ACTAVIS UK LTD v ELI LILLY & CO 1

Reports of Patent, Design and Trade Mark Cases, Feb 2015

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ACTAVIS UK LTD v ELI LILLY & CO 1

Patents Act ACTAVIS UK LTD v ELI LILLY & CO1 PATENTS COURT European Patent - Declaration of non-infringement - UK and non-UK designations - Pharmaceuticals - Swiss form claims - Infringement - “Pemetrexed disodium” - Construction - Person skilled in the art - Scope of protection - Relevance of prosecution history - Indirect infringement - Means essential - Availability of declaratory relief - Applicable law - Characterisation of pre-action requirements - Construction of Rome II - Whether declaratory relief a “remedy” - Multiplicity of actions - Abuse of process 1 It is understood that this decision is the subject of an appeal to the Court of Appeal which is due to be heard in March 2015. - H3 H4 H5 infringe the UK, French, Italian or Spanish designations of European Patent No. 1,313,508 (“the Patent”) the claims of which were directed to the use of a compound called pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof and optionally a folic protein binding agent. The Patent was not due to expire until 2021. Pemetrexed and its pharmaceutically acceptable salts were also the subject of a supplementary protection certificate (“SPC”) due to expire in December 2015. Lilly was the proprietor of both the SPC and the Patent and it marketed a cancer treatment of which pemetrexed disodium was the active ingredient under the name ALIMTA. Actavis intended to launch a generic pemetrexed product with pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine as its active ingredient and to obtain regulatory approval for their product by reference to ALIMTA. They accepted that they could not market such a product until after the expiry of the SPC but sought determination of the infringement issues at a single trial with a view to launching their proposed product after that date. Lilly had counterclaimed for infringement of the UK designation of the Patent, but not the French, Italian or Spanish designations. It had however commenced proceedings for infringement of the German designation of the Patent before the Du¨ sseldorf Landgericht (although apparently seized of the matter after the Patents Court here), which had found in its favour (although that decision was under appeal). Lilly had earlier challenged the court’s jurisdiction to determine the issues arising in relation to the non-UK designations on grounds, inter alia, of forum non conveniens. In particular, it had argued that the determination of those issues would involve consideration of the relevant laws of construction and contributory infringement applying in relation to each designation and that the issue of infringement would more conveniently be dealt with in each of the respective territories. However Lilly’s challenge had been unsuccessful.2 It should be noted that this was not a case in which the court was required to decline jurisdiction under art.22(4) of Council Regulation 44/2001/EC (“Brussels I”) as Actavis had undertaken not to challenge the validity of the Patent or to contend that it was invalid in the present proceedings if the court accepted jurisdiction. Lilly had also unsuccessfully tried to argue in advance of the trial that a number of the later of these actions, brought to overcome procedural objections raised by Lilly in the earlier actions, should be struck out as abuse of process. However this application had been dismissed on grounds that it was premature.3 The main issues at the trial of the various actions were essentially (i) the identification of the person or team skilled in the art to the different claims of the Patent were addressed; (ii) the construction of claims 1 and 12 of the Patent and, in particular, of the term “pemetrexed disodium”; (iii) the relevance of the prosecution history of the Patent; (iv) whether there had been direct or indirect infringement of the UK, French, Italian or Spanish designations; (v) the identification of the law governing the issue whether a declaration of non-infringement could be made in relation to each of those designations (which depended on the proper interpretation of the Rome II Regulation); and (vi) whether the commencement of such a multiplicity of actions amounted to an abuse of process in the circumstances of these proceedings as a matter of the laws of England and Wales. It was common ground that the law applicable to whether Actavis’ 2 [2012] EWHC 3316 (Pat) (Arnold J.). The forum conveniens issue was not considered in the later appeal to the Court of Appeal, which concerned the question whether there had been an agreement to accept service of the proceedings: see [2013] EWCA Civ 517, [2013] R.P.C. 37. 3 [2013] EWHC 3749 (Pat), Pat. Ct. Published by Oxford University Press for the Intellectual Property Office H7 H8 proposed acts would infringe each non-UK designation of the Patent was the lex loci protectionis, i.e. the substantive patent law of the relevant country. The evidence adduced by the parties was extensive and included expert evidence on foreign law supported by extensive references to legislation, case law and commentaries, all with accompanying translations. The title of the Patent was “Combination containing an antifolate and methylmalonic acid lowering agent”. Claims 1 to 11 were in Swiss form and claims 12 to 14 were product claims. Claims 1 and 12 read as follows: “1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.” “12. A product containing pemetrexed disodium, vitamin B 12 or a pharmaceutical derivative thereof said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo10- chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.” Actavis argued that the Patent (at least for purposes of post-grant issues) was addressed to a team including (i) a medical oncologist and (ii) someone with experience in pre-formulation work (e.g. a process chemist or a formulation scientist) supported by an analytical chemist, and that the expression “pemetrexed disodium” meant pemetrexed disodium and nothing else. It was a precise chemical expression with a clear meaning. Further, the skilled team would have understood that this expression had been chosen to identify a specific chemical and this would have been confirmed by (a) the contrast between the reference to “pemetrexed disodium” on the one hand and the references to “vitamin B12 or a pharmaceutical derivative thereof” and a selected “folic protein binding agent” on the other and (b) the prosecution history of the Patent, which confirmed that the limitation of the claims to pemetrexed disodium was both intentional and made for good reason and that the claims would have been invalid if construed more broadly. Lilly argued that the claim 1 of the Patent was a Swiss form claim and directed only to a medical oncologist, although it accepted that claim 12 was directed to a medial oncologist and a chemist. It argued, inter alia, that the addressee of the Patent did not have to be the same for each claim and could be different in other circumstances too, i.e. (i) when considering infringement as opposed to insufficiency and (ii) when considering different aspects of the assessment of infringement (i.e. Improver4 question 1 as opposed to Improver questions 2 and 3). In any event, the relevant persons would understand “pemetrexed disodium” to mean (at least) pemetrexed diacid and any salt of pemetrexed which was pharmaceutically acceptable (i.e. 4 Improver Corp v Remington Consumer Products Ltd [1990] F.S.R. 181, Pat. Ct. [2015] R.P.C., Issue 2 Crown Copyright H10 H11 could be made, was safe, sufficiently stable and did not affect the efficacy of the drug) and sufficiently soluble. It would have been obvious to such persons that substitution of the free acid or a different salt would have no material effect on the way in which the invention worked, in particular because (a) the invention was about reducing the toxicity, while maintaining the efficacy, of pemetrexed and (b) the active chemotherapeutic principle was the pemetrexed anion, and the skilled team would therefore have concluded that “pemetrexed disodium” was being used in a figurative sense which was exemplary of the means of obtaining the benefits of the invention. As to the history of the prosecution of the application, Lilly contended that, as a general rule, prosecution history was rarely useful as an aid to construction and that the present case was no exception. In so far as concerned infringement of the UK designation of the Patent, both parties argued their cases at least partly by reference to the Improver questions. There was no dispute that none of the proposed compounds were “pemetrexed disodium” accordingly to the primary, literal or acontextual meaning of that term but were variants, the main areas of dispute being essentially Improver questions 2 (whether lack of material effect obvious) and 3 (whether strict compliance essential). Similarly, as to the French, Italian and Spanish designations, it was common ground that none of pemetrexed diacid, dipotassium or ditromethamine fell within the scope of the claims of the Patent on a literal designation. The issue in each case was whether they fell within the scope of those claims applying the doctrine of equivalents as applied in those jurisdictions. There was little dispute as to the applicable principles of French law on construction, but there was disagreement as to both the applicable principles of Italian and Spanish law on construction and their operation in the present case. It should be noted that the judgment focused on whether claims 1 and 12 extended to pemetrexed diacid. This was Actavis’ lead candidate for manufacture and if this compound was caught, so too were the others.5 As to Italian law on construction, there was a dispute as to whether the enactment of art.52 of the Code of Industrial Property (set out at [167] of the judgment) had changed the previous law. It was common ground that, in addition or in the alternative to an “obviousness” test (set out at [171] of the judgment reported here), the Italian courts frequently applied a “triple identity” test: does the variant (i) perform substantially the same function, (ii) in substantially the same way, (iii) to achieve substantially the same result. However, the question was whether this jurisprudence correctly reflected the relevant legal provisions and, in particular, whether it paid sufficient regard to the role of the claims. Further, although it was common ground that there was no doctrine of prosecution history estoppel in Italian patent law and no clear rule as to whether it was of any relevance in claim construction, there was disagreement as to whether recent case law showed any trend one way or the other. As to whether pemetrexed diacid, dipotassium or ditromethamine fell within the scope of the claims of the Italian designation of the Patent applying the doctrine of equivalents, Lilly argued that it made no difference whether the “obviousness” or “triple identity” test was adopted. The proposed compounds fell within the scope of the claims whichever test was applied. For its part, Actavis did not argue that these compounds were not equivalent to pemetrexed disodium as a matter of Italian law but contended that the correct interpretation of the claims was that such equivalents were nevertheless excluded from the scope of protection because (i) on its face the Patent 5 See [116]. Published by Oxford University Press for the Intellectual Property Office H13 clearly demonstrated a conscious intention to limit the claims to pemetrexed disodium and (ii) this was amply confirmed by the prosecution history. As to Spanish law, the experts were agreed that in a pharmaceutical case a test which was particularly likely to be applied by the Spanish courts was an adapted Improver test and which was sometimes referred to as the “obviousness” test. This test is set out at [182] of the judgment. The dispute in relation to the Spanish law on construction primarily concerned the proper application of the doctrine of one’s own acts (“doctrina de los actos propiosi” – see [181] and [184] of the judgment) and, in particular, whether that doctrine was only applicable where the patentee had expressly