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NL – Eli Lilly v. Fresenius – Case on the merits

21 Jun 2019

Eli Lilly and Company v. Fresenius Kabi Nederland B.V., District Court The Hague, 19 June 2019, Case no. ECLI:NL:RBDHA:2019:6107

Contrary to the Court of Appeal in summary proceedings, and contrary to various foreign decisions in parallel proceedings, the District Court of the Hague rules in the case on the merits that the scope of protection of Eli Lilly’s patent EP 1 313 508 (hereafter: EP 508), entitled ‘Combination containing an antifolate and methylmalonic acid lowering agent’ is limited to the use of pemetrexed disodium and that the pemetrexed tromethamine used by Fresenius falls outside the scope of protection, as the claims are consciously limited to pemetrexed disodium.

The Court reasons as follows. As the literal wording of the relevant part of the claim, read in light of the description, are not in line with the inventive concept of the patent, the man skilled in the art will wonder how he should interpret the limitation.

Upon consulting the prosecution file, the nature of the limitation and the way it occurred according to the prosecution history, the man skilled in the art or a third party will not consider the literal wording of the patent as a (clearly) unintentional limitation.

The prosecution file shows that Lilly after a Communication from the Examiner -without any discussion whatsoever- limited the claim to pemetrexed disodium. According to the Court, a third party may assume that this limitation was consciously made since Lilly -being a pharmaceutical superpower- is a knowledgeable applicant and was under no time pressure.

Therefore, Pemetrexed Fresenius, the pemetrexed tromethamine, does not fall within the scope of the claims of EP 508.

A copy of the decision (in Dutch) can be read here.