a patent application in 1998 for a drug called Alendronate used in the treatment of bone wasting diseases including osteoporosis. The principal patent was revoked and Arrow started to sell Alendronate in the UK and other jurisdictions, believing it was commercially safe to do so. However Merck had filed four divisional patent applications with the same priority date covering substantially the same subject matter. Merck had further made a public announcement that it would enforce its intellectual property rights on the drug and, indeed, had commenced infringement proceedings against Arrow in Italy and Sweden and against other generic companies in other European jurisdictions.

The Judge summarised Arrow's request to the Court as follows: "In short, therefore, Arrow seeks a declaration that its own product was obvious at the priority date of the divisional applications. Such a declaration would give Arrow the security that dealing with its own Alendronate product in this country will not give rise to any liability to Merck for infringement of any patent granted pursuant to the divisional applications or any further divisionals arising under them. It says this Court had jurisdiction to grant such a declaration and that it is appropriate so to do because Merck had shown every intention of (a) pursuing and (b) relying upon the divisional applications against Arrow inter alia in the United Kingdom."

The Judge accepted that the jurisdiction to grant the declaratory relief is an entirely discretionary one. He cross-referred to the current proceedings between Nokia and Interdigital Technology Corporation where Pumfrey J referred to a line of authorities to support the assertion that the correct approach to the question of whether to grant negative declarations was one of discretion rather than jurisdiction. He has said: "The use of negative declarations should be scrutinised and their use rejected where it would serve no useful purpose, but where such a declaration would help ensure that the aims of justice were achieved, the Court should not be reluctant to grant a negative declaration."

Merck relied on section 74 of the Patents Act saying that it set out the various proceedings in which the validity of a patent may be put in issue and that it was a "closed set". Arrow argued that section 74 related only to patents, and not applications. Section 79 provided that the word "patent" should include an application in relation to certain sections of the Act, but those sections did not include section 74.

Kitchin J said: "Arrow seeks a declaration as to its right to make and sell its own product. In my judgment, clear words are required to exclude that right and section 74 should be interpreted no more widely than necessary to give effect to its purpose."

Kitchin J decided to allow the proceedings for a declaration to proceed, and we will have to wait to see what the outcome is. He said: "I must also consider whether the underlying issue is sufficiently clearly defined to make it properly justiciable. As indicated earlier in this judgment, the declarations sought in the claim form are framed in general terms. But the substance of what is sought has now been clarified. Arrow does not contend it would be proper for this Court to declare that no valid patent could be granted on the remaining divisional applications. Instead, Arrow seeks much more limited declarations, namely that its own product was obvious at their priority date…in my judgment this is a clearly defined issue which is readily susceptible to determination. Indeed, it is the kind of determination which this Court is well used to making."

This raises a whole host of interesting issues. There is clearly some uncertainty over the appropriateness of an order of this nature. In the Nokia v Interdigital case Lord Justice Carnwath quoted earlier authority of Lord Justice Robert Walker where he had said: "In patent cases the Court should be particularly wary of granting declarations of non-infringement under the general jurisdiction, because of the existence of the special jurisdiction under section 71 of the 1977 Act and the detailed requirements which it imposes."

He went on to say that a negative declaration should be regarded as "an unusual remedy" and that this justified caution in extending the circumstances where such declarations are granted.

What may be interesting when the application for the declaration is actually heard by the Court, is the basis on which the decision is arrived at. The application is for the claimant's own products to be declared obvious over a piece of prior art. Obviousness, as a concept, is a creature of the 1977 Act, but the Act cannot be used as the basis for such an application – there is no provision within the Act for it. The Gillette defence itself is a creature of case law, rather than being based on any statutory provision.

Accordingly, are the usual obviousness criteria properly to be employed? Will secondary evidence be, as usual, relegated to "its place"? This will be a very interesting application and I sincerely hope that it goes to Court.

There is one further case I would like to refer to before concluding. In Monsanto v Cargill the issue was whether the defendant's expert witness statement evidencing the results of experiments was admissible despite the fact that the experiments had not been the subject of a notice of experiments served in accordance with the directions, and whether the claimant's prior knowledge of the experiments affected the decision as to admissibility.