limited the claim to overcome a prior art objection. In addition to direct infringement, indirect infringement was alleged in this case. Lilly argued (i) the proposed pemetrexed compounds were means relating to an essential element of the invention as they provided a source of pemetrexed ions, (ii) that such means were for putting the invention into effect in precisely the same manner as ALIMTA, (iii) that Actavis had the requisite knowledge, and (iv) that the persons to whom Actavis supplied its product were not entitled to work the invention. Actavis admitted that in use their product would be reconstituted and/or diluted in much the same way as ALIMTA and result in a solution containing, inter alia, pemetrexed ions and sodium ions. Actavis also admitted (i) that it would be obvious to the skilled team that this would be so, and (ii) that their product would be administered in combination with vitamin B12 and folic acid and they knew this. However, they denied any such infringement, contending that at no point was pemetrexed disodium used in the manufacture of a medicament by anyone. It was no answer to this to say that pemetrexed ions on their own constituted an essential element of the invention, as this was just another way of saying that the claim did not require pemetrexed disodium, but merely required any form of pemetrexed which made pemetrexed ions available. As to the law governing whether a declaration of non-infringement could be made, it was common ground that this depended on the proper construction of Regulation 864/2007/EC (“Rome II”). Actavis contended that the rules for obtaining such relief in each jurisdiction were matters of procedure within the meaning of art.1(3) of Rome II and consequently fell outside the scope of that regulation. This had the consequence that the question of the applicable law fell to be determined by English private international law under which the applicable law was the lex fori as English law regarded such rules as procedural. Lilly argued that they fell within the scope of the lex causae as determined by art.15 of Rome II. Consequently a key issue was the characterisation of the relevant laws in each of France, Italy and Spain. However it was common ground that they had to be given an autonomous characterisation for purposes of Rome II and that how they were characterised under the respective national laws was not determinative. There were also significant legal issues arising under French, Italian and Spanish law in relation to the availability of declarations of non-infringement in the circumstances of the present case in the event that those were indeed the applicable laws to determine that question. As to French law, Lilly argued, inter alia, that such relief was not available for one or more of four reasons: (i) art.L.615-9 of the Intellectual Property Code (set out at [308] of the judgment) had to be complied with; (ii) Actavis had not given Lilly three months’ notice; (iii) Actavis had not carried out the necessary “serious and effective preparations”; and (iv) it was not possible for Actavis to cure such defects within an existing action, but only by starting again and commencing a new action. H17 As to Italian law, it was common ground that Actavis had to show “legitimate interest” and that the test for this in the present case was that there had to be an objective uncertainty giving rise to a present, concrete prejudice to the claimants which the judgment of the court was capable of curing. It was also common ground that there was no need for a cease-and-desist letter to have been sent. The main issue was whether there had to be some form of actual articulated objection from the patentee in order for the required uncertainty to exist. As to Spanish law, there were numerous issues as to the proper construction of art.127 of the Patents Act 1986 (set out at [335] of the judgment). The main issues were (i) whether it was necessary for a demand to have been made through notarial channels one month before filing the action if the patentee had already clearly taken a position on the opposability of its patent to the product, and, if not, in what circumstances that requirement could be dispensed with (ii) whether, if the patentee had stated its position clearly, this also removed the need for the claimants to show that they had made serious and effective preparations for industrial exploitation, (iii) whether any such necessary the demand had to be in the form of a notarial summons (“acta de requiriminto”) in accordance with art.202 of the Notary Rules and Regulations or merely a notarial notification (“acta de notificacio´n”), (iv) what constituted “serious and effective preparations” and, in particular, whether mere experimental acts would suffice, (v) whether such preparations had to be undertaken in Spain, (vi) whether a claimant could remedy deficiencies in its claim, such as a failure to send a demand through notarial channels one month before the claim, during the course of the proceedings or by starting a further action during the pendency of the first action. Lilly contended that the relief sought was not available to Actavis under Spanish law for one of more of the following reasons: (i) art.127.2 of the Patents Act 1986 had to be complied with; (ii) Actavis have not given Lilly one month’s notice through notarial channels; (iii) Actavis had not at the relevant dates, and still had not, carried out the necessary serious and effective preparations; and (iv) it was not possible for Actavis to cure defects within an existing action, but only by starting again and commencing a new action. Lilly also argued that if (i) on the proper interpretation of Rome II the law applicable to the non-contractual obligation included the rules with regard to interest and pre-notification under French and Spanish law on which it relied, (ii) the First and Third Actions were not well founded due to non-compliance with those rules at the dates of those actions, but (iii) the Fourth or any of the subsequent Actions were well founded because by the date of those actions Actavis had complied with the relevant rules, the Fourth and subsequent actions should be struck out as an abuse of the process in so far as they related to the French and Spanish designations (“the Main Abuse Argument”). Lilly also contended that, if Actavis was correct that the First and Third Actions were well founded in relation to the Spanish designation as from the making of amendments to its pleadings in October 2013, the making of those amendments was itself an abuse of process (“the Amendment Abuse Argument”). H21 Held, ruling that the claimants were entitled to each of the declarations of noninfringement of sought, Published by Oxford University Press for the Intellectual Property Office H22 The skilled person or team (1) Apart from the fact that claim 1 was in Swiss form whereas claim 12 was a purpose-bound product claim, the scope of claim 12 was the same as claim 1. ([57]) (2) Claims 1 and 12 were not directed to different skilled addressees. The court was not aware of any authority for the proposition that different claims of the same scope in the same patent could be addressed to different skilled persons for the purposes of the same issue, none had been cited and such an approach would be contrary to principle. ([58]) Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819, [2010] R.P.C. 33, CA considered. (3) Claims 1 and 12 were both addressed to a team comprising a medical oncologist and a chemist. A medical oncologist would be unable to make a single combined preparation for simultaneous use falling within claim 12, whether the combination consisted just of pemetrexed disodium and vitamin B12 (or derivative) or all three components and would require the assistance of a chemist for that purpose. ([61]) Halliburton Energy Services Inc v Smith International (North Sea) Ltd [2006] EWCA Civ 1715, CA and KCI Licensing Inc v Smith & Nephew Plc [2010] EWHC 1487 (Pat), [2010] F.S.R. 31, Pat. Ct referred to. (4) The same conclusion would have been reached had claim 1 stood on its own. The fact that it was a Swiss form claim, this being a legal fiction designed to circumvent art.52(4) of the European Patent Convention 1973, did not mean that it should be interpreted as if it were a claim to a method of treatment. Further, it was directed at the manufacturer of the pemetrexed disodium medicament and it embraced a single combined preparation for simultaneous use. In the real world the teams who dealt with developing and making medicaments for use in treatment comprised a range of disciplines, and in this context would comprise both a medical oncologist and a chemist. ([62]) Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444, [2009] 1 WLR 1186, [2008] R.P.C. 26, CA; Ranbaxy (UK) Ltd v AstraZeneca AB [2011] EWHC 1831 (Pat), [2011] F.S.R. 45, Pat. Ct and G 05/83 EISAI/Second medical indication [1985] OJ EPO 64, [1979–85] E.P.O.R. B241, Enlarged EPO BoA referred to. (5) (Obiter) If Lilly was right to contend that other forms of pemetrexed could fall within the scope of the claims too, it necessarily followed that the skilled team had to include a chemist in any event. The choice of an appropriate salt would not be something the medical oncologist could assist with and the claim would in such circumstances be insufficient for this reason alone. ([63]) Construction – UK designation – general (6) Once due account had been taken of equivalents in determining the scope of a claim in accordance with art.2 of the Protocol, that claim scope was determinative of questions of both infringement and validity. Equivalents could not be used to extend protection outside the claims for the purposes of infringement, but with attention being confined to the claims when considering validity. ([103]) (7) The law recognised that drafting patent claims was a difficult and imprecise art and that third parties should not be allowed to exploit infelicities of drafting where it was reasonably clear that they should not affect the scope of the claim. However it was necessary to strike a balance between providing “fair protection for the patent proprietor” and “a reasonable degree of legal certainty for third parties”. In striking [2015] R.P.C., Issue 2 Crown Copyright H29 H30 H31 H32 that balance, it was important to bear in mind that both the patentee and the third party would generally rely on skilled professional advice (and might have a remedy if the advice was incompetent). ([105]) Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] R.P.C. 9, HL and Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062, [2010] R.P.C. 8, CA referred to. (8) Where a patentee regretted a decision taken during the course of prosecution of the patent application and was trying to avoid the consequences of that decision, there was no reason why the law should be sympathetic. If the courts allowed decisions as to claim scope made by the examiner during the course of prosecution which had not been successfully appealed effectively to be overturned by decisions on claim construction, the courts undermined the important role of the examiner, particularly if the courts allowed decisions as to claim scope made by the applicant during the course of prosecution effectively to be reversed by decisions on claim construction. ([107]) (9) The courts should be cautious before relying upon prosecution history as an aid to construction. In the real world, however, anyone interested in ascertaining the scope of a patent and professionally advised would obtain a copy of the prosecution file and would consider it to see if it shed light on the matter. Consideration of the prosecution file could assist in ensuring that patentees did not abuse the system by accepting narrow claims during prosecution and then arguing for a broad construction of those claims for the purpose of infringement. The present case provided a good illustration of this. ([111]) Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc [1999] R.P.C. 253, Pat. Ct; Rohm & Haas Co v Collag Ltd [2001] EWCA Civ 1589, [2002] F.S.R. 28, CA; Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] R.P.C. 9, HL and Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062, [2010] R.P.C. 8, CA referred to. (10) As a matter of