Novartis AG & Anor v Johnson & Johnson Medical Ltd & Ors

Novartis and its exclusive licensee, Cibavision (whose combined case was argued by Mr John Baldwin QC and Mr Andrew Waugh QC) appeals the decision of Kitchin J of 10^th July 2009, [2009] EWHC 1671 (Pat). He held that although J&J’s Oasys contact lenses fall within the scope of claims 1 and 24 of Novartis’ EP (UK) No. 0,819,258, the Patent was invalid. The ground of invalidity was insufficiency (patent law jargon for failure to comply with Art. 83 of the EPC). The Judge rejected J&J’s contentions that the Patent was invalid for obviousness or lack of novelty (patent law jargon for the latter is “anticipation”).

In addition to supporting the Judge’s conclusion as to insufficiency, J&J (whose case was argued by Mr Simon Thorley QC and Mr Justin Turner QC) contends in the alternative that the Judge was wrong in respect of some but not all of the other invalidity attacks. The points which J&J seeks to raise in this court, contingently only if the sufficiency appeal succeeds, are obviousness over common general knowledge (“cgk”), anticipation by two documents called Hopken and Domschke and obviousness over a document called Lai.

Novartis for its part does not challenge the Judge’s decision that the Patent is not entitled to its priority date (thus bringing in Hopken and Domschke, published between the claimed priority date and the date of application for the Patent, as available prior art for novelty but not obviousness attacks, see EPC Art.54(3)). Nor does it challenge the finding that claims 8-11 are invalid and that in any event those claims do not cover the Oasys lenses.

Finally, J&J now accepts the Judge’s finding that its Oasys lenses fall within claims 1 and 24.

So the only points now in issue relate to validity. It is now common ground that this stands or falls by reference to claim 1 only. The issues formally before us are therefore:

The Judge summarised this at [36-58] in a manner accepted as correct by both sides. So I borrow with gratitude:

[36] In the early days contact lenses were made of glass but they had limited success as they were difficult to produce and uncomfortable to wear. In the 1940s a major advance was made with the discovery of the plastic poly(methyl methacrylate) (“PMMA”). This was found to be a suitable hard lens material in terms of its biocompatibility, mechanical and optical properties and relative ease of manufacture. However, PMMA lenses suffered from the drawback that they were still relatively uncomfortable and impermeable to liquids and gases.

[37] In the 1970s a further important advance was made with the invention of polymers known as hydrogels. The first of note was called 2-hydroxyethyl methacrylate (“HEMA”), also known as polyHEMA. The rights to make lenses from this material were purchased by B&L, and in the early 1970s it introduced its polyHEMA “Soflens” contact lens.

[38] Hydrogels are a rather unusual kind of polymer in that they are hydrophilic yet insoluble in water. When placed in water they swell to an extent which is related to the hydrophilicity of the monomers used in their production. Stability is introduced by the use of cross linking monomers such as poly (ethylene glycol) dimethacrylate to produce a three dimensional network. In addition to hydrophilic monomers and cross linkers, a hydrogel formulation may also contain other monomers such as methylmethacrylate (“MMA”) as a physical property modifier and solvent to facilitate processing.

[39] A wide range of other hydrophilic monomers were also investigated. In particular, N-vinylpyrrolidone (“NVP”) and N,N-dimethyl acrylamide (“DMA”) proved useful, as did acid containing monomers such as methacrylic acid (“MAA”). The aim of those working in the field was to develop formulations with a high water content and so also high oxygen permeability. Polymerisation could be initiated using UV light and a photoinitiator.

[40] Although hydrogel based lenses were initially all sold for daily wear, in the early 1980s the FDA approved the use of such lenses for extended periods of wear of up to 30 days. By 1987 it was estimated that they were being used in this way by around 4.1 million Americans. These extended wear lenses were primarily HEMA based and included copolymers with hydrophilic monomers such as DMA, NVP and MAA. Their oxygen permeability (sometimes referred to as “Dk” and measured in barrers or Dk units, and generally using the polarographic method) ranged from about 10 barrers for HEMA lenses to about 30 barrers for lenses made with HEMA and other hydrophilic monomers.

[41] Unfortunately a number of those using these lenses for extended periods of wear began to show clinical complications. Most seriously it was found such users had a significantly greater risk of developing ulcerative keratitis, an extremely painful condition affecting the cornea. As a result, the FDA revised its approval and recommended a maximum extended wear time of seven days. Nevertheless hydrogel lenses, including a lens sold by the defendants under the name Acuvue, remained very popular.

[42] In parallel with the development of hydrogel lenses, scientists were also looking to design lenses made from silicones, materials which combine the elements silicon, carbon and oxygen. One particular class of materials, those made of polydimethylsiloxane (“PDMS”), appeared to be ideal candidates for extended wear lenses because PDMS possesses excellent transparency and high oxygen permeability. However, due to the hydrophobic nature of silicone, these lenses were found to be essentially non wettable (and so required surface treatment) and their elastic nature made them susceptible to corneal adhesion. By 1995, B&L had one surface treated silicone elastomer lens on the market. It was called Silsoft and was used for extended wear in speciality cases only.

[43] A further class of lenses under development at this time also justify a mention at this stage. Rigid gas permeable (“RGP”) lenses based on silicone (meth)acrylates were made by combining the stability and processing characteristics of MMA with the high oxygen permeability characteristics of silicone. In particular, it was found that copolymerization of MMA with the silicone 3-(methacryloxy)propyl tris(trimethysiloxyl)silane (“TRIS”) and wetting agents such as MAA allowed the production of a lens with good scratch resistance, wettability, dimensional stability and oxygen permeability. As a result, TRIS formed part of the general knowledge as being one of the standard building blocks for silicone containing contact lenses. But RGP lenses were not a success. Their rigid nature means they do not mould to the eye and so are not comfortable. In addition they have a tendency to bind to the cornea if worn overnight.

Some essential characteristics of a contact lens

[44] As a result of all this work, and indeed the further work in relation to silicone hydrogels which I consider later in this section, it was well understood that the design of any contact lens for extended wear must address a number of essential criteria.

[45] The first is oxygen transmissibility. At the outset it is important to note that the oxygen transmissibility of a lens is a measure of the amount of oxygen that can pass through a particular lens and is calculated by dividing the oxygen permeability of the lens material by the lens thickness. Hence oxygen transmissibility (Dk/t) is a characteristic of a particular lens and is expressed in terms of barrers/mm where t is the average thickness of the material. Oxygen permeability, on the other hand, is a characteristic of the material from which the lens is made and does not depend on thickness. It is also expressed in terms of barrers or Dk units, but curiously a barrer in the case of permeability is defined as being an order of magnitude smaller than it is in the case of transmissibility. Hence a lens of a material having a permeability (Dk) of 100 barrers and a thickness of 0.1mm will have a transmissibility (Dk/t) of 100 barrers/mm.

