Actavis UK Ltd v Novartis AG

Novartis appeals Warren J’s decision of 16^th January 2009, [2009] EWHC 41 (Ch), that its EP (UK) 0948320 is invalid for obviousness.

Mr Richard Meade QC (replacing Mr Richard Arnold QC following his appointment as a judge) and Mr Mark Chacksfield appear for Novartis. Actavis, the respondent, is represented as it was below by Mr Roger Wyand QC and Mr Piers Acland.

The Patent, whose priority date is October 1996, is for a sustained release formulation of fluvastatin. In 1996 fluvastatin was a well-known statin available in an immediate release formulation consisting of capsules containing 20 or 40 mg of the sodium salt. By that date there was a strong and well-known school of thought in favour of a dosage regime consisting of a 40 mg capsule to be taken twice a day.

Also at the priority date there was extensive knowledge of sustained release formulations generally. The Patent puts it this way under the heading “background art”:

[0002] In recent years there has been a large increase in the development and use of sustained-release tablets which are designed to release the drug slowly after ingestion. With these types of dosage forms, the clinical utility of drugs can be improved by means of improved therapeutic effects, reduced incidence of adverse effects and simplified dosing regimens.

Mr Meade suggested that this paragraph should be read as specific to the invention and was saying that the invention would lead to improved therapeutic effects, reduced adverse effects and simplified dosing regimens. But it is clear that it is no more than a general background statement about the increasing use of sustained release drugs and the reasons therefor. It is saying you may or may not get improved therapy (for one or other or both reasons) and you will (obviously) get a simplified dosing regime. That was common general knowledge.

The Patent then explains that by “sustained release” is meant a release which takes typically more than 3 and less than 30 hours. It then points out that there are several different known types of sustained release formulation and describes three types: use of an insoluble matrix, an eroding matrix, and release through a semipermeable membrane. Just before it describes these it says:

[0004] …. The actual approach taken for a given drug depends inter alia on the physical chemical properties of the drug. One of these is the solubility of the drug, which has a major impact on the pharmaceutical formulation strategy. A high solubility of the drug substance may induce problems, as discussed further below.

The Patent later returns to high solubility and the problems it may cause:

[0008] As mentioned above, the drug release from sustained release formulations is related to the drug solubility. The higher the water solubility of the drug, the faster the drug release and the shorter the duration of drug delivery. A fast release of the drug might mean that the desired rate and duration can not be obtained and that the beneficial effects of sustained release administration are lost. Thus, a special challenge is met when trying to formulate water soluble substances for sustained release formulations. One way to try to solve this problem would be to include large amounts of slow release excipients in the formulation. However, this approach has drawbacks such as increased costs and increased size of the formulation. Increased physical size of the dosage form may present problems for some patients, since the tablet will be more difficult to swallow. Another possibility is to use a less water soluble salt. However, such a change requires a more extensive development work and may also lead to bioavailability problems due to incomplete dissolution.

This is all perfectly general, still under the general heading “Background, sustained release formulations.”

The Patent then goes on to discuss statins generally and then fluvastatin, which it acknowledges is known. It then suggests that its solubility is so great that one would expect problems in creating a sustained release formulation:

[0012] Fluvastatin is a water soluble drug. For example, the solubility of the sodium salt of fluvastatin in water extends to more than 50 g/l. Biopharmaceutical requirements of a sustained release product of this water soluble drug would then at first sight impose formulation problems as discussed above.

The Patent then explains why, in relation to each of the types of sustained release formulation, high solubility causes problems.

The Patent then says what problem the invention is aimed at:

[0015] Consequently, there is a need for pharmaceutical formulations of HMG-CoA reductase inhibitors which avoid the above mentioned drawbacks and are possible to prepare, e.g., without including large amounts of slow release excipients or the use of highly advanced techniques. Preferably, the production costs of the formulations should be low.

Clearly in context the “need” referred to is a need for slow-release formulations, not merely any kind of formulation. That is the problem the invention of the Patent seeks to overcome

The clear message of all this is simple: there is a need for a sustained release formulation of fluvastatin but its solubility is so high that there is at least a perception that any of the conventional methods would not work.