principle, there was no good reason why prosecution history should be useful as an aid to construction only where the claims had been limited during prosecution to avoid objections of novelty or obviousness as opposed to objections of lack of support /added matter or clarity. ([112]) Construction – UK designation – assessment (11) The answer to Improver question 2 depended crucially on what was meant by “the way in which the invention works”, and in particular the level of generality at which that was assessed. The problem was much the same if one asked whether the variant solved the problem underlying the invention by means which had the same technical effect. ([120]) Improver Corp v Remington Consumer Products Ltd [1990] F.S.R. 181, Pat. Ct referred to. (12) The correct approach to Improver question 2 was to ask whether it was obvious from the skilled team’s common general knowledge that the variant would have no material effect on the way the invention worked. The skilled team had to be able to ask and answer question 2 before investing what could be four years’ effort and considerable expense to obtain regulatory approval even on the basis of bioequivalence. ([126]) Merck & Co Inc v Generics (UK) Ltd [2003] EWHC 2842 (Pat), [2004] R.P.C. 31, Pat. Ct applied. Published by Oxford University Press for the Intellectual Property Office H34 H35 (13) The answer to Improver question 2 was “no”. Although Lilly’s argument that the variant solved the same problem as the invention, namely reducing the toxic side effects of pemetrexed, by means which had precisely the same technical effect as pemetrexed disodium, was a powerful one, it was not accepted. Although the underlying invention was an improved method of treatment, the only patentable invention was the use of the drug for the manufacture of a medicament for use in the combination therapy (claim 1) or a product containing the drug in combination with the other ingredient(s) for use in therapy (claim 12). Either way, the patentable invention involved making the medicament or product. If the proposed source of pemetrexed anions was not sufficiently soluble or was not pharmaceutically acceptable for some other reason, then as a practical matter the skilled team could not make that medicament or product and therefore could not obtain the benefit of the patented invention. To that extent, therefore, it would not have been obvious to the skilled team that pemetrexed diacid would have no material effect on the way the invention worked. The same applied in the case of pemetrexed dipotassium and ditromethamine. ([128]) (14) Even if the answer to Improver question 2 had been “yes”, Actavis’ arguments as to Improver question 3 were more persuasive than those of Lilly and the answer to that question was “yes”. In particular (i) it was necessary to consider where the logic of Lilly’s argument on construction led (particularly on the issue of validity) and (ii) the prosecution history supplied a clear answer why the claims had been limited to pemetrexed disodium and this shed light on the correct interpretation of the claims. If, as had been accepted in argument, Lilly would have been unlikely to have succeeded in obtaining a claim which explicitly referred to pemetrexed or any pharmaceutically acceptable and sufficiently soluble effectively been thereof on grounds of added matter, it could not be right to construe the term “pemetrexed disodium” in claims 1 and 12 as having that meaning for purposes of infringement. ([145]–[148]) (15) Having considered the points raised individually, it remained necessary to stand back and to consider overall which construction of the expression “pemetrexed disodium” accorded with the Protocol and combined fair protection for the patentee and reasonable certainty for third parties. This was Actavis’ construction. Lilly had deliberately limited the claims of the Patent to pemetrexed disodium. There had been nothing to prevent it seeking broader claims if it thought it was entitled to them. There was nothing in the specification or the common general knowledge of the skilled team to suggest to the skilled team that Lilly intended to use the expression “pemetrexed disodium” in anything other than its conventional sense or that it had made some mistake in using that expression, and the prosecution history showed that the opposite was the case. Confining Lilly to the scope of claim that it chose with the benefit of skilled professional advice provided Lilly with fair protection, and did not expose it to the risk of the Patent being invalid on the grounds of added matter and/or insufficiency. Construing the claim as extending to (at least) any form of pemetrexed which was pharmaceutically acceptable and sufficiently soluble would not provide a reasonable degree of certainty for third parties. Any other conclusion would fail to give effect to the Protocol and would be tantamount to treating the claims as a mere guideline. ([149]) Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] R.P.C. 9, HL and Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062, [2010] R.P.C. 8, CA applied. (16) Although judgments of the Du¨sseldorf Landgericht were entitled to considerable respect, the court was unable to agree with its conclusions. Reasons H38 H39 H40 H41 for the different conclusions reached included the following: (i) it had not had the benefit of hearing the chemist experts cross-examined; (ii) the arguments advanced by the parties had differed in a number of respects; (iii) it had considered the matter solely from the perspective of an oncologist; (iv) in finding infringement by reason of equivalence alone it had not given proper effect to the Protocol on art.69 EPC but had treated the claims as a mere guideline; (v) it had not had regard to the prosecution history; and (vi) it had not considered the consequences of its construction for the validity of the Patent. ([152]–[158]) Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] R.P.C. 9, HL, Celltech R & D Ltd v MedImmune Inc [2004] EWHC 1124 (Pat), Pat. Ct and Occlusion Device (Case X ZR 16/09) (unreported) 10 May 2011, Bundesgerichtshof, referred to. Construction – French designation (17) Where a claim was narrowly worded to cover specific means (“moyens particuliers”) rather than general means (“moyens ge´ne´reaux”), then the court had to consider the function of that means and consider whether it was a novel function. If the function of the means was not novel then the claim monopoly was limited to the particular claimed structure. Conversely, if the function of the particular claimed means was novel, then even though the claim was explicitly drafted in a narrow sense, the claim would be treated as covering a means which performed the same function and which achieved a similar result. ([160], [161]) Institut Pasteur v Chiron Healthcare (Appeal No. S 09-15.668, Decision No. 1194 F–D) (unreported) 23 November 2010, Cour de Cassation; Mundipharma Laboratories GmbH v Sandoz SAS (Case 09/01863) (unreported) 2 July 2010, Tribunal de Grande Instance, Paris and B2M Industries v Acome (Appeal No. 0617915), 20 November 2007, Cour de Cassation, referred to. (18) Prosecution history was of particular relevance when the scope of the claims had been narrowed during the prosecution process, in particular where that narrowing had been necessary to obtain the grant of the patent at issue. ([162]) Hewlett Packard GmbH v Agilent Technologies Deutschland GmbH (Case No. 08/00882) (unreported) 27 January 2010, Cour d’Appel, Paris referred to. (19) Pemetrexed diacid, dipotassium and ditromethamine were not within the scope of the claims for two main reasons: (i) the doctrine of equivalents did not apply in the circumstances of the present case as the means in issue was “pemetrexed disodium”, which was a specific means (“moyen particulier”). The function of that means was not novel: its function was its efficacy in inhibiting tumour growth, and that was known at the date of the Patent. It followed that the expression “pemetrexed disodium” had to be interpreted as limited to the particular compound specified by that expression; (ii) the prosecution history showed that the claims had been limited to pemetrexed disodium in order to obtain the grant of the Patent. In those circumstances it would not be appropriate to interpret the claims as having a broader scope. ([164], [165]) Construction – Italian designation (20) Article 52 of the Code of Industrial Property seemed to be calculated to require the Italian courts to focus more closely on what was required by art.69 and the Protocol, particularly with the recent addition of art.52.3bis which required the court to consider equivalence on an element by element basis, dividing the claim Published by Oxford University Press for the Intellectual Property Office H42 H43 H44 H45 into integers and considering whether or not each integer was present either literally or by equivalence. In future the Italian courts would be bound by art.52 to pay closer attention to the wording of the claims. ([170], [173]) Forel SpA v Lisac (Case No. 257) (unreported) 13 January 2004, Corte Suprema di Cassazione; Barilla G.e.R. Fratelli SpA v Pastifico Fazion SpA (Case No. 30234) (unreported) 30 December 2012, Corte Suprema di Cassazione; Entsorga Italia Srl v Ecodeco Srl (Case No. 622) (unreported) 11 January 2013, Corte Suprema di Cassazione and EG SpA v AstraZeneca AB (Case No. 4114/2011) (unreported) 1 April 2011, Tribunale Ordinario, Turin referred to. (21) As to prosecution history, the Italian Supreme Court could be expected, when called upon to consider this question, to adopt a similar position to that adopted by other European appellate courts on this issue i.e. not to encourage reference to the prosecution history, but nevertheless to hold that, in an appropriate case, the prosecution history could be relied upon as an aid to construction of the claims, particularly where it was clear that the applicant had intentionally limited the scope of the claims during the course of prosecution. ([175]) EG SpA v AstraZeneca AB (Case No. 4114/2011) (unreported) 1 April 2011, Tribunale Ordinario, Turin referred to. (22) The correct interpretation of the claims was that pemetrexed diacid, dipotassium and ditromethamine were excluded from the scope of protection because (i) on its face the Patent clearly demonstrated a conscious intention to limit the claims to pemetrexed disodium and (ii) this was amply confirmed by the prosecution history. ([179]) Construction – Spanish designation (23) The evidence established that the “doctrine of one’s own acts” was most likely to be applied where the patentee had expressly limited the claim to overcome a prior art objection but did not establish that it was limited to that situation. ([185]) Ros Roca Group SL v Sistemas y Veh´ıcuols de Alta Technolog´ıa SA (Judgment No. 292/2008) (unreported) 1 December 2009, Audiencia Provincial, Madrid referred to. (24) Applying the adapted Improver questions, the answer to question 2 was “no” for the reasons given when answering the equivalent question under UK law. Even if the answer to question 2 was “yes”, the answer to question 3 was “yes” for the reasons given when answering the equivalent question under UK law. In so far as those reasons involved considering the prosecution history, the requirements for application of the “own acts” doctrine were met. The amendments to the claims made by Lilly, and the reasons for making those amendments, were explicit, unequivocal, clear, precise, conclusive, undoubted and did not reflect any kind of ambiguity. Accordingly, pemetrexed diacid, dipotassium and ditromethamine were not within the scope of the claims of the Spanish designation. ([187]) Ros Roca Group SL v Sistemas y Veh´ıcuols de Alta Technolog´ıa SA (Judgment No. 292/2008) (unreported) 1 December 2009, Audiencia Provincial, Madrid applied. Direct Infringement – all designations H46 (25) Given that neither pemetrexed diacid, dipotassium nor ditromethamine fell within the scope of claims 1 and 12 of the UK, French, Italian or Spanish [2015] R.P.C., Issue 2 Crown Copyright H47 H48 H49 H50 H51 H52 designations of the Patent, dealing in them would not constitute direct infringement of any of those designations. ([189]) Indirect infringement – all designations (26) There would be no indirect infringement by Actavis of the UK designation of the Patent. The fact that, when Actavis supplied their product to third parties who reconstituted (or in the case of diacid, diluted) the products with saline, there would be sodium ions and pemetrexed ions floating around, did not mean that those third parties were implementing the invention; they had not used pemetrexed disodium in the manufacture of a medicament as required under claim 1. It was no answer to this to say that pemetrexed ions on their own constituted an essential element of the invention, as this was just another way of saying that the claim did not require pemetrexed disodium, but merely required any form of pemetrexed which made pemetrexed ions available. The issue of indirect infringement only arose if claim 1 was required pemetrexed disodium and not any form of pemetrexed that is pharmaceutically acceptable and sufficiently soluble. ([199]–[201]) Grimme Landmaschinenfabrik GmbH & Co KG v Scott [2010] EWCA Civ 1110, [2011] F.S.R. 7, CA referred to. (27) Given that it had not been contended that Lilly could succeed under any of the other designations if indirect infringement of the UK designation was not established, it was concluded that Actavis would not indirectly infringe the French, Italian or Spanish designations either. ([203]) The law applicable to the declaration of non-infringement claims (28) The rules of each jurisdiction as to the conditions to be satisfied by a claimant in order to obtain a declaration of non-infringement, although operating in different ways, all dealt with the same kind of issue and accordingly had to characterised in the same way for purposes of Rome II. ([214]) (29) Those national rules served two main purposes: (i) to ensure that the claimant had a sufficient justification for seeking an adjudication by the court and thereby avoid unnecessary litigation, and (ii) to ensure that the dispute was sufficiently well defined for the court to adjudicate upon it. They were not concerned with substantive rights and obligations with regard to infringement of the patent in suit. Decisions made under these rules that such claims were inadmissible did not give rise to any res judicata with regard to the substantive rights and obligations of the parties. Furthermore, the court could adjudicate upon the substantive rights and obligations of the parties with regard to the infringement of the patent in suit without these rules being engaged at all, namely if the patentee brought a claim for infringement. ([217]–[220]) (30) Article 15(c) of Rome II had to be interpreted in a manner which gave effect to the objectives of the regulation. While it did not aim for uniformity of outcomes, it did aim to ensure a consistent application of the law applicable to the non-contractual obligation. It was well arguable that it extended beyond the assessment of damages and embraced the financial remedy claimed. ([227]) (31) However, the term “remedy” in art.15(c) of Rome II could not extend to any remedy. The wording of art.15(d) made it clear that there was a distinction between the question of principle as to whether an injunction should be granted, which would be a matter for the lex causae, and the procedural conditions to be observed, which would be a matter for the lex fori. ([228]) Published by Oxford University Press for the Intellectual Property Office H53 H54 H55 H56 H57 H58 H59 H60 OJSC TNK-BP Holding v Lazurenko [2012] EWHC 2781 (Ch), Ch.D. referred to. (32) Even if a declaration of non-infringement was a “remedy” within the meaning of art.15(c) at all (which was doubted given that it was little more than a formal record of the court’s decision on the substantive issue), art.15(c) should be interpreted as only having the effect that the question of principle as to whether it was available at all was a matter for the law applicable to the non-contractual obligation. It did not follow that rules of the kind presently under consideration, which were essentially concerned with whether it was necessary or possible for the court to consider the substantive issue at all, fell within art.15(c). ([229]) (33) Lilly’s reliance upon art.15(h) of Rome II was misplaced. There was no analogy to be drawn between a rule of limitation or prescription and those presently under consideration. The same applied to art.22 and the burden of proof. ([231]) (34) The rules of national law in issue were accordingly matters of procedure within art.1(3) and were not governed by the law applicable to the non-contractual obligation in accordance with art.15. It followed that they were governed by English law. ([236]) Wall v Mutuelle de Poitiers Assurances [2014] EWCA Civ 138, [2014] 1 WLR 4263, CA considered. Declaration of non-infringement of the UK, French, Italian and Spanish designations applying English law (35) The modern law was that a negative declaration would be granted if it was right in all the circumstances to do so, and in particular if it would serve a “useful purpose”. It would do so if the claimant had a “real commercial interest” in the negative declaratory relief sought or a “real commercial reason” for it to be granted. ([304]) Messier-Dowty Ltd v Sabena SA [2000] 1 WLR 2040, [2001] 1 All ER 275, CA and Nokia Corp v InterDigital Technology Corp [2006] EWCA Civ 1618, [2007] F.S.R. 23, CA referred to. (36) It was not seriously disputed that, if Actavis established that dealings in their products would not amount to an infringement of the UK designation of the Patent, then they should be granted a declaration of non-infringement in respect of that designation pursuant to the inherent jurisdiction of the Court. It followed that it was unnecessary to consider whether Actavis had satisfied the requirements of s.71 of the Patents Act 1977. ([305]) (37) On the basis that the law applicable to the question of whether Actavis were entitled to a declaration of non-infringement in respect of the French, Italian and Spanish designations of the Patent was English law, Actavis should be granted such relief in respect of those designations pursuant to the inherent jurisdiction of the Court because they had clearly demonstrated that they had a real commercial interest in obtaining such declarations and that such declarations would serve a useful purpose. ([307]) Messier-Dowty Ltd v Sabena SA [2000] 1 WLR 2040, [2001] 1 All ER 275, CA and Nokia Corp v InterDigital Technology Corp [2006] EWCA Civ 1618, [2007] F.S.R. 23, applied. Declaration of non-infringement of the French designation applying French law (38) Article L.615-9 of the Intellectual Property Code was a special derogation from art.31 of the Civil Procedure Code and was necessary because art.31 had not allowed H61 H62 H63 H64 H65 H66 the grant of a declaration of non-infringement. Accordingly it was not possible to obtain a declaration under art.31 if it was not available under art.L.615-9. ([310], [311]) Eurodif v Gravisse (unreported) 17 January 1995, Tribunal de Grande Instance, Lyon referred to. (39) For the court to grant of such relief it was not necessary for a patentee to have expressed its position irrevocably or in a patent infringement action provided that the patentee had unambiguously expressed its position on the opposability of its French patent to the other party’s product. ([313], [314]) Hembert v Composites Aquitaine SA (unreported) 9 April 2002, Cour d’Appel, Bordeaux and SEB SA v Euromenage SARL (unreported) 22 April 2003, Tribunal de Grande Instance, Paris, referred to. (40) It was not possible for the party seeking a declaration of non-infringement to avoid the requirement to show that it had made serious and effective preparations for industrial exploitation if the patentee had unambiguously expressed its position on the opposability of its French patent to the other party’s product. ([315]) Hembert v Composites Aquitaine SA (unreported) 9 April 2002, Cour d’Appel, Bordeaux referred to. (41) It was possible in accordance with arts.122 and 126 of the Civil Procedure Code for the party seeking a declaration of non-infringement to rely upon a taking position letter, and the failure of the patentee to give an acknowledgement of noninfringement within the following three months, sent during the pendency of the proceedings. ([316]) Biberian v Commissariat a l’E´ nergie Atomique (unreported) 22 November 1996, Tribunal de Grande Instance, Paris; Justamente v Ho¨pital Broussais (unreported) 28 June 2000, Tribunal de Grande Instance, Paris and SEB SA v Euromenage SARL (unreported) 22 April 2003, Tribunal de Grande Instance, Paris, referred to. (42) The superior French courts would conclude that marketing a product is enough to amount to “industrial exploitation” for purposes of art.L.615-9. Marketing an infringing product was a form of industrial exploitation and it was an act of direct infringement. Furthermore, there was no rational reason for restricting the availability of declarations of non-infringement to manufacturers. ([317]) Boston Scientific SA v Cordis Corp (unreported) 23 June 1999, Tribunal de Grande Instance, Paris; Boston Scientific SA v Palmaz (unreported) 28 October 1998, Tribunal de Grande Instance, Paris; Abbott Ireland v Evysio Medical Devices ULC (unreported) 14 January 2009, Tribunal de Grande Instance, Paris and Yamanouchi Pharmaceutical Co Ltd v Biogen NV, 16 March 1999, Tribunal de Grande Instance, Paris, referred to. (43) “Serious and effective preparations” within the meaning of art.L.615-9 supposed that investments had already been launched, or at least, means had been put in place to enable an exploitation to be implemented, but it was possible to rely upon further preparations made during the pendency of the proceedings for this purpose. ([318]) SEB SA v Euromenage SARL (unreported) 22 April 2003, Tribunal de Grande Instance, Paris; Dijkstra Plastics v Saier (unreported) 24 March 2004, Tribunal de Grande Instance, Paris and Yamanouchi Pharmaceutical Co Ltd v Biogen NV, 16 March 1999, Tribunal de Grande Instance, Paris, referred to. (44) It did not matter whether Actavis had properly complied with the requirement to send a taking position letter three months before they had commenced the Sixth Action. Lilly had unambiguously taken a position on the opposability of the French designation of the Patent to each of Actavis’ proposed products at a case management Published by Oxford University Press for the Intellectual Property Office H67 H68 H69 H70 conference on 17 October 2013 and in its statement of case. It was immaterial that it had not positively alleged infringement (or threatened infringement). The only reason it had not done so was that it wanted, so far as possible, to preserve its position that Actavis should have brought the claim in France in accordance with French procedure rather than in England in accordance with English procedure, and thereby make it more difficult for Actavis to obtain a DNI even if right on the merits. However, this did not relieve Actavis of the obligation under art.L.615-9 to demonstrate that they had made serious and effective preparations for industrial exploitation. ([321], [322]) (45) Actavis had made serious and effective preparations to manufacture and market each of the products (particularly pemetrexed diacid) by 20 December 2013 (when they served their combined reply in the First, Third, Fourth and Fifth Actions) and certainly by the time of the trial. They had a developed formulation of each product which they could be reasonably confident would receive regulatory approval and which they could manufacture on an industrial scale, although further work remained to be done. Accordingly, even if French law applied, Actavis were entitled to a declaration of non-infringement pursuant to art.L.615-9 of the Intellectual Property Code. Even if only the intended manufacturer could obtain such relief, Actavis Italy was the intended manufacturer and would, if necessary, import the product into France. ([323], [376(vi)]) (46) Even if Actavis could not circumvent the requirement for a “taking position” letter by relying upon Lilly’s statements in these proceedings, by the date of the Sixth Action, more than three months had elapsed since Actavis’ “taking position” letter dated 16 September 2013 