Sustained release fluvastatin formulations – The UK Court of Appeal opinion in Activis UK Limited v Novartis AG [2010] EWCA Civ 82

Post from Paul Cole

Sometimes a decision as to obviousness hinges on a single short point. In Graham v John Deere, the tipping point testimony was during cross-examination of the witness for the patentee, when he said that the allegedly inventive feature made no significant difference to the operation of the device. Once that evidence had been given, the outcome was inevitable, and references to Thomas Jefferson, though decorative, were mere dicta.

The controversy concerning the fluvastatin sustained release patent EP-B-0948320 (UK) falls into the same category. The patent was based on the premise that fluvastatin was so water-soluble that it was difficult to devise a sustained release formulation. Claim 1 as amended read:

A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.

The tipping point fact was that fluvastatin was not of such extreme water-solubility as to give rise to the difficulties alleged. After that had been established, the whole basis for patentability collapsed, as explained concisely by Jacob L.J. at the conclusion of his opinion, which also contains an implied warning that although it may be appropriate to rely on an earlier decision for a rule of law, the facts on which that earlier decision was reached are of little relevance:

Once the obstacle put forward in the Patent against being able to make a sustained formulation was shown to be illusory, then a sustained release formulation is obvious. You might get better efficacy or fewer side effects, but you would certainly get better compliance. In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation. For that there was a technical motivation and no difficulty, real or apparent.

The PSA [problem-solution analysis] gives the same answer. What is the objective problem? Why that which the patentee himself stated – to produce a sustained release form of fluvastatin. Was the solution obvious? Yes, any of the standard methods for such formulations would clearly work: there is no reason why they would not.

There is no need and it would be wrong to re-formulate the problem as suggested by Mr. Meade. This is not a case where some prior art unknown to the patentee has turned up. Nor is it right to reformulate the problem as one of looking for better medical effects when that was not the problem as seen by the patentee or to reformulate the solution as having found such effects when the patentee has not promised any.

In the latter respect this case is quite unlike the case, relied upon by Mr. Meade, about a sustained release form of oxycodone recently considered by this court, Napp v Ratiopharm [2009] EWCA Civ 252, [2009] RPC 539. Oxycodone was, until the patent, known as a minor weak opiod generally administered, to the extent that it was administered at all, as a co-drug. The slow-release form transformed it, as the patent said, into a serious alternative to morphine – something that was wholly unexpected. Of course the invention was non-obvious.

The upshot is that I would uphold the decision of the Judge. Unlike him, however, I do not think the case was finely balanced. Once the basis of the Patent was proved illusory there was nothing left to save it.

Jacob L.J.’s opinion contains a lengthy discussion of the respective approaches to inventive step of the UK courts under Windsurfing/Pozzoli and of the EPO approach using PSA which may be valuable to students and has been praised as “a tutorial in the law of obviousness”. Readers may recall John Mortimer’s fictional barrister Rumpole, who knew little law, but was an expert on bloodstains and used his instinct for tipping point facts with devastating effect in the cases for which he was responsible. No magic touchstone is to be found either in the USA under Graham/KSR or in the UK under Windsurfing/Pozzoli because in both jurisdictions after certain mandatory preliminary enquiries the issue has to be decided on a case by case basis according to the evidence and without the distortion introduced by preconceptions in the mind of the decision-maker. The legal background is only a guide as to the appropriate enquiries to be made and what matters is the evidence as to the tipping point facts, of which in the present case there was only one.

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