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.