and accordingly Actavis had fully complied with the requirements of art.L.615-9. Alternatively, Actavis could rely upon the First and Third Actions and the “taking position” letter sent during the pendency of those proceedings. Accordingly, even if French law applied, Actavis were entitled to a declaration of non-infringement on these grounds also. ([325], [326]) Declaration of non-infringement of the Italian designation applying Italian law (47) As a matter of Italian law, it was unnecessary for some form of actual, articulated objection (“contestazione”) already to have been made by the patentee as at the date of commencement of the proceedings for a declaration of noninfringement to be made. Italian law on this question appeared to be evolving in the same direction as English law had evolved. ([331]) Ranbaxy UK Ltd v AstraZeneca AB (Case 89281/2012) (unreported) 12 February 2013, Tribunale Ordinario, Milan; Medexpo International Srl v Medel Group SpA (Case 77566/2011) (unreported) 1 February 2012, Tribunale, Milan; Mylan SpA v AstraZeneca AB (Case 11770/2011), 2 April 2013, Tribunale, Milan and M.E.P. Maccine Elettroniche Piegatrici SpA v Titanfer Srl (Case 4074/2009) (unreported) 19 May 2011, Corte d’Appello, Milan referred to. (48) Actavis had a legitimate interest in obtaining a declaration of non-infringement in respect of the Italian designation of the Patent because there was an objective uncertainty giving rise to a present, concrete prejudice to Actavis which the declaration of the court was capable of curing. A declaration of the court would cure this uncertainty. Accordingly, even if Italian law applied, Actavis were entitled to a declaration of non-infringement. ([333], [376(vi)]) [2015] R.P.C., Issue 2 Crown Copyright H71 H72 H73 H74 H75 H76 H77 (49) Even if an objection from Lilly was required, Lilly had expressly alleged that pemetrexed diacid, dipotassium or ditromethamine fell within the scope of the claims of the Italian designation of the Patent and had adduced evidence and arguments in support of that allegation. It was immaterial that Lilly had not expressly alleged that Actavis have committed or threaten to commit any infringing acts. The only reason why Lilly had not done so is because it would prefer Actavis to have to bring their claim in the Italian courts. ([334]) Declaration of non-infringement of the Spanish designation applying Spanish law (50) The evidence demonstrated that compliance with the requirement in art.127.2 of the Spanish Patents Act for a prior demand through notarial channels could be dispensed with, but only if the purposes it served had already been achieved before commencement of the claim. This would be the case if the patentee had been made aware of the product in question, had had at least a month to consider its position and has clearly taken a position on the opposability of its patent to the product in issue. ([339]) Teodosio v Metro Bilbao SA (Judgment 156/02), 24 June 2012, Court of First Instance of Bilbao referred to. Laboratorios Cinfa SA v Novartis AG (Judgment 130/2011) (unreported) 27 May 2011, Audiencia Provincial, Navarre, distinguished. (51) The logic for dispensing with the requirement for a notarial request one month before the claim where the purposes of that requirement had already been achieved did not justify dispensing with the requirement for serious and effective preparations. ([341], [355]) Teodosio v Metro Bilbao SA (Judgment 156/02), 24 June 2012, Court of First Instance of Bilbao and Laboratorios Cinfa SA v Novartis AG (Judgment 130/2011) (unreported) 27 May 2011, Audiencia Provincial, Navarre referred to. (52) The requirement for a demand through notarial channels (“requerira´ notarialmente”), assuming that it was not sufficient for the patentee to have clearly stated his position on the opposability of the patent, merely required a notarial notification (“acta de notificacio´ n”). ([342]) (53) Mere experimental acts were not “serious and effective preparations” within the meaning of art.127. It was unnecessary for a claimant to demonstrate that exploitation was imminent. However if there were concrete and well developed plans for industrial exploitation and preparations had been made to implement those plans extending beyond mere experimental acts, that would suffice. Such preparations did not have to be in Spain but had to be for industrial exploitation in Spain. ([348], [349]) Laboratorios Cinfa SA v Novartis AG (Judgment 130/2011) (unreported) 27 May 2011, Audiencia Provincial, Navarre referred to. (54) It was unnecessary to resolve the issues as to whether a claimant could remedy deficiencies in its claim, such as a failure to send a demand through notarial channels one month before the claim, either during the course of the proceedings or by starting a further action during the pendency of the first action. ([351], [352]) (55) Lilly had clearly taken a position on the opposability of the Spanish designation of the Patent to the products by 20 December 2013. Again, the only reason why Lilly had not positively alleged infringement of the Spanish designation was that it wanted, so far as possible, to preserve its position that Actavis should have brought the claim in Spain in accordance with Spanish procedure rather than in Published by Oxford University Press for the Intellectual Property Office H78 H79 H80 H81 H82 England in accordance with English procedure, and thereby make it more difficult for Actavis to obtain a DNI even if they were right on the merits. Accordingly, it did not matter whether they had properly complied with the requirement to send a “taking position” letter through notarial channels one month before the Sixth Action. ([354], [355]) (56) The evidence demonstrated that Actavis had made serious and effective preparations to manufacture and market each of the products, and particularly the diacid, by 20 December 2013. Accordingly, even if Spanish law applied, Actavis were entitled to a declaration of non-infringement pursuant to art.127. ([356], [376(vi)]) (57) Even if Lilly was correct that Actavis could not circumvent the requirement of art.127.2 for a letter to be sent through notarial channels one month prior to the action by relying upon Lilly’s statements in these proceedings, by the date of the Fifth Action, more than one month had elapsed since Actavis’ “taking position” letter dated 16 September 2013, and accordingly Actavis had fully complied with the requirements of that provision. The same applied in the case of the later actions. Alternatively, Actavis could rely upon amendments which it made in the First and Third Actions on 22 October 2013 and the “taking position” letter dated 16 September 2013. Accordingly, even if Spanish law applied, Actavis were entitled to a declaration of non-infringement on these grounds also. ([357]–[359]) (58) Even if Actavis had to prove transmission of a “taking position” letter through notarial channels, Actavis had complied with all the notarial requirements relied on by Lilly with respect to its letter dated 4 April 2014. The Ninth Action was issued more than one month after that. Furthermore, even if Actavis had not made serious and effective preparations by the dates of the Sixth Action, they had done so by the date of the Ninth Action, having continued to progress their plans. Accordingly, if Spanish law applied Actavis were also entitled to a declaration of non-infringement pursuant to art.127 on this basis. ([360]) Abuse of process in relation to the French and Spanish designations (59) As Lilly had not contended that there had been abuse under the laws of France or Spain, it had to be assumed that the Fourth and subsequent actions would not be struck out or dismissed as an abuse of process or on an equivalent ground applying French and Spanish law. It would also be assumed (although it was doubted) that the question whether it was legitimate for Actavis to try to ensure compliance with rules of French and Spanish law by starting fresh actions during the pendency of earlier actions or by amending pending actions should be judged by reference to the lex fori as Lilly contended. ([363]) (60) The Amendment Abuse Argument was not open to Lilly because (i) it had not resisted the amendments in question on the ground that they were in and of themselves an abuse of process; (ii) it had not appealed or applied to set aside such the order giving permission to amend; and (iii) it had not pleaded that the amendments were an abuse of process. In any event, Actavis had been given permission to make the amendments by an order of the court, there is no dispute that this Court had had power to do so and, viewed from the perspective of English procedural law. Even if Lilly were right that no such amendment could have been made under Spanish procedural law, and Actavis would have had to start a new action, that was immaterial. ([364]) [2015] R.P.C., Issue 2 Crown Copyright H83 H84 H85 (61) As to the Main Abuse Argument, it was not an abuse of process to bring a further claim on the same cause of action during the pendency of an existing claim if there was a good reason for doing so and case management tools like consolidation were used to avoid unnecessary duplication of effort and cost. ([371]) Rosenberg v Nazarov [2008] EWHC 812 (Ch), Ch.D. referred to. (62) There was no reason why Actavis should have been obliged to discontinue claims which were properly constituted, jurisdictionally well founded and had a perfectly good prospect of success. Even if it should have discontinued the First and Third Actions because they were destined to fail, that would at best found an argument that maintaining the First and Third Actions was an abuse. It would not follow that bringing the Fourth and subsequent Actions was an abuse. Lilly’s argument simply amounted to saying that it was an abuse for Actavis to pursue an alternative case while maintaining their primary case, which was commonplace in English litigation (and in litigation in many other legal systems). ([373]) Hunter v Chief Constable of the West Midlands [1982] AC 529, [1981] 3 WLR 906, HL; Johnson v Gore Wood & Co [2002] 2 AC 1, [2001] 2 WLR 72, HL; Jameel v Dow Jones & Co Inc [2005] EWCA Civ 75, [2005] QB 946, CA and Summers v Fairclough Homes Ltd [2012] UKSC 26, [2012] 1 WLR 2004, SC considered. Carter Commercial Developments v Bedford Borough Council [2001] EWHC Admin 669, QBD, distinguished. (63) What Lilly was really complaining about was not the bringing of the Fourth and subsequent Actions during the pendency of the First and Third Actions, but the fact that Actavis had brought these proceedings before the Patents Court. However that argument was not open to it as its jurisdictional challenge to the First and Second Actions had failed and it had rightly accepted that this Court had jurisdiction over the Third and subsequent Actions. Further it was not an abuse of process for a claimant to bring a claim before a forum which it perceived to be more advantageous (e.g. because it was quicker) in order to forestall the defendant from bringing proceedings in a forum which the claimant perceived to be less advantageous (e.g. because it was slower) provided that the first forum was one which properly had jurisdiction in respect of the claim. Lilly could only have complained of abuse of process in this respect if it had been prevented by Actavis’ conduct from bringing infringement actions against Actavis in France and Spain that it would otherwise have brought. However it had neither adduced any evidence nor even asserted that it would have brought such actions but for Actavis’ conduct. By contrast, it had brought and pursued a claim in Germany even though the Patents Court had been the court was first seized. Lilly’s stance with regard to France and Spain was simply obstructive. ([374], [375]) Research In Motion UK Ltd v Visto Corp [2008] EWCA Civ 153, [2008] F.S.R. 20, CA and Pell Frischmann Consultants Ltd v Prabhu [2013] EWHC 2203 (Ch), [2013] ICR 153, Ch.D. referred to. Observed: “. . . Experience shows that patentees resort to arguments about equivalents in three main classes of case. The first is where, with the benefit of hindsight, it can be seen that the patent was unfortunately drafted . . . . The second class is where technology has