The Patent now moves on to “Disclosure of the invention”. The first paragraph under this heading sets out what the inventors claim to have discovered and the second the consequential invention:

[0017] It has surprisingly been found that sustained-release compositions, comprising fluvastatin as a water soluble salt, exhibit particularly favorable release characteristics such as unexpectedly long duration and slow rate of drug release. In the present context, the term "water soluble" should be understood as a solubility of more than 30 mg/ml in water at +37°C.

[0018] Consequently, the present invention provides a pharmaceutical composition for sustained release comprising a water soluble salt, preferably the sodium salt, of f1uvastatin as an active ingredient. The sustained-release f1uvastatin compositions for which these favorable properties are obtained are selected from the group comprising matrix formulations, diffusion-controlled membrane coated formulations; and combinations thereof.

This is saying that, contrary to what the skilled person would have thought from its high solubility, you can in fact make sustained release formulations of fluvastatin by using any of the three conventional techniques already acknowledged.

After some detail which does not matter the Patent says this, and only this, about the utility of the invention:

[0027] The pharmaceutical formulations according to the invention are useful for lowering the blood cholesterol level in animals, in particular mammals, e.g. humans. They are therefore useful as hypercholesterolemic and anti-atherosclerotic agents.

The Patent presents some data which shows that fluvastatin is released more slowly from a sustained release formulation than two other, less soluble drugs. This is done “to exemplify the unexpectedly favorable properties of fluvastatin in matrix and membrane coated formulations.”

It is worth noting that there is no comparison with a drug which has such a high solubility that it cannot put into a sustained release form.

Examples of sustained release formulations are given (nothing turns on these) and then the Patent comes to its claims. Although there were lurking in the background some arguments about other claims, the only claim which really matters is claim 1, as permitted to be amended by Warren J:

A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.

The statutory question is beguilingly simple and is set out in the European Patent Convention, enacted by the Patents Act 1977. The Convention says:

Art 52 Patentable Inventions

(1)

European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.

Art 56 Inventive Step

An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.

So at bottom the question is simply whether the invention is obvious. Any paraphrase or other test is only an aid to answering the statutory question.

In our courts we have found a structure helpful to approach – not answer - the question. In its latest refinement (see Pozzoli v BDMO [2007] FSR 37) it runs as follows:

(1)(a) Identify the notional "person skilled in the art"

(b)

Identify the relevant common general knowledge of that person;

(2)

Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;

(3)

Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;

(4)

Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

Obvious for the purposes of step 4 means technically rather than commercially obvious.

I would only add an extra word about step 2 – identifying the inventive concept. It originally comes from Oliver LJ’s formulation of the approach in Windsurfing v Tabur Marine [1985] RPC 59 at 73. Strictly, the only thing that matters is what is claimed – as Lord Hoffmann said in Conor v Angiotech [2009] UKHL 49, [2008] RPC 716 at [19]:

the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description.

The “inventive concept” can be a distraction or helpful. It is a distraction almost as soon as there is an argument as to what it is. It is helpful when the parties are agreed as to what it is. In this case, for instance, although the claim has a numerical limitation defining what is meant by “sustained release”, as a practical matter both sides proceeded on the basis that it was for a sustained release formulation of fluvastatin.

The first three steps merely orientate the tribunal properly. Step 4 is the key, statutory step.

I am conscious that some appear to think that this structured process is something peculiarly British. I do not think it is. It merely makes explicit that which is implicit in all other approaches. No one would dispute for instance, that obviousness must be considered through the eyes of the skilled man (steps 1(a) and (b)). Nor that you have to identify the target of alleged obviousness (step 2). Nor that you have to identify the differences between the target and the prior art (step 3).

As to step (4), all it does is to pose the question. It does not attempt to provide any structure for answering it. Depending on the facts, various approaches may assist.

