1. Assessment of inventive step

CH Switzerland

Federal Patent Court, 27 May 2015 (O2013_11)

Keywords: inventive step – problem-solution approach – closest prior art

At issue was a supplementary protection certificate based on European patent 0 491 443. The patent concerned a contraceptive containing desogestrel, 3 ketodesogestrel or mixtures of the two, and its use and manufacture. The independent claims differed from the prior art in specifying a quantity, per dosage unit, of 70-80 μg of desogestrel, 3 ketodesogestrel or mixtures as the sole contraceptively effective ingredient. The problem addressed by the patent was thus to determine the effective dose of progestagen.

The Federal Patent Court found that at the date of filing it was known that the minimum amount of desogestrel for complete inhibition of ovulation was 60 μg, and also that a dose of 150 μg could be tolerated. Arriving at a dose of 70-80 μg – i.e. within that range – was therefore a routine task for the skilled person (here: a team, comprising a medical doctor and a pharmacologist, working on the practical development of contraceptives). The patent should therefore be revoked.

That view was reinforced by the decisions in parallel cases in Germany (Federal Patent Court judgment of 6 May 2014) and France (Paris Regional Court judgment of 5 December 2014), which had used largely the same documents as the Swiss court as closest prior art, and which had both found that the patent was not inventive.

The patentee argued that the wrong closest prior art had been used. Taking as the closest prior art the conventional "minipill" known at the priority date, the patent was indeed inventive.

The Federal Patent Court observed that the prior art comprised everything made available to the public – before the date of filing or priority – through a written or oral description, by use, or in any other way. An invention should not be obvious from any of that prior art. As a rule, under the problem-solution approach normally followed when assessing that, the starting point was the "closest prior art" – but it did not have to be.

The Court, citing EPO board of appeal decision T 967/97, ruled that inventive step could be acknowledged only if it held good against all the documents cited as potentially being the closest prior art. If any single one of them rendered the invention obvious, the patent had to be revoked.

DE Germany

Federal Court of Justice, 14 October 2014 (X ZR 35/11) – Access rights

Keywords: inventive step – skilled person – earlier version of a technical standard

At issue in this case was European patent 1 186 189, which was for a method of allocating access rights to a telecommunications channel.

The decision for the Court was whether the skilled person had reason to consider not only the latest mobile telecommunications standard as at the priority date, but also earlier versions. It ruled that just because a solution had been applied only in a previous version, but later dropped, that did not necessarily mean that the solution was not obvious.

Such might be the case if a newer version of a standard offered a better, simpler or more elegant solution to a technical problem. The reasons for modifying the standard did not necessarily have to be technical, however. Even if technical reasons had played a decisive role, that did not rule out reconsidering the discarded solution in new circumstances.

Here the skilled person did have reason to consider earlier versions of the standard that had addressed the problem in question.

DE Germany

Federal Court of Justice, 13 January 2015 (X ZR 41/13) – Quetiapine

Keywords: inventive step – objective technical problem

European patent 0 907 364 claimed a sustained-release pharmaceutical (a retard formulation with quetiapine as active ingredient).

The Federal Patent Court had defined the technical problem underlying the patent as being to provide a quetiapine formulation with the most constant release profile possible over the longest period of time possible (i.e. a retard formulation). But according to the Federal Court of Justice that definition was too narrow; the problem was in fact to provide a formulation that was more effective.

The description as worded did suggest the definition used by the lower court, but the wording of the description was not necessarily decisive. According to the Court's case law, the starting point for assessing inventive step was not necessarily the "problem" taken from the description (X ZR 72/08 – Cosmetic sunscreen III), but rather what the invention actually achieved over the prior art (X ZR 200/99 – High-pressure cleaner).

The Patent Court's definition was too narrow, because the case raised inter alia the question whether the skilled person was prompted to consider a long-lasting sustained-release formulation for quetiapine.

The purpose of defining the technical problem was not to take a pre-emptive decision about patentability. Elements forming part of the claimed solution therefore had to be disregarded (Federal Court of Justice X ZR 124/88 – Folding machine; and Xa ZR 22/06 – Three-seamed tubular foil sachet).

