Actavis UK Limited and others v Eli Lilly & Company  EWHC 1511 (Pat)
Judgment was handed down today in the long-running patent case between Actavis and Eli Lilly in relation to the anti-cancer drug pemetrexed disodium (Alimta®). In a first of its kind, Actavis sought declarations of non-infringement in relation to the UK, French, Italian and Spanish designations of Lilly’s European patent EP 1 313 508. Lilly’s patent discloses the use of pemetrexed disodium in combination with vitamin B12 and optionally a folic binding protein agent for inhibiting tumour growth. The declarations sought related to pemetrexed dipotassium, pemetrexed diacid and pemetrexed ditromethamine. Lilly counterclaimed for threatened infringement in relation to the UK designation of the patent.
In a 376 paragraph judgement, Arnold J found that none of Actavis’ proposed products fell within the scope of the patent and that Actavis were entitled to the declarations sought in respect of each of the UK, French, Italian and Spanish designations of the patent.
Initially, Lilly had challenged the UK court’s jurisdiction to rule on the foreign designations of the patent, however, this challenge was rejected by both Arnold J in the High Court ( EWHC 3316 (Pat)) (as reported here and by the Court of Appeal ( EWCA Civ 517,  RPC 37).
Findings on the merits
The key issue in the case was whether the expression “pemetrexed disodium” in claims 1 and 12 should be interpreted to include other forms of pemetrexed, such as pemetrexed dipotassium, pemetrexed diacid and pemetrexed ditromethamine. Lilly argued that the skilled team would interpret this term as any pharmaceutically acceptable and sufficiently soluble salt of pemetrexed. In contrast, Actavis argued that this term would be read to mean only this specific chemical compound. On the question of equivalence, Actavis argued that the skilled team would not know whether an alternative form of pemetrexed would be suitable until it had been tested. Actavis also argued that the court should consider the prosecution history of the patent as an aid to construction. In this case, Lilly had amended the claims of the patent during prosecution from “antifolate” to "pemetrexed" and finally to “pemetrexed disodium” in order to overcome objections made by the examiner. Arnold J agreed that, although caution should be exercised, the prosecution history was relevant.
Having considered Article 69 and the Protocol on its interpretation and having applied the Improver questions, Arnold J agreed with Actavis that Lilly had deliberately limited the claims of the patent to pemetrexed disodium and that the skilled team would have no reason to think Lilly meant to claim anything more than this specific compound. Arnold J also held that there was no indirect infringement of the patent as a result of sodium ions being present when Actavis’ proposed products are reconstituted or diluted in saline.
It was also necessary for Arnold J to consider construction of the claims of the French, Italian and Spanish designations under the laws of those countries respectively, including the doctrine of equivalence as it exists in each country and considering the prosecution history as permitted. In each case it was held that pemetrexed dipotassium, diacid and ditromethamine do not fall within the scope of the patent.
Lilly argued that the law applicable to the question of whether the UK court had power to grant declarations of non-infringement in relation to foreign patents was the applicable law of the country in question. This was on the basis that such rules are not questions of procedure, but rather fall within the scope of the lex causae as determined by Article 15 of the Rome II Regulation. Actavis argued that the rules for obtaining declarations of non-infringement were matters of procedure within Article 1(3) and hence fall outside the scope of the regulation. These rival contentions led to a large amount of foreign law expert evidence being adduced. However, Arnold J held that this is a question of procedure and therefore falls outside the scope of the Rome II Regulation and is governed by English private international law. As English private international law provides that the applicable law is the lex fori, English law should be applied. Arnold J held that under English law Actavis were entitled to declarations of non-infringement, but that in any event they would have been so entitled under each of the relevant foreign laws, had these been the applicable laws in each case.
This is the first time that the High Court has exercised jurisdiction in relation to foreign designations of a European patent. This paves the way for parties to bring proceedings in relation to multiple designations of European patents in a single court, provided that validity is not in issue.
In house Counsel for Actavis commented that: "Actavis is extremely pleased with the outcome of this hard-fought litigation, particularly with the fact that cross-jurisdictional declarations have been granted. Our excellent legal team, managed by Mark Hilton at Bird & Bird, has worked tirelessly in these complex and innovative proceedings."
Actavis estimates that sales of Lilly’s Alimta® product in the UK, France, Italy and Spain in 2013 were approximately EUR 325 million.