[46] Contact lenses rest on the cornea, a transparent body which transmits and refracts light into the eye. The cornea derives the oxygen it needs directly from the air. If it is deprived of oxygen it becomes hypoxic and begins to swell. In a seminal study published in 1984, Dr Brien Holden and Dr George Mertz investigated the relationship between corneal oedema (swelling) and the oxygen transmissibility of extended wear contact lenses. Holden and Mertz found that the oxygen transmissibility that limits overnight swelling to 4% (the level experienced by a non-contact lens wearer) is 87 barrers/mm. I am satisfied that as a result of this work and a number of similar studies it was a matter of common general knowledge by 1995 that an oxygen transmissibility of in excess of about 70 barrers/mm was necessary to avoid unnatural corneal swelling.

[47] Unfortunately, this degree of oxygen transmissibility could not be achieved with hydrogel lenses. They derive their oxygen permeability from their water content and although it was known it was possible to increase the water content of polyHEMA, and hence also its oxygen permeability, by the incorporation of small amounts of MAA into the polymer, there was still a limit to how much water hydrogel lenses could absorb whilst maintaining their structural integrity and durability. As a consequence, the oxygen transmissibility of hydrogel lenses could not be increased beyond a certain point, commonly from 10 to 30 barrers/mm. Hydrogel lenses could therefore cause a high degree of hypoxia when used in extended wear applications. By contrast, silicone elastomers were known to be highly permeable to oxygen.

[48] The second is movement on the eye. It was understood that in the healthy eye the cornea is covered by a continuous tear film which allows the exchange of ocular fluid, the provision of metabolic products to the cornea and the removal of metabolic by-products from the cornea. The ideal contact lens therefore allows the eye to maintain a tear film between the lens and the cornea, and this in turn was known to be affected by the degree to which the lens was free to move on the eye. One of the factors which was known to affect the ability of a lens to move on the eye was the hydrophilicity of the lens surface. The hydrogel lenses fulfilled this requirement admirably. But unfortunately the silicone elastomer lenses did not. They suffered both from adhesion of lipid deposits to the lens surface and adhesion of the lens to the cornea. As a result, silicone elastomer lenses were sometimes surface treated to make their surfaces more hydrophilic, but they were still prone to deposits of lipids and proteins on the lens surface and to adhesion to the cornea. It was also found that the surface treatments had a tendency to degrade fairly rapidly, giving poor vision and comfort.

[49] The third is wettability. This is related to the lens characteristics which permit movement on the eye. The surfaces of the lens must be wettable so that a smooth, stable and continuous tear film is formed both behind and on front of the lens when it is worn, so ensuring corneal health, good vision and comfort. Again this was not a problem with the hydrogel lenses but it was a serious issue with silicone elastomer lenses, and one which was only partially addressed by the use of surface treatments.

[50] In addition to these characteristics, a successful lens must also be optically transparent and biocompatible, possess chemical and thermal stability and have suitable mechanical properties, including (in the case of hydrogels) a low modulus of elasticity for patient comfort and a high tear strength for durability.

Silicone hydrogels

[51] In the 1970s scientists began to combine silicone materials with hydrogels with the aim of obtaining the beneficial properties of both types of material. The theory was straightforward: such lenses would have the oxygen transmissibility characteristics of the silicones and the wettability and comfort of the hydrogels. One of the pioneers was Dr Karl Mueller of Ciba-Geigy who made a copolymer from a silicone containing macromer and the monomers HEMA, NVP and MMA which collectively introduced a hydrophilic quality. Others followed, including the inventors of Keogh, Chang and Lai. I have no doubt that by 1995 the general concept of making a silicone hydrogel lens from hydrophilic monomers such as DMA, NVP and HEMA and silicone monomers such as TRIS and PDMS was a matter of common general knowledge.

[52] The production of a satisfactory extended wear lens did not, however, prove straightforward. One of the problems facing researchers was that the two different kinds of monomers are generally immiscible, and copolymerisation can result in opaque phase separated materials. This was addressed, at least to some extent, by the preparation of intermediate siloxane macromers containing hydrophilic groups. Several approaches were known, including synthesis of hydrophilic TRIS derivatives and of siloxanes containing hydrophilic end caps, blocks or side chains which aid their miscibility with the hydrophilic monomers and so assist in the formation of a clear polymer.

[53] Another problem was achieving the right balance between wettability and oxygen permeability. It was appreciated that, in contrast to conventional hydrogels where the oxygen permeability is derived from the water content and so the two increase in proportion to each other, the opposite is true in the case of the silicone hydrogels. Here the presence of water decreases the oxygen permeability of the polymer composition. This relationship was well understood and is illustrated in this figure taken from an article published by Dr Jay Kunzler and Dr Joseph McGee (both of B&L) in August 1995:

[54] Kunzler and McGee reported, as indeed is evident from the graph, that silicone hydrogels could be formulated to achieve a wide range of water content and oxygen permeability, with Dk values in the 50-200 barrer range. As is also apparent from the graph, lenses made of these materials could have a satisfactory oxygen permeability and a reasonably high water content of say 30%, which, as Professor Valint explained, was sufficient to get movement on the eye. However, an obstacle remained and that was how to achieve a surface chemistry which provided good biocompatibility and wetting characteristics. The hydrophobic surface characteristics of the lens, derived from its silicone content, made it difficult to maintain an adequate tear film, despite the lens itself having a reasonable, or even high, water content. This phenomenon was not well understood in 1995 but appeared to arise from the tendency of hydrophilic siloxane groups to dominate the surface chemistry of any resultant lens. Considerable research was therefore undertaken by workers in the field to find a polymer structure which would produce a single clear material from which to make a homogenous, clear lens whilst incorporating the oxygen permeability of silicone elastomers, but retaining the biocompatibility and wettability of conventional hydrogels.

[55] The issue of wettability was therefore fundamental to the development of an extended wear lens. The evidence established that the skilled person would have been aware of the possibility of surface treatment, using techniques such as plasma coating and plasma oxidation, to improve the wettability of a silicone hydrogel lens. Professor Valint considered this was the case, it was something to which B&L resorted and, as will be seen, it was described by Chang. Similarly, Dr Port agreed that plasma treatment in general, including those plasma treatments carried out by a Dr Yasuda and published in 1985, were well known to the person skilled in the art by 1995. Professor Koßmehl also accepted that the concept of surface treatment was well known.

[56] The effectiveness of surface treatment in the context of silicone hydrogels had not, however, been established. Professor Valint agreed that the ordinary skilled person would not have had experience of the successful modification of lens surfaces to make an extended wear lens. Professor Koßmehl explained that the skilled person would have considered that the then known surface treatments for silicone elastomers were short lived. Indeed the Kirk-Othmer encyclopaedia, published in 1995 and which was accepted to contain the common general knowledge, recited that although surface treatments, both physical and chemical, had demonstrated the ability to alter the specific properties of contact lens surfaces, most treatments “fail as a result of alteration of bulk lens properties, instability of surface treatment, or poor ocular compatibility.” Moreover, it continued, “Research is expected to continue in the characterization and modification of contact lens surfaces”.

