Fuzzy boundaries, woolly limitations and over-broad claims: a case-study in insufficiency

Author: (Matthew Fisher, University College London)

Novartis AG & Cibavision AG v Johnson & Johnson [2010] EWCA Civ 1039, Court of Appeal for England and Wales, 30 September 2010

Journal of Intellectual Property Law & Practice (2011) doi: 10.1093/jiplp/jpq190, First published online 11 January 2011.

The central question when assessing sufficiency of disclosure for the purpose of establishing the validity of a patent is to ask whether the skilled person can readily perform the invention over the whole area claimed without undue burden and without needing inventive skill.

Legal context

Where a patent is granted, consideration must move to the public. Accordingly, by eschewing secrecy, the inventor who seeks the exclusivity of a patent must disclose their claimed invention in a form that is clear enough and complete enough for it to be carried out by a person skilled in the art. In other words, their disclosure must be sufficient. Failure to satisfy this condition renders the patent invalid and liable to be revoked.

The Court of Appeal's decision in Novartis & Cibavision v Johnson & Johnson explores the sufficiency requirement and, in doing so, sheds some light on fuzzy boundaries, woolly limitations and over-broad claims.

Facts and analysis

Novartis and its exclusive licensee, Cibavision, appealed against the decision of Kitchin J [2009] EWHC 1671 (Pat), in which he held that although Johnson & Johnson's (J&J) Oasys contact lenses fell within the scope of claims 1 and 24 of Novartis' European Patent (EP (UK) No. 819,258), the patent itself was invalid on grounds of insufficiency.

By the time of the appeal, J&J had accepted the judge's finding of infringement and so the patent's validity was the only issue. Moreover, it was common ground that Novartis' case was to stand or fall by reference to claim 1 only.

Claim 1 of the patent related to the manufacture of contact lenses made from a polymeric substance comprising at least one of both oxyperm- and ionoperm-polymerizable materials. The essential requirement, according to the claim, being that the lens should have high oxygen and high ion permeability, thereby making it suitable for extended periods of continuous wear.

The decision

Lord Justice Jacob, giving a judgment with which Ward and Patten LLJ agreed, quickly set the tone: by paragraph 8 it was eminently clear that things had gone very wrong indeed for the patentee. Thus, the claim was criticized from the outset for its ‘extreme breadth’ and ‘essentially purely functional nature’, being described as ‘practically a claim to anything that works’. Thereafter, by a process of slow evisceration over the course of the next 84 paragraphs, Jacob LJ proceeded to dissect, scrutinise, and chronicle the precise failings of Novartis' claim.

While the patent was thoroughly pulverized, this was not a judgment in which words were minced. Accordingly, after listing the claim's main elements, Jacob LJ stated:
"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".
For the patentee this was arguably a high point, as things went rapidly downhill from here. Not only were the criteria for choosing the constituent components of the substance from which the lens was to be created ‘extremely wide’, but each was also described as having ‘woolly limits’ as well. There was, according to the Court, ‘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’ – i.e. the requirement for clarity and support. However, while such non-compliance is a ground for refusing grant, it is not, of itself, a ground of invalidity once the patent has issued. Unhappily for Novartis, other grounds took up the slack. Accordingly, ‘[u]ndue width’, as it was shortly called, could be excised using either non-obviousness, or insufficiency, or a combination of the two.

Returning to the claim, Jacob LJ highlighted the use of the phrase ‘ophthalmic compatibility’, a property that the lens envisaged by the patent was required to possess. Satisfaction of this requirement, he noted, had been found by the Judge to require ‘a small scale test on actual people’. But even this was ‘somewhat fuzzy’, as it was unclear what effect a failure of such a trial would have.

The remainder of the integers were found to add precious little; sufficing to limit the claim to things that ‘work’ but giving little guidance as to how to discern this without carrying out clinical tests. A key comment is found at [50] of the judgment:
So we come to an astonishing conclusion. Although the claim has a number of elements, hardly any of them have any significance … . 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.
Accordingly, the teaching of the patent was held to give the skilled reader hardly any assistance in determining whether a combination of polymers ‘works’ – and this notwithstanding that it stretched to 422 paragraphs over 53 pages. ‘Something fishy’ had gone on. Such fishiness became ‘all the fishier’ when the examples given in the patent were considered.

Surveying the other European decisions in which Novartis' claim had been litigated, Jacob LJ considered that the Dutch, German and French courts, as well as the Technical Board of Appeal of the EPO, had all made one fatal error. Not having the ‘benefit of the intensive probing of the facts and expert evidence afforded by cross-examination which is provided by English procedure’, they all assumed that the examples given in the patent did, in fact, work; however, this was not actually the case. Consequently, each failed to notice ‘just how devoid of meaningful limitations claim 1 is.’
Being unable to predict from the patent documentation whether any of the examples therein ‘worked’ or not, the addressee was left with a vexing question: what was he to do? Trial and error would be a major enterprise: the patent suggested selection of two polymerizable materials from two vast classes, with little guidance on proportions and no advice on how to assess if the blend is successful short of actual trial. If a selection ‘worked’ then this was all ‘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.’
This, according to Jacob LJ, was ‘a long way off from satisfying the sufficiency test’. Brushing over the leading English authority, Mentor v Hollister [1993] RPC 1, he stated that he preferred ‘to go to Board of Appeal authority’ to support his view, and so turned to two decisions of the Technical Board: Decision T-0435/91 UNILEVER/Detergents and Decision T-0494/92 MYCOGEN/Plant gene expression. From these he drew the heart of the test to be applied: ‘Can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?’

Following consideration of the decision in T-1743/06 INEOS/Amorphous silica, Jacob LJ agreed with J&J's submission that Novartis' 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.’

The judge had therefore been correct to conclude that the patent was insufficient. Its instructions clearly did not meet the standard required.
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.
Accordingly, it fell to be revoked in its entirety.

Practical significance

While the decision is unremarkable in its application of the legal principles – the test for sufficiency being adopted from the Board of Appeal authorities is essentially identical to that laid down in Mentor – the manner in which Jacob LJ's judgment is orientated, and the clear focus on the wider European context is worthy of note. It has been evident in a number of recent Court of Appeal decisions that Jacob LJ has his sights on a far more unified patent system in Europe than currently exists – the reference in Grimme Landmaschinenfabrik GmbH & Co KG v Derek Scott [2010] EWCA Civ 1110 to a wealth of German case law on the interpretation of the indirect infringement provisions within the Patents Act 1977 is cast from the same mould. It is therefore clear that, while the main thrust of the decision vents spleen over the canker that is the over-broad claim, the intended audience for this vitriol is not limited to those practising in England & Wales.

This is not really a decision aimed at English lawyers at all: there is not a single reference to the Patents Act 1977 to be found within the text. It is a judgment aimed at those on the Continent by whom the fishiness had gone unnoticed.

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