Pemetrexed - Europe

The dispute all over Europe is basically related to Eli Lilly’s European patent EP1313508 B1 (“EP ‘508”) entitled “Combination containing an antifolate and methylmalonic acid lowering agent”.  The EP’508 patent protects the drug marketed by Eli Lilly under brand name “ALIMTA” (Pemetrexed disodium). Generic filers have sought declaration of non-infringement with respect to their product which utilizes salt other than disodium.

Herein below is the quick snapshot of recent proceedings/decisions in major countries across Europe.

Netherlands: By judgment of 24 October 2017, the PI judge of District Court of the Hague held that Fresenius and Teva’s  generic drug with pemetrexed diacid infringes EP’508 patent.

Switzerland: By judgment of 20 October 2017, The Swiss Federal Supreme court overturned the previous declaratory judgment of non-infringement of the Swiss Federal Patent Court and found Actavis’ generic pemetrexed diacid product, Amtiris, to directly infringe Eli Lilly’s patent E’508.

Italy: By judgment of 10 September 2017, The Milan court ruled that Fresenius, with its pemetrexed product, does not infringe EP’508.

United Kingdom:  By judgment of 12 July 2017, The UK Supreme Court has ruled that the scope of EP’508 patent extends to other salts than pemetrexed disodium, so that the pemetrexed products mentioned by Actavis directly infringes EP’508.

Germany: By judgment of 14 June 2016, The Federal Court of Justice (Bundesgerichtshof – BGH) referred the case back to the Oberlandesgericht Düsseldorf, since BGH held that the Oberlandesgericht (which found non-infringement of pemetrexed dipotassium) had not properly applied the German equivalent theory. The case is pending before Oberlandesgericht Düsseldorf court.

Portugal, Sweden and Finland:  Lilly and Actavis also have procedures in Portugal, Sweden and Finland. None of these matters have yet been decided.