One, for instance, is “obvious to try”. The limits of that approach were discussed in Conor by Lords Hoffmann and Walker. Lord Hoffmann said this:

[42] In the Court of Appeal, Jacob LJ dealt comprehensively with the question of when an invention could be considered obvious on the ground that it was obvious to try. He correctly summarised the authorities, starting with the judgment of Diplock LJ in Johns-Manville Corporation's Patent [1967] RPC 479, by saying that the notion of something being obvious to try was useful only in a case in which there was a fair expectation of success. How much of an expectation would be needed depended upon the particular facts of the case.

Another approach, often used in the EPO both for examination and opposition is the “problem and solution approach” (“PSA”). It is conveniently described in the EPO’s Guidelines for Substantive Examination:

11.7

Problem-and-solution approach

In practice, in order to assess inventive step in an objective and predictable manner, the examiner should normally apply the so-called “problem-and-solution approach”.

In the problem-and-solution approach, there are three main stages:

(i)

determining the “closest prior art”,

(ii)

establishing the “objective technical problem” to be solved, and

(iii)

considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.”

I have a few comments about the PSA. First, and most important, is to emphasise that no-one suggests or has ever suggested that it is the only way to go about considering obviousness. The Guidelines say no more than that the examiner should “normally” apply it. That makes sense for an examining office which needs a common structured approach. When it comes to a national court making a full multifactorial assessment of all relevant factors (which may include so-called “secondary indicia” such as commercial success, especially if there has been a long-felt want) it may perhaps be used less often – particularly where there is significant room for argument about what the “objective technical problem” is. In this case, however, as will be seen, I think the approach is indeed useful.

My second comment is about stage 1 - identify the closest piece of prior art. It is not related to the remaining steps. It is about where they start from. Generally it is an immensely practical way of dealing with the fact that practitioners before the Office seem to think they can improve opposition attacks by the citation of a very large number of pieces of prior art. Currently there is nothing in the procedural rules (for instance a fee or costs sanction) to prevent this. Nor, in many cases, have practitioners themselves developed a culture of identifying their best piece or pieces (perhaps 2 or 3 maximum) of prior art. What is the Office to do when faced with a profligate number of citations? Laboriously consider the question of obviousness over each, one by one? Even though there may be fifty or more? That would be intolerable besides leading to even worse delays than there are now. So step 1 is essentially Office protective. It is an attempt to identify the best obviousness attack. The logic is simple: if that succeeds it does not matter if there are other attacks which might also succeed. And if it fails, other, weaker attacks would also do so.

So step 1 is a useful tool when there are many citations. It can have its difficulties – for instance deciding which piece of prior art is the closest can lead to something of a satellite dispute. You could argue, for instance, about whether you use a mechanical approach of just identifying which citation has the highest number of elements corresponding to elements in the claim, or use a more holistic approach of asking which is conceptually or technically closest.

It will be noticed that there is nothing like PSA step 1 in the Pozzoli/Windsurfing approach. The reason is essentially this: that practitioners before the English Patents Court have learned to confine themselves to their best cases, especially by the time of trial. English patent judges are simply not faced with profligate citations. And indeed if a party attempted to indulge in profligate citation it would be likely to find that when the case-management stage of the case was reached, it would be made to identify its best case, or few best cases. Moreover wasteful conduct, which would generally include profligate citation of prior art, is likely be met with adverse costs orders.

I turn to the next step – establishing the “objective technical problem.” The Guidelines say this:

In the context of the problem-and-solution approach, the technical problem means the aim and task of modifying or adapting the closest prior art to provide the technical effects that the invention provides over the closest prior art. The technical problem thus defined is often referred to as the “objective technical problem”.

The objective technical problem derived in this way may not be what the applicant presented as “the problem” in his application. The later may require reformulation, since the objective technical problem is based on objectively established facts, in particular appearing in the prior art revealed in the course of the proceedings, which may be different from the prior art of which the applicant was actually aware at the time the application was filed. In particular, the prior art cited in the search report may put the invention in an entirely different perspective from that apparent from reading the application only.

