Broad claim construction leads to invalidity of Novartis's patent for EXELON Alzheimer's patch

Authors: Sebastian Moore and Grace Pead: Herbert Smith Freehills LLP

Novartis AG, LTS Lohmann Therapie-Systeme AG, Novartis Pharmaceuticals UK Limited v Focus Pharmaceuticals Ltd, Actavis Group PTC EHF, Actavis UK Limited, Teva UK Ltd [2015] EWHC 1068 (Pat), Patents Court, England and Wales, 27 April 2015

Journal of Intellectual Property Law & Practice (2015) doi: 10.1093/jiplp/jpv119, first published online: July 9, 2015

The Patents Court has held that Novartis's patent, covering its EXELON rivastigmine transdermal patch to treat Alzheimer's disease, is invalid. The broad claim construction that Novartis proposed in order to establish infringement meant that the patent included added matter over the application as filed and was obvious over a prior US patent.

Legal context

Patentees bringing infringement actions in England and Wales frequently face difficulties putting forward claim constructions broad enough to cover the allegedly infringing activities, but not so broad that the claims are invalid on grounds including added matter, obviousness, and insufficiency. Where patentees do not get this right, or cannot get this right because of the wording of their application as filed, they risk the alleged infringer successfully running a ‘squeeze argument’, as the generics did in this case, essentially saying that ‘if we infringe on that construction, the patent must be invalid’.

Another challenge that Novartis faced here, common to patentees litigating European patents in England and Wales, is the possibility of inconsistent findings when proceedings are heard in different jurisdictions across Europe. Particularly when deciding on infringement, courts in different jurisdictions can take markedly different approaches.

Facts

Novartis's patent EP (UK) No 2 292 219, titled ‘Transdermal therapeutic system for the administration of rivastigmine’, is a divisional patent derived from international patent application No WO 2007/064407. Before the introduction of transdermal therapeutic systems, which most commonly come in the form of patches, rivastigmine was administered orally, which led to side effects such as nausea, vomiting and diarrhoea. Patients would be prescribed a starting dose of oral rivastigmine, which was sub-therapeutic, and then increased to a therapeutically effective dose as they got used to the side effects. According to the patent, the use of a transdermal patch meant that patients could take a much higher starting dose with greater tolerability, so that their treatment was simplified.

Rivastigmine

Novartis brought infringement proceedings in the Patents Court against Focus, Actavis and Teva, who denied infringement and counterclaimed for revocation of the patent. Before the matter was heard, equivalent patents had been litigated in 11 European countries. Although most of the proceedings to date had involved only interim injunction applications, requiring a lower standard of proof, some of those courts had found that generics had infringed and others found they had not, on the same facts. Although the Patents Court was the first to give a final determination on validity, the European Patent Office (EPO) and courts in The Netherlands and Germany had expressed opinions that the patent was invalid.

Analysis

Skilled team and common general knowledge

Before Arnold J, the parties agreed that the patent was addressed to a skilled team interested in developing a new formulation for rivastigmine. The team would consist of a formulator skilled in transdermal administration, and a clinician and/or neuroscientist in the field of dementia. There was, however, substantial dispute as to the skilled clinician's common general knowledge of how tolerability of rivastigmine could be increased. Arnold J agreed with the generic parties that it was generally accepted at the priority date that rivastigmine should be administered with food, and that it was a reasonable hypothesis that this increased tolerability because it reduced peak plasma concentration of rivastigmine and increased the time at which peak plasma concentration was reached. This was widely stated in reviewed papers put into evidence by the generics.

Novartis's broad claim construction accepted

Arnold J accepted Novartis's construction that the single claim of the patent involved three components:

• rivastigmine for use in treating dementia or Alzheimer's;
• rivastigmine administered via a patch; and
• a ‘starting dose’ of rivastigmine that ‘is that of’ a reference patch with a structure and composition specified in three final integers of the claim.

Because of the wording ‘the starting dose is that of’, the claimed patch could have any structure or composition provided it could deliver the same starting dose as the reference patch. It was not correct to restrict the claim to a rivastigmine patch with the precise structure and composition specified in the final integers of the claim. These features merely described the reference patch.

