Actavis UK Ltd and Others v Eli Lilly & Company
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 15 May 2014 |
| Neutral Citation | [2014] EWHC 1511 (Pat) |
| Docket Number | Case Nos: HC12E02962, HP13A01487, HP13B04212, HP13E04604, HP13B05505, HP14D00753, HP14A01611, HP14F01792 |
| Court | Chancery Division (Patents Court) |
| Date | 15 May 2014 |
[2014] EWHC 1511 (Pat)
The Hon Mr Justice Arnold
Case Nos: HC12E02962, HP13A01487, HP13B04212, HP13E04604, HP13B05505, HP14D00753, HP14A01611, HP14F01792
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
Richard Meade QC, Thomas Raphael and Isabel Jamal (instructed by Bird & Bird LLP) for the Claimants
Simon Thorley QC, Thomas Mitcheson QC and Stuart Baran (instructed by Hogan Lovells International LLP) for the Defendant
Hearing dates: 9–10, 15–16 April 2014
Approved Redacted Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Contents
| Topic | Paragraphs |
| Introduction | 1–9 |
| The witnesses | 10–23 |
| Fact witness | 10 |
| Technical experts | 11–15 |
| French law experts | 16–17 |
| Italian law experts | 18–19 |
| Spanish law experts | 20–22 |
| General comments on the evidence of foreign law | 23 |
| Burden of proof | 24 |
| The Patent | 25–34 |
| The claims | 35 |
| The prosecution history of the Patent | 36–45 |
| The skilled person or team | 46–64 |
| UK law: general | 47–49 |
| UK law: Swiss form claims | 50–55 |
| Analysis | 56–64 |
| Common general knowledge | 65–86 |
| UK law | 66–67 |
| Assessment: common general knowledge of the oncologist in 2000/2001 | 68–73 |
| Antifolates | 69 |
| Pemetrexed | 70–71 |
| Vitamin B12 and folic acid | 72 |
| Salt forms and counter-ions | 73 |
| Common general knowledge of the oncologist in 2007 | 74 |
| Common general knowledge of the chemist in 2000/2001 | 75–86 |
| and in | 2007 |
| Salts and counter-ions | 76–79 |
| The impact of the salt form on a drug and the difficulties in making salts | 80 |
| Salt screening | 81 |
| Predictability of the viability of salts | 82 |
| Sodium salts | 83 |
| Potassium salts | 84 |
| Tromethamine salts | 85 |
| Free acids | 86 |
| Article 69 and the Protocol | 87–88 |
| Construction of the UK Patent | 89–149 |
| UK law: general | 89–107 |
| UK law: prosecution history as an aid to construction | 108–112 |
| Assessment | 113–149 |
| Improver question 1 | 118–119 |
| Improver question 2 | 120–128 |
| Improver question 3 | 129–149 |
| The judgment of the Düsseldorf Regional Court | 150–158 |
| Construction of the French designation of the Patent | 159–165 |
| French law | 159–162 |
| Assessment | 163–165 |
| Construction of the Italian designation of the Patent | 166–179 |
| Italian law | 166–175 |
| Assessment | 176–179 |
| Construction of the Spanish designation of the Patent | 180–187 |
| Spanish law | 180–185 |
| Assessment | 186–187 |
| Actavis' proposed products | 188 |
| Direct infringement | 189 |
| Indirect infringement | 190–203 |
| Infringement of the UK designation | 190–201 |
| The law | 190–193 |
| The facts | 194–198 |
| Assessment | 199–201 |
| Infringement of the French, Italian and Spanish designations | 202–203 |
| Law applicable to the DNI claims | 204–236 |
| The relevant provisions of the Rome II Regulation | 206–209 |
| Brief summary of the rival contentions | 210 |
| Characterisation of the rules | 211–220 |
| Interpretation of the Regulation | 221–236 |
| Procedural timetable | 237–292 |
| Actavis' preparations for launch of a pemetrexed product | 293–303 |
| DNI respect of the UK designation applying English law | 304–306 |
| DNI respect of the French, Italian and Spanish designations applying English law | 307 |
| DNI respect of the French designation applying French law | 308–326 |
| French law | 308–318 |
| Assessment | 319–326 |
| Route 1 | 320–323 |
| Route 2 | 324–325 |
| Route 3 | 326 |
| DNI in respect of the Italian designation applying Italian law | 327–334 |
| Italian law | 327–332 |
| Assessment | 333–334 |
| DNI in respect of the Spanish designation applying Spanish law | 335–360 |
| Spanish law | 335–352 |
| Assessment | 353–360 |
| Route 1 | 354–356 |
| Route 2 | 357–358 |
| Route 3 | 359 |
| Route 5 | 360 |
| Lilly's abuse of process argument in relation to the French and | 361–375 |
| Spanish designations | |
| Summary of conclusions | 376 |
Introduction