There is recognition here of that fact that in many cases the patentee did not start from the closest piece of prior art identified by step 1. He may have thought he was solving some larger or different problem. He may not have known of this piece of prior art.

The “reformulation” referred to thus involves the court or tribunal artificially creating a problem supposed to be solved by the invention. It is perhaps here that there can be real difficulties: for so much may depend on that reformulation however objectively one attempts the reformulation.

The Guidelines grapple with those difficulties:

It is noted that the objective technical problem must be so formulated as not to contain pointers to the technical solution, since including part of a technical solution offered by an invention in the statement of the problem must, when the state of the art is assessed in terms of that problem, necessarily result in an ex post facto view being taken on inventive activity (T 229/85, OJ 6/1987, 237).

The expression “technical problem” should be interpreted broadly; it does not necessarily imply that the technical solution is a technical improvement over the prior art. Thus the problem could be simply to seek an alternative to a known device or process providing the same or similar effects or which is more cost-effective.

For myself, I think the re-formulation – which really means retrospective construction - of a problem is perhaps the weakest part of the PSA. It will be noted that with the Pozzoli/Windsurfing approach, once one has finished the orienting step 3, the question is simply left open: is the invention obvious? There is no attempt to force the question into a problem/solution.

Moreover the PSA does not really cope well with cases where the invention involves perceiving that there is a problem, or in appreciating that a known problem, perhaps “put up with” for years, can be solved. Take for instance the “Anywayup Cup” case, Haberman v Jackel International [1999] FSR 683. The invention was a baby’s drinker cup fitted with a known kind of valve to prevent it leaking. Babies drinker cups had been known for years. Parents all over the world had put up with the fact that if they were dropped they leaked. No-one had thought to solve the problem. So when the patentee had the technically trivial idea of putting in a valve, there was an immediate success. The invention was held non-obvious, a conclusion with which most parents would agree. Yet fitting reasoning to uphold the patent into a PSA approach would not really work. For by identifying the problem as leakage and suggesting it can be solved, one is halfway to the answer – put in a valve.

Another aspect of obviousness which is not readily answered by the PSA is illustrated by the 5¼ inch plate paradox. This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no-one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.

What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive. And although “inventive step” is defined as being one which is not obvious, one must always remember the purpose of that definition – to define what is inventive. That which is not inventive by any criteria is not made so by the definition. Trivial limitations, such as specifying the plate diameter, or painting a known machine blue for no technical reason are treated as obvious because they are not inventive.

The PSA does not assist in providing an answer to the paradox. This is for the simple reason that there is no problem and so no solution to it.

Having said that the PSA has its limitations I hasten to add this: the PSA is apt to work very well when there is no need to reformulate the problem. This, as will be seen, is such a case. And it also generally works where, although there needs to be a reformulation, the reformulation is not controversial.

The last step of the PSA, asking whether the invention is obvious starting from the closest prior art and the objective technical problem corresponds to Pozzoli/Windsurfing step 4, though the latter is not limited to any “objective technical problem”. As I have said it leaves the question unconstrained by any necessary requirement to identify a problem.

That is because in the end obviousness is a multifactorial question. Kitchin J put thus in a manner approved by Lord Hoffmann at [42] in Conor:

The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success. (Generics v Lundbeck [2007] RPC 32 at [72]).

Finally I should say a word about what is sometimes called the could/would point. For it was part of Mr Meade’s submissions that even though it was conceded that the idea of a slow-release formulation of fluvastatin would occur to the skilled person, that was not enough to make a claim to it obvious. It was necessary to show that skilled person would implement it.

The argument went on in this way: since in practice implementation would involve quite a lot of trouble and expense by way of trials going right through to clinical trials, it was not shown that the idea, although conceptually obvious, would be followed through: it was not shown that the skilled person would actually make a sustained release form.

In support of his “would” argument Mr Meade relied upon the Guidelines and two TBA cases, s-triazines/CSIRO T632/91 and Xanthin ketals/Beecham-Wuelfing T116/90.