moved on since the priority or filing date of the patent . . . . The third class is where the patentee now regrets a decision taken during the course of prosecution of the patent application, . . . . . as is trying to avoid the consequences of that decision. As will appear, in my view the present case is a clear example of this.” ([104]) Published by Oxford University Press for the Intellectual Property Office Cases referred to in the judgment: G 02/08, ABBOTT RESPIRATORY/Dosage regime [2010] E.P.O.R. 26, EPO Enlarged BoA Abbott Ireland v Evysio Medical Devices ULC (unreported) 14 January 2009, Tribunal de Grande Instance, Paris Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444, [2009] 1 WLR 1186, [2008] R.P.C. 26, CA Actavis Group HF v Eli Lilly & Co [2012] EWHC 3316 (Pat), Pat. Ct Actavis Group HF v Eli Lilly & Co [2013] EWCA Civ 517, [2013] R.P.C. 37, CA Actavis UK Ltd v Eli Lilly & Co [2013] EWHC 3749 (Pat), Pat. Ct Actavis UK Ltd v Eli Lilly & Co [2014] EWHC 838 (Pat), Pat. Ct Actavis UK Ltd v Eli Lilly & Co [2014] EWHC 839 (Pat), Pat. Ct Alcon v Corneal (unreported) 16 November 2007, Tribunal de Grande Instance, Paris American Home Products Corp v Novartis Pharmaceuticals UK Ltd [2001] R.P.C. 8, CA B2M Industries v Acome (Appeal No. 06-17915), 20 November 2007, Cour de Cassation (France) Barilla G.e.R. Fratelli SpA v Pastifico Fazion SpA (Case No. 30234) (unreported) 30 December 2012, Corte Suprema di Cassazione (Italy) Biberian v Commissariat a l’E´ nergie Atomique (unreported) 22 November 1996, Tribunal de Grande Instance, Paris Boston Scientific SA v Cordis Corp (unreported) 23 June 1999, Tribunal de Grande Instance, Paris Boston Scientific SA v Palmaz (unreported) 28 October 1998, Tribunal de Grande Instance, Paris Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc [1999] R.P.C. 253, Pat. Ct Carter Commercial Developments v Bedford Borough Council [2001] EWHC Admin 669, QBD Catnic Components Ltd v Hill & Smith Ltd [1982] R.P.C. 183, [1981] F.S.R. 60, HL Celltech R & D Ltd v MedImmune Inc [2004] EWHC 1124 (Pat), Pat. Ct Clark v University of Lincolnshire and Humberside [2000] 1 WLR 1988, [2000] 2 All ER 752, CA Clay, Re [1919] 1 Ch 66, CA Dijkstra Plastics v Saier (unreported) 24 March 2004, Tribunal de Grande Instance, Paris EG SpA v AstraZeneca AB (Case No. 4114/2011) (unreported) 1 April 2011, Tribunale Ordinario, Turin G 05/83, EISAI/Second medical indication [1985] OJ EPO 64, [1979–85] E.P.O.R. B241, Enlarged EPO BoA Entsorga Italia Srl v Ecodeco Srl (Case No. 622) (unreported) 11 January 2013, Corte Suprema di Cassazione (Italy) Eurodif v Gravisse (unreported) 17 January 1995, Tribunal de Grande Instance, Lyon Forel SpA v Lisac (Case No. 257) (unreported) 13 January 2004, Corte Suprema di Cassazione (Italy) Goldsmith v Sperrings Ltd [1977] 1 WLR 478, [1977] 2 All ER 566, CA Grimme Landmaschinenfabrik GmbH & Co KG v Scott [2010] EWCA Civ 1110, [2011] F.S.R. 7, CA H. Lundbeck A/S v Laboratorios Cinfa SA (Judgment No. 434/2012) (unreported) 19 December 2012, Audiencia Provincial, Barcelona [2015] R.P.C., Issue 2 Crown Copyright Halliburton Energy Services Inc v Smith International (North Sea) Ltd [2006] EWCA Civ 1715, CA Harding v Wealands [2004] EWCA Civ 1735, [2005] 1 WLR 1539, CA Harding v Wealands [2006] UKHL 32, [2007] 2 AC 1, HL Hembert v Composites Aquitaine SA (unreported) 9 April 2002, Cour d’Appel, Bordeaux Hewlett Packard GmbH v Agilent Technologies Deutschland GmbH (Case No. 08/00882) (unreported) 27 January 2010, Cour d’Appel, Paris Hunter v Chief Constable of the West Midlands [1982] AC 529, [1981] 3 WLR 906, HL Improver Corp v Remington Consumer Products Ltd [1990] F.S.R. 181, Pat. Ct Institut Pasteur v Chiron Healthcare (Appeal No. S 09-15.668, Decision No. 1194 F–D) (unreported) 23 November 2010, Cour de Cassation (France) Jameel v Dow Jones & Co Inc [2005] EWCA Civ 75, [2005] QB 946, CA Johnson v Gore Wood & Co [2002] 2 AC 1, [2001] 2 WLR 72, HL Justamente v Ho¨pital Broussais (unreported) 28 June 2000, Tribunal de Grande Instance, Paris KCI Licensing Inc v Smith & Nephew Plc [2010] EWHC 1487 (Pat), [2010] F.S.R. 31, Pat. Ct KCI Licensing Inc v Smith & Nephew Plc [2010] EWCA Civ 1260, [2011] F.S.R. 8, CA Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] R.P.C. 9, HL Laboratorios Cinfa SA v Eli Lilly & Co Ltd (“Olanzapine”) (Judgment No. 309/2011) (unreported) 10 May 2011, Tribunal Supremo (Spain) Laboratorios Cinfa SA v Novartis AG (Judgment 130/2011) (unreported) 27 May 2011, Audiencia Provincial, Navarre Medexpo International Srl v Medel Group SpA (Case 77566/2011) (unreported) 1 February 2012, Tribunale, Milan M.E.P. Maccine Elettroniche Piegatrici SpA v Titanfer Srl (Case 4074/2009) (unreported) 19 May 2011, Corte d’Appello, Milan Merck & Co Inc v Generics (UK) Ltd [2003] EWHC 2842 (Pat), [2004] R.P.C. 31, Pat. Ct Messier-Dowty Ltd v Sabena SA [2000] 1 WLR 2040, [2001] 1 All ER 275, CA Mundipharma Laboratories GmbH v Sandoz SAS (Case 09/01863) (unreported) 2 July 2010, Tribunal de Grande Instance, Paris Mylan SpA v AstraZeneca AB (Case 11770/2011), 2 April 2013, Tribunale, Milan Nokia Corp v InterDigital Technology Corp [2006] EWCA Civ 1618, [2007] F.S.R. 23, CA Occlusion Device (Case X ZR 16/09) (unreported) 10 May 2011, Bundesgerichtshof OJSC TNK-BP Holding v Lazurenko [2012] EWHC 2781 (Ch), Ch.D. Pell Frischmann Consultants Ltd v Prabhu [2013] EWHC 2203 (Ch), [2013] ICR 153, Ch.D. Plastus Kreativ AB v Minnesota Mining and Manufacturing Co [1995] R.P.C. 438, Pat. Ct Ranbaxy (UK) Ltd v AstraZeneca AB [2011] EWHC 1831 (Pat), [2011] F.S.R. 45, Pat. Ct Ranbaxy UK Ltd v AstraZeneca AB (Case 89281/2012) (unreported) 12 February 2013, Tribunale Ordinario, Milan Research In Motion UK Ltd v Visto Corp [2008] EWCA Civ 153, [2008] F.S.R. 20, CA Published by Oxford University Press for the Intellectual Property Office 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 keeping, offering to dispose of and disposing in the UK and in Spain, France, Italy and Germany of a medicament containing pemetrexed dipotassium for use in combination therapy for inhibiting tumour growth in mammals would not infringe the UK and the foreign designations of the Patent in the respective countries. On 26 July 2012 Lilly’s solicitors, Hogan Lovells, wrote to Bird & Bird, not giving the acknowledgment sought, but instead seeking further information about the proposed acts, in particular asking about the details of the pharmaceutical form, including qualitative and quantitative composition and a list of excipients (see [PP/3]). On 26 July 2012 Bird & Bird replied saying that the claims of the Patent do not claim particular forms, posology or excipients. On 27 July 2012 Actavis Group ehf (the second claimant) issued the claim form in action HC12E02962 (“the First Action”), seeking (1) a declaration pursuant to s.71 of the Patents Act 1977 that dealings in pemetrexed dipotassium in the UK as proposed in Bird & Bird’s letter dated 12 July 2012 would not infringe any claim of the UK designation of the Patent and (2) a declaration pursuant to the Court’s inherent jurisdiction that dealings in pemetrexed dipotassium in France, Germany, Italy and Spain as proposed in Bird & Bird’s letter dated 12 July 2012 would not infringe the relevant designations of the Patent. On 31 July 2012 Hogan Lovells replied to Bird & Bird confirming that they were instructed to accept service on behalf of Lilly. On 1 August 2012 Bird & Bird wrote to Hogan Lovells enclosing by way of service the claim form, particulars of claim and response pack in the First Action. On 15 August 2012 Hogan Lovells filed an acknowledgement of service on behalf of Lilly contesting jurisdiction. On 23 August 2012 Hogan Lovells wrote to Bird & Bird disputing that Bird & Bird’s letter of 1 August 2012 constituted valid service of the claim form in the First Action. On 29 August 2012 Lilly filed an application contesting the Court’s jurisdiction to hear the First Action in respect of the non-UK designations. Also on 29 August 2012 Medis ehf (the fourth claimant) issued the claim form in action HC12 A03340 (“the Second Action”), seeking the same relief as that sought in the First Action. On the same day Bird & Bird wrote to both Hogan Lovells and Dr Burnside enclosing the claim form, particulars of claim and the response pack in the Second Action by way of service. On 4 September 2012 Hogan Lovells wrote to Bird & Bird disputing service of the claim form in the Second Action insofar as it related to the non-UK designations of the Patent. On 26 September 2012 Lilly filed an application contesting the Court’s jurisdiction to hear the Second Action in respect of the non-UK designations. On 11 October 2012 Bird & Bird wrote to Lilly at the Windlesham address enclosing the claim form, particulars of claim etc. in the First Claim without prejudice to the contention that these documents had already been served. On 27 November 2012 I handed down my judgment dismissing Lilly’s applications contesting jurisdiction. Lilly appealed against this decision. On 17 April 2013 Actavis (i.e. all of the claimants) issued and served the claim form in the action HC13 A01487 (“the Third Action”) seeking DNIs in relation to the use of pemetrexed ditromethamine and pemetrexed diacid, as well as in relation to pemetrexed dipotassium. On 1 May 2013 Lily filed an acknowledgement of service in respect of the Third Action contesting jurisdiction. Published by Oxford University Press for the Intellectual Property Office 254 255 256 257 258 259 260 261 262 263 264 265 On 15 May 2013 Lilly filed an application contesting the court’s jurisdiction to hear the Third Action in respect of the non-UK designations. On 21 May 2013 the Court of Appeal dismissed Lilly’s appeal contesting jurisdiction. In its judgment the Court of Appeal concluded that the Second Action was unnecessary, and for that reason only dismissed it. On 26 June 2013 Lilly filed an acknowledgement of service in the First and Third Actions defending the claim. By a consent order dated 27 June 2013 the parties agreed that Lilly’s application challenging jurisdiction of the non-UK designations in the Third Action be dismissed and that the First and Third Actions be case managed together, with Actavis serving a combined particulars of claim. On 3 July 2013 Actavis served their combined particulars of claim. On 18 July 2013 Lilly served its combined defence in the First and Third Actions. Lilly contended in its defence, contrary to its previous position, that the applicable law for determining the conditions of negative declaratory relief was that of the lex loci protectionis, and claimed that Actavis had not complied with various requirements for obtaining DNIs under the relevant laws of France, Italy, Germany and Spain. The defence also stated that Actavis was required to prove that the use of sodium hydroxide as an excipient did not result in literal infringement. Lilly also brought a counterclaim for infringement of the UK designation of the Patent. On 16 September 2013, as a response to Lilly’s claim in the defence that Actavis had not complied with certain requirements under French and Spanish law, Actavis sent a further taking position letter to Lilly. This letter was sent through an English notary. On 18 September 2013 Actavis issued and served the claim form in action HP13 E04212 (“the Fourth Action”). The Fourth Action included for the first time claims in relation to pemetrexed dipotassium by claimants other than Actavis Group ehf. Actavis also applied to amend its claim form in the First and Third Actions to add the other Actavis companies as claimants and to include the other products as well as the dipotassium product. On 30 September 2013 Actavis served its combined reply in the First and Third Actions, which explained Actavis’ position that the applicable law relating to the conditions for seeking negative declaratory relief was the lex fori, but that in any event Actavis had complied with the relevant requirements under foreign law. On 7 October 2013 Lilly filed an acknowledgement of service in the Fourth Action, defending the claim. On 17 October 2013 I gave directions for the trial of the First and Third Actions at a case management conference. Among other things I granted Actavis permission to amend the claim forms in the