The UK Court of Appeal Gives Guidance on Sufficiency: Novartis AG and Cibavision AG v Johnson & Johnson

This article was included in our Winter 2010 edition of Inside IP magazine.

The Court of Appeal has upheld the judgement of Mr Justice Kitchin in the High Court that found Novartis’ patent for extended wear ophthalmic lenses invalid for insufficiency.  In a decision dated 29 September 2010, Lord Justice Jacob denounced the “avaricious ambit” of the patent and confirmed that the patent should be revoked in its entirety.  This decision may prove controversial in light of recent French and Dutch decisions in parallel proceedings which saw the patent upheld on this point, and may lead to a further appeal to the Supreme Court in the United Kingdom.

Background

Novartis is the proprietor of European patent 0819258, which is exclusively licensed to Cibavision in the UK.  The patent, entitled ‘extended wear ophthalmic lens’ was granted by the EPO in September 2001.  The patent was subsequently opposed at the EPO by Bausch & Lomb and Johnson & Johnson Vision Care.  Following oral proceedings on 17 September 2003, the patent was revoked on the grounds of lack of novelty, and inadmissibility of the auxiliary requests for lack of clarity.  Novartis appealed this decision and in a decision of 12 July 2007, the Technical Board of Appeal overturned this decision and maintained the patent as granted (T0246/04).  In late 2007, Novartis began legal proceedings against Johnson & Johnson, seeking to block the sale of their ‘Acuvue Oasys’ contact lenses in the UK, Netherlands, France and Germany.

In their suit, Novartis alleged infringement of the ’258 patent by the Oasys product.  In turn, Johnson & Johnson argued that no infringement arose and counter claimed for invalidity on the grounds of lack of novelty, obviousness and insufficiency.  The issue of infringement of the patent by the Oasys product was not a particularly contentious one with Johnson & Johnson’s Oasys product being found to fall within the scope of the claims of the ’258 patent in all of the jurisdictions in which this patent was litigated.  However, the sufficiency of the patent proved to be divisive, with the French and Dutch Courts rejecting Johnson & Johnson’s insufficiency claims, and agreeing with the Technical Board of Appeal that “the description of the patent in suit contains a plurality of specific examples of lenses according to the invention”.  Although the German Court expressed concern about the sufficiency of the patent, in the end it did not decide on this point.

The Patent

The patent at issue in these proceedings was directed to extended-wear contact lenses, with claim 1 drawn to a polymeric material formed from two classes of polymerizable materials.  The remaining features of the claim were recited partly in terms of physical parameters, such as ion permeability and oxygen transmissibility, and partly in terms of certain desired characteristics of the lenses, such as ophthalmic compatibility and on-eye movement. The patent also included a large number of specific examples of the preparation of polymers from each of the classes of polymerizable materials, and of the use of combinations of these materials for the preparation of contact lenses. However, none of the exemplified lenses were shown by data to be ophthalmically compatible.  In the case of on-eye movement, some of the lens examples were tested, of which a number did not show the required characteristic, i.e. these examples did not ‘work’.

High Court

The facts of the case before the Patents Court, which is part of the High Court, were as follows.  In response to Novartis’ allegation of infringement, Johnson & Johnson had counterclaimed for revocation on the basis of lack of novelty, obviousness and insufficiency.  In the first of these attacks, Johnson and Johnson alleged that the priority date of the patent was unsustainable, and that the claims lacked novelty over two earlier documents in the name of Ciba-Geigy AG (Novartis’ predecessor in title to the patent), these documents hereinafter referred to as Hopken and Domschke.  In their second attack, Johnson & Johnson alleged lack of novelty and obviousness based on the common general knowledge and three different prior art documents.  Finally, Johnson & Johnson attacked the patent for insufficiency, contending that the teaching of the patent did not provide sufficient information for the person skilled in the art to make contact lenses across the range of the claims without undue experimentation.  On the facts of the case, it was the first and third of these attacks that were to catch the patentee in a ‘squeeze’ argument between novelty and sufficiency.