For the same reason, it could not simply be assumed that for the skilled person it was obvious to consider a particular problem. In many cases, the problems the prior art would have prompted him to address might indeed be clear from the description or otherwise. But if that was not beyond doubt, the question of what promptings he received from the prior art should not already be examined when defining the technical problem – which should instead be formulated in such general and neutral terms that this question arose solely in the context in which it was relevant, namely when assessing inventive step.

ES Spain

Supreme Court, 20 May 2016 (334/2016) – Accord Healthcare et al. v AstraZeneca

Keywords: inventive step – identifying the state of the art – significance of the description

The Spanish Supreme Court confirmed the decision of the Barcelona Court of Appeal (Section 15) on the nullity of AstraZeneca's European patent 0 907 364 (ES 2 182 079) relating to sustained-release formulations of quetiapine. It was noted that in order to assess inventive step in an objective and predictable manner, the "problem-and-solution approach" had been applied by the Court of Appeal. The parties did not dispute the method applied, but how it had been applied by the Court of Appeal. The identification of the state of the art was the main issue.

The patentee (appellant) was of the opinion that the principles applied by the Court of Appeal prevented the reformulation of the "objective technical problem" of the invention. The Supreme Court noted that it had to be considered that an objective definition of the problem to be solved by the invention should normally start from the problem described in the contested patent. It agreed with the appellant's assertion that the description was only a starting point. However, only if examination showed that the problem disclosed had not been solved or if inappropriate prior art was used to define the problem was it necessary to investigate what other problem objectively existed (following the criteria set out in the relevant decisions of the boards of appeal of the EPO). The Court found that the decision of the Court of Appeal acknowledged the significance of the description in relation to the determination of the technical problem to be solved. The Court noted that the appellant itself had written the description from which it was now distancing itself. The Court of Appeal had stated that in view of the principles of good faith, certainty and accountability for one's actions, it was not possible to ignore the relevance of that description for the purposes of evidence and the interpretation of claims (Art. 69(1) EPC). In the Court's opinion, the appellant had sought to replace the problem identified in the description of the patent with a broad and generic one. Accordingly, the Supreme Court rejected the appellant's argument and confirmed the assessment made by the Court of Appeal.

For parallel proceedings in other national jurisdictions concerning this European patent, see chapter H.1. Quetiapine.

GB United Kingdom

Court of Appeal, 28 July 2015 – Teva UK Ltd v Leo Pharma A/S [2015] EWCA Civ 779

Keywords: inventive step – expectation of success – obvious to try

Leo's European patents (UK) 1 178 808 and 2 455 083 concerned an ointment for the treatment of psoriasis, containing two active ingredients, calcipotriol and betamethasone, and a commercially available solvent. Each active was well established for use as the sole active in a psoriasis ointment before the priority date. Each had a different effect, so they were often both prescribed. However, they could not be used at the same time, as each was unstable save in narrow ranges of pH which did not overlap. It was well known that there can only be a pH at all if water is present, so in theory the way to produce a dual product would be to make one containing no water, i.e. a non-aqueous solvent. The solution of the patents was to use Arlamol E.

The trial judge had found that the patents were invalid for lack of inventive step. The Court of Appeal held that the trial judge had erred in his application of the law on the assessment of inventive step, thereby allowing it to revisit the question of obviousness de novo.

The Court of Appeal stressed that the "obvious to try" test for obviousness had limitations: 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 (Conor v Angiotech [2008] UKHL 49). According to the Court, it was far from established that any non-aqueous non-toxic solvent would produce a stable ointment. Keeping water wholly out was a known real problem. It could not be said that a formulator would have anything like a strong expectation that any particular non-aqueous solvent would work. On the contrary he would have to undergo a research project. The trial judge had said the use of non-aqueous solvents would be "well-worth investigating" but that was not the same as saying any particular such solvent had a fair expectation of success.

The Court of Appeal disagreed with the trial judge that the idea of including Arlamol E as part of a research project amounted to obviousness; the "obvious to try" standard required a higher expectation of success than that. Otherwise, as observed in Saint-Gobain v Fusion [2005] EWCA Civ 177: "Mere possible inclusion of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions which were patentable. The only research which would be worthwhile (because of the prospect of protection) would be in areas totally devoid of prospect."

In conclusion, the trial judge's finding on obviousness was reversed and the appeal allowed.