First and Third Actions. The effect of those amendments was to introduce claims by all the claimants in respect of pemetrexed diacid and ditromethamine in the First Action and by all the claimants in respect of pemetrexed dipotassium in the Third Action. The amended claim forms were issued and served on 22 October 2013. Also on 17 October 2013 Actavis issued and served the claim form in action HP13 E4604 (“the Fifth Action”), which was brought by Actavis to overcome Lilly’s reliance on an alleged one month’s notice requirement under Spanish law (as the claim was started one month after the 16 September 2013 letter), but without prejudice to Actavis’ primary case that it did not need to send the 16 September 2013 letter. [2015] R.P.C., Issue 2 Crown Copyright 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 On 1 November 2013 Lilly acknowledged service of the Fifth Action, defending the claim. On 11 November 2013 Lilly applied to stay the Fourth and Fifth Actions until 28 days after judgment on the First and Third Actions on the ground that the Fourth and Fifth Actions were an abuse of process. On 12 November 2013 Actavis issued an application for the Fourth and Fifth Actions to be heard together with the First and Third Actions. On 27 November 2013 I dismissed Lilly’s application to stay the Fourth and Fifth Actions and gave directions for the trial of the Fourth and Fifth Actions with the First and Third Actions. On 3 December 2013 Actavis served their amended combined particulars of claim in the First, Third, Fourth and Fifth Actions. On 10 December 2013 Bird & Bird wrote to Hogan Lovells providing some confidential information about the formulations of the products which Actavis had been working on and explaining that Actavis had no intention to use sodium hydroxide or any other sodium salt as an excipient. On 11 December 2013: Lilly served its amended combined defence and counterclaim in the First, Third, Fourth and Fifth Actions. The amended combined defence alleged that the Fourth and Fifth Actions were an abuse of process. On 20 December 2013 Actavis served on Lilly a draft re-amended combined reply, which referred to and relied upon the information set out in Actavis’ letter of 10 December 2013. Also on 20 December 2013 Actavis issued and served the claim form in action HP13 B05505 (“the Sixth Action”) and served further particulars in the First, Third, Fourth and Fifth Actions re-iterating Actavis’ claims, both of which were intended to overcome Lilly’s reliance on an alleged three months’ notice requirement under French law (as the claim was started three months after the 16 September 2013 letter). Lilly did not file an acknowledgement of service in respect of the Sixth Action, and thus did not dispute jurisdiction in respect of it. On 7 January 2014 it was ordered by consent that the Sixth Action should be tried with the First, Third, Fourth and Fifth Actions. On 13 January 2014 Actavis sent Lilly a further “taking position” letter referring to, relying on and enclosing copies of the letters dated 16 September 2013 and 10 December 2013, although again without prejudice to their primary case that they did not need to send this further taking position letter. This letter was again sent through an English notary. On the same date Actavis served Dr Stefa´nsson’s first witness statement explaining Actavis’ preparations for launch of the pemetrexed diacid, dipotassium and ditromethamine products. On 7 February 2014 there was a case management conference at which Lilly objected to Actavis’ amendments to the reply relating to and relying upon the 10 December 2013 letter. Actavis were given permission to make some of the amendments to the reply on condition that they amended the prayer for relief in the combined particulars of claim to clarify that they were not seeking a declaration in relation to the use of the products with sodium hydroxide or any other sodium salt as an excipient. On 14 February 2014 Actavis served a re-amended combined particulars of claim with the clarification regarding the scope of the declaration pursuant to the order of 7 February 2014 and an amended combined reply. On 18 February 2014 Actavis issued and served the claim form in action HP14 D00753 (“the Seventh Action”). This action was issued in order to overcome Published by Oxford University Press for the Intellectual Property Office 281 282 283 284 285 286 287 288 289 290 291 292 293 294 Lilly’s reliance on the alleged one month’s notice requirement under Spanish law (as the claim was started one month after Actavis’ 13 January 2014 taking position letter). On 26 February 2014 Lilly served a re-amended combined defence, which alleged that the Sixth Action was also an abuse of process. Lilly did not file an acknowledgement of service in respect of the Seventh Action, and thus did not dispute jurisdiction in respect of it. On 17 March 2014 it was ordered by consent that the Seventh Action be tried with the First, Third, Fourth, Fifth and Sixth Actions. Also on 17 March 2014 Actavis served a re-re-amended combined particulars of claim which incorporated the Seventh Action. On 19 March 2014 Lilly served a re-re-amended combined defence which alleged that the Seventh Action is an abuse of process. Lilly also alleged for the first time that the letters of 16 September 2013 and 13 January 2014 were not sent through proper notarial channels, although it did not explain why. On 20 March 2014 Actavis re-sent the letter of 13 January 2014 through a Spanish notary (without prejudice to its case that this is not necessary). Lilly has acknowledged that it received this at its premises in Indianapolis, Indiana, USA on 31 March 2014. The Spanish notary has produced a certificate of transmission and by the date this judgment is handed down will have produced a certificate of receipt. On 21 March 2014 Lilly served a response to a request for further information alleging that the letter of 13 January 2014 had not been properly notarised as it did not comply with certain features of Spanish notarial practice which it alleged was required. On 24 March 2014 Actavis served a re-amended combined reply which incorporated the Seventh Action. On 26 March 2014 Actavis served Mr Stefa´nsson’s second witness statement, updating Actavis’ preparations for launch. On 4 April 2014 Actavis sent a new taking position letter with regard to the French and Spanish designations of the Patent, referring to, relying on and enclosing copies of the letters dated 16 2013 September 10 December 2013 and 13 January 2014 and Dr Stefa´nsson’s second statement. Again, this letter was sent without prejudice to Actavis’ case that it is not necessary, and as a precaution. This was notarised by a Spanish notary and hand delivered by a US notary to Lilly at its premises in Indianapolis on 4 April 2014. On 14 April 2014 Actavis issued and served the claim form in action HP14 A01611 (“the Eighth Action”), and I made an order that it be tried with the earlier actions. On 6 May 2014 Actavis issued and served the claim form in action HP14 F01792 (“the Ninth Action”). Actavis’ preparations for launch of a pemetrexed product Again due to Lilly’s objections under French, Italian and Spanish law, I must describe Actavis’ preparations for launch of a pemetrexed product and how they have developed over time. Since Actavis regards the details of its preparations as confidential, I shall be circumspect in what I say. It was Dr Stefa´nsson’s idea to develop an alternative salt to pemetrexed disodium in order to avoid infringing the Patent. This was discussed internally at Actavis at a meeting in [REDACTED]. Dr Stefa´nsson suggested three alternatives and another person suggested a fourth. [REDACTED]. [2015] R.P.C., Issue 2 Crown Copyright 295 296 297 298 299 300 301 302 303 304 305 On [REDACTED] a business case was finalised and expenditure on the project was approved by Actavis’ Pipeline Committee. In [REDACTED], solubility tests were carried out on the calcium salt which showed that it was insufficiently soluble. The results of those tests are in evidence. [REDACTED] As a result, Actavis’ Research & Development department came up with some alternative suggestions, which led to the selection of pemetrexed diacid and ditromethamine as additional candidates some time before 17 April 2013. [REDACTED] Actavis’ manufacturing site in Nerviano, Italy is owned and operated by Actavis Italy SPA a Socio Unico (“Actavis Italy”), the tenth claimant. Actavis Italy has been chosen to perform the industrial scaling up necessary for the commercial manufacture of whichever of the pemetrexed formulations gets legal clearance and goes through the regulatory process. In due course, the manufacture of commercial batches of Actavis’ pemetrexed product will also be done at Nerviano. Actavis’ Confidential PPD dated 28 November 2013 sets out test data obtained by Actavis by that date in respect of the (a) solubility, (b) stability, (c) shelf-life and (d) toxicity of pemetrexed disodium, dipotassium, diacid and ditromethamine. [REDACTED] Exhibit SES3 to Dr Stefa´nsson’s first witness statement shows the status of the project as at 17 December 2013. [REDACTED] Exhibit SES6 to Dr Stefa´nsson’s second witness statement shows the status of the project as at 19 March 2014. [REDACTED] Actavis’ Confidential Supplementary PPD dated 21 March 2014 sets out additional test data obtained by Actavis since the date of the original PPD. [REDACTED] In addition to the test data which they have generated themselves, it appears that Actavis have obtained some data from the manufacturer of the API, although the evidence does not establish precisely what data they have obtained from this source. As stated above, Actavis’ preferred candidate at present is pemetrexed diacid. [REDACTED] Dr Stefa´nsson explains in his witness statements that the launch companies in each country are planned to be chosen from among the remaining claimants in these actions near to the launch date. If necessary, Actavis will launch through Actavis Italy in France, Germany and Spain as well as in Italy. DNI in respect of the UK designation applying English law Under its inherent jurisdiction, this court has a broad discretionary power to grant a negative declaration if it is in the interests of justice to do so: see Messier-Dowty at [41]–[42] (Lord Woolf M.R.). The old restrictive approach under which a negative declaration would not be granted unless there was a claim of right (Re Clay [1919] 1 Ch 66) has been abandoned. The modern law is that a negative declaration will be granted if it is right in all the circumstances to do so, and in particular if it will serve a “useful purpose”: Messier-Dowty at [41]–[42]. It will do so if the claimant has a “real commercial interest” in the negative declaratory relief sought or a “real commercial reason” for it to be granted: Nokia Corp v InterDigital Technology Corp [2006] EWCA Civ 1618, [2007] F.S.R. 23 at [19]–[20] (Jacob L.J.). Lilly does not seriously dispute that, if Actavis establish that dealings in their products would not amount to an infringement of the UK designation of the Patent, then Actavis should be granted a DNI in respect of that designation pursuant to the inherent jurisdiction of the Court. It follows that it is unnecessary for me to consider whether Actavis have satisfied the requirements of s.71 of the Patents Act 1977. Published by Oxford University Press for the Intellectual Property Office I would emphasise that, although I have found it convenient in writing this judgment to address this issue after determining the substantive issue between the parties on the merits, which is the same order adopted by the parties in their submissions, it would make no difference if I had considered the issues the other way round. I would add that Lilly did not seek the trial of this issue as a preliminary issue, as it could have done if there had been any real doubt about Actavis’ entitlement to a DNI even if Actavis were right on the substantive issue. DNI in respect of the French, Italian and Spanish designations applying English law If, as I have concluded, the law applicable to the question of whether Actavis are entitled to a DNI in respect of the French, Italian and Spanish designations of the Patent is English law, then I consider that Actavis should be granted DNIs in respect of those designations pursuant to the inherent jurisdiction of the Court because Actavis have clearly demonstrated that they have a real commercial interest in obtaining such declarations and such declarations would serve a useful purpose. Nevertheless, in case I am wrong about the applicable law, in the remainder of this judgment, I shall consider the position on the assumption that the relevant law is the law applicable to the non-contractual obligation. DNI in respect of the French designation applying French law French law 308 Article L.615-9 IPC provides as follows: “Any person who proves exploiting industrially on the territory of a Member State of the European Economic Community, or serious and effective preparations to that effect, may invite the owner of a patent to take position on the opposability of his title against such industrial exploitation, the description of which shall be communicated to him. If such person disputes the reply that is given to him or if the owner of the patent has not taken a position within a period of three months, he may bring the owner of the patent before the Court for a decision on whether the patent constitutes an obstacle to the industrial exploitation in question, without prejudice to any proceedings for the nullity of the patent or subsequent infringement proceedings if the working is not carried out in accordance with the conditions specified in the description referred to in the above paragraph.” “The right of action is available to all those who have a legitimate interest in the success or dismissal of a claim, without prejudice to those cases where the law confers the right of action solely upon persons who it authorises to raise or oppose a claim, or to defence a particular interest.” 