[57] Overall, Professor Valint agreed with Professor Koßmehl’s opinion that in 1995 the area of silicone hydrogels was still experimental. Research had been going on for 20 years and many different materials had been proposed, but none had been proven. There were no commercially available silicone hydrogel lenses and significant challenges remained.

[58] By 1995 there were two principal ways of making soft contact lenses, namely lathing and cast moulding. In the case of the former, rods of polymer are formed and these are then cut into buttons and lathed to form lenses. In the case of the latter, the liquid mixture of silicone monomers and macromers and hydrophilic monomers is placed into a mould and cured, typically with UV radiation. The mould is then opened and the lens extracted, washed and treated as necessary. I am satisfied that the skilled person would have been well aware of both techniques in 1995. The evidence also established that the manufacturing method may affect the chemical and morphological structure of a lens and the topography of the finished lens material.

The Judge also later made some other detailed findings about the cgk concerning polymer composition to which I will refer later.

Unusually, I go to this before considering the specification. I do so for several reasons. First there is now no dispute as to construction: so there is no need to use the body of the specification as an aid to considering the ambit of the claim. Secondly I intend to demonstrate the extreme breadth of the claim against which the issues fall to be determined. And above all I need to set out early the essentially purely functional nature of the claim – practically a claim to anything that works.

Claim 1, broken up conveniently into elements, reads:

(A)

An ophthalmic lens having ophthalmically compatible inner and outer surfaces,

(B)

wherein said ophthalmic lens is selected from the group consisting of contact lenses for vision correction, contact lenses for eye colour modification, ophthalmic drug delivery devices and ophthalmic wound healing devices,

(C)

said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids,

(D)

said lens comprising a polymeric material,

(E)

which has high oxygen permeability and high ion permeability,

(F)

said polymeric material being formed from polymerizable materials comprising:

(a)

at least one oxyperm polymerizable material as defined in section I of the description, and

(b)

at least one ionoperm polymerizable material, as defined in section I of the description,

(G)

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended continuous contact with ocular tissues and ocular fluids, and

(H)

wherein said lens allows ion or water permeation in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

(I)

wherein said ophthalmic lens has an oxygen transmissibility as defined in section I of the description of at least about 70 barrers/mm and

(J)

an ion permeability characterized either by

(1)

an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or

(2)

an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min,

wherein said coefficients are measured with respect to sodium ions, and according to the measurement techniques described in sections II.F.1 and II.F.2 of the description respectively.

The reader might be forgiven for initially supposing that this apparently detailed list of elements would lead to a monopoly of reasonably defined scope, that each of the elements actually meant something by way of delineating the monopoly. But the reader would be wrong. Upon analysis it turns out that the elements are mostly meaningless and what is left is no more than a claim to a lens made from two types of polymer, provided it works.

I start with Element F because this is fundamental, specifying as it does the two materials from which the polymeric material of a claimed lens is made. F requires that the lens is made from two types of polymerisable material. The patent calls one type “oxyperm”, the other “ionoperm.” These are new terms, coined by the patentee. But it is not suggested that the polymers themselves are new or not the sorts of polymer which would have been contemplated for use in a contact lens.

The criterion for each type of polymer is extremely wide. Thus section 1 of the description defines “oxyperm materials” as including:

A wide range of materials which may be polymerized to form a polymer displaying a relatively high oxygen diffusion rate therethrough. In addition these materials must be relatively ophthalmically compatible.

That is all there is to it – “a high relatively oxygen diffusion rate” and “relatively ophthalmically compatible.” Each of these has “woolly” limits. As to a “high oxygen diffusion rate” there is no further definition as such at all. Indirectly there is something of a limit because the definition says something about the “oxygen transmissibility” of the ultimate lens. This depends not only on the inherent nature of the material (the oxygen diffusion rate) but also the thickness of the lens. [39] says “”the oxygen transmissibility (Dk/t) of the lens is preferably at least 70 barrers/mm”. So even this is not precise.

“ionoperm polymerizable materials” is defined in [23] which says:

[23] A “polymerizable material which is capable of polymerizing to form a polymer having a high ion permeability” as used herein, refers to monomers, oligomers, macromers and the like, and mixtures thereof, which are capable of polymerizing with like or unlike [polymerizable] materials to form a polymer which displays a relatively high rate of ion or water permeation therethrough. For convenience of reference, these materials will be referred to herein as “ionoperm polymerizable materials” and the resultant polymers will be referred to as “ionoperm polymers.”

Although the rate of permeation is to be “relatively high” one is not told in relation to what.

[41] says a little more about “ionoperm polymerizable materials”:

Ionoperm polymerizable materials include a wide range of materials which may be polymerized to form a polymer displaying a relatively high ion diffusion rate therethrough. In addition these materials must be relatively ophthalmically compatible.

What is clear is that the patentee considers that the mere fact of the polymer having a “relatively high ion diffusion rate” is not in itself enough to confer ophthalmic compatibility. He uses the word “in addition.”

I pause to observe that the functional requirement of “ophthalmic compatibility” applies to each individual polymerisable material of the ultimate lens, i.e. before polymerisation. Quite why that should matter I do not know. Nor do I know how it is supposed to be tested. No point was taken about this in these proceedings so I do not pursue it further. It may be available in other jurisdictions.

“Ophthalmic compatibility” is a requirement which depends on testing on real people rather than one which can be determined by physical characteristics using instrumentation. That is because the definition is functional:

“Ophthalmically compatible” as used herein refers to a material or surface of a material which may be in intimate contact with the ocular environment for an extended period of time without significantly damaging the ocular environment and without significant user discomfort.

This woolly definition calls for closer examination. There is, as the Judge found at [99]:

no generally accepted threshold of ophthalmic compatibility, that different wearers can have different responses and that even the claimants’ FND commercial product can cause damage to the eye. As for corneal swelling, paragraph [0040] of the Patent contemplates corneal swelling of less than about 8% using preferred extended wear contact lenses and claim 47 limits the degree of permissible swelling to less than about 8%, suggesting that a greater degree of swelling may be acceptable in the case of claim 1.

Accordingly there is a lot to be said for the view that the claim should never have been allowed as not complying with Art. 84 of the EPC. This requires that:

The claims shall define the matter for which protection is sought. They shall be clear and concise and supported by the description.

Unfortunately failure to comply with Art. 84 is not itself a ground of invalidity. However some of the grounds which are available for an invalidity attack overlap with Art.84. The jurisprudence of the Boards of Appeal has had to deal with undue width of claim by resorting to either the requirement of non-obviousness or that of sufficiency or both. As will be seen I think they come into play here.

