On Dec 08, 2017, Danish Maritime and Commercial High Court
held that Fresenius generic drug with pemetrexed tromethamine infringes EP1313508 patent.The case concerns the infringement of
Lilly’s patent DK/EP’508 which relates to the use of
the active ingredient pemetrexed in combination therapy with vitamin B12 and
optionally folic acid.
Initially, the Court noted that the product "Pemetrexed
Fresenius Kabi" does not constitute a literal infringement of the patent,
as pemetrexed disodium is not used in this product. With respect to infringement
under equivalence court said that the
amendment of the patent claims from pemetrexed to pemetrexed disodium was due
to the EPO's preliminary objection to added matter for "pemetrexed"
in accordance with Article 123(2) EPC. The reason for this preliminary
objection and the resulting amendment was not lack of novelty or inventive
step. Therefore there was no clear estoppel.
Court further held that based on both the wording and the
description in the patent, It is undisputed that the pemetrexed anion, i.e. the
diacid, is the active ingredient of the medicinal products and that the counterion
is not important to the efficacy of the medicinal product. Also it was obvious
to this skilled person that the invention could be carried out by using other
salts than the specific salt pemetrexed disodium. Therefore the skilled person
could expect to find another counterion for the pemetrexed diacid based on the
most commonly used salt formations, including tromethamine.
Based on this, the Court found that infringement by
equivalence was rendered probable & asked Fresenius Kabi to pay legal costs
to Eli Lilly.
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