GB United Kingdom

Patents Court, 16 November 2015 – Actavis Group PTC EHF & Anor v Eli Lilly and Company [2015] EWHC 3294 (Pat)

See Chapter D. Sufficiency of disclosure.

GB United Kingdom

Patents Court, 13 January 2016 – Accord Healthcare Ltd v medac Gesellschaft für Klinische Spezialpräparate mbH [2016] EWHC 24 (Pat)

Keywords: inventive step – obviousness over common general knowledge alone

In the revocation proceedings concerning medac's patent EP (UK) 2 046 332, Birss J concluded that all claims were obvious over an item of prior art. However, he rejected a different obviousness attack, which was based on common general knowledge alone, and in that context set out some more general observations on the problems of such a line of argument.

In ratiopharm v Napp [2008] EWHC 3070 (Pat), Floyd J had warned that such attacks needed to be scrutinised with care since they could be favoured by parties because the starting point was not obviously encumbered by inconvenient details of the kind found in documentary disclosures. Birss J agreed. Normally the person attacking validity would rely on a particular concrete document or well defined prior use as a starting point. The fact that such a concrete item of prior art could be part of the common general knowledge was not the point. That was different from an attack based on common general knowledge alone.

Many inventions involved a combination of known features. However a combination of features, all of which individually were common general knowledge, could give rise to a valid patent claim if that combination was new and non-obvious. Patent trials were inevitably ex post facto and a key problem was to identify and avoid hindsight. Combinations of features could pose a particularly acute hindsight problem. The thing about concrete items of prior art was that whatever combination of features that concrete prior art consisted of, was not one which had been created with hindsight knowledge of the invention.

The problem with arguments over common general knowledge alone was that the combination of features relied on was always and necessarily one created with hindsight knowledge of the invention, and worse, was one which the person attacking validity had not been able to find as a pre-existing combination in the concrete prior art. If they had they would have relied on that concrete prior art. Either the combination had not been made in the concrete prior art at all or it only appeared with additional inconvenient details. If an invention was not obvious over the concrete prior art relied on, the court was entitled to be sceptical that an argument that it was nevertheless obvious over common general knowledge alone was correct.

In the present case, the two documents pleaded by Accord contained what might have been thought of as "inconvenient" details. To invent as a starting point in the prior art an amalgam of the best bits of the two cited documents while leaving out the inconvenient aspects, which was in effect what the argument was, created a combination which did not hitherto exist.

GB United Kingdom

Patents Court, 11 April 2016 – American Science & Engineering Inc v Rapiscan Systems Ltd [2016] EWHC 756 (Pat)

Keywords: inventive step – instructing expert witnesses – secondary evidence

In this infringement action by AS&E in respect of its European patent (UK) 1 558 947 ("X-ray backscatter mobile inspection van"), Rapiscan had counterclaimed for revocation on the basis that the claims in issue were obvious in the light of a scientific paper, "Swift". Arnold J's conclusion was that the claims were not obvious over Swift.

Each side had put forward an expert witness and Arnold J considered how each had instructed its expert. Both had proceeded in a carefully structured manner by first asking the expert to consider the person skilled in the art and the common general knowledge, then to consider the prior art relied upon by the defendant and only then to consider the patent. However, AS&E's expert, Dr B, had been asked to consider obvious developments of the prior art before being shown the patent, whereas Dr L for Rapiscan was asked to consider the question of obviousness after being shown it.

According to the judge, AS&E's approach had the advantage of enabling Dr B to consider obvious developments of the prior art free from knowledge of the patent; but it meant that he had never addressed in his reports the question whether the differences between Swift and the claimed invention constituted steps which would have been obvious to the skilled person. The mere fact that a step did not occur to Dr B when reviewing the prior art was not sufficient to exclude the possibility that he might agree that it was obvious if asked. Unlike the skilled person, real people sometimes missed the obvious. The approach adopted by Rapiscan avoided that difficulty. The problem was that, whereas the correct question was whether, viewed without any knowledge of the claimed invention, the differences constituted steps which would be obvious, Dr L expressed his understanding of the question he had been asked to consider without referring to the need to exclude knowledge of the claimed invention. Moreover, he confirmed in cross-examination that his approach had been to consider obviousness as if the skilled person had been shown the claims and asked if they were obvious. Thus Dr L did not appear to have understood the importance of trying to avoid hindsight.

