Friday, October 1, 2010

Novartis AG & Cibavision AG v. Johnson & Johnson [2010] EWCA Civ 1039

The Court of Appeal roared back into action yesterday with its first patent decision of the new term: Novartis AG & Cibavision AG v. Johnson & Johnson [2010] EWCA Civ 1039 (available on Bailii here). Novartis and Cibavision appealed against the decision of Kitchin J ([2009] EWHC 1671 (Pat) – reported by tytoc collie here), in which he had held that whilst 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, however, invalid on grounds of insufficiency. J&J had also contended that the Patent was invalid for obviousness and lack of novelty, but these arguments were rejected at first instance.

The appeal centres around the issue of insufficiency, and J&J’s contingent cross-appeals (to be deployed if the insufficiency appeal was successful) got nary a look-in.The tone of the Court is apparent from the outset. Describing claim 1 of the patent, Jacob LJ noted:

"[10] “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.”

He continued:

"[19] Accordingly there is 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. This requires that:

The claims shall define the matter for which protection is sought. They shall be clear and concise and supported by the description.

Unfortunately failure to comply with Art. 84 is not itself a ground of invalidity. However some of the grounds which are available for an invalidity attack overlap with Art.84. The jurisprudence of the Boards of Appeal has had to deal with undue width of claim by resorting to either the requirement of non-obviousness or that of sufficiency or both. As will be seen I think they come into play here.”

However, the hammer-blow comes slightly further on into the judgment:

"[50] So we come to an astonishing conclusion. Although the claim has a number of elements, hardly any of them have any significance. The claim is to a lens made from a polymeric material consisting of two vast classes of polymerisable materials, one having a high oxygen diffusion rate and the other having a high ion or water diffusion rate provided the lens “works”. 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.”

[51] What help does the teaching of the Patent give the reader to find a combination of polymers which “works?” The answer is again astonishing - hardly anything.”

Skipping on a little, Jacob LJ continues:

“[70] The only way the Patent offers to find out whether you have got everything right is to test it. You can test for oxygen transmissibility. But then you are on your own. You will have to do a clinical trial. If it “works” well and good – but that would tell you nothing about the remainder of the vast ambit of the claim.

[71] If it does not “work” then the Patent does not help you as to what to do next. Generally patents with functional claims give you guidance as to what to do if you embark on a trial and error process. The reader can learn from the errors so as to reach something that works. But not here.”

Thus, readers will not be surprised that the patent was held to be insufficient. Jacob LJ summarised his conclusions with damning criticism of the patent before him:

“[92] The upshot of all this is that the Judge was entirely right to decide that the Patent was insufficient. 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. It should be revoked in its entirety. There is no need to consider any of the other points raised.”

Ouch!

History of contact lenses: here

When contact lenses attack: here


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