Turning back to “ophthalmic compatibility” there was, not surprisingly, some dispute about what the threshold for this was. Before the Judge J&J contended that the compatibility had to be sufficient for submission to a regulatory authority. That would have required a mass of data and have involved masses of work and great expense. The Judge rejected that, holding that the threshold was lower. He said at [100]:

I believe the Patent is directed to a team interested in making workable prototypes of lenses which can then be carried forward into more extensive clinical trials. Such a team would carry out small scale clinical assessments, using a minimum of from 6 to 10 patients but reasonably up to about 30, and look to mean and median responses for the group, just as the defendants did in seeking to reproduce the prior art.

That finding was not challenged on appeal. So, a small scale test on actual people is needed to find out whether a particular lens is “ophthalmically compatible” and so satisfies this requirement of the claim. Even that is somewhat fuzzy: what if you test 10 patients and one shows an adverse reaction whereas the other 9 are all right? Do you then go on to test 10 more? Or is the single first result enough to say that the feature is not satisfied? And suppose the same lens tested on a different 10 people caused no trouble? It can hardly be satisfactory to say that compliance with the claim depends on which batch of 10 people you use first.

For the purposes of the appeal, it was in effect agreed that a lens “worked” if it passed the Judge’s small clinical evaluation test. I shall use “work” in that sense.

Even small scale clinical evaluation is neither cheap nor quick. You of course have to make the lens. You would have to do some toxicology tests first. They can be done relatively cheaply in vitro (Mr Thorley went further and suggested animal testing was required but there was no evidence that was so), but done they must be. Then you have to find the volunteers and test the product on them. The Judge found:

[313] Conducting clinical trials of a new lens is by no means a straightforward matter. Dr Brennan gave evidence in his third report that a trial of two new lenses over a 24 hour period with up to thirty subjects per lens would cost a great deal of money. In cross examination he put it at somewhere in the region of 100,000-140,000 US dollars. A trial for that number of subjects for an extended period of up to 30 days would obviously be rather more.

Mr Waugh not unnaturally sought to downgrade this cost. He suggested that testing of a single lens would be cheaper. All that was needed was to test a single lens with only about 6 or 7 patients. Mr Waugh suggested a figure of about US$70 to $100,000. He submitted it was not a lot pointing to the fact that some such experiments had been done in the context of litigation on the parallel patent in the US. I do not regard that as particularly relevant. The spending of a lot to try to defeat a very substantial commercial claim is not the same as a notional skilled man (team) just trying to find out whether a lens falls within the claim.

There is also this: suppose, for nearly $100,000, you try a pair of polymers and they do not “work.” Then you try another pair, and they also do not work? How many times you have to try is completely unclear. It is not as though the Patent teaches that most combinations of polymers will work, or even that most combinations which achieve on-eye movement and sufficient oxygen will work.

To all the difficulty posed by “ophthalmically compatible” I will return. For the present I return to examine the remaining claim elements.

Element A is no more than stage setting and adds no independent meaningful limitation.

Element B causes no difficulty of construction. It is really saying the claim covers all known sorts of contact lens, thus emphasising the breadth of the claim. It provides no meaningful limitation.

As to element C – “extended periods of wear” – the Patent says at [10]:

Another object of the invention is to provide an ophthalmic lens capable of extended continuous wear periods of at least 24 hours without substantial adverse impact on ocular health or consumer comfort, and more preferably [longer].

There was no dispute that the lens of the claim had to be suitable for at least 24 hours continuous wear.

Element D – “polymeric material” – clearly adds nothing as such.

Pausing there (i.e. having considered elements A, B, C, D and F) the claim is for a lens made from a two members each of a very wide class of polymers, provided the ultimate lens “works” in the limited sense of the Patent.

One naturally asks whether the claim has any other limitation. Is there anything else to narrow it or is it really so vast? As I shall show, the answers are no, and yes. I go to examine the other elements.

Element E – “high oxygen and high ion permeability” – is not in itself an independent limitation because the claim goes on to specify these in more detail.

Element G (allowing sufficient oxygen permeation) is an essential part of any lens which “works”. It is not even suggested that G adds any meaningful limitation.

Element H (sufficient on-eye movement) likewise adds nothing. This is because you have to have on-eye movement in any lens which “works”. On-eye movement is a necessary, but not sufficient condition for ophthalmic compatibility. The patentees do not suggest element H adds anything. At first blush one might get the impression that something important is being added, for the early part of this element (“ion or water permeation in an amount sufficient to ….”) sounds as though it might be adding something technical about ion or water permeability. But in reality it merely means that the properties are such that there is sufficient on-eye movement.

Element I (oxygen transmissibility at least 70 barrers/mm) again adds nothing to the functional requirement of ophthalmic compatibility. The lower limit of 70 barrers/mm was well-known. Below that you would get unnatural corneal swelling – see [46] of Kitchin J’s judgment cited above.

Element J (ion permeability), given the assertion of the Patent (see below) about its importance, is the place where you would expect to find some meaningful limitation. But you do not. What you find is quite extraordinary. For it turns out that notwithstanding that you would expect the two alternatives to lead you to, roughly at least, the same lens properties, not only do they not do that but also the two criteria are between them virtually meaningless. It is important to spell this out in more detail.

A lens complies with this element of the claim if it satisfies one of two alternative criteria. The alternatives are (1) an “Ionoton Ion Permeability Coefficient” of greater than about 0.2 x 10^-6 cm²/sec or (2) “an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min.”

The Patent tells the reader what it means by each of these Coefficients. [61-65] tells you how about what it calls the “Ionoflux Technique” involving the use of specified apparatus, how it is to be used and how the Ionoflux Diffusion Coefficient is to be calculated from the results. It then says:

[066] An Ionoflux Diffusion Coefficient of greater than about 6.4. x 10^-6 mm²/min is preferred for achieving sufficient on-eye movement. More preferably, the Ionoflux Diffusion Coefficient is greater than about 2.6 x 10^-6 mm²/min, while most preferably the Ionoflux Diffusion Coefficient is greater than about 15. x 10^-6 mm²/min. It must be emphasized that the Ionoflux Diffusion Coefficient correlates with ion permeability through the lens, and thereby is a predictor of on-eye movement (my italics).

The alternative Permeability Coefficient is dealt with in the same way. [67-71] tells the reader about the “Ionoton Technique” involving the use of specified apparatus, how it is to be used and how the “Ionoton Ion Permeability Coefficient” is to be calculated from the results. The Patent then says:

[72] An Ionoton Ion Permeability Coefficient, P, of greater than about 0.2 x 10^-6 cm²/sec is preferred, while greater than about 0.3 x 10^-6 cm²/sec is more preferred, and greater than about 0.4 x 10^-6 cm²/sec is most preferred. It must be emphasized that the Ionoton Ion Permeability Coefficient correlates with ion permeability through the lens, and thereby is a predictor of on-eye movement (again my italics).