Invalidity for added matter

The generics' primary objection to validity was that the claim involved added matter in that the patent presented information about the invention which was not directly and unambiguously derivable from the application on which it was based. Although the application disclosed a patch with the same structure and composition as the reference patch in the patent claim, it did not suggest that this should be used as a starting dose. In contrast, the patent explicitly disclosed a rivastigmine patch with a starting dose the same as that of the reference patch. Arnold J accepted that, if the claim was construed as Novartis contended, the amendments to the application made during prosecution amounted to disclosure of a new invention over the application as filed so that the patent was invalid for added matter.

Invalidity for obviousness

In their obviousness attack, the generics relied only on United States patent No 6 335 031, co-owned by Novartis. There was no dispute that the US patent disclosed administration of rivastigmine by a transdermal patch with a structure and composition the same as that of the reference patch in the patent in suit. The essential difference was that the US patent did not disclose a starting dose of that released by a reference patch. The key area of disagreement between the parties was the starting dose the skilled team would select when administering rivastigmine using patches of the kind disclosed in the US patent.

Although it did not disclose a starting dose, the US patent stated that the size of the patch could be determined using tests which involved observing blood levels of rivastigmine ‘after oral administration of a therapeutically effective dose of the compound’. Novartis submitted that this would lead the skilled team to administer as a starting dose a patch of a dose equivalent to that of the starting dose in the oral rivastigmine regimen, that is the sub-therapeutic dose. This would mean the starting dose would be half that released by the reference patch disclosed in the patent. The generics on the other hand said that this statement in the US patent would lead the skilled team to do exactly what the statement said, and administer the lowest therapeutic oral dose of rivastigmine as a starting dose. This would mean the starting dose would be that released by the reference patch in the patent in suit. Arnold J accepted the generics' position and found the patent obvious in light of the US patent.

Patent not insufficient

On the basis of the expert evidence, Arnold J did not agree with the generics that the claim in Novartis's patent was insufficient. In particular:

The claim was not overly broad. Even though the benefit of tolerability was not obtained for any patch within the claim (with the starting dose of the reference patch), a skilled person would know to use a formulation that would have that benefit.

The claim was not ambiguous. Even though the specification did not provide a method for determining whether any other patch delivers ‘the same’ starting dose as the reference patch, the skilled team would be able to select an appropriate statistical test.

Generics would have infringed

Arnold J found that, had the patent been valid, the generics would have infringed. There was no dispute that the generics' patches were identical to Novartis's Exelon patches (save for the branding), were made by the same manufacturer, and would be used for the claimed indication to administer rivastigmine with the claimed starting dose.

Practical significance

Arnold J's decision highlights a number of considerations for patentees bringing infringement actions in England and Wales today. First, patentees need to take care that where possible the claim construction they propose to cover the alleged infringement is not so broad as to lead to a finding that the patent is invalid. Patent applicants should also consider the breadth of the claims from an infringement and a validity point of view at the time the patent application is drafted.

Secondly, patentees involved in pan-European litigation seeking to restrain generic entry to the market should have a strategic co-ordination plan in place from the outset, given the possibility of strikingly diverse findings in different jurisdictions. Despite the divergent views on infringement when this case was heard across Europe, the case indicates that courts in different jurisdictions may be more likely to make the same findings as to validity of a respective national designation of a European patent.

Arnold J has granted Novartis permission to appeal, stating that the appeal from the finding of added matter has a real prospect of success, but he is only narrowly persuaded that the same is true of the appeal from the finding obviousness ([2015] EWHC 1553). It remains to be seen whether the Court of Appeal will uphold Arnold J's findings. In the meantime, Novartis's European patent remains under opposition at the EPO by 13 opponents and the Opposition Division has already issued a provisional opinion that the patent is invalid for added matter and insufficiency. Oral proceedings are scheduled for 15–17 December 2015.

Constructing a case for infringing particle-size patents

Author: Christopher Hayes (H Lundbeck A/S)

Cephalon Inc, Cephalon France SAS and Cephalon (UK) Ltd v Orchid Europe Ltd and Generics (UK) Ltd (t/a Mylan) [2011] EWHC 1591 (Pat), Patents Court, England and Wales, 24 June 2011

Journal of Intellectual Property Law & Practice (2011),doi: 10.1093/jiplp/jpr126, first published online: July 23, 2011

The Patents Court (England and Wales) had to determine how to construe patent claims relating to particle-size formulations of a drug substance, whether those claims were infringed by a competitor's product, and whether the claims were obvious or insufficient.