Under the rubric of secondary evidence, Arnold J considered the familiar question of why, if the invention was obvious, it had not been made before. Rapiscan's suggestion was that this was because AS&E had patent protection for X-ray backscatter systems, and, moreover, that the burden lay on AS&E to show that this was not so. Arnold J rejected this submission. It was plain that where a party who was attacking the validity of a patent on the grounds of obviousness wished to rely upon a fact as explaining why the invention had not been made before the patent – whether that fact related to the availability of raw materials, a regulatory restriction, a commercial factor, or the existence of an earlier patent owned by the patentee or a third party – then the burden of proving the existence and relevance of that fact lay upon that party.

GB United Kingdom

Patents Court, 12 May 2016 – GlaxoSmithKline UK Ltd v Wyeth Holdings LLC [2016] EWHC 1045 (Ch)

Keywords: inventive step – common general knowledge – material available online

At issue was Wyeth's European patent (UK) 2 343 308. Henry Carr J referred to the legal principles in respect of common general knowledge (CGK) set out by Arnold J in KCI Licensing v Smith & Nephew [2010] EWHC 1487 (Pat), and approved by the Court of Appeal at [2010] EWCA Civ 1260. He then referred to the following passage from the judgment of Sales J in Teva v AstraZeneca (asthma) [2014] EWHC 2873 (Pat):

"The authorities indicate that CGK includes not just information directly in the mind of the notional skilled person, but such information as he would be able to locate by reference to well-known textbooks. This guidance needs to be adapted and kept appropriately up to date for the procedures for dissemination of scientific knowledge in the age of the internet and digital databases of journal articles. Searches of such databases are part and parcel of the routine sharing of information in the scientific community and are an ordinary research technique. In my view, if there is a sufficient basis (as here) in the background CGK relating to a particular issue to make it obvious to the unimaginative and uninventive skilled person that there is likely to be – not merely a speculative possibility that there may be – relevant published material bearing directly on that issue which would be identified by such a search, the relevant CGK will include material that would readily be identified by such a search."

Henry Carr J agreed with this analysis. This passage did not mean that all material available online constitutes common general knowledge. Rather it indicated that material which the skilled addressee knows to be available online and which is generally accepted as a good basis for further action (such as material which might be found offline in a textbook or a key journal article) may constitute common general knowledge.

GB United Kingdom

Court of Appeal, 27 July 2016 – Hospira UK Ltd v Genentech, Inc [2016] EWCA Civ 780

Keywords: inventive step – could/would approach

Both patents in issue, European patents (UK) 1 516 628 and 2 275 119, were concerned with pharmaceutical formulations of the breast cancer drug Herceptin. The trial judge had held the patents invalid, inter alia on the ground of lack of inventive step. That was because the claimed combination was simply an example of the work product of the necessary screening programme to find a satisfactory combination of excipients. To arrive at such a combination would not have involved any inventive effort.

The Court of Appeal dismissed the appeal, finding that the trial judge had not fallen into any error of principle which would justify the Court of Appeal interfering with his decision on obviousness. The Court addressed the question whether the skilled person would, or whether he or she could, arrive at the claimed invention without inventive effort. It held that it was not necessary in every case for the court to conclude that the skilled person acting only on the basis of the prior art and his common general knowledge would arrive without invention at the precise combination claimed. In the case in hand, the screening methods were part of the common general knowledge, the tests involved were routine, and the excipients were common general knowledge excipients. Thus, the claimed combination was one that could be made by the skilled team.

With regard to whether it was, in such circumstances, necessary to go further and ask whether the skilled person would necessarily have made the precise combination claimed, the Court stated that in an empirical field it would seldom be possible to predict in advance that any individual experiment would work. In many cases, the fact that a routine screening exercise could be carried out would be inadequate to establish obviousness. Nevertheless, in a case such as this one, the team might have a reasonable degree of confidence that a series of experiments would produce some which would work. To impose a requirement that the skilled team must be able to predict in advance which would be the successful combinations was wholly unrealistic. It would lead to the grant of patents for a whole variety of combinations which in fact involved no inventive effort.

