This article was included in the spring 2011 issue of Innovate - the patents newsletter.
A Court of Appeal judgment in a case in which the sufficiency of a patent was at issue (Novartis AG and another v Johnson & Johnson Medical Ltd and others  EWCA Civ 1039) has demonstrated the need for careful drafting of claims to avoid terms that cannot be defined.
Novartis AG ("Novartis") were the proprietor of a patent for extended wear contact lenses ("the Patent"). They alleged that Johnson & Johnson ("Johnson")'s Acuvue Oasis range of contact lenses infringed the Patent. Johnson counter-claimed that the Patent was invalid on grounds of insufficiency, obviousness and anticipation. The High Court agreed with Johnson and held that the Patent was invalid due to insufficiency. Novartis appealed to the Court of Appeal.
It was agreed by both parties that the case for invalidity centred solely on the interpretation of Claim 1 of the Patent. In analysing Claim 1, Jacob LJ came to the conclusion that there was little or no meaningful limitation to each of the claim’s elements. The High Court had been correct in deciding that the Patent was invalid due to insufficiency.
Claim 1 of the Patent
The first element of Claim 1 stated that the patented lens should be "ophthalmically compatible". This was defined in the Patent as a lens that could be in contact with the eye for an extended period of time without significantly damaging the eye or causing discomfort. The court noted that this was a functional definition in that it was dependent on the testing of real people. Thus an ophthalmically compatible lens could not be defined by the physical characteristics of the lens, nor measured by instrumentation. This definition, described by Jacob LJ as "woolly", was unsurprisingly a point of contention in the High Court proceedings. There it was decided that an ophthalmically compatible lens was one which would satisfy a small-scale clinical trial. Although Jacob LJ accepted this interpretation, predominantly because it was not contested by either side on appeal, he noted that it still lacked certainty. For example, if ten people were tested and one experienced discomfort or damage, would that mean that the lens was ophthalmically incompatible? Or would you test another ten and if none of them experienced discomfort or damage, then the lens was ophthalmically compatible?
Another element of Claim 1 stated that the lens should be made from two materials; oxyperm and ionoperm. The Patent defines oxyperm, a made-up term, as a material which displays "a relatively high oxygen diffusion rate" and that must be "relatively ophthalmically compatible". Again, this provides little certainty or limitation as to what a "relatively high" oxygen diffusion rate is. Furthermore, as discussed above, "ophthalmically compatible" is a functional definition that lacks sufficient definition, let alone "relatively ophthalmically compatible".
Jacob LJ analysed the remaining elements of Claim 1 of the Patent. He came to the conclusion that there was hardly any significance, nor meaningful limitation, to any of the elements of Claim 1. He summarised that Claim 1 effectively said "if you try any pair of polymers to see if they work, and find anything that does, we claim it".
Furthermore, of the numerous examples detailed in the Patent none provided results illustrating an ophthalmically compatible lens.
These examples also featured in Novartis' parallel European proceedings. In stark contrast to the English proceedings, the courts of France, Germany and Holland held that the examples detailed in the Patent did in fact "work", i.e. they demonstrated what was required to produce an ophthalmically compatible lens. Furthermore, none of the European courts seemed to question the fact that Claim 1 lacked any meaningful limitation. As such, the Patent escaped a finding of insufficiency, (although the German court found the Patent to be invalid on the grounds of lack of novelty). Jacob LJ suggested that this difference of opinion may be because the English procedure, in contrast to that of the European courts, allows for intensive probing and cross-examination of expert witnesses.
Jacob LJ looked to the EPO Board of Appeal for the test for insufficiency of a patent. Referring to Detergents/UNILEVER (T 0435/91) and Plant gene expression/MYOCGEN (T 0494/92). He concluded that the test is "can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?" Jacob LJ concluded that, due to the lack of meaningful limitation of the elements of Claim 1, coupled with unhelpful examples, the patentee could not define what worked and what did not. Given that a third party could not ascertain whether or not they infringed, the High Court had been correct in deciding that the Patent was insufficient.
This case provides yet another example of the dangers of drafting the claims of a patent in terms that cannot be defined. Jacob LJ noted that not only was the Patent unhelpful, its avaricious ambit made it a hazard to those conducting research into extended wear contact lenses. It seems likely that patents whose claims lack sufficient limitation and definition will be dealt with short shrift by the English courts.
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