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IT – Eli Lilly / Alimta® – decision overturned

01 Nov 2018

Court of Milan overturns first instance decision on appeal (“reclamo”) and orders a preliminary injunction based on equivalent infringement of Eli Lilly’s Alimta® patent

In a decision of 15th October 2018 in urgent proceedings, the Court of Milan’s appeal panel (comprised of President and Judge rapporteur, Mr Claudio Marangoni and Judges Anna Bellesi and Alima Zana) overturned the first instance decision (reported here on EPLAW on 3 October 2017) in its entirety and refused to grant Fresenius Kabi’s a declaration of non-infringement. The Court found that Kabi’s generic pemetrexed product infringed Lilly’s patent by equivalence and ordered a preliminary injunction preventing its manufacture or supply in Italy.

Claim 1 of Lilly’s patent, covering Eli Lilly’s product Alimta®, is worded as a Swiss-type claim and refers to the use of pemetrexed disodium in a combination therapy together with vitamin B12 for inhibiting tumor growth. Kabi’s product is pemetrexed diacid in combination with tromethamine.

The Court dealt first with the relevance of prosecution file history when construing patent claims. They held that the role of the file history is secondary to the wording of the claims which the description and drawings can be used to interpret.

Lilly had amended as a result of an objection by the EPO examiner, under Art 123(2) EPC on added matter, from “pemetrexed” to “pemetrexed disodium”. The Italian Court held that the examination of the file history, if relevant at all, is substantially limited to the aspects of novelty and/or inventive step. An amendment introduced due to added matter cannot materially affect the application of the doctrine of equivalents since such objection only concerns formal issues regarding the literal wording of the amended claims, as compared to the patent application as filed.

On the facts, the Court held that the amendments made by Lilly did not restrict the interpretation of the patent’s scope of protection in such a manner as to exclude compounds that are equivalent to pemetrexed disodium.

The Court then agreed with the independent panel of experts that the skilled person would treat the disodium as a non-essential part of the invention since the invention was aimed at solving the clinical issue of toxicity by administering vitamin B12 with the pemetrexed anion. The skilled person would understand that the active moiety is the pemetrexed anion and the counterion has no therapeutic or toxic effect.

The Court agreed that it would therefore have been obvious to the skilled person to replace pemetrexed disodium with pemetrexed diacid (with tromethamine as in Kabi’s product) and that Fresenius Kabi’s products infringed Lilly’s patent by equivalence.

The decision brings Italy back into line with the UK, Germany, the Netherlands, Switzerland, Austria, Sweden, Denmark and Finland where the courts have all, to date, found that pemetrexed salt or acid variants infringe Lilly’s patent under their respective national tests in line with Art. 69 EPC.

The decision (in Italian) can be read here.
An informal translation of the decision in English can be read here.

Headnote: Daniel Brook and Emma Fulton (Hogan Lovells International LLP), Giovanni Ghirardi, Riccardo Fruscalzo and Giovanni Trabucco (Hogan Lovells Studio Legale Milano), who assisted Lilly during the PI proceedings in Italy together with Dr. Cristina Freyria Fava (Buzzi, Notaro & Antonielli d’Oulx) as Lilly’s technical expert.