The Court further stated that a finding of obviousness on the basis of a "could" test was not limited to a case of an invention which was an arbitrary selection. The case where the invention was simply a choice of one candidate from a field where all the individual candidates were the same was an extreme case. The present case was one where the skilled person would expect there to be a range of different results, some good and some bad, but that there was no invention in embarking on a screening process to pick out the good from the bad. The fact that one could not say in advance which the good ones would be did not, in every case, foreclose a finding of obviousness.

GB United Kingdom

Court of Appeal, 30 November 2016 – Hospira UK Ltd v Genentech, Inc [2016] EWCA Civ 1185

Keywords: inventive step – second medical use – expectation of success

Claim 1 of Genentech's European patent (UK) 1 037 926 was a Swiss-form claim directed to the use of trastuzumab (Herceptin) in combination with a chemotherapeutic agent, a taxane, for the treatment of a certain type of breast cancer. A prior art document disclosed a phase III clinical trial of trastuzumab in combination with a taxane, but did not disclose any results from that trial. The trial judge considered the invention obvious, because the skilled person would have had a fair expectation of success in the phase III trial.

The Court of Appeal emphasised the multi-factorial nature of the test for obviousness. As had been approved at the highest level, the court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These could 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.

With regard to the latter, the Court reiterated that whether a route had a reasonable or fair prospect of success would depend upon all the circumstances including an ability rationally to predict a successful outcome, how long the project might take, the extent to which the field was unexplored, the complexity or otherwise of any necessary experiments, whether such experiments could be performed by routine means and whether the skilled person would have to make a series of correct decisions along the way.

The Court rejected Genentech's argument that where a second medical use claim required the treatment to be clinically effective, there was a higher threshold for the expectation of success in the assessment of obviousness. This would amount to the creation of a lex specialis for claims which included as part of their technical subject-matter a therapeutic effect or benefit. There was no basis for imposing such a rigid rule. The test would rather be the flexible one described above, based on asking whether there was in all the relevant circumstances a fair expectation of success.

In conclusion, the Court of Appeal stated that the trial judge's analysis did not display any errors of principle and dismissed Genentech's appeal.

2. Problem-solution approach

AT Austria

Supreme Court, 22 September 2015 (4 Ob 17/15a)

Keywords: inventive step – prior art – problem-solution approach

At issue was a patent for a sliding bearing for internal combustion engines which had been opposed on the ground of lack of inventive step. The Austrian Patent Office had rejected the opposition, but Vienna Higher Regional Court had later overturned its decision and revoked the patent.

The Supreme Court observed that an invention could not be considered obvious from the prior art simply because the skilled person could have arrived at it on the basis of that art. It was obvious only if, given sufficient reason, he would actually have proposed it in expectation of some improvement or advantage (Supreme Patent and Trade Mark Chamber ("OPM") Op 3/12; Supreme Court, 17 Ob 24/09t). One test for this was the problem-solution approach taken by the European Patent Office (OPM, Op 3/12; Op 1/12).

The Higher Regional Court had found that the claimed solution did not have the advantage of lower forming forces asserted by the patent proprietor. The Supreme Court agreed that, indeed, only half of the embodiments had this advantage. When an alleged advantage could be achieved by only part of the claimed subject-matter and the claim also encompassed – not only on its periphery – embodiments of no advantage or effect, this usually meant that the claim was too broad and thus included embodiments which were obvious from the prior art because they had no effect justifying a patent (see T 1188/00). That a problem had to be addressed across the entire scope claimed followed, first, from the cause-and-effect relationship between the problem tackled by an invention and its solution and, secondly, from the rule that claimed subject-matter could be considered to involve an inventive step on account of a given technical effect only if that effect was achievable over the whole breadth of the claim. Only this approach ensured due observance of the generally accepted legal principle that the extent of the monopoly conferred by a patent must be commensurate with the technical contribution to the art (see T 939/92, T 409/91, T 435/91). In the case in hand, however, the Supreme Court found that the other embodiments at least had the – albeit more modest – advantage that only smaller segments needed to be made. It sufficed that this advantage (effect) was implicitly disclosed in the application (OPM, Op 5/05). The Supreme Court thus restored the Patent Office's decision and maintained the patent in its entirety.

