Judgment was handed down on 15 May 2014 in the long-running patent dispute between Actavis and Eli Lilly regarding Lilly’s patent relating to the use of the anti-cancer drug pemetrexed disodium with vitamin B12 and (optionally) folic acid. Actavis sought declarations of non-infringement in relation to the UK, French, Italian and Spanish designations of Lilly’s European patent.
There was an initial jurisdictional challenge raised by Lilly in relation to the claims for declarations of non-infringement of the foreign designations, which was rejected by the High Court and by the Court of Appeal (judgment). As such this is the first case in which the High Court has exercised jurisdiction over foreign designations of a European patent.
The declarations sought by Actavis related to the use of pemetrexed dipotassium, pemetrexed diacid and pemetrexed ditromethamine. Lilly counterclaimed for threatened infringement in relation to the UK designation of the patent.
The key substantive issue was whether or not the words “pemetrexed disodium” used in the claims of the patent were used figuratively to cover any forms of pemetrexed which were pharmaceutically acceptable and sufficiently soluble, or whether they only meant the specific chemical compound pemetrexed disodium. In considering this issue Arnold J held that, under English law, although caution should be exercised, the prosecution history of the patent was of relevance. The prosecution history showed that Lilly had amended the claims of the patent during prosecution from “antifolate” to "pemetrexed" and eventually to “pemetrexed disodium” in order to overcome objections raised by the examiner.
Arnold J found that none of Actavis’ proposed products fell within the scope of the patent or the foreign designations. In doing so he considered not only Article 69 of the Protocol and issues of construction under English law (in particular by looking at the Improver questions and the principles in Kirin Amgen), but also the approach to construction and infringement under French, Italian and Spanish law.
As well as the substantive patent law dispute, there was a substantial procedural dispute between the parties. Lilly argued that the law applicable to the question of whether the court had power to grant declarations of non-infringement in relation to the foreign designations was the applicable law of the country in question pursuant to Article 15 of the Rome II Regulation. However, Arnold J held that this issue was a question of procedure and therefore fell outside the scope of the Rome II Regulation, and that English law should be applied. Arnold J held that under English law Actavis were entitled to declarations of non-infringement for each of the foreign designations, but that in any event, even if the issue had been one that should be decided under the laws of each of the foreign jurisdictions, Actavis had complied with the various procedural requirements under the relevant foreign laws.
Thomas Raphael acted for Actavis (instructed by Bird & Bird LLP