In Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and Daiichi Sankyo Co Ltd [2009] EWCA Civ 646, Jacob LJ in the Court of Appeal provided further guidance on the law of obviousness and the Supplementary Protection Certificate (SPC) Regulations.

Business Impact

The action concerned the SPC protecting Daiichi's blockbuster anti-microbial, Levofloxacin. Generics (UK) Ltd relied on two grounds of appeal from Kitchin J.'s first instance judgment. These were that the SPC was invalid because (1) the patent from which it derived was obvious and/or (2) Levofloxacin was not a new "product" as required by the SPC Regulation.

The decision clearly sets out the approach of the English courts to obviousness and also has particular significance for SPCs for enantiomeric medicinal products as it clarifies the requirements for their validity.

Obviousness and Common General Knowledge

Jacob LJ reaffirmed that for obviousness the only question to be addressed by the court is that of Article 56 of the European Patent Convention as transposed into English patent law by section 3 of the Patents Act 1977, namely: '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?'. All other tests or formulas, including the Windsurfing/Pozzoli questions, are useful to focus the mind on the key elements to be considered in answering this question, but provide no more than a structured approach. Jacob LJ refuted the allegation that the Windsurfing/Pozzoli questions represent a 'peculiarly English test' differing from the European Patent Office 'problem/solution' approach or the tests of other national patent offices and courts. The first three questions of the Windsurfing/Pozzoli approach simply make explicit what is implicit in those other tests. Finally, in addressing the fourth question in Windsurfing/Pozzoli, Jacob confirmed that, following the House of Lords decision in Conor v Angiotech, the obvious to try test can only be applied to cases in which there was a 'fair expectation of success' with the degree of such expectation dependant on the facts.

When considering the common general knowledge, while Jacob LJ agreed that this consists of both material that the skilled person is taken to know in their head and material that is not carried in their head but which can be found, he emphasised that the latter was only a consideration if the skilled person recognised the need to refer to such reference material. Consequently, unless one specific citation causes the skilled person to read another specific citation or either of these citations would be taken as being in their head, putting the information in each citation together may be inventive. If this was not the case, this would lead to the unimaginative skilled person recognising elements of one piece of prior art in light of another and having the wit to draw the necessary conclusions: this cannot be the case as it involves 'a level of intuition – of invention'.

Jacob LJ also reiterated that it is the role of the judge at first instance to perform the balancing task of forming an overall opinion on the evidence on whether something was attractive enough to be considered obvious to try. In doing so, the judge adopts the mantle of the skilled person, who, although a legal construct, is one that operates in the real world and would consider their technical and commercial environment and other areas of research that were open to them.

The SPC Regulations

Jacob LJ considered the meaning of the term 'product' as defined by Article 1 (b) of the SPC Regulations. He noted that the definition of 'product' in the SPC Regulations as 'the active ingredient or combination of active ingredients of a medicinal product' must be read with the words 'as the case may be' at the end. Therefore, a combination of active enantiomers (eg, a racemate) and a single active enantiomer derived from that combination are capable of being different 'products'. In light of this and considering the basis of the SPC Regulations in both patent law and the medicinal regulations, when identifying the 'product' of a given 'medicinal product' relevant considerations are that:

  1. the single enantiomer was the subject matter of its own patent, as an improvement patent over the patent for the racemate;
  2. the single enantiomer was for all practical purposes a new and better medicine requiring its own marketing authorisation; and
  3. each enantiomer (and the racemate) had its own individual biological properties.

Finally, in considering the SPC Regulations, Jacob LJ considered that case law from non-EU jurisdictions was unlikely to be helpful. The Australian, Israeli and American cases concerning term extensions for enantiomers arose out of differing political and policy backgrounds and involved the interpretation of differing statutory language.