So each of the two alternatives is said to be a predictor of on-eye movement. That is why the reader would expect that whichever alternative is used would lead to much the same prediction. You want on-eye movement. If one method predicts it, so should the other.

But that turns out to be far from the case. The two thresholds are vastly different one from the other. The Judge put it this way:

[256] Next, it is apparent that the ion permeability thresholds of the claims are very different depending on whether the parameter is measured using the Ionoton or Ionoflux technique. To recap, the Ionoton threshold of claim 1 is 0.2 x 10^-6 cm²/sec, or 2 x 10^-7 cm²/sec whereas the Ionoflux threshold is 1.5 x 10^-6 mm²/min, or 2.5 x 10^-10 cm²/sec, a difference of three orders of magnitude. This, said Professor Freeman, is very surprising because both measure ion permeability and so one would expect the thresholds to be about the same. I agree.

The skilled reader would conclude that something fishy is going on here. How can both coefficients be good predictors of on-eye movement? And what is the point of the Ionoton level when the material is going to pass the Ionoflux test anyway?

The fishiness the reader would perceive becomes all the fishier when he or she comes to consider the values of each of the coefficients, in the experimental data given in the Patent and their stated correlation with on-eye movement.

As to the Ionoton technique the Judge summarised the position thus:

[257] Dealing first with the Ionoton technique, Table E of the Patent sets out Ionoton values which are said to have been measured on the particular lenses listed in the left hand column of the table. This constitutes the only experimental evidence in the Patent of how the threshold Ionoton values relate to “on-eye movement.” … The Patent specifies that “the lowest value of Ionoton Ion Permeability Coefficient for which a lens moves on the eye is 0.25x10^-3 cm²/sec,” and “the highest value of Ionoton Ion Permeability Coefficient for a lens which is bound on the eye is 0.008x10^-3 cm²/sec.” Professor Freeman explained, and I agree, that based on the description and the experimental evidence presented in Table E, the Ionoton Ion Permeability Coefficient threshold for on-eye movement of a contact lens must lie somewhere between 0.008x10^-3 cm²/sec and 0.25x10^-3 cm²/sec.

[258] This deduction, whilst undoubtedly sound on the basis of the data presented, faces major problems. The first is that all the lenses in Table E for which on eye movement was recorded had Ionoton values in excess of the ion diffusion coefficient of sodium chloride in water, which is 2.1 x 10^-5 cm²/sec at 35°C. This is wholly improbable, as Professor Freeman explained. He is not aware of any literature source which reports an ion permeability value for a polymer which is higher than the transport rate of sodium chloride through water.

[259] Second, the values in table E differ by orders of magnitude from ion permeability values given for contact lenses in the literature.

[260] Third, the Ionoton permeability threshold of claim 1 of the Patent is 0.2x10^-6 cm²/sec. This is 40 times lower than 0.008x10^-3 cm²/sec, which is the lowest conceivable threshold value based on the data in Table E, and is 1,250 times lower than 0.25x10^-3 cm²/sec, which corresponds to the lowest Ionoton value for which there was on-eye movement, based on the data in Table E. Thus, as Professor Freeman put it, the claimed value is markedly lower than the on-eye movement threshold which the inventors have deduced from the experimental measurements which they have purported to carry out and is unsupported by any experimental evidence in the Patent. It was unclear to him, and it is unclear to me, from where the Ionoton Ion Permeability Coefficient threshold of claim 1 is derived. Indeed, Table E appears to show that a lens with an Ionoton permeability value above the claimed threshold did not move on the eye.

[261] Dr Port initially expressed the opinion that Professor Freeman’s approach was fundamentally flawed as a matter of science. However, in cross examination he accepted that it was confusing that there was such a large difference between the threshold of claim 1 and the Ionoton values which are said to have been determined by the inventors experimentally and are set out in Table E. He also had no scientific explanation for these values being so high.

So the Ionoton values are improbably high. What about the Ionoflux values? The Judge found the position to be thus:

[262] In contrast to the position in relation to the Ionoton permeability values, at least the claimed threshold for Ionoflux Ion Permeability Coefficient bears a relationship to the teaching in the Patent. The experimental data are set out in Table F. As I have explained, the Patent teaches that the lowest value of the Ionoflux Ion Permeability Coefficient for which a lens moved on the eye was 2.6 x 10^-6 mm²/min; and the highest value of the Ionoflux Ion Permeability Coefficient for which a lens bound to the eye was 1.5 x 10^-6 mm²/min. The Ionoflux limitation in claim 1 corresponds to that lower value of 1.5 x 10^-6 mm²/min, or 2.5 x 10^-10 cm²/sec.

[263] Nevertheless, the difference between the claim thresholds for Ionoton and Ionoflux permeability is very striking. Professor Freeman described them as “vastly different”. In fact, the Ionoton threshold is 800 times greater than the Ionoflux threshold. But the position is yet worse when the reported experimental values are compared. The lowest Ionoflux value for which movement on the eye is reported is 2.6 x 10^-6 mm²/min or 4.33 x10^-10 cm²/sec. By contrast, the lowest Ionoton value for which movement on the eye is reported is 0.25 x10^-3 cm²/sec – a difference of more than 500,000 times and such that Professor Freeman considered the two values to be irreconcilable.

[264] Indeed the Ionoflux threshold of all the claims is so low that, as Professor Freeman demonstrated in Figure 8 of his first report, the prior art contact lenses such as example 3 of Chang, example 4 of Lai and example VI of Keogh all soar above even the highest threshold of claim 17.

[265] What then is the explanation for this discrepancy between the Ionoton and Ionoflux permeability values? No doubt it is attributable in part to the improbably high experimental values of Ionoton permeability to which I have referred. But it also seems tolerably clear the Ionoflux values are set far too low to provide any meaningful threshold.

The Judge considered why there was the discrepancy. Professor Freeman had looked at some of the documents disclosed by Novartis and came up with an explanation. I do not think this was a valuable exercise because the skilled reader would not have those documents. He or she would only have the Patent claims and the data in the Patent to go by. The reader might speculate as to whether there had been a mistake, but he would have no way of knowing whether one had been made or if so what it was. And most particularly the reader would not be able to discern limitations to the Patent claim other than those which are set out.

The upshot of this analysis of element F is that it is essentially meaningless. Virtually nothing will pass the Ionoton test and virtually everything will pass the Ionoflux test.

So we come to an astonishing conclusion. Although the claim has a number of elements, hardly any of them have any significance. The claim is to a lens made from a polymeric material consisting of two vast classes of polymerisable materials, one having a high oxygen diffusion rate and the other having a high ion or water diffusion rate provided the lens “works”. In substance the claim amounts to this: “if you try any pair of polymers, to see if they work (perhaps only after surface treatment) and find anything that does, we claim it.”