The Guidelines say this:

Could-would approach

In the third stage the question to be answered is whether there is any teaching in the prior art as a whole that would (not simply could, but would) have prompted the skilled person, faced with the objective technical problem, to modify or adapt the closest prior art while taking account of that teaching, thereby arriving at something falling within the terms of the claims, and thus achieving what the invention achieves (see IV, 11.4).

In other words, the point is not whether the skilled person could have arrived at the invention by adapting or modifying the closest prior art, but whether he would have done so because the prior art incited him to do so in the hope of solving the objective technical problem or in expectation of some improvement or advantage (see T 2/83, OJ 6/1984, 265). This must have been the case for the skilled person before the filing or priority date valid for the claim under examination.”

I do not read this as involving a requirement that the notional skilled person would actually physically implement the idea. What the passage is saying, sensibly enough, is that it not enough the skilled man could have arrived at the invention from the prior art, it must be shown that he would have done. Whether he would actually press ahead and implement the idea depends on a host of other, commercial considerations.

That that must be so seems to me to be self-evident. A requirement that an idea can only be held obvious upon proof that it would actually be implemented would make many self-evident ideas non-obvious. For many obvious ideas may not be worth implementing commercially.

Take an example close to this very case. Consider a variant of the known immediate release capsule formulation of fluvastatin – say a pill instead of a capsule or even a capsule using a different inert excipient. No one could seriously say that the variant was non-obvious and patentable because it was not proved that anyone would actually make the variation.

As to the cases, neither support Mr Meade’s submission. They are both cases where the TBA concerned used the PSA. In each case the opponent was arguing that the prior art could have been modified so as to come up with the claim to solve the objective technical problem. In each, not surprisingly, the Board said that was not good enough.

Thus in Beecham, the Board, having identified the objective problem as being finding additional compounds which had a particular pharmacological use and the closest prior art as disclosing ketones of a particular structure, had to consider whether a variant of that structure consisting of ketals instead of ketones was obvious. It said:

[6.5] … There is no doubt that ketals are structurally closely related to the parent ketones and that, normally, there are no great difficulties to overcome in their preparation. Thus, the skilled person could have considered them as possible and perhaps easily obtainable derivatives of the said parent ketones. This, however, is not the proper question to be asked. According to the established jurisprudence of the Boards it has to be investigated, when it comes to the issue of inventive step, whether a skilled person would have prepared the compounds in question with a reasonable expectation that they would successfully solve the technical problem under consideration. In the absence of any useful information to that end (cf. the above paragraphs 6.1 and 6.2) the Board cannot see why the skilled person would have suggested the claimed ketals with the expectation that they would be useful in the treatment of pvd.

That is far from applying a test of “would actually make”. It is saying no more than that there was no reason for the skilled person to propose the ketals to solve the problem. The other case adds nothing.

The Judge analysed the evidence in detail, for which I am very grateful. Because of that it is unnecessary to go over it all again. Before going to the Judge’s conclusions, it is worth noting that Actavis put its case higher than it needed to. It advanced a case that a sustained release form of fluvastatin would be expected not only to be a more convenient formulation for patient compliance but would be likely to have significant medical advantages, namely improved therapeutic effect and fewer side effects. Hence, the argument ran, there was a strong motive to create a sustained release form and a strong expectation that all three types of benefit would be obtained, the two medical and the convenience.

On the facts the Judge rejected the “medical advantage” motivation as having a significant enough expectation of success. But he did accept the “more convenient” advantage point. His detailed summary of the position, which is unchallenged, reads as follows:

[312] In the light of the totality of the evidence, the essentials of which I have discussed above, I reach the following conclusions:

a.

The skilled team is to be seen as engaged upon the task of formulating fluvastatin for use in humans for the treatment of hypercholesterolemia. There is no suggestion that the team would be formulating the drug for the treatment of different animals or for the treatment of any other condition.

b.

Part of the common general knowledge of the team includes the fact that an immediate release formulation was already available. That formulation could be taken at a dose of up to 40 mg once a day and up to 80 mg per day in two doses.

c.