Legal context

Construing patent claims are fundamental to determining the ambit of what is claimed. Consequently, a given construction will also delineate the bounds of potential infringing and non-infringing acts. This case also reviews the inventive step and sufficiency of disclosure of patents claiming particle size formulations of a drug.

Facts

This dispute centred around the drug modafinil. Mylan intended to market modafinil, made by Orchid. Cephalon brought an action for infringement in the Patents Court, which was heard by Floyd J. Mylan contended that it did not infringe any of the Cephalon patents and that, in any event the patents were invalid for lack of inventive step and insufficiency.

Modafinil was discovered and partially developed by a French company, Lafon. Cephalon licensed modafinil in the USA and conducted further development with a view to bringing modafinil to the market as an agent to treat sleep disorders. During the development programme, it was noticed that in US clinical trials, modafinil caused more side effects than in corresponding trials conducted in Europe.

Cephalon discovered that the particle size of the active pharmaceutical ingredient (API) used to formulate tablets of modafinil was smaller in the US tablets than in those used in the European trials. The US API had a median particle size of 30–50 micrometres (µm), compared with 80–150 µm in Europe. The smaller particle sizes led to an increased absorption, and hence increased bioavailability leading to an increased plasma concentration of modafinil. Consequently, lower doses of modafinil made from API with a smaller particle size could be used to achieve effective plasma concentrations of the drug.

Cephalon was the owner of three patents which claimed formulations of modafinil, comprised of specific particle sizes. There were two patents claiming formulations of modafinil; EP0731698 ('698) claimed compositions with 95 per cent of particles having a diameter of less than 200 µm; EP0966962 ('962) claimed compositions with a median particle size of 2–60 µm; and a method of manufacture patent, EP1088549 ('549) for compositions with 95 per cent of particles having a diameter less than 200 µm with a median particle size of 2–60 µm. All three patents contained similar disclosure and claimed the same priority date of October 1994.

A key issue is that during the tableting process, the size of the particles in the final finished tablet differs from that in the API from which the tablets are made. Therefore, the sizes of the particles in the API do not correspond to the size of the particles in the finished tablets, and vice versa.

Analysis

Claim construction
The central issue on claim construction was whether the particle sizes claimed in the various patents referred to the particle size in the final tablets or whether, as contended by Mylan, it referred to the particle size of the API. Both sides pointed to claim language which, they contended, supported their particular construction. Cephalon urged the language of the claims in the '698 patent, which claimed ‘compositions comprising’ modafinil particles. According to Cephalon, this could be literally interpreted as referring to the size of the particles in the final tablets.

Mylan favoured the language of the claims in the '962 patent for use of a ‘substantially homogenous mixture of modafinil particles … about 95% … have a diameter of less than about 200 micrometres for the manufacture of a pharmaceutical composition’. In Mylan's view, this demonstrated that it was the particle size of the API which was claimed.

Based on the evidence before Floyd J, he concluded that it was routine in the pharmaceutical industry to measure the particle size of API, rather than the final tablets. Indeed, in most medicines, the tableting process would not alter the particle size in the final tablet. It is the particle size of the API which tablet formulators alter to assess the properties of the final product, such as bioavailability. This was precisely the property affected by the alteration of the particle size of modafinil. Significantly, while it was routine to measure the particle size of API, the particle size in finished tablets could not have been measured at the priority date of the patents.

This led Floyd J to construe that the patents claimed formulations of modafinil made from API containing particles of the specified ranges. In other words, he accepted the Mylan construction that the references to particle size were the particle size of the API and not the finished tablet.

Infringement
The parties agreed that, if Mylan's claim construction was correct, the Orchid/Mylan product would not infringe, as 95 per cent of the particles in the Orchid/Mylan API were larger than 220 µm. Therefore there was no infringement.

Obviousness: drugs of the future
The patents were also attacked for lack of inventive step, in light of a publication, Drugs of the Future, and common general knowledge (CGK). It was found that the relationship between lowering particle size and improving bioavailability was part of the CGK. In developing a product, there would be motivation to improve dissolution and hence bioavailability, to improve the safety and efficacy of the drug. It would be routine to investigate the particle size with a view to improving the bioavailability of a compound, and furthermore there would be an expectation that this would be successful. Such investigations would confirm the benefits of having a smaller particle size. It would also be relatively straight forward to produce API with smaller particle size, within the ranges claimed in the patents. On the basis of this publication and the CGK, the Cephalon patents were found to be obvious.

