UK: Obviousness In The United Kingdom - Levofloxacin From Daiichi Is Not Obvious

Last Updated: 2 September 2009
Article by Jacqueline Needle

Confirming that the Court of Appeal had not found Daiichi's medicine, Levofloxacin, to be obvious, Jacob LJ commented "I am not sorry to reach this conclusion. Daiichi's work led to a better medicine than ofloxacin. Levofloxacin is not just twice as active as ofloxacin ....but is a lot more soluble and less toxic than was predictable. It can be used in higher dosages than might have been expected with corresponding medical benefit. Only a curmudgeon would say there was no invention here."

In his judgement, delivered on 2nd July 2009, in Generics v Daiichi

[2009] EWCA Civ 646 Jacob LJ began by noting that the validity of the patent had been attacked at first instance on many grounds. He once again warned that it is not good practice to include masses of different objections in a case, as it serves only to convince the court that none of the individual attacks holds up to scrutiny.

The only claim of the patent under consideration on appeal claimed Levofloxacin. Levofloxacin is the (-) enantiomer of a racemic compound called ofloxacin, which is a quinolone. Ofloxacin was known to be an excellent synthetic anti-microbial and Levofloxacin had proved to be a broad spectrum anti-microbial of low toxicity.

The Law of Obviousness

In the judgement, Jacob LJ reviewed the law of obviousness and confirmed, as we also saw in a subsequent judgement in Wake Forest University v Smith & Nephew, [2009] EWCA Civ 848 of 31st July 2009, that the Windsurfing/Pozzoli questions are fundamental to determining if an invention is obvious.

When considering obviousness, we are told that "There is at bottom only one test, namely that posed by Art. 56 of the EPC transposed into UK law by s.3 of the Patents Act 1977. Was the invention obvious to a person skilled in the art having regard to any matter which forms part of the state of the art?"

Jacob LJ noted that a tool for answering this statutory question is the Windsurfing/Pozzoli questions and noted that these questions provide: "a structure by which the question, obvious or not, is to be approached. The first three steps do no more than put the court in the right state to answer that question. They are necessary inherent preliminary matters to be determined before one can properly set about answering the fourth question. Implicitly I think all courts (and patent offices) do and must do the same. The approach in the Windsurfing/Pozzoli way merely makes explicit that which is implicit."

..."Some have suggested that Pozzoli/Windsurfing is different from the EPO's problem/solution approach. It is not. The problem/solution approach only applies at stage four. The first three stages must be carried out at least implicitly as much for the problem/solution approach as for any other."

Obvious to Try

It was noted that reliance was placed on "obvious to try" considered recently by the House of Lords in Conor v Angiotech [2008] UKHL 49. Whilst accepting that a particular route would not be any less obvious to take just because there were a number of other obvious routes, Jacob LJ noted "it does not mean that a skilled man will pursue every avenue relentlessly when he has only the mildest of motives for doing so."

The argument was made that as the prior art informed as to how the enantiomers of flumequine were made, the skilled man would recognise that the same method would probably work for ofloxacin. He would follow this up by experiment and reach the invention. At first instance the judge had rejected this attack.

"In the end, the Judge having decided that the skilled man "would have considered it worthwhile exploring whether ofloxacin could be resolved, but only to a point", did not consider that the proposed route was attractive enough. That seems to me to be a perfect example of a Judge properly carrying out the balancing task of forming an overall value judgment which it is so often the task of a first instance Judge to perform. There is no error of principle. The patent, whilst it subsisted, was valid."

Common general knowledge

Jacob J considered the comments of Laddie J in Raychem's Patent [1998] RPC 31 at 40 in which he commented:

"the common general knowledge is the technical background to the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. It includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art."

Jacob J commented:

"Of course material readily and widely to hand can be and may be part of the common general knowledge of the skilled person – stuff he is taken to know in his head and which he will bring to bear on reading or learning of a particular piece of prior art. But there will be other material readily to hand which he will not carry in this head but which he will know he can find if he needs to do so (my emphasis). The whole passage is about material which the skilled man would refer to "as a matter of course". It by no means follows that the material should be taken to be known to the skilled man if he has no particular reason for referring to it."

..."It would be wholly subversive of patents and quite unfair to inventors if one could simply say "piece of information A is in the standard literature, so is B (albeit in a different place or context), so an invention consisting of putting A and B together cannot be inventive." The skilled man reads each specific piece of prior art with his common general knowledge. If that makes the invention obvious, then it does. But he does not read a specific citation with another specific citation in mind, unless the first causes him to do so or both are part of the matter taken to be in his head."

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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