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Intellectual Property Law

: IPKat

Two bites and you're out

By Johanna Gibson, David Pearce, Jeremy Phillips and Ilanah Simon.

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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

Full post as published by IPKat on February 17, 2010 (boomark / email).