Whether or not the team was expressly directed to consider formulating fluvastatin in a sustained release dosage form, it would at least consider such a formulation as a possible way forward and not dismiss it out of hand.

d.

The skilled team would seek to identify the benefits (or incentives) and problems (or disincentives) of a sustained release formulation.

e.

The team would regard improved patient compliance as a benefit which would certainly be obtained if a satisfactory formulation of an 80 mg dose could be successfully achieved.

f.

The team would be concerned about clinical efficacy. It would be uncertain about whether improvement could be achieved. It could not be ruled out. But it certainly could not be said with any confidence that any improvement would be achieved, nor that there was a strong expectation that it would be achieved.

g.

The team would also be concerned with side-effects. Again, it would be unable to predict with anything approaching certainty that any reduction in the risk of side-effects would be achieved, but there would be some hope of reduced risks of hepatotoxicity (on a population basis as explained above) and a reasonable expectation of improvements in myopathy. However, neither of these was seen as serious problems with fluvastatin at the priority date.

h.

The team would have, as a result of common general knowledge and secondary common general knowledge, an expectation of being able to develop an 80 mg sustained release formulation which released over at least 3 hours in vivo and would be confident that it would have some clinical efficacy. But it would have no confidence that it would achieve better, or even the same, efficacy as the existing maximum dosage of 2 x 40 mg daily immediate release. It would expect, but could not be certain, that this would not produce a greater risk of side-effects than the existing maximum dosage.

i.

It would have been rational, from a technical perspective, for the team to have produced a sustained release formulation for 80 mg once daily dosage with a view to improved patient compliance, anticipated reduction in side-effects and possible improved efficacy. But in the light of the uncertainties, such a course might well be seen as commercially unjustifiable; but that would be a matter for the decision of commercial people not of the skilled team.

j.

The team, if it were asked to do so, would be confident of producing a sustained release formulation of fluvastatin at various doses which had the release characteristics in vitro described in the Patent. It would be confident that such a formulation could be taken by humans and would have some therapeutic effect albeit perhaps of lesser efficacy than the equivalent dosage taken in immediate release form as a single dose (up to 40 mg daily) or two doses (up to 80 mg daily). There would, however, be no reason for producing such a formulation for its own sake if it were thought impossible or highly unlikely that such a formulation would have, or would lead to a product which would have, improved efficacy and/or reduced side-effects.

I should also set out a further finding:

[320] The Patent claims that, surprisingly, fluvastatin sodium exhibits particularly favourable release characteristics. The evidence, however, shows that the high absolute solubility of a drug is a problem only at very high and very low levels. The evidence also shows that the high (but not very high) solubility of fluvastatin would not have been seen as a serious problem at least in vitro; it would only have been seen as limiting the available technology for producing a sustained release formulation releasing in vitro over a period of 3 hours or more.

So the whole basis for the invention as set out in the Patent was destroyed. The Patent says the skilled man would think the solubility of fluvastatin was so high that the skilled man would think a sustained release form could not be made. But that was not so. The skilled man would not think that, based on his common general knowledge alone. The problem presented in the Patent was illusory (Lloyd LJ’s happy choice of word) – it was in reality a non-problem because fluvastatin is not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained release form.

I will be more specific about this. Combining finding (c) and (h) first sentence leads to this: that the skilled person would consider a sustained release formulation and would expect (contrary to what the Patent says) that he could develop a formulation within claim 1 which had some clinical efficacy. Finding (j) is to the same effect (“confident that such a formulation could be taken by humans and would have some therapeutic effect albeit perhaps of lesser efficacy ….”). Later the Judge put the same findings this way:

[321] .. the skilled team (including clinician) would be confident that some level of dose could be given in sustained release form which it would also be confident (i) would have some efficacy (perhaps not as good as the existing immediate release formulations) and (ii) would not produce unacceptable side-effects.