What help does the teaching of the Patent give the reader to find a combination of polymers which “works?” The answer is again astonishing - hardly anything. This is so notwithstanding the length of the disclosure, 422 paragraphs on 53 pages.

I start with the examples – for a skilled reader would consider these as being likely to provide the most specific teaching as to how to perform the invention. The Patent introduces the examples as follows:

[298] The previous disclosure will enable one having ordinary skill in the art to practice the invention. In order to better enable the reader to understand specific embodiments and the advantages thereof, reference to the following examples is suggested.

From that the reader would expect the Patent to set out examples of the claimed invention. They are supposed to be “specific embodiments” after all. You would take it that they worked. But in fact if you study the data there is nothing showing that any of the many examples actually works even within the limited meaning of the Patent. Not one example is shown by data in the Patent to be “ophthalmically compatible.” In the case of most examples on-eye movement was not assessed at all. Only 33 were tested for eye movement. Of these 9 did not show it. That would make it plain that at least these did not “work”.

As to the others the patentees took and take an extraordinary position. They say they do not know whether the examples of their own Patent “work.” They were forced into that position by the procedure in this case. What happened was this. At an early stage in the proceedings J&J applied for summary judgment on the basis that the intervening publications Hopken and Domschke anticipated the claims.

Hopken relates to what the Patent calls class B compounds, Domschke to class C. The point is the same for both, so I can confine myself to Hopken. Examples A-1 to A-4 of Hopken correspond exactly to examples B-1 to B-4 of the Patent. Examples B1 to B-4 of Hopken correspond to examples B-5 to B-8 of the Patent. Examples B-12 and B-13 of Hopken correspond to B9 and B10 of the Patent). The information in table B-I of the Patent is also in the table at p.31 of Hopken.

It follows, of course, that Hopken is a prior disclosure of these examples. So if those examples fall within claim 1, then it lacks novelty. To escape such a finding the Patentees said (and it is apparently the case) that they did not admit or know whether any of the examples “worked”, that is to say had the necessary ophthalmic compatibility. The same position was taken in relation to Domschke (which also has a number of examples corresponding to some of those in the Patent. It was on that basis that the patentees escaped summary judgment.

Furthermore although the Patentees naturally gave discovery (what the English now call “disclosure”) of their relevant documents, none of that showed that any of the examples worked in the sense of the Patent. The patentees had not done any clinical trials on the examples save for B5 (in Hopken). It was not suggested (as perhaps it might have been) that the disclosure of the work done on B5 showed it did “work.”

The Patentees’ position was and is this: you could conduct clinical trials on any of the Hopken or Domschke examples and find out if it worked. If it did, it is within the claim, if not not. There is no anticipation proved unless and until an experiment proves the example works and none has been done.

It does not appear the Patentees made this position clear in the parallel proceedings in Holland, Germany and France. As regards the Dutch proceedings, the District Court of the Hague said this:

Novartis has rightly pointed out that the patent specification contains many examples of lenses that have the required ophthalmic compatibility and which the person skilled in the art can easily reproduce.

If that accurately records what was submitted, then Novartis are saying different things in this court to what they were saying to the Dutch Court. I hope that is not so. Whether or not there was this inconsistency the Dutch Court clearly thought the examples “worked.” That lay at the heart of its decision to reject the sufficiency attack. What the Court would have said if it had known what has emerged in these proceedings – that even Novartis has no idea whether the “examples” or any of them, “work" - one can only guess.

As regards the French decision the Tribunal de Grand Instance de Paris assumed, or was allowed to assume, that many of the examples worked. It said:

However the patent specification contains many examples of the manufacture of lenses having the claimed structural features and functions.

The Bundespatentgericht also took it that the examples worked. That court found on that basis, not surprisingly, that Hopken and Domschke (which it labelled K5 and K6) anticipated. It is worth nothing that the Court clearly also had severe doubts as to whether the patent was sufficient although in the end it did not decide this point. It said:

The question, whether or not the teaching of the patent in suit, as a result of the special wording of the claim, the breadth of the claim and features 2, 4, 7 and 8 of the claim [corresponding to features A, C, G and H of the breakdown used above] which can only be determined by clinical tests, indeed represents an invitation to carry out a research programme or whether it really constitutes a Reach-Through-claim (cf. EPO 10637/06 of February 3, 2009) and whether enablement must be denied for this reason – irrespective of the principles of the Taxol decision may remain undecided.

Likewise the Technical Board of Appeal which considered this very Patent (T 0246/04) thought that:

.. the description of the patent in suit contains a plurality of specific examples of manufacture of lenses according to the invention.

I would add one other thing about these parallel decisions. None of them recognise just how devoid of meaningful limitations claim 1 is. Quite why is perhaps explicable on the basis that the courts concerned assumed that the examples worked and did not have the benefit of the intensive probing of the facts and expert evidence afforded by cross-examination which is provided by English procedure. Sometimes that procedure is wasteful, but not in this case.

Turning back to the Patent, as I have said the skilled reader would not be able to discern from the Patent that any of the examples “worked”. Once it comes to sufficiency this matters. For without any guidance from the examples, what is the skilled person to do?

This calls for some examination. He could try the examples one by one and see. That alone would be a major enterprise. But more generally the skilled person is to select two polymerisable materials from two vast classes. The Patent suggests four subclasses of groups of materials (which it calls A, B, C and D, each vast on their own) but is not limited to these.

The reader is given little guidance as to the respective proportions of the polymers. All the Patent says about proportions generally is:

[42] The ratios of oxyperm to ionoperm materials may vary substantially, depending on the selected balance of oxygen permeability and ion permeability for the chosen end use of the molded polymeric article. Preferably the volumetric ratio of oxyperm to ionoperm material (including water) in the fully hydrated lens is about 40 to about 60 to about 60 to about 40. [a little more detail about ratios by weight adds no more]

The reader is told that ion permeability is a predictor of on-eye movement. This is said to be unexpected. But the reader is not really told how to use this. As explained above almost any ion permeability will satisfy feature J. And whilst on-eye movement is essential it is far from a sufficient condition for ophthalmic compatibility.

The first problem is how to get both on-eye movement and sufficient oxygen to the eye. Even if you have on-eye movement the lens may not “work”. If you find you have no on-eye movement for a particular pair of polymers you can try to vary things.

Thus you may stay with your pair of materials and vary the proportions – but how? There is no guidance from the Patent. And if you change the ion permeability you may reduce the amount of oxygen by too much.

Or you may try surface treatment (or more precisely one or more surface treatments). Mr Waugh submitted that no one had made surface treatment work before the patent. That is true, but the Patent has no new proposals or teaching about surface treatment. If a man finds a lens which works when surface treated in a particular way, the patentee claims his lens without having provided any guidance about surface treatment not known in the prior art.