ES Spain

Supreme Court, 14 April 2015 (182/2015) – Aventis Pharma SA, May & Baker Ltd & Sanofi Aventis SA v Hospira Productos Farmacéuticos y Hospitalarios SL

Keywords: inventive step – problem-solution approach – could/would approach

In infringement proceedings brought by Sanofi Aventis, the Supreme Court confirmed the finding of Granada Court of Appeal that European patent 827 745 was valid (under Art. 138(3) EPC, Granada Court of First Instance having previously declared the nullity of claims 1 to 4 and confirmed the validity of claims 5 to 8) and that there had been contributory infringement of claims 5 to 8.

The Supreme Court first stated that the primary purpose of the appeal was to dispute the Court of Appeal's assessment on the issue of obviousness. In this respect, the evaluation of the evidence in the case at issue was not aimed at determining facts, but constituted a legal assessment by means of which the requirement of patentability (i.e. the inventive step requirement) was examined. The Supreme Court pointed out that what the average expert in the field would or would not have considered obvious at the priority date of the patent constituted a point of law which, as such, was subject to review by the Supreme Court ("cassation"). A subsequent judgment of the Supreme Court of 18 June 2015 (325/2015) confirmed this point of law on interpretation.

On the methodologies employed for evaluating inventive step, the Supreme Court stated that there was no single method, but that one must be followed which would ensure that the evaluation took into account the decisive factors. The Supreme Court, in its judgment 434/2013 of 12 June 2013, had already confirmed the validity and appropriateness of the "problem and solution approach", which had been followed by Granada Court of Appeal itself. Such a method, in line with R. 27 EPC, was generally used by the EPO and had been upheld by courts of other contracting states to the EPC as a useful method of assessing inventive step in the majority of cases. The main point at issue was, however, whether the prior art features would have led the skilled person, at the time of filing of the application, to perform the combination which was the subject-matter of claim 5. The Supreme Court found that it was not enough to establish obviousness on the basis that the expert in the technical field could have opted for the solution proposed by the applicant for a patent. This was in line with the "could/would approach" as applied by the EPO. Thus, the Supreme Court held that Granada Court of Appeal had correctly analysed the issue, and upheld its decision.

FR France

Paris District Court, 21 November 2014 (10/14073) – Ethypharm v AstraZeneca AB  & Cipla Ltd

Keywords: inventive step – problem-solution approach

AstraZeneca is the owner of European patent 1 020 461, which had been revoked by an EPO opposition division for lack of inventive step; on appeal, however, it had been maintained in amended form by the board of appeal (T 1677/11). Ethypharm was seeking its revocation.

AstraZeneca claimed that the arguments put forward by Ethypharm in support of its complaint of infringement of Art. 123 EPC were the same as those already rejected by the EPO departments. On that point, the Court observed that, while certainly read with great interest, the decisions of the EPO, an administrative body, were not binding on French patent courts. Following a detailed review of the complaint, the Court concluded that claims 9 and 1, together with their dependent claims, could be unambiguously derived from the application as filed, and so could not be revoked for extension beyond the content of the application.

On inventive step, Ethypharm argued that AstraZeneca's patent provided no evidence, for instance, in the form of the results of a study, of the reality of the problem that it sought to solve. AstraZeneca countered this on the basis of the problem-solution approach, describing in detail how it applied in this case.

The Court noted that Art. 56 EPC did not prescribe the problem-solution approach, in which the first step was to identify the prior art closest to the contested patent, as the method of ascertaining whether or not the patent involved an inventive step. Though established in the case law of the EPO boards of appeal, it was not binding upon the French courts. What had to be assessed was whether, on the basis of this prior art and his common general knowledge, the skilled person would be able to arrive at the contested claims without any inventive effort. Ethypharm had rightly pointed out that it was part of the common general knowledge that enantiomers could sometimes exhibit different properties from the racemic compound, particularly pharmacokinetic properties. On the statements given by AstraZeneca inventors and staff which had been submitted as evidence of an alleged prejudice, the Court held that the inventive merit of an invention had to be assessed from the point of view of the notional skilled person, not on the basis of an account written after the event for the purposes of proceedings by inventors with ties to AstraZeneca who might have played down any existing knowledge. On the degree of optical purity, it was well established that for a compound destined for use as a pharmaceutical, this was not an aspect of inventive step. The purification of a compound belonged to the common general knowledge of the skilled person, unless there was something in the prior art that interfered with the use or the effectiveness of conventional purification processes.

The Court revoked all the claims of AstraZeneca's patent for lack of inventive step.

