Actavis UK Ltd & Ors v Eli Lilly & Company, Court of Appeal - Patents Court, May 15, 2014, [2014] EWHC 1511 (Pat)

Resolution Date:May 15, 2014
Issuing Organization:Patents Court
Actores:Actavis UK Ltd & Ors v Eli Lilly & Company

Neutral Citation Number: [2014] EWHC 1511 (Pat)Case Nos: HC12E02962, HP13A01487, HP13B04212, HP13E04604, HP13B05505, HP14D00753, HP14A01611, HP14F01792 IN THE HIGH COURT OF JUSTICECHANCERY DIVISIONPATENTS COURTRolls BuildingFetter Lane, London, EC4A 1NLDate: 15 May 2014Before :THE HON MR JUSTICE ARNOLD- - - - - - - - - - - - - - - - - - - - -Between :- - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -Richard Meade QC, Thomas Raphael and Isabel Jamal (instructed by Bird & Bird LLP) for the ClaimantsSimon Thorley QC, Thomas Mitcheson QC and Stuart Baran (instructed by Hogan Lovells International LLP) for the DefendantHearing dates: 9-10, 15-16 April 2014- - - - - - - - - - - - - - - - - - - - -MR JUSTICE ARNOLD : ContentsTopic ParagraphsIntroduction 1-9The 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 23Burden of proof 24The Patent 25-34The claims 35The prosecution history of the Patent 36-45The skilled person or team 46-64 UK law: general 47-49 UK law: Swiss form claims 50-55 Analysis 56-64Common general knowledge 65-86 UK law 66-67 Assessment: common general knowledge of the oncologist 68-73 in 2000/2001 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 80 in making salts Salt screening 81 Predictability of the viability of salts 82 Sodium salts 83 Potassium salts 84 Tromethamine salts 85 Free acids 86Article 69 and the Protocol 87-88Construction 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 3 129-149The judgment of the Düsseldorf Regional Court 150-158Construction of the French designation of the Patent 159-165 French law 159-162 Assessment 163-165Construction of the Italian designation of the Patent 166-179 Italian law 166-175 Assessment 176-179Construction of the Spanish designation of the Patent 180-187 Spanish law 180-185 Assessment 186-187Actavis' proposed products 188Direct infringement 189Indirect 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 202-203Law 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 221-236Procedural timetable 237-292Actavis' preparations for launch of a pemetrexed product 293-303DNI respect of the UK designation applying English law 304-306DNI respect of the French, Italian and Spanish designations applying 307English lawDNI 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 326DNI in respect of the Italian designation applying Italian law 327-334 Italian law 327-332 Assessment 333-334DNI 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 360Lilly's abuse of process argument in relation to the French and 361-375Spanish designationsSummary of conclusions 376 Introduction1. 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.2. 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.3. 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.4. 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.5. 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.6. 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.7. 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. 8. 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 thanks to the industry and efficiency of counsel on both sides, the hearing was completed in less than four days. Indeed, the cross-examination of all five witnesses was completed in only just over one court day.9. I make no apologies for the length of this judgment. There are many significant issues between the parties, I must consider and apply the laws of four different countries and a great...

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