The only way the Patent offers to find out whether you have got everything right is to test it. You can test for oxygen transmissibility. But then you are on your own. You will have to do a clinical trial. If it “works” well and good – but that would tell you nothing about the remainder of the vast ambit of the claim.

If it does not “work” then the Patent does not help you as to what to do next. Generally patents with functional claims give you guidance as to what to do if you embark on a trial and error process. The reader can learn from the errors so as to reach something that works. But not here.

To my mind this is a long way off from satisfying the sufficiency test. As to that, there was no real dispute. The leading English case is Mentor v Hollister [1993] RPC 1 but I prefer to go to Board of Appeal authority. I only need to go to two cases. The first is Detergents/UNILEVER, T 0435/91. The Board laid down some principles:

2.2.1

… In the Board's judgment the criteria for determining the sufficiency of the disclosure are the same for all inventions, irrespective of the way in which they are defined, be it by way of structural terms of their technical features or by their function. In both cases the requirement of sufficient disclosure can only mean that the whole subject-matter that is defined in the claims, and not only a part of it, must be capable of being carried out by the skilled person without the burden of an undue amount of experimentation or the application of inventive ingenuity.

The peculiarity of the "functional" definition of a component of a composition of matter resides in the fact that this component is not characterised in structural terms, but by means of its effect. Thus this mode of definition does not relate to a tangible component or group of components, but comprises an indefinite and abstract host of possible alternatives, which may have quite different chemical compositions, as long as they achieve the desired result. Consequently, they must all be available to the skilled person if the definition, and the claim of which it forms a part, is to meet the requirements of Article 83 or 100(b) EPC. This approach is based on the general legal principle that the protection covered by a patent should correspond to the technical contribution to the art made by the disclosure of the invention described therein, which excludes that the patent monopoly be extended to subject-matter which, after reading the patent specification, would still not be at the disposal of the skilled person. …

There cannot, of course, be a clear-cut answer to the question of how many details in a specification are required in order to allow its reduction to practice within the comprehensive whole ambit of the claim, since this question can only be decided on the basis of the facts of each individual case. Nevertheless, it is clear that the available information must enable the skilled person to achieve the envisaged result within the whole ambit of the claim containing the respective "functional" definition without undue difficulty, and that therefore the description with or without the relevant common general knowledge must provide a fully self-sufficient technical concept as to how this result is to be achieved.

In Plant gene expression/MYOCGEN T 0494/92 the Board explained how Art 83 can interplay with Art 84 considerations:

[5] Article 83 EPC requires an invention to be disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. As made clear in [citation omitted] the extent to which an invention is sufficiently disclosed is highly relevant when considering the issue of support within the meaning of Article 84 EPC, because both these requirements reflect the same general principle, namely that the scope of a granted patent should correspond to its technical contribution to the state of the art. Hence it follows that, despite being supported by the description from a purely formal point of view, claims may not be considered allowable if they encompass subject matter which in the light of the disclosure provided by the description can be performed only with undue burden or with application of inventive skill. As for the amount of technical detail needed for a sufficient disclosure, this is a matter which depends on the correlation of the facts of each particular case with certain general parameters, such as the character of the technical field, the date on which the disclosure was presented and the corresponding common general knowledge, and the amount of reliable technical detail disclosed in a document [citation omitted]. In certain cases a description of one way of performing the claimed invention may be sufficient to support broad claims with functionally defined features, for example where the disclosure of a new technique constitutes the essence of the invention and the description of one way of carrying it out enables the skilled person to obtain without undue burden the same effect of the invention in a broad area by use of suitable variants of the component features [citation omitted]. In other cases, more technical details and more than one example may be necessary in order to support claims of a broad scope, for example where the achievement of a given technical effect by known techniques in different areas of application constitutes the essence of the invention and serious doubts exist as to whether the said effect can readily be obtained for the whole range of applications claimed [citation omitted]. However, in all these cases, the guiding principle is always that the skilled person should, after reading of the description, be able to readily perform the invention over the whole area claimed without undue burden and without needing inventive skill [citation omitted]. On the other hand, the objection of lack of sufficient disclosure presupposes that there are serious doubts, substantiated by verifiable facts, in this respect [citation omitted].

Mr Waugh accepted that this case summarised the law. The heart of the test is: “Can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?”

Mr Thorley took us to a more recent case, amorphous silica/INEOS T 1743/06. He suggested it was closely analogous to this case, showing the test in action as it should be applied here. The claim was to an amorphous silica characterised by 11 different parameters. The Board set out the test which I have described as “the heart”. It then set out a key fact, leading to the question it had to decide:

1.2

… The board however observes that the definition "amorphous silica" comprises a host of possible chemical compounds which may or may not satisfy the multiplicity of parameters defined in the claims of the requests at issue and in this context, the question arises whether the patent contains sufficient information about how these parameters are to be reliably achieved so that the person skilled in the art has at his disposal a process which leads him in a direct way to the amorphous silicas claimed.

The process described in the patent would not necessarily make amorphous silica within the claim. The patentee said you could vary the process conditions to get there. The Board accepted that trial and error by varying a stirring speed might not amount to an undue burden for the two examples of the patent but then went on to say:

[1.8] ….. However, this reasoning which can be accepted only for the two examples, does not hold good for the other claimed but non-exemplified amorphous silicas and in the absence of any specific recipe concerning the preparation of such silicas, the problems concerning the stirring speed still remain for silicas claimed over the whole range.

[1.9] The skilled person is thus confronted with the uncontested fact that he has a lot of process variables affecting the claimed parameters, but once he has encountered failure in one parameter value, there is no clear guidance enabling him to adjust the multitude of process steps in order to arrive with certitude at silicas meeting the parameter requirements defined in claim 1 of both requests at issue. Even though a reasonable amount of trial and error is permissible when it comes to assessing sufficiency of disclosure, there must still be adequate instructions in the specification, or on the basis of common general knowledge, leading the skilled person necessarily and directly towards success, through evaluation of initial failures. This is not the case here, since the preparation of the amorphous silicas claimed is made dependent on the adjustment of different process parameters for which no guidance is given in the patent in suit, so that the broad definition of an amorphous silica as presently claimed is no more than an invitation to perform a research program in order to find a suitable way of preparing the amorphous silicas over the whole area claimed.

[1.10] It follows from the above, that the principle underlying Article 83 EPC that the skilled person should be given sufficient guidance for performing the invention without undue burden over the whole range claimed is thus not fulfilled.

Mr Thorley said that all applied, mutatis mutandis, to this case. This patent did no more than to invite the reader to perform a research program where, if he succeeded, the patent claimed the fruits of his research. I agree.

I turn to how the Judge dealt with insufficiency, what Mr Waugh submitted was wrong with that and why I do not agree with Mr Waugh.