NL Netherlands

Supreme Court, 3 October 2014 – Leo Pharma v Sandoz

Keywords: inventive step – problem-solution approach

At issue was Leo Pharma's European patent 0 679 154 for "calcipotriol monohydrate", a crystalline form of calcipotriol, which is a substance used in medicinal products for treating psoriasis.

Sandoz, which already sold ointments for treating psoriasis containing calcipotriol as an active ingredient both in and outside the Netherlands, had announced plans to launch a cream there too. Leo Pharma was seeking an order that Sandoz desist from infringing its patent. Sandoz counterclaimed for revocation of the Netherlands part of the patent.

In the judgment contested here, the Court of Appeal, having examined the validity of Leo Pharma's patent and concluded that the decision hinged on inventive step, had held that such a step was lacking (see "Case Law from the Contracting States to the EPC" (2011-2014), supplementary publication – OJ 2/2015, 151). The Supreme Court dismissed Leo Pharma's appeal and upheld the Court of Appeal's ruling.

The question for the Court was, more specifically, to what extent it mattered for assessing inventive step whether the average skilled person would have recognised the problem the patent proposed to solve.

It held that, broadly speaking, it was irrelevant for the purposes of establishing inventive step whether – to use the terminology of the "problem-solution approach" applied by the lower courts in line with the parties' submissions – the skilled person would have recognised the objective technical problem the patent solved or alleviated. The crucial factor was that the invention was not obvious to the skilled person from the prior art (Art. 6 Netherlands Patent Law 1995).

This meant, on the one hand, that inventive step could be established where it became apparent only through the invention itself that there had been a pre-existing problem for which the invention offered a solution. On the other hand, there was generally no need for courts to establish that the skilled person would have recognised the problem solved in order to find a lack of inventive step.

For courts to reach such a finding, it was usually enough that the proposed solution was obvious from the prior art. This was different only if the patent proprietor was asserting that the inventive step lay more in the recognition of the problem and less in its (subsequently) identified solution. However, as was clear from the pleadings, that was not the basis Leo Pharma had cited for its position that calcipotriol monohydrate was inventive and no such view could be inferred from its supporting arguments.

In support of its appeal, Leo Pharma had also cited the Court's Rockwool judgment of 15 February 2008, but the Court held that it made no difference to its finding, observing that the invoked passage "the purpose of this assessment is to establish whether the average skilled person would have recognised the problem solved by the claimed method" was not to be understood as describing an essential part of the assessment of inventive step but was instead an elaboration on the rule that it was not permissible for courts to assess claimed subject-matter with hindsight. In order to keep to that rule, it might also be important to establish whether the skilled person would have recognised the problem solved.

SE Sweden

id="p66" See Stockholm District Court, 12 August 2016 (T 258-15) – Actavis Group PTC ehf. v Warner-Lambert Company LLC in Chapter H.2 Pregabalin.

3. Technical effect

GB United Kingdom

Court of Appeal, 8 November 2016 – Idenix Pharmaceuticals Inc. v Gilead Sciences Inc. & Ors [2016] EWCA Civ 1089

Keywords: inventive step – technical contribution – plausibility

European patent (UK) 1 523 489 claimed a family of nucleoside analogues for treating hepatitis C and other Flaviviridae infections. Gilead argued that the patent was invalid for lack of inventive step because it did not make a technical contribution. It was not plausible that substantially all of the compounds encompassed by the claims would be effective against Flaviviridae. The trial judge declared the patent invalid, inter alia for lack of inventive step.

Referring to the case law of the EPO boards of appeal (see T 939/92 and T 1329/04), the Court of Appeal stated that the scope of the monopoly claimed must correspond to and be justified by the technical contribution or, put another way, everything falling in the scope of the claim must be inventive. In the case of a claim to a new class of chemical compounds, the selection of those compounds must not be arbitrary but justified by a technical effect which distinguished the claimed compounds from many other compounds. Moreover, this technical effect must be shared by substantially all of the claimed compounds.

The Court of Appeal further held that the claimed technical effect must be plausible in light of the teaching of the specification and the common general knowledge. The requirement of plausibility was a low threshold test designed to prohibit speculative claiming. Nevertheless, there must be a real reason for supposing that the claimed invention would indeed have the promised technical effect.

