Pemetrexed: Italian Court reversed the first instance decision ordering a PI on the basis of Eli Lilly's patent

In fact, diverging from the previous decision, the Court pointed out that the relevance of the file history to construe the scope of protection of a patent and then the infringement of equivalence has to be carefully and prudentially evaluated.

In particular, according to the Judges, the file history may narrow the scope of protection only if the patentee has limited its patent during prosecution to overcome novelty/inventive step objections of the EPO and not merely for added matter reasons (deemed by the Court a formal issue concerning the literal wording of the amended claims).

As a consequence, in the case at stake, agreeing on what declared by the Panel of Court Experts who were appointed in the appeal PI proceedings, the Court denied that the amendment of the claim made by Eli Lilly during the prosecution before the EPO can be considered as a limitation implying that EP '508 has to be interpreted as exclusively referring to Pemetrexed disodium and not also to compounds equivalent of it. Neither did the reading of the patent lead to a different conclusion. Indeed, according to the Judges, the invention at issue did not regard the selection of a Pemetrexed salt but the reduction of the toxic effects of the active part of the active ingredient, the anion. At the date of filing of EP '508, the skilled person knew that the active part of Pemetrexed (that was able to penetrate into the cells and carry out its inhibition and toxic activity) is the anion, which may be obtained by different pharmaceutical forms of Pemetrexed. Therefore the skilled person would not have attributed a particular meaning to the fact that Pemetrexed was in the form of…