Actavis UK Ltd and Others v Eli Lilly & Company
| Jurisdiction | England & Wales |
| Judge | Lord Justice Floyd,Kitchin LJ,Longmore LJ |
| Judgment Date | 25 June 2015 |
| Neutral Citation | [2015] EWCA Civ 555 |
| Docket Number | Case No: A3 2014 2047 |
| Court | Court of Appeal (Civil Division) |
| Date | 25 June 2015 |
[2015] EWCA Civ 555
Lord Justice Longmore
Lord Justice Kitchin
and
Lord Justice Floyd
Case No: A3 2014 2047
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
MR JUSTICE ARNOLD
Royal Courts of Justice
Strand, London, WC2A 2LL
Henry Carr QC, Thomas Mitcheson QC and Stuart Baran (instructed by Hogan Lovells International LLP) for the Appellant
Richard Meade QC, Thomas Raphael QC and Isabel Jamal (instructed by Bird & Bird LLP) for the Respondents
Hearing dates: 9–12 March 2015
Introduction and issues
This appeal is from the judgment of Arnold J dated 15 May 2014 and his consequent order in an action by companies in the Actavis group of companies (together "Actavis") for declarations of non-infringement ("DNIs") of European Patent (UK) No. 1 313 508 and the corresponding national designations in France, Italy and Spain. I will refer to European Patent 1 313 508 as "the 508 patent" or "the patent". The patentee of the 508 patent and the appellant is Eli Lilly & Company ("Lilly"). The appeal first raises issues of substantive patent law, which I shall call "the patent law issues". The first of the patent law issues concerns the correct approach under our law (and the law of certain other designated states) to the construction of the 508 patent claims, in particular the requirement under the European Patent Convention 2000 ("EPC 2000") to take account of "equivalents" as well as the extent, if at all, to which it is permissible to make use of the prosecution history of the patent in reaching conclusions about construction. The second of the patent law issues concerns whether the application of our law of contributory infringement (as well as that of the other designated states) justifies a finding of infringement in this case.
Depending on the outcome of the patent law issues, there are further issues about whether European Parliament and Council Regulation 864/2007/EC of 31 July 2007 ("the Rome II Regulation" or " Rome II") means that the English court must apply the corresponding foreign laws governing the conditions for applying for DNIs in each of the foreign jurisdictions, or whether English law, as the lex fori, applies. I will call this "the Rome II issue". Finally, if the foreign laws apply, there would be further issues about precisely what the foreign laws provide about the conditions for applying for DNIs in those countries and whether Actavis have complied with those conditions. I will call these "the DNI factual issues" notwithstanding that, as is well known, issues of foreign law are a rather special type of issue of fact.
Pemetrexed disodium is a cancer treatment which Lilly has marketed under the brand name Alimta since 2004. Lilly had patent protection for pemetrexed disodium by way of European Patent No 0 432 677 ("the 677 patent"). Actavis sought the DNIs of the 508 patent in order to place themselves in a position to market a competing product to Alimta on the expiry of the 677 patent in December 2015. They did so in a single action in this jurisdiction. Actavis make no challenge to the validity of the 508 patent: to do so would have meant that this court did not have jurisdiction to deal with the DNIs in respect of the foreign designations, because there is exclusive jurisdiction in relation to issues of validity in the courts of the country where the patent is registered. In an earlier judgment Arnold J rejected Lilly's challenge to the English court's jurisdiction to hear and determine Actavis' action for DNIs in respect of the foreign designations and his judgment was upheld in this court: [2013] EWCA Civ 517; [2013] RPC 37. This court considered that there was jurisdiction on the ground that Lilly had accepted service of the proceedings. It did not find it necessary to decide an alternative issue concerning whether Arnold J had been right to refuse to stay the proceedings on the ground of forum non-conveniens.
The 508 patent relates to the use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy with vitamin B12 and, optionally, folic acid. The active ingredient in Actavis' proposed product is one of (a) pemetrexed diacid, (b) pemetrexed ditromethamine or (c) pemetrexed dipotassium ("the Actavis AIs"). Actavis' case is a simple one. It is that, because they intend to use the Actavis AIs and not pemetrexed disodium, the 508 patent's claims to the use of pemetrexed disodium are not infringed. Lilly does not agree and contends that there will be either direct or indirect infringement of the 508 patent if Actavis launch any of the Actavis AIs in the UK or in any of the other states in relation to which DNIs are sought.