According to the Court of Appeal, it was not plausible that substantially all of the compounds covered by the claim had anti-Flaviviridae activity. As had been stressed by the trial judge, the patent contained neither experimental data to suggest that any of the claimed compounds might be effective nor any rationale for the assertion that they might be so, which thus appeared to be nothing more than speculation. Moreover, the specification did not add anything to the common general knowledge as to what nucleoside analogues might exhibit Flaviviridae activity. It followed that the claim covered compounds which made no technical contribution to the art.

In conclusion, the Court of Appeal upheld the trial judge's decision and dismissed the appeal.

4. Skilled person

AT Austria

Vienna Higher Regional Court, 25 March 2015 (34 R 16/15w)

Keywords: inventive step – definition of skilled person

In this case, the Court observed that what the prior art taught and how prior-art documents were to be understood had to be assessed from the point of view of the average skilled person. This notional person was ultimately no more than a device helping the courts to elaborate on an undefined legal term in practice. The skilled person had an average level of knowledge but was familiar with the entire prior art in the relevant field.

Whether an invention involved an inventive step was essentially a point of law (Supreme Court, 17 Ob 24/09t; 17 Ob 13/09z). However, as the degree of inventiveness had to be measured against the prior art, i.e. the technical knowledge of the "average skilled person" in the field, this assessment depended primarily on the factual question whether or not the patented invention was obvious to such a skilled person from that prior art. What therefore had to be decided was whether the technical teaching of the patent at issue would have been obvious to the skilled person from the cited prior-art documents at the priority date.

The patent proprietor contended in this connection that the Austrian Patent Office's decision was vitiated by a failure to establish relevant facts owing to an error in law in that it contained no findings as to the average skilled person's knowledge and skills. The Court held that there was no need to define a particular skilled person in this case, as the relevant skilled person's skills were determined by the patent itself, which therefore formed the basis for assessment. The skilled person was generally understood to be an expert/specialist of average skill in overcoming technical problems who was familiar with the prior art. What had to be established above all was what that skilled person would have understood from the prior-art documents at the priority date (Supreme Court, 17 Ob 4/11d). The Patent Office had made such findings and so had not failed to establish any relevant facts (see also Vienna Higher Regional Court, 34 R 80/14f and 34 R 81/14b).

FR France

Paris Court of Appeal, 30 October 2015 (13/07821) – Boegli v Darsail

Keywords: inventive step – skilled person

This case had been remitted to the Court for a fresh ruling in a different composition following the Court of Cassation's annulment (by judgment of 20 November 2012 in appeal No. 11-18440) of its first judgment, in which it had revoked the claims in Boegli's European patent 1 324 877 without precisely defining the skilled person.

The patent was for a device for embossing and satin finishing a flat material. The Court stated that the skilled person was a technician working in the technical field of the invention who had average knowledge and skills both in that field and generally and lacked typically inventive qualities. Darsail had defined him as a machine tool engineer specialising in the development of embossing and satin finishing devices, while Boegli had maintained he was an expert in micromechanics with a knowledge of optics. But, in the Court's view, Darsail's definition was too vague and Boegli's too precise, so it could not accept either of them without thereby setting the threshold for assessing reproducibility of the invention (and, by the same token, inventive step) either far too low or far too high. The Court thus found that the skilled person was an engineer specialising in machine parts used in the printing and engraving sector.

The Court then addressed Darsail's objection of insufficient disclosure and, after reiterating the applicable test, concluded that it was unfounded.

Turning to inventive step, it found that the technical problem underlying the invention was how to provide a device capable of producing signs that changed in appearance on satin finished sheets of packaging foil. It considered the cited prior art and concluded that the skilled person could readily arrive at the invention on that basis by taking simple measures which were routine in his field. Not only was the step from the problem to the claimed solution obvious but there was nothing to discourage him from taking it. Darsail's objection that claim 1 lacked inventive step was therefore well founded.

Turning then to novelty, the Court found that, in the absence of translations, the foreign-language evidence Darsail had adduced in support of alleged prior use lacked probative value, as did its copy of an affidavit, given that it had failed to produce the original even after being ordered to do so.

Editor's note: See also Paris Court of Appeal, 23 September 2014 (13/01377) – Gaztransport & Technigaz v Chantier de l'Atlantique (diverging opinions of different experts – prejudice).