Obviousness: Nguyen
Nguyen, a PCT application from Lafon, was published in September 1994. Nguyen was concerned with a process to produce materials useful in therapeutics, but it described modafinil formulations with a particle size of 2–5 µm. The only aspect of the Cephalon patents which was missing from Nguyen was the dosage of modafinil. Floyd J did not accept Cephalon's proposition that it would have taken significant investment to find the appropriate dose of modafinil. Had he not have found the patent obvious over CGK and Drugs of the Future, he would have required Cephalon to amend its claims to avoid this attack: Cephalon had an application to amend which was not pursued.

Insufficiency
Insufficiency was run as a squeeze argument against the construction. Mylan submitted that, if the claims covered the particle size in the final tablet, it was not sufficiently described so as to enable a person of skill to perform the invention. Starting with an API with known particle sizes, following the '549 and '962 patents, the skilled person would not have been to determine what particle size in the finished modafinil tablets would be. On that basis, the '549 and '962 patents, ie the patents claiming the formulations, were held to be insufficient. Conversely, as the '698 patent claimed a method to make modafinil formulations, it was held to be sufficiently enabled, as it contained at least one method to make the product.

Practical significance

This case represents an interesting commercial battleground regarding pharmaceutical formulation patents. Successful drug compounds are usually the subject of a host of formulation and process patents. Such patents can be found in the patent estates of the originator company, and also increasingly in non-originator companies.

The commercial benefits of such patents should not be underestimated. For the originator company, it may allow them to develop an improved formulation in the knowledge that they can maintain market exclusivity. For competitors, developing and patenting a new formulation with improved properties of a successful drug may give them a competitive advantage when they do enter the market, as they will have exclusivity on the new and improved formulation.

Such patents for competitors may also represent a strategic tool to facilitate an earlier market entry with a greater degree of certainty. Given that such drugs will be subject of several patents, if a competitor also has its own patent estate for that compound it could conceivably plot a course to market as soon as the compound patent expires, within the confines of its own patent estate.

Finally, this judgment highlights the potential issues in determining infringement of particle size patents. Often, a decision to raise infringement proceedings is based on product from the market, and this case sharply demonstrates the risks of determining particle size in tablets, in claims covering the particle size of the API: they may be one and the same.

‘Leave all love and 'ope behind, out of sight is out of mind’

Authors: Alex Batteson and Ian Karet (Linklaters)

Citation: Journal of Intellectual Property Law 2009, doi:10.1093/jiplp/jpp173

Folding Attic Stairs Limited v The Loft Stairs Company Limited [2009] EWHC 1221 (Pat) 9 June 2009

The Patents Court (England and Wales) considered the terms ‘preset’ and ‘predetermined’ and interpreted the expression ‘made available to the public’ under Article 54 European Patent Convention (‘EPC’).

Legal Context

Construction of patent claims

In Kirin-Amgen Inc v Hoechst Marion Rousell Ltd [2004] UKHL 45, Lord Hoffmann said:

48. The Catnic principle of construction is therefore in my opinion precisely in accordance with the Protocol. It is intended to give the patentee the full extent, but not more than the full extent, of the monopoly which a reasonable person skilled in the art, reading the claims in context, would think he was intending to claim.

Anticipatory disclosures

Article 54 EPC states:

(1) An invention shall be considered to be new if it does not form part of the state of the art.

(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. ...

Facts

Folding Attic Stairs (FAS) owned a patent for a process for manufacturing a folding attic stairway. It sued The Loft Stairs Company and its owner for infringement; the defendants counterclaimed for revocation on the grounds of anticipation and obviousness.

The technology concerned stairways for accessing roof spaces or attics of buildings. In their simplest form, these stairways involve the insertion of a generally wooden and rectangular frame within an aperture or ‘ope’ created between the ceiling joists. The following example (not specifically cited as prior art in the proceedings) was employed by the deputy judge as an illustration:

The stairway is provided in three hinged sections. The uppermost is fixed to a trapdoor, being hinged to the frame and spring-biased towards it by means of folding metal support arms. When not required for use, the stairway is folded up and the metal arms force the folded stairway into a nesting position above the ope. The arms also act as a counterbalance when folding and unfolding the stairway.

