In an extremely long decision ([2009] EWHC 1671 (Pat)), running to 356 paragraphs, and dated 10th July 2009, Kitchin J of the English Patents Court found European patent (UK) No. 0819258 of Novartis to be new, non-obvious and infringed by contact lenses called Acuvue Oasys sold by Johnson & Johnson. In these respects the judgement was entirely consistent with a decision in similar proceedings in respect of the same patent handed down on 11th February 2009 by the Hague District Court.
The patent was found not to be anticipated, even though it was determined that it was not entitled to its two earliest priority dates. Unfortunately for the patentee, and for consistency with other European jurisdictions, the patent was found to be invalid for insufficiency.
The patent
The patent was concerned with an ophthalmic lens having a balance of oxygen permeability, ion permeability, on-eye movement and tear exchange, sufficient for corneal health and wearer comfort during extended periods of continuous wear. As explained by Kitchin J, "Whilst the desirability of high oxygen permeability was known, the desirability of high ion permeability was not known – and the Patent teaches for the first time that ion permeability is an important predictor of on-eye movement".
Claim 1 was directed to an ophthalmic lens "being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, ... said lens comprising a polymeric material, ... which has high oxygen permeability and high ion permeability." The claim required that the lens allow oxygen permeation in an amount to maintain corneal health and specified the oxygen transmissibility required. Claim 1 also required that "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." Further characteristics of the amount of ion permeability were set out in the claim in terms of permeability coefficients.
Kitchin J noted that the claim was not "limited to lenses made of materials which have been identified using ion permeability as a way of filtering out those materials which are suitable from those which are not." An expert had accepted "that ion permeability has not become the touchstone by which suitable silicone hydrogels are identified." The judge also commented that the claim was "limited by function in that it only encompasses lenses which are ophthalmically compatible during a period of extended wear. In short, it only covers lenses which "work" ".
Insufficiency
Kitchin J acknowledged that the first principle for an invention to be sufficient is that "the specification must enable the invention to be performed to the full extent of the monopoly claimed." This was established by the House of Lords in Biogen v Medeva [1977] RPC 1. This principle was reaffirmed in Kirin Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 169 and Generics (UK) Limited v Lundbeck [2009] RPC UKHL 12. This principle is also supported by the Boards of Appeal of the EPO.
Kitchin J acknowledged that whether a disclosure is clear and complete enough for someone skilled in the art to perform it is a question of degree, and agreed that in some circumstances there was no objection to functional statements in the claims, as exemplified by No-Fume v Frank Pitchford (1932) 52 RPC 231. However, whilst the skilled person may need to carry out ordinary methods of trial and error, he should not be required to carry out prolonged research.
"It follows, in my judgment, 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. Further, 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 the case of a claim limited by a function, it must still be possible to perform the invention across the scope of the scope of the claim without undue effort."
In this case, the defendants in their sufficiency attack argued, "that the specification sets a puzzle because merely finding a material which has the oxygen transmissibility and ion permeability characteristics required by the claim is plainly not sufficient to work the invention"... "the difficulties faced by the skilled person are compounded by the fact that the teaching of the specification and limits of the claims with respect to ion permeability are of no practical use. A material satisfies these limits if it has an ion permeability in excess of certain thresholds when measured either by the Ionoton or the Ionoflux techniques. The thresholds in respect of Ionoton are set so high that practically nothing will pass and in respect of Ionoflux are set so low that practically nothing will fail."
Kitchin J concluded that the ion permeability coefficient values set out in Claim 1 provided little or no practical assistance in making an ophthalmically compatible lens suitable for extended wear. There was no teaching to enable any particular silicone hydrogel formulation to be chosen with any certainty that it would be suitable for making such a lens. In the absence of any unifying characteristic or principle of general application which would enable the skilled person to predict which silicone hydrogel formulations were likely to be useful, "it would involve a research programme to identify silicone hydrogel formulations which are useful for producing an ophthalmically compatible lens suitable for extended wear."
"In my judgment a finding that the Patent is insufficient is therefore inevitable."
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