Eli Lilly’s patent, EP 1313508 covers the cancer drug permetrexed disodium in combination with vitamin B12 or pharmaceutical derivatives thereof. Actavis intend to launch a generic pemetrexed product, the active ingredient of which will be pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine, and sought a declaration of non-infringement prior to launch.
The key question was whether the claims to permetrexed disodium extend to pemetrexed diacid, dipotassium and ditromethamine. Both sides accepted that there was no literal infringement of the claims, however Lilly argued that in addition to pemetrexed disodium, other forms (alternative salts) of pemetrexed may fall within the scope of the claims. Considering the Protocol on Article 69 EPC and applying the Improver questions, Justice Arnold concluded that these other forms of pemetrexed were outside the scope of the claims and that therefore there would be no infringement.
Taking into consideration amendments made during prosecution of the Patent, Arnold found that Lilly had deliberately limited the claims to pemetrexed disodium and that other pharmaceutically acceptable and sufficiently soluble salts were not covered. Justice Arnold considered this to be a “clear example” of the “patentee regretting a decision taken during the course of prosecution … and … trying to avoid the consequences of that decision”. Justice Arnold stated that in such a case “there is no reason why the law should be sympathetic to the patentee”, particularly where decisions as to claim scope made by the applicant during prosecution would be effectively reversed by decisions on claim construction. He stated that where prosecution history is “short, simple and shows clearly why the claims are expressed in the manner in which they are to be found in the granted patent and not in some broader manner” then there is “no good reason why the court should shut its eyes” to the prosecution history.
Arnold commented specifically on the judgment of the German Court: “in finding infringement by reason of equivalence alone, … the Dusseldorf Regional Court has not given proper effect to the Protocol but rather has treated the claims as a mere guideline”. In relation to France, Italy and Spain, based on reports by foreign law experts for each country, Arnold found, as for the UK, that dealings in pemetrexed diacid, dipotassium and ditromethamine by Actavis will not constitute direct infringement. Arnold also concluded that there will be no indirect infringement in the UK and that – based on reports by experts in French, Spanish and Italian national law – as the law on indirect infringement is broadly similar to the UK in France, Italy and Spain, there will be no infringement of the French, Italian or Spanish designations either. This judgment therefore confirms that the UK courts will hear non-infringement actions in relation to multiple European jurisdictions in a single court Action.