The widths between ceiling joists, and therefore the ope widths that need to be accommodated, vary from building to building. Rather than manufacture the stairways with varying widths to fit each type of ope width that might be encountered, which would have been too expensive, the prior art settled on a standard width and adjusted for the difference by bending the metal support arms. A problem with the prior art was a limit to the width that could be tolerated by bending. If the ope width departed too far from the standard, the arms were unable to operate freely and more strain was applied to them, eventually leading to failure of the pivot joints. The patent sought to solve these problems as follows:

It introduced an ‘inner frame’ [in addition to the ‘outer frame’ (6) which remained inserted in the ope] and attached the metal support arms (19) to the long sides (or side beams) (14) of the inner frame rather than the top section of the stairway (30). Thus, the width of the inner frame could be varied during the course of manufacture to accommodate various ope widths by varying the length of the end beams (16, 17) of the inner frame. This avoided the need to bend the metal support arms. The key point was that the stairway could remain of standard width.

Claim 1 of the patent reads (emphases supplied by the deputy judge):

A manufacturing process for manufacturing a folding stairway comprising the steps:

forming a rectangular outer mounting frame for complementary engagement and mounting within an associated rectangular ceiling ope of a predetermined size, the outer frame having a pair of spaced-apart side members interconnected by end members extending between associated ends of the side members;

forming an inner stairway carrying frame for pivotally mounting on the outer frame for movement between a nesting position within the outer frame and a downwardly extending in-use position hanging downwardly from the outer frame, the inner frame having a pair of spaced-apart side beams interconnected by an associated pair of spaced-apart end beams, connecting the side beams to the end beams such that each side beam is spaced a preset distance inwardly of the side members of the outer frame when the inner frame is mounted within the outer frame in the nesting position;

preparing an extendable stairway which is foldable between a collapsed stored position for nesting within the outer frame and an extended in-use position;

mounting the inner frame within the outer frame by securing a hinge between an outer frame end member and an end beam of the inner frame thus pivotally mounting the inner frame on the outer frame;

mounting a folding support arm between each side beam on the inner frame and an associated side member on the outer frame, each arm being pivotally mounted on each frame and being foldable intermediate its ends between an extended position corresponding to the downwardly extending in-use position of the inner frame and a folded position corresponding to the nesting position of the inner frame,

each arm having bias means for urging the arm towards the folded position for retaining the inner frame in the nested position within the outer frame; and

mounting an inner end of the stairway between the end beams on the inner frame such that the stairway is foldable between the collapsed and extended positions when the inner frame is in the in-use position.

Analysis

Claim construction

The deputy judge summarized the claim as follows (emphasis transposed from that applied to the full claim above): a manufacturing process for making folding stairways in which you

make an outer frame ‘for complementary engagement and mounting within’ a given ceiling ope,

make an inner frame (for carrying the stairway) by connecting side beams to end beams ‘such that each side beam is spaced a preset distance inwardly of the side members of the outer frame’,

make a foldable stairway that can nest within the outer frame,

hinge one end of the inner frame to one end of the outer frame,

mount spring-biased foldable support arms, one end pivoted to the side beam of the inner frame, the other end pivoted to the side beam of the outer frame, and

mount one end of the stairway between the end beams of the inner frame so that it can fold up in use.

The deputy judge held that a ceiling ope of a predetermined size meant the size of the given ope in which the stairway was to be fitted; effectively, an ope of a size predetermined by the house-builder. He distinguished Nikken Kosakusho Works v Pioneer Trading Company ([2005] EWCA Civ 906), in which Jacob LJ expressed surprise that the words ‘annular groove of predetermined depth’ could appear in a patent claim because the expression begged the question. He did not believe that Nikken criticized the use of the word ‘predetermined’ as such, not least because the words ‘predetermined’ and ‘preset’ very frequently appeared in granted patent claims. In Nikken, it was impossible, even following a reading of the patent as a whole, to deduce the purpose of having a groove of predetermined depth and according to which criterion the depth fell to be predetermined.

Spaced a preset distance meant that the separation between the side beams of the inner (14) and outer (6) frame, respectively, was chosen by the manufacturer (or one to whom he left the decision) with the aim of coping with various ope widths while avoiding excessive bending or cranking of the metal arms. Such a construction would be reasonably certain for third parties: a third party manufacturer would know whether he infringed the claim if he was presetting the distance between the respective side beams himself (in order not too bend the arms too much).