Mr Meade had to accept that the basis of the invention as presented by the patentee would not in reality have been seen as a problem by the skilled person. So he pointed to the PSA, submitting that this clearly allowed for a reformulation of the problem. It would be good enough to support the Patent if there was another problem in the way. That problem, he suggested was this: that the skilled person would not have a sufficient expectation of success to make it worthwhile trying to make a sustained release formulation. This case should be considered on an “obvious to try” basis. And because of an insufficient expectation of success Actavis should fail.

The Judge went along with this approach, but only up to a point. For after his summary of the facts he went on to conclude that the invention was not obvious on the basis of a notional project to develop a sustained release formulation which had a fair expectation of success. By “success” he meant a formulation which had improved therapeutic effects or fewer side effects as compared with immediate release formulations.

Having got this far the judge went on to consider the case on the basis of the 5¼ inch plate paradox. At this point he held that there was no motivation to produce a sustained release form and said this:

[323] In my judgment, this absence of motivation does not prevent claim 1 from being technically obvious. The skilled team would, for reasons already given, not reject a sustained release formulation out of hand. Even though its focus will be on the end result of an 80 mg once daily formulation having improved efficacy and less serious side effects, coupled with better patient compliance, the concept of sustained release will be present. It does not need a commercial boss to ask the question “Can you make a formulation [within claim 1]” for the skilled formulator to appreciate its technical obviousness any more than it needs a commercial boss to ask a similar question of the plate designer for that designer to appreciate the technical obviousness of the odd-sized plate. I conclude that claim 1 is obvious over the common general knowledge.

I am not sure why the judge at this point said there was no motivation. After all finding (i) had indicated a technical motivation – patient compliance at the very least. Moreover, the Patent itself said there was a motive – see [a] above I think he must have meant commercial motivation – but the absence of that is not enough to defeat an obviousness attack.

Because of the way the Judge dealt with the matter, Mr Meade appealed in respect of the “technically obvious” finding and Mr Wyand challenged the decision that apart from that point the invention was not obvious. I have to say I do not think that the two-bite approach is actually a convenient way to deal with obviousness. It is, after all, a multi-factorial assessment. The thing to do is to identify all the relevant factors, orientate oneself à la Pozzoli and then decide whether the invention is obvious.

I start with Mr Wyand’s challenge. He submitted that the Judge had made an error in assessing what was meant by “success” in terms of the Patent. It was not improved clinical efficacy or the same efficacy with fewer side effects. It was simply a sustained release formulation which one would expect to work. Moreover if one wanted a motive, there was one – improved patient compliance. Whether it was worth actually developing such a formulation (there would be costs of testing and compliance with regulatory requirements) was irrelevant. As the Patent said at [15] there was a need for a slow release formulation which it was possible to prepare.

I accept that submission. Once the obstacle put forward in the Patent against being able to make a sustained formulation was shown to be illusory, then a sustained release formulation is obvious. You might get better efficacy or fewer side effects, but you would certainly get better compliance. In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation. For that there was a technical motivation and no difficulty, real or apparent.

The PSA gives the same answer. What is the objective problem? Why that which the patentee himself stated – to produce a sustained release form of fluvastatin. Was the solution obvious? Yes, any of the standard methods for such formulations would clearly work: there is no reason why they would not.

There is no need and it would be wrong to re-formulate the problem as suggested by Mr Meade. This is not a case where some prior art unknown to the patentee has turned up. Nor is it right to reformulate the problem as one of looking for better medical effects when that was not the problem as seen by the patentee or to reformulate the solution as having found such effects when the patentee has not promised any.

In the latter respect this case is quite unlike the case, relied upon by Mr Meade, about a sustained release form of oxycodone recently considered by this court, Napp v Ratiopharm [2009] EWCA Civ 252, [2009] RPC 539. Oxycodone was, until the patent, known as a minor weak opiod generally administered, to the extent that it was administered at all, as a co-drug. The slow-release form transformed it, as the patent said, into a serious alternative to morphine – something that was wholly unexpected. Of course the invention was non-obvious.

The upshot is that I would uphold the decision of the Judge. Unlike him, however, I do not think the case was finely balanced. Once the basis of the Patent was proved illusory there was nothing left to save it.

I agree.

I also agree.