Two bites and you're out

Readers with good memories may recall the decision of Mr Justice Warren (Patents Court, England and Wales) in Actavis v Novartis [2009] EWHC 41 (Ch) (noted briefly by the IPKat here) concerning the validity of Novartis's European patent EP0948320 which claimed a sustained release formulation for fluvastatin, a drug intended to prevent heart attacks caused by high cholesterol. Fluvastatin, as the name suggests, was a statin, used to lower levels of LDL cholesterol in the body by affecting its synthesis in the liver.

Presented with a large volume of evidence, Warren J considered that the matter was "finely balanced" but held the patent invalid for lack of inventive step in that fluvastatin was itself known for a long time before the patent was applied for and the sustained release formulations claimed in the patent were well known at the time. Since the skilled person, in the form of a research team, would know of these facts, it would be an obvious step to combine them. The patent was consequently found to be invalid for being obvious.

The Court of Appeal (Lords Justices Jacob, Lloyd and Stanley Burnton) today held, in [2010] EWCA Civ 82, that Novartis's appeal should be dismissed. Their Lordships agreed with the trial judge that the invention as claimed was obvious. Jacob LJ however took the opportunity to disagree with him about the "finely balanced" bit:
"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."
The same judge reminded us that the proper route to the determination of inventive step is via Pozzoli:
"I have to say I do not think that the two-bite approach [Merpel says, which are the two bites?] is actually a convenient way to deal with obviousness. It is, after all, a multi-factorial assessment. The thing to do is to identify all the relevant factors, orientate oneself à la Pozzoli and then decide whether the invention is obvious".
Says the IPKat, Pozzoli is a great case for big Kats, being possibly the first occasion on which Lions in the Path were linked with Paper Tigers in the same piece of judicial analysis.

Lion in the path here
Lions in the bath here
Paper Tigers here and here
Two bites and you're out Two bites and you're out Reviewed by Jeremy on Wednesday, February 17, 2010 Rating: 5


  1. I personally prefer this kind of lion in a bath ;-)

  2. I have to say that this is an instant knee-jerk reaction. I need more time to digest Jacob LJ on "could/would" but already I'm disappointed (even embarrassed) by paragraph 36, on the obvious plate and para 35 on the inventive cup. Robin Jacob confidently asserts that EPO-PSA can't handle either of them. I think it can handle both of them in good multi-factorial (para 41) style, with dexterity and aplomb, and in a way to which the man skilled in the art can enthusiastically relate.

    Before we go any further down this road, can't EWCA just extend an informal and discreet invitation to some competent TBA Chairman, of UK nationality, to provide it with a little private tutorial on EPO-PSA?

    I too have a huge criticism of EPO-PSA. It is this. The EPO has made it so simple and elegant that patent experts outside the EPO filing and prosecution circles decide that they know it and understand it without having to go to the trouble of studying it. How many readers have had the experience of talking to American patent lawyers who confidently assert that there is no need to walk through EPO-PSA because they already have a full understanding of it, but then they show, in their subsequent writings and utterances, that they haven't the foggiest clue how it works in real life cases?

    I hope this won't be the last comment on this thread.

  3. You are completely correct. Jacob should be ashamed of how ignorant this decision makes him look. He should call up his old mate Gerald Paterson and take a tutorial. Or go on an EQE revision course. He sits in London and criticises the PSA even though he evidently doesn't understand it. The EPO judges in Munich will read his decision and be reinforced in their views that the UK courts can't be trusted. RJ's the person most in favour of a consistent EP-wide approach so he should be particularly ashamed of ignorant decisions like this one. Maybe the end result is correct (I don't know the case) but the route he took to get there is wrong wrong wrong.

  4. Duff patent, correct result, shame that the reasoning went off on a frolic. The UK courts have appeared to have been inching towards a EPO style approach to obviousness following Kitchin's multifactorial approach in Generics v Lundbeck getting approved by H o L / Hoffmann in Conor v Angiotech, but we are back to square one again. (Pozzoli is a sideshow - it was merely RJ getting his oar in to re-state Windsurfing-style obviousness before the House of Lords overturned him in Conor v Angiotech, which by the way makes no mention of Pozzoli). It's a shame that a new line in the sand appears to have been drawn between the UK and the EPO. Would be interested to see what the TBA makes of this decision when it is inevitably waved around at the EPO in the forthcoming appeal...


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