The Judge considered the evidence of the various witnesses about the usefulness of the teaching of the Patent under a heading “Ion permeability and oxygen transmissibility is not enough”. He concluded, and there was ample material for him so to do, that:

[291] In my judgment it emerges from this evidence that the Patent does not enable the skilled person to predict whether any particular lens will satisfy the requirements of the claims without clinical testing. Moreover, and subject to the general teaching to which Professor Koßmehl referred, and which I consider immediately below, the Patent provides no practical assistance how to find potentially suitable polymer compositions beyond those described in families A to D.

The Judge went on to consider whether the general teaching of the Patent helped. There is indeed a lot of teaching, but nothing new in any of it. The Judge concluded, and again he had ample material so to do:

[297] In summary, these teachings were either matters of common general knowledge which did not permit the production of an extended wear silicone hydrogel lens without invention or are not such as to provide any general teaching as to how such lenses can be made without undue effort.

As to the specific families of materials A to D he said:

[312] I have largely addressed these in considering other aspects of the teaching. But to summarise, they remain subject to the overriding criticisms that first, the Patent does not teach which materials within the specific families and examples described are suitable for the production of ophthalmically compatible extended wear lenses; and second, the Patent does not permit the skilled person to make a prediction that any lens is likely to be ophthalmically compatible over a period of extended wear. I am satisfied that both of these criticisms are sound.

The Judge then drew the following overall conclusions:

[315] First, the Ionoton Ion Permeability Coefficient values taught by the Patent and set by the claims are extremely confusing and of little or no practical assistance to the skilled person seeking to make an ophthalmically compatible lens suitable for extended wear.

[316] Second, the threshold Ionoflux Ion Permeability Coefficient values taught by the Patent and set by the claims are so low that that they will easily, if not inevitably, be satisfied. As such, they provide little or no practical assistance to the skilled person seeking to make an ophthalmically compatible lens suitable for extended wear.

[317] Third, the Patent does not enable the skilled person to make any prediction as to whether a lens is ophthalmically compatible over a period of extended wear without clinical testing; nor can he make any prediction as to whether a particular silicone hydrogel formulation is suitable for making such a lens.

[318] Fourth, the skilled person cannot even make any prediction as to whether any and, if so which, of the lenses described in the Patent are ophthalmically compatible over a period of extended wear; nor can he make a prediction as to whether any, and if so which, of the formulations described in the Patent are suitable for making such a lens.

[319] Fifth, the Patent does not teach which, if any, of the lenses or formulations described in the Patent have continuous or co-continuous phases or pathways and provides no or no adequate teaching as to how to produce lenses having such co-continuous phases or pathways in any event.

[320] Sixth, it follows there is no or no adequate teaching in the Patent of any unifying characteristic or principle of general application which would enable the skilled person to predict which silicone hydrogel formulations are likely to be useful for producing an ophthalmically compatible lens suitable for extended wear. The teaching is not such that success may be achieved and ensured.

[321] Seventh, it would involve a considerable amount of work and great expense to test any reasonable number of lenses on a reasonable number of subjects to ascertain whether they are ophthalmically compatible over a period of extended wear.

[322] Eighth, in the light of the foregoing and the absence of such a unifying characteristic or principle of general application, it would involve a research programme to identify silicone hydrogel formulations which are useful for producing an ophthalmically compatible lens suitable for extended wear. I have made a like finding in relation to the allegation that it was obvious how to produce such a formulation in the light of the common general knowledge and the cited art.

Mr Waugh bravely but hopelessly submitted that these findings did not lead to a conclusion of insufficiency. In detail his submissions were:

I reject these submissions. The Judge’s findings which I have set out above unarguably lead to the conclusion that the specification is not sufficient. The instructions do not enable the skilled person readily to perform the invention over the whole area claimed without undue burden and without needing inventive skill.

It is irrelevant that J&J did not perform any experiments. Of course a skilled man could make a lens falling within the very wide physical limitations of the claim. And he could test it on people to see whether it “worked”. It might or might not – the Patent gives no clue as to whether he will be successful. If he happens to have chosen a pair of polymers and proportions which “work” that will be his luck, not something contributed by the Patent. And even if he is lucky, that luck will tell him nothing about the whole of the remaining vast area claimed. The Patent is manifestly not enabling across the range claimed.

Mr Waugh was wrong about predictability too. It can be relevant to sufficiency and is here, where the functional limitation of the claim to ophthalmic compatibility is so crucial. Suppose for example, that the odds against success are 100 to 1. No one could reasonably contend that the Patent had provided adequate instructions, even though on average one out of a hundred skilled people would achieve “success” on a first try. On the other hand suppose almost any pair of polymers in almost any proportions would “work”. Then the instructions would indeed be adequate.

The Patent itself gives no indication as to predictability of success. To find that out the skilled reader would have to do his own research, requiring the making and testing of many pairs of polymers, various proportions and also perhaps various surface treatments.

Mr Waugh submitted that the onus lay on J&J to prove that success was unlikely and it had failed so to do. There are at least two answers to that. First on the facts it is wholly improbable that success with any pair of polymers in the vast range claimed is likely. After all people had been researching for years to find lenses with the right balance of oxygen permeability and water content. The pairs of polymers used for this research were essentially no different from those of the Patent claim. As the Judge recorded at [255]:

Those in the art had attempted for some time to produce a silicone hydrogel lens suitable for extended wear by balancing water content against oxygen permeability.

What the Patent teaches is not about using different pairs of polymers from the kinds tried in the past, it is about using ion permeability rather than water content as a predictor of on-eye movement using the same general kinds of polymer. Since people were not getting “success” with the old method, one can fairly say that “success” was not likely with just any pair of claimed polymers. So there is no missing evidential proof. Proof did not require the experiments said by Mr Waugh to be essential.

Secondly however, suppose success is indeed very likely. Then it would also be likely for those using the prior art method of using water content. So to claim any pair of polymers provided it works would be claiming just what the prior art was seeking to do. This is one of those rare cases where the Patentee would be caught by a squeeze between obviousness and insufficiency.

As to the suggestion that the Judge had wrongly brought in considerations of novelty and obviousness, I simply do not see where he did that. He had the correct test in mind (see [232-244]) as indeed is accepted and then had regard to all the evidence.

Before concluding on sufficiency I must say something about the only part of the Patent which says something novel – that ion permeability is a predictor of on–eye movement. This is said to be unexpected. At first blush one might perhaps think that the Patentees had hit upon something really useful here – and thereby found a way of making extended wear contact lenses. One would be wrong for the following reasons, some of which I have already mentioned but which can usefully be gathered together here:

The upshot of all this is that the Judge was entirely right to decide that the Patent was insufficient. It is no more than a “if you can find it, we claim it” patent. Its avaricious ambit coupled with its failure to provide any help makes it nothing but a hazard to those conducting research into extended wear contact lenses. It should be revoked in its entirety. There is no need to consider any of the other points raised.

I agree.

I also agree.