Pemetrexed disodium is a cancer treatment which has been marketed by the Defendant ("Lilly") or its subsidiaries under the brand name Alimta since 2004. Pemetrexed and its pharmaceutically acceptable salts were protected by European Patent No. 0 432 677 ("677"), which expired on 10 December 2010. The protection conferred by that patent has been extended by Supplementary Protection Certificates ("the SPCs") which will expire on 10 December 2015. Lilly also owns European Patent No. 1 313 508 ("the Patent"), which will not expire until June 2021, for the use of pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof and optionally a folic protein binding agent. The Claimants (whom I will refer to as "Actavis" save when it is necessary to distinguish between them) intend to launch a generic pemetrexed product the active ingredient in which will be either pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine. Actavis intend to obtain regulatory approval for their product by reference to Alimta. Actavis contend that dealings in their product will not infringe the Patent. Lilly disputes this. Actavis would like a resolution of this issue in good time for them to enter the market on expiry of the SPCs. Furthermore, Actavis wanted the issue to be determined with respect to the French, German, Italian, Spanish and United Kingdom designations of the Patent, which cover the major pharmaceutical markets in Europe, in a single trial. Accordingly, Actavis commenced these proceedings seeking declarations of non-infringement ("DNIs") in respect of each of those designations of the Patent. Lilly has counterclaimed for threatened infringement only of the UK designation.
At an early stage of these proceedings, I heard a jurisdictional challenge by Lilly in relation to the French, German, Italian and Spanish designations which I rejected for the reasons given in my judgment dated 27 November 2012, [2012] EWHC 3316 (Pat) (affirmed [2013] EWCA Civ 517, [2013] RPC 37). Since then, there have been a number of developments, of which the following are the most significant for present purposes. A detailed procedural timetable is set out in paragraphs 237–292 below.
First, as indicated in paragraph 1 above, Actavis now seek DNIs in relation to pemetrexed diacid and ditromethamine as well as dipotassium. Indeed, the diacid is currently Actavis' lead candidate.
Secondly, a number of additional Actavis subsidiaries have been joined as claimants. Recently, however, Actavis Deutschland GmbH & Co KG, Actavis France SAS and Actavis Spain SA have ceased to be claimants consequential upon the sale of those companies to the Aurobindo Group.
Thirdly, as explained in more detail below, Lilly brought proceedings against Actavis for threatened infringement of the German designation of the Patent before the Düsseldorf Landgericht (Regional Court). Despite the fact that this court was first seized, Actavis' jurisdictional challenge was rejected and on 3 April 2014 the Düsseldorf Regional Court gave judgment on the merits of Lilly's claim. In those circumstances, Actavis decided to discontinue the present proceedings so far as they relate to the German designation.
Fourthly, whereas it was common ground at the time of the hearing before me in November 2012, as I recorded in my judgment at [30], that the law applicable to the question of whether this Court has power to grant DNIs with regard to the non-UK designations of the Patent was English law as the lex fori, since this was a question of procedure or remedy, Lilly subsequently changed its position and now contends that the applicable law is the law of the country in question. Furthermore, Lilly contends that Actavis have not satisfied certain requirements, which Lilly characterises as requirements of locus standi and Actavis characterise as procedural requirements, under French, Italian and Spanish law.
Fifthly, in an attempt to circumvent Lilly's objections under the foreign laws, Actavis have brought a series of further claims. In essence, Actavis say that, even if Lilly's procedural objections were well founded as at the date of the first and second actions, the relevant procedural requirements had been satisfied by the date of one or more of the later actions. Lilly contend that the bringing of the later actions amounts to an abuse of the process of the court. In a judgment given on 27 November 2013 ( [2013] EWHC 3749 (Pat)) I dismissed an application by Lilly to strike out the fourth and fifth actions as an abuse of process, primarily on the ground that, for the reasons given in that judgment, the application was premature.
Sixthly, at a pre-trial review on 20 March 2014, I ruled, for the reasons given in my first judgment of that date ( [2014] EWHC 838 (Pat)), that there should be no cross-examination of the foreign law experts upon their reports. I also ruled, for the reasons given in my second judgment of that date ( [2014] EWHC 839 (Pat)), that there should no cross-examination of Dr Maria Rotaru of Sindan Pharma SRL ("Sindan"), who had verified a Product and Process Description ("PPD") served by Actavis in lieu of giving disclosure with regard to relevant properties of pemetrexed diacid, dipotassium and ditromethamine. As a result, and...
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