The judge rejected the idea that words of intent should not be used in patent claims. There was nothing in the EPC to support such a proposition. Moreover, the burden would be on the patentee, not the third party manufacturer, to prove the necessary intent. The deputy judge drew an analogy with so-called ‘Swiss-style’ claims in the form ‘use of a known ingredient X for making a medicine for treating disease Y’. He suggested that this really meant use of X with the intention of treating disease Y. If that was permissible in pharmaceutical cases, he saw no reason why it should not be in other industries.

Anticipation

FAS had invited an Irish Government Minister and a newspaper photographer to its factory in order to publicize a recently obtained business accreditation. The visit took place before the priority date of the patent. A prototype of the invention was on display in the factory on the day of the visit. A photographer took a photograph of the owner in front of the prototype; this was subsequently published in a newspaper, again before the priority date of the patent.

The deputy judge found as a fact that the photographer and Minister ‘could have gazed at all parts of the prototype’ if they had wanted to and were free to do so. The judge also found as a fact that no terms of confidentiality had been imposed on the photographer or the Minister, so that they ‘were free to impart to others whatever they did perceive and were able to recall’. However, it was relevant that there was no evidence that the photographer or Minister had in fact inspected the prototype ‘in any detailed sort of way’ and that it was unlikely that they would have had any interest or motivation to do so.

The publication of the photograph was not an anticipation as it did not depict the prototype in full. The question was what would the skilled person have discerned from the photograph. Given the problem addressed by the patent, the judge held that it was not only a patent for a process for manufacturing folding stairways but, based on a purposive construction, for doing so on a repeat basis. Thus, he identified the person skilled in the art as a manufacturing carpenter. It was necessary to avoid defining the common general knowledge to be attributed to that person too narrowly—there was no recognized profession of designing folding attic stairways. Thus, at the filing date, the skilled person would have been only vaguely aware of folding stairways in general terms; the common general knowledge did not include the prior art. The judge found that the photograph would not have divulged to such a skilled person the need to vary the width of the inner frame in accordance with that of the outer frame. He also held that the disclosure of the prototype to the Minister and photographer did not anticipate the claim. This was because the prototype product could not have anticipated a claim to a manufacturing process since it could not have disclosed to the skilled person the need to vary the side beam spacings.

The judge accepted that if the prototype had been in a public place, for example, a street, where anyone might have stopped to examine it, its design would have been deemed to have been made available to the public. However, the judge decided that the prototype was not in a public place at all. It was relevant that it was available for viewing only by a small and defined class, which was uninterested in manufacturing attic stairs or, moreover, the existence of the prototype (Lux Traffic Controls v Pike Signals [1993] RPC 107 distinguished). If information that is available for viewing in private premises by a small and defined class of visitors is to become part of the state of the art, that information must actually be imparted to at least one human mind which is free in law to divulge it to anyone else. It was not enough that it could have been imparted but was not. There was no irrebuttable presumption that information capable of being perceived by persons on private premises was in fact perceived by them, if the circumstances were such as to make it unlikely that those persons were interested in the subject matter. That would amount to an unnecessary legal fiction. On the facts, the judge found that it was unlikely that either the photographer or Minister would have been able to recall the spaced side beams of the prototype.

Practical Significance

The deputy judge seems to have found it important that the disclosure was on private premises. However, it is not clear how this decision fits with previous decisions. In Lux, Aldous J. said: ‘... it is settled law that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public’. In G01/92 Availability to the Public [1993] EPOR 241 at 243–244, the Enlarged Board said:

‘There is no support in the EPC for the additional requirement ... that the public should have particular reasons for analysing a product put on the market, in order to identify its composition or internal structure. According to Article 54(2) EPC the state of the art shall be held to comprise everything made available to the public. It is the fact that direct and unambiguous access to some particular information is possible, which makes the latter available, whether or not there is any reason for looking for it. ... The introduction of such an additional requirement would remove a commercially available and reproducible product from the public domain. It would mean an unfounded deviation from the principles applied in respect of the other sources of the state of the art as defined in Article 54(2) EPC and it would obviously represent an element of subjectivity leading to uncertainty in applying the concept of novelty as defined in this Article’.

If correct, this decision appears to introduce state of mind as an element in the question of novelty, which may lead to uncertainty. However, the facts are unusual and cases like this should be infrequent.