In Mayne Pharma Pty Ltd v Pharmacia Italia SpA  EWCA Civ 137 the Court of Appeal yesterday allowed Mayne's appeal against the trial judge's ruling of non-infringement.
Mayne's patent was for an injectable ready-to-use anthracycline glycoside solution "which has not been reconstituted from a lyophilisate". Italia made its own solution from an anthracycline glycoside hydrochloride which had been subjected to a lyophilisation process. At first instance Roger Wyand QC said there was no infringement: the essence of Mayne's invention was the manufacture of a ready-to-use solution which did not involve the previously essential lyophilisation stage. On a purposive construction of the claim, the solution itself had not to be made by reconstitution and it was irrelevant that the starting raw material had been lyophilised. Mayne appealed, arguing that the main thrust of the patent lay in the formulation of the ready-to-use solution. The invention was an injectable ready-to-use solution and the starting materials for the formulation were not part of the invention. According to Mayne, the whole teaching of the patent was about the complete avoidance of lyophilisation, which was not needed at any stage.
Allowing the appeal, the Court of Appeal (whose judgment was given by Lord Justice Jacob, as usual) held as follows:
* the notional person skilled in the art, being a pharmaceutical manufacturer and not just a hospital pharmacist, would know not only how the end product was to be used but also how to make it. He would see the real point of the teaching in the description as being the provision of a stable, ready-to-use solution. This substance was not previously available and he could now make it without having to lyophilise the material in the vials. He knew that he would have to start his formulation with active ingredient raw material but he would not regard the nature of that as part of the formulation process: the patent taught him how to do away with a previously essential lyophilisation.
Mayne Pharma: their success on appeal shows that British courts are not so hostile to patents
* When the skilled person came to read the claim, knowing that its legal functions was to set out a monopoly, he would see that it was the ready-to-use solution which must not "have been reconstituted from a lyophilisate". With the understanding of the purpose and teaching of the description he would read it as meaning that the solution itself had not been made by reconstitution: it was avoidance of that which fulfilled the purpose of doing away with the previously essential step. If he considered the nature of the starting raw material, lyophilised or not, he would see that it made no real difference. That construction was consistent with the inventor's purpose as disclosed in his specification: the manufacture of a ready-to-use solution which did not involve the previously essential lyophilisation stage.
"I was most disappointed to see the quite extraordinary number of files of paper produced, quite unnecessarily, for this appeal. We were only referred to two pages not included in the one main file. They were obviously not wanted on voyage or to put it more formally not "relevant to proceedings in the Court of Appeal" ..."How to dispose of waste paper here and here