Arnold J agreed with Actavis that their proposed uses of the Actavis AIs would not infringe any claim of the 508 patent as a matter of English law. Next, he had to consider whether the same result would follow under the laws of France, Italy and Spain. It was common ground that those foreign laws applied to the issue of whether the Actavis AIs would infringe in those countries. He concluded that applying the infringement laws of those countries would lead to the same result as the application of English law, and that, therefore, there was no infringement in those countries either.
This meant that the judge needed to go on and deal with the Rome II issue before he could decide whether it followed that his decisions thus far would lead to DNIs in respect of the French, Italian and Spanish designations of the 508 patent. He concluded that English law, as the lex fori, applied to the conditions for the admissibility of a DNI, rejecting Lilly's argument that it was the lex loci protectionis or lex causae, that is to say the patent law of the contracting state in respect of which the declaration was sought. Because there is no difference on the facts of this case between these two Latin descriptors, I will use the term lex causae in this judgment to describe the laws of the designated states in respect of which the DNI is requested.
Those conclusions were sufficient to enable the judge to grant DNIs in respect of each of the designations sought by Actavis, but the judge went on to consider whether, if he was wrong as to the applicability of the lex fori, Actavis had in fact complied with the conditions for obtaining a DNI under the lex causae. He concluded that Actavis had so complied.
Lilly appeals with the judge's permission. On the appeal Mr Henry Carr QC, Mr Thomas Mitcheson QC and Mr Stuart Baran presented the arguments for Lilly. Mr Richard Meade QC, Mr Thomas Raphael QC and Ms Isabel Jamal did the same for Actavis.
In summary, therefore, the issues we have to decide on this appeal are:
i) whether the judge was wrong to decide that there was no direct or indirect infringement applying English law by use of the Actavis AIs as a matter of English law;
ii) whether the judge was wrong to decide that the same result followed under the laws of France, Italy and Spain;
iii) if the judge was wrong on issue (ii), whether the judge was also wrong on the Rome II issue;
iv) if the judge was wrong on the Rome II issue, whether he was also wrong on the DNI factual issues.
I turn first to deal with the patent law issues.
The 508 patent and its claims
The 508 patent is entitled " Combination containing an antifolate and methylmalonic acid lowering agent". It has an earliest claimed priority date of 30 June 2000. Pemetrexed is a member of the class known by the name antifolates. Vitamin B12 is a methylmalonic acid lowering agent.
The specification begins at [0001] by stating that " Potentially, life-threatening toxicity remains a major limitation to the optimal administration of antifolates". It is explained at [0002] that antifolates work by inhibiting anti-folate-requiring enzymes by competing with reduced folates for binding sites on those enzymes. The specification identifies several antifolate drugs as being in development, including Lilly's Alimta.
The specification then explains at [0003] that a limitation to the development of these drugs is that they may be associated with substantial toxicity, including mortality, for some patients. These toxicity effects had led to the abandonment of the development of some antifolates. In [0004] the specification explains that previous work had been done on the use of folic acid as a treatment for toxicity in this area. It also records work on vitamin B12 as a predictor of cytotoxic events.
The specification then continues:
"[0005] Surprisingly and unexpectedly, we have now discovered that certain toxic effects such as mortality and non-hematologic events, such as skin rashes and fatigue, caused by antifolates, as a class, can be significantly reduced by the presence of a methylmalonic acid lowering agent as vitamin B12, without adverse adversely affecting therapeutic efficacy. The present invention thus generally relates to a use in the manufacture of a medicament for improving the therapeutic utility of antifolate drugs by administering to the host undergoing treatment with a methylmalonic acid lowering agent as vitamin B12. We have discovered that increased levels of methylmalonic acid is a predictor of toxic events in patients that receive an antifolate drug and that treatment for the increased methylmalonic acid, such as treatment with vitamin B12, reduces mortality and nonhematologic events, such as skin rashes and fatigue events...
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