‘Working Examples’

Mr Justice Kitchin found for the defendant on the first of the above points, namely that the claims of the patent were not entitled to priority and that the earlier Hopken and Domschke documents constituted valid prior art.  Of these, Hopken disclosed materials for use in the preparation of lenses, and, in particular, a number of the exemplified materials in this document corresponded exactly to examples of the patent in suit, prompting the defendant to seek summary judgement on the basis that this document anticipated the claims.

It was during this hearing for summary judgement that, what Lord Justice Jacob on appeal described as “an extraordinary position” was adopted by the patentee.  In short, the patentee, in response to the allegations of anticipation, contended that it was not possible to tell from the patent whether or not the exemplified materials would satisfy the functional requirements of the claims unless and until they were tested - effectively putting the defendants to proof that any of the specific lenses described in the prior art, even if materially identical to examples described in the patent, would fall within the scope of claim 1.

In deciding on novelty, Mr Justice Kitchin reluctantly agreed with the patentee on this point, noting that he was unable to conclude without experimental evidence that the examples in the prior art would, conclusively, satisfy all of the functional conditions of the claims.

Functional limitations

However, the earlier submissions in relation to the prior art were to have consequences for the patentee.  In considering the insufficiency allegation, Mr Justice Kitchin took into account the earlier contention of the patentee that it was “not possible to tell from a reading of the patent, which, if any, of the examples fall within claim 1”, i.e. it was not possible to establish from the patent whether any of the specific examples actually exhibited the required functional features of the claim.  He further noted that, again as submitted by the patentees themselves, in order to tell if a lens exhibited ophthalmic compatibility and therefore was made in accordance with the invention, it would be necessary to conduct “substantial clinical trials”.  At this point, Mr Justice Kitchin sounded a warning against the use of functional language in claims, remarking that “a claim to a class of products said to possess a useful activity must be based upon the identification of a common principle which permits a reasonable prediction to be made that substantially all the claimed products do indeed share that activity…”and noting that “it is not permissible to by-pass that requirement simply by adding a functional limitation which restricts the scope of the claim to all the products which do have the relevant activity, that is to say all those which ‘work’”.   In this case, he found that no such common principle had been identified, since merely “finding a material which has the oxygen transmissibility and ion permeability characteristics required by the claim” was “plainly not sufficient to work the invention”, and indeed the patent itself included examples of lenses which did not show the desired characteristics.  Consequently, it was not clear from the description which, if any, of the exemplified lenses would actually “work” within the context of claim 1.  On this basis, Mr Justice Kitchin came to what he described as the ‘inevitable’ conclusion that the patent was insufficient.

Court of Appeal

Lord Justice Jacob, before the Court of Appeal, confirmed the decision of the lower Court that the patent should be revoked for insufficiency.  In a scathing judgement, he agreed that the patent was no more than a “if you can find it, we claim it” patent and “a hazard to those conducting research into extended wear contact lenses”.

Lord Justice Jacob also firmly rejected the patentee’s arguments that predictability of success was not a relevant consideration to insufficiency confirming that, in the United Kingdom, predictability of success or reproducibility of the invention is relevant to sufficiency of disclosure in circumstances where a functional limitation is included within a claim; in effect following the findings of the EPO Enlarged Board of Appeal decision in G01/03, in relation to non-working embodiments.

Parallel Proceedings

The fact that the patent was upheld by the Technical Board of Appeal at the EPO, as well as by the District Court of The Hague and the Cour d’Appel of Paris, highlights the inharmonious situation that exists in patent litigation between different European jurisdictions.  Lord Justice Jacob attributed the differences in this case to an assumption by the Dutch and French courts that the examples of the patent actually worked, which was not contradicted by the patentee’s submissions in these jurisdictions.  However, he also championed what he described as the  “intensive probing of the facts and evidence afforded by cross-examination…provided by English procedure” which allowed such “assumptions” to be avoided and which arguably led to the findings of insufficiency in the United Kingdom.

Eimear Sampson 29 Nov 2010

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