The prior knowledge arose in the course of European Patent Office opposition proceedings in which the experiments had been fully disclosed and used.

Mr Justice Kitchin held that in the normal course of events, the fact that a notice of experiments is not served in accordance with the directions should lead to evidence of the outcome of the experiments being excluded since the notice provides the other party with the opportunity to inspect the experiments, answer and/or criticise them, and to conduct experiments in reply if necessary. However, in this case, since Monsanto was already fully familiar with the experiments as a result of the EPO litigation, he was not satisfied that Monsanto would suffer any real prejudice through its late notice of the experiments.

Conclusion

I am reliably informed that in the past Lord Justice Jacob has publicly stated his view that intellectual property is "the grit in the wheels of industry". Every decision we have seen this year seems to bear that out, and there is more than a clue that his views have influenced other judges.

In the Conor v Angiotech case Lord Justice Jacob said: "I also take the view that one can over-elaborate a discussion on the subject of "obviousness" so that it becomes metaphysical or endowed with unwritten and unwarranted doctrines, sub-doctrines, or even sub-sub-doctrines."

What "sub-doctrines" have we seen emerging this year?

Lord Justice Jacob has referred to a question of whether or not his decisions fit into the context of "a rational patent policy". Surely this is a matter for government?

He has referred to the economic consequences of his decisions in Conor v Angiotech, and speculated on the effect on the Australian economy of their approach to patents. Is that the business of a Judge? The Judges have repeatedly referred to the question of whether or not the inventor "deserves" the patent – a subjective issue in a field which they repeatedly tell us is entirely objective.

As I have already mentioned, the "track record" of Mr Justice Pumfrey reveals that a patentee has barely a 1 in 10 chance of success in front of him. He is now on his way to join Lord Justice Jacob in the Court of Appeal – the dynamic duo!

In all seriousness, there does need to be a debate on the way in which patents are litigated in the United Kingdom. Whilst, procedurally, we seem to have everything right in terms of the speed of cases, and the thoroughness with which investigations are undertaken, the success rate for patentees in the United Kingdom cannot be right. No-one denies that many bad patents are granted, and it is true to say that only a tiny fraction of all patents come to Court. There is an argument which would suggest that it is only the most problematic that get there, but there is in fact no logic behind that. People do not choose to infringe patents purely because they believe them to be "iffy". The sample of patents litigated is, in all probability, representative of the quality of patents as a whole, and yet they are hardly ever found to be both valid and infringed. I suspect on occasions that, having made a finding of non-infringement, the Judges feel able to find a patent valid in order to get their "run rate" up!

The language says it all. The passages I find most telling this year both belong to Lord Justice Jacob. I have already mentioned the comments he made in Conor v Angiotech, but it is worth reconsidering his comments in the Aerotel case. You will recall his speculation as to whether or not the granting of software patents by the US Courts constituted "a Good Thing". He set out his assessment of the "price" of patents referring to their cost, the impediment to competition, the compliance cost of ensuring non-infringement, the cost of uncertainty, litigation costs and so on. That is quite an array of weaponry to have in your mind aimed at patents. If that is the mindset of the Judge, it is hardly surprising that he seems to start with a presumption that patents should be treated with scepticism, and may even be presumed invalid before a case starts.

That flies in the face of the law. As I have commented in the past, a patent should be assumed to be valid. It is a piece of property on a public register – it has been examined and considered carefully before grant. As I have mentioned, we all know that many bad patents do get granted. However, the onus must always be on the person seeking to set a patent aside. If the burden shifts, the system is failing.

I sense some anger beginning to develop over this issue. I hope that it can be properly channelled into a sensible and rational debate which will lead to improvement. It has been a struggle this year to find a home for my "Judge of the Year" award. In the end, after lengthy consideration, I have decided that the relative newcomer to the patents world, Mr Justice Warren, should receive the award. His judgments are sensible and well-argued and as yet he still sees himself as a judge and not a legislator – an attitude I would like to see repeated by others!

For the meantime the answer to the question "when is a patent not a patent?" might be "when it has been litigated in the UK Patent Courts"!

This speech was delivered by Gordon Harris at the 12th Annual Patents Seminar.