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

By Evelina Marchesoni


In the case Fresenius Kabi Oncology Plc and other v Eli Lilly and Company and other, by decision of 15 October 2018, the Court of Milan overturned the first instance decision (reported here) ascertaining the prima facie infringement by equivalence of Eli Lilly's patent EP 1 313 508 ("EP '508"), claiming the use of pemetrexed disodium in combination with vitamin B12 and optionally a folic binding protein agent for inhibiting tumour growth, by Fresenius' product containing pemetrexed diacid in combination with tromethamine to be reconstituted in glucose.

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,

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