UK Court of Appeal judgment in Actavis v Novartis

02 March 2010

Neil Jenkins, Rachel Fetches

On 17 February 2010, the Court of Appeal unanimously upheld the finding of Warren J that Novartis’ European Patent (UK) No. 0 948 320 was invalid for obviousness albeit adopting a different approach to that adopted by the Judge.[1]  The case was an appeal by Novartis, with a cross-appeal by Actavis, against Warren J’s Order made on his judgment of 16 January 2009[2] (the first instance decision was reported in the March 2009 edition of the Life Sciences Update).  The only issue in the appeal was obviousness.

The Patent was directed to certain types of sustained release formulations of fluvastatin sodium, a well-known statin that was available in an immediate release formulation at the priority date of the Patent.  The problem stated to be solved by the Patent was that the solubility of the sodium salt of fluvastatin was so great that one would expect problems in making a sustained release formulation.

At first instance, Warren J had held, on the evidence, that the skilled person would not have, in fact, have viewed fluvastatin sodium’s solubility as a problem.  Warren J had also held however that the skilled team engaged on the task of formulating fluvastatin would not be certain that they could make a sustained release formulation which had improved clinical efficacy or a better side effect profile and that as a consequence the Patent was not obvious unless it could be so held apart from consideration of the motivation for and prospects of success of the notional task.

However, Warren J then went on to hold that the Patent was obvious on the basis of the so-called “5¼ inch plate” argument bearing in mind the claimed invention namely a sustained release formulation which was therapeutically useful i.e., had some clinical efficacy without unacceptable side-effects.

Novartis appealed the finding of obviousness by the Judge on the basis of the 5¼ inch plate argument; Actavis cross-appealed on the basis that task on which the Judge had engaged the skilled team was unrealistically burdensome and did not reflect the claimed invention i.e., that the Judge had set the “success” bar too high for the notional project.

Jacob LJ, giving the only reasoned judgment, reviewed the law of obviousness comparing the English court’s approach to the issue of obviousness through the Windsurfing/Pozzoli[3] questions and the EPO’s problem-and-solution approach (PSA).  Jacob LJ noted that following Conor,[4] when considering step 2 of the Pozzoli questions which requires the Court to identify the inventive concept of the claim in question, strictly, the only thing that matters is what is claimed.  Jacob LJ also noted that he did not find the Judge’s two-bite approach to deciding obviousness a convenient way to deal with the issue.  He reiterated that the approach to be taken is a multifactorial assessment.  The Court should identify all the relevant factors, orientate itself according to Pozzoli and then decide whether the invention is obvious.  

Jacob LJ agreed with Actavis’ submission that the Judge had set the barrier for success too high.  It was not better efficacy or improved side-effect profile but merely a formulation that worked.  He also held that there was a technical motivation to make such a formulation namely improved patient compliance.  He held that once the obstacle put forward in the Patent had been found to be illusory (as was held by the Judge) then a sustained release formulation was obvious.  Putting it another way, the only difference between the claim and the prior art was the idea of making a sustained release formulation and for that there was a technical motivation and no practical difficulty.  The same result was achieved using the PSA approach. 

[1] Actavis UK Limited v Novartis AG [2010] EWCA Civ 82, 17 February 2010.
[2] Actavis UK Limited v Novartis AG [2009] EWHC 41 (Ch), 16 January 2009.
[3] Windsurfing v Tabur Marine [1985] RPC 59; Pozzoli v BDMO [2007] FSR 37.
[4] Conor v Angiotech [2009] UKHL 49, [2008] RPC 716 at [19].