Comfy lenses, shame about the patent ...

It was decided rather earlier this month, but the ruling of Mr Justice Kitchin in Novartis AG and Cibavision AG v Johnson & Johnson Ltd and another [2009] EWHC 1671 (Pat) has taken a while to reach the top of the IPKat's must-blog pile. 356 paragraphs can take a long time for a Kat to read and, though he hates to admit it, even longer to get the hang of what it's all about.

In brief, Novartis claimed that J&J's Acuvue Oasys products infringed its European patent for extended-wear silicone hydrogel contact lenses that could be left in the eye overnight or even for several days. J&J counterclaimed for revocation on the bases of insufficiency (ie the teaching in the invention as disclosed did not provide sufficient information for the person skilled in the art to make contact lenses within or across the range of the claims without undue experimentation), lack of novelty and absence of inventive step.

Kitchin J ruled that the patent was invalid for lack of sufficiency. He reasoned as follows:

* As to lack of novelty, it had to be shown that the prior art contained a clear description of, or clear instructions to make, something that would necessarily infringe the patentee's claim if carried out after the grant of the patent. Since the examples in two earlier patent applications cited by J&J did not satisfy all the requirements of any of the patent's claims, this burden of proof had not been met.

* The way of making a silicone hydrogel lens which was ophthalmically compatible over a period of extended wear was not obvious in the light of (i) the common general knowledge or (ii) the content of three earlier cited patents.

* For a patent to be valid its specification had to disclose the invention in a way that was sufficiently clear and complete for it to be performed by a person skilled in the art. In this context, the specification had to enable the invention to be performed to the full extent of the monopoly claimed (citing Biogen Inc v Medeva).

* Whether the specification disclosed an invention clearly and completely enough for it to be performed by a person skilled in the art involved a question of degree: the specification need not set out every detail necessary for performance, but the skilled person should not be required to carry out any prolonged research, enquiry or experiment.

* In this case, the ion permeability values taught by the patent and set by the claims were "extremely confusing and of little or no practical assistance to the skilled person seeking to make an ophthalmically compatible lens suitable for extended wear": it would require a research programme to identify silicone hydrogel formulations which were useful for producing such lenses.

Says the IPKat, this judgment has some interesting material on priority (paras 113 to 140), and a whole mini-thesis on insufficiency (paras 230 to 323). Kitchin J bases his reasoning on the House of Lords decision in Lundbeck, which he sees as reaffirming the reasoning in Biogen, both support the basic rule for sufficiency (see paras 233-234). He cites Lord Hoffmann quoting the Technical Board of Appeal of the EPO in Exxon/Fuel Oils (T 409/91) [1994] O.J. EPO 653: "the extent of the patent monopoly ... should correspond to the technical contribution to the art in order for it to be supported, or justified" (para 233).

Merpel adds: if you want to know all about the place of silicone 3-(methacryloxy)propyl tris(trimethysiloxyl)silane (TRIS) in the history of silicone hydrogel development, or the use of SANS, SAXS, TEM, EDX, AFM, DSC and FEGSTEM in the analysis of microphase structures, you will find the judge's analysis quite un-put-downable.

The Dutch proceedings, in which the same patent is held valid and infringed, here

Contact lenses for cats here

Wild Cat contact lenses here
Cats' eyes here