309 Article 31 of the Civil Procedure Code (“FCPC”) provides as follows: 310 There are a number of issues between the parties concerning these provisions. The first concerns the relationship between art.L.615-9 IPC and art.31 FCPC. Prof Aze´ma considers that art.L.615-9 IPC is a special derogation from art.31 FCPC and that this [2015] R.P.C., Issue 2 Crown Copyright 311 312 313 314 315 provision was necessary because a DNI was not previously allowed under art.31 FCPC. Prof Galloux considers that art.L.615-9 IPC is not a derogation from art.31 FCPC and that a DNI can be obtained under art.31 FCPC even if the conditions laid down by art.L.615-9 are not satisfied. On this question I prefer the opinion of Prof Aze´ma, which is supported by three main points: (i) Before art.L.615-9 IPC was introduced in 1984, no action for a DNI was in fact admitted by a French court. (ii) The weight of scholarly comment on art.L.615-9 IPC accords with Prof Aze´ma’s view. (iii) The maxim specialia generalibus derogant (the specific overrides the general) applies. This is supported by the decision of the President of the First Instance Court of Lyon in Eurodif v Gravisse dated 17 January 1995. The second issue is whether it is always necessary for the party seeking a DNI pursuant to art.L.615-9 IPC to show that it has invited the patent owner to take a position three months before bringing the action. Lilly admits in para.25 of its combined defence that it is possible for the party seeking the declaration to avoid this procedure “if the patentee has expressed his position irrevocably and unambiguously in a patent infringement action brought against the party seeking the declaration”. The existence of this qualification is supported by the decisions of the Court of First Instance of Paris in Yamanouchi Pharmaceutical Co Ltd v Biogen NV of 16 March 1999 and Alcon v Corneal of 16 November 2007 cited by Prof Galloux. Prof Galloux considers, however, that it is not necessary for the patentee to have expressed its position irrevocably or in a patent infringement action provided that the patentee has unambiguously expressed its position on the opposability of its French patent to the other party’s product. In support of his opinion Prof Galloux cited the decision of the Court of Appeal of Bordeaux in Hembert v Composites Aquitaine SA of 9 April 2002, in which a claim by Composites Aquitaine under art.L.615-9 IPC was held admissible where the patentee had sent letters alleging infringement to another defendant, to the Ministry of Industry and to the Maritime Prefect of Toulon, and the allegation of infringement had been widely disseminated amongst potential customers. (Prof Galloux also cited the decision of Court of First Instance of Paris in SEB SA v Euromenage SARL of 22 April 2003, but in that case Compania Menaje Domestico SL (“CMD”) had sent a request for an acknowledgement of non-infringement in respect of a modified product a few days after Euromenage had applied to join CMD as a third party to infringement proceedings brought by SEB against Euromenage in respect of a product supplied by CMD, and SEB subsequently alleged that the modified product also infringed.) I accept Prof Galloux’s opinion on this point. Although Prof Aze´ma states in para.13 of his second report that the “amicable phase” set out in the first para. of art.L.615-9 IPC is a pre-requisite to obtaining a DNI, he does not explicitly contradict what Prof Galloux says in his first report on this issue, nor does he comment on the case law cited by Prof Galloux. The third issue is whether it is also possible for the party seeking a DNI to avoid the requirement to show that it has made serious and effective preparations for industrial exploitation if the patentee has unambiguously expressed its position on the opposability of its French patent to the other party’s product. Prof Galloux Published by Oxford University Press for the Intellectual Property Office 316 317 318 319 considers that this is possible, but as I understand it, on the basis that a DNI could still be obtained under art.31 FCPC. I have already concluded that it is not possible to obtain a declaration under art.31 FCPC if it is not available under art.L.615-9. Furthermore, I note that in the Hembert case the Court of Appeal went on to consider whether Composites Aquitaine had made serious and effective preparations, holding that the Court of First Instance had been entitled to conclude that it had. One can understand why the Court of Appeal was willing to dispense with strict compliance with the requirement for a “taking position” letter to be sent when the patentee had unambiguously alleged infringement in letters to other parties, but nevertheless required Composites Aquitaine to show that it had a sufficient interest in obtaining a DNI. The fourth issue is whether it is possible for the party seeking a DNI to rely upon a taking position letter, and the failure of the patentee to give an acknowledgement of non-infringement within the following three months, sent during the pendency of the proceedings. Prof Galloux considers that this is possible in accordance with arts.122 and 126 FCPC, and his opinion is supported by the decisions of the Court of First Instance of Paris in Biberian v Commissariat a l’Energie Atomique of 22 November 1996 and Justamente v Hopital Broussais of 28 June 2000 he cited. It appears to me that it is also supported by the judgment in the SEB case. Prof Aze´ma considers that this is not possible, and that it is necessary for the claimant to start a new action, but he does not address arts.122 and 126 FCPC or the case law cited by Prof Galloux. I therefore prefer Prof Galloux’s opinion. The fifth issue is what is meant by “industrial exploitation”. Prof Aze´ma considers that this means manufacture, whereas Prof Galloux considers that it includes marketing the product. Prof Aze´ma’s opinion is supported by three first instance decisions: Boston Scientific SA v Palmaz (28 October 1998), Boston Scientific SA v Cordis Corp (23 June 1999) and Abbott Ireland v Evysio Medical Devices ULC (14 January 2009). Prof Galloux’s opinion receives some support from the Yamanouchi judgment. In my judgment the superior French courts will conclude that marketing the product is enough for this purpose. Marketing an infringing product is a form of industrial exploitation and it is an act of direct infringement. Furthermore, there is no rational reason for restricting the availability of DNIs to manufacturers. The sixth issue is what is meant by “serious and effective preparations”. The experts agreed that this “supposes that investments have already been launched, or at least, means have been put in place to enable an exploitation to be implemented”. Lilly contends that the seriousness and effectiveness of the preparations must be assessed at the date the action is commenced, whereas Actavis contend that it is possible to rely upon further preparations during the pendency of the proceedings. Prof Galloux’s evidence supports Actavis’ position, as do the decisions in SEB, Dijkstra and Yamanouchi cited by him. Prof Aze´ma does not contradict Prof Galloux, and so I accept Prof Galloux’s opinion. Assessment Actavis rely upon no less than six alternative “routes to admissibility” of their claim for a DNI in respect of the French designation. Lilly contends that all six routes fail for one or more of four reasons: (i) art.L.615-9 IPC must always be complied with; (ii) Actavis have not given Lilly three months’ notice; (iii) Actavis have not carried out the necessary serious and effective preparations; and (iv) it is not possible for Actavis to cure defects within an existing action, but only by starting again and commencing a [2015] R.P.C., Issue 2 Crown Copyright 320 321 322 323 new action. For reasons that will appear, I consider that it is sufficient for me to deal with Actavis’ first three routes. Route 1. Actavis contend that, by the date of the Sixth Action (20 December 2013), Lilly had unambiguously taken a position on the opposability of the French designation of the Patent to each of pemetrexed diacid, dipotassium and ditromethamine. In support of this contention, Actavis rely in particular on (i) Lilly’s counsel’s confirmation at the case management conference on 17 October 2013, which was formally recited in the order made on that date, that “it is Lilly’s positive case in these proceedings that Actavis’ proposed products fall within the scope of the claims of the foreign designations of [the Patent], whether literally or by equivalence”, (ii) Lilly’s pleading with regard to the scope of the claims of the French designation of the Patent in its statement of case served pursuant to that order on 8 November 2013 and (iii) Lilly’s statement in a letter from Hogan Lovells to Bird & Bird dated 10 December 2013 that “It necessarily follows [from Lilly’s positive case on the construction of the claims] that Lilly considers that the products do fall within the scope of those claims . . .”. Lilly relies on the facts that (i) counsel for Lilly also made it clear that, as the recital to the order continued, “Lilly raises no positive case of infringement in respect of the foreign designations” and (ii) no allegation of infringement was made in the Statement of Case or in the letter dated 10 December 2013. In my judgment Lilly did unambiguously take a position on the opposability of the French designation of the Patent to each of Actavis’ proposed products at the case management conference on 17 October 2013 and in its statement of case. It is immaterial that Lilly did not positively allege infringement (or threatened infringement) by Actavis. Furthermore, the reality of Lilly’s position was perfectly clear by that date from the fact that Lilly had (i) brought a counterclaim for threatened infringement of the UK designation and (ii) brought proceedings in Du¨ sseldorf for threatened infringement of the German designation. The only reason why Lilly had not positively alleged infringement of the French designation was that it wanted, so far as possible, to preserve its position that Actavis should have brought the claim in France in accordance with French procedure rather than in England in accordance with English procedure, and thereby make it more difficult for Actavis to obtain a DNI even if they were right on the merits. Accordingly, I agree with Actavis that it does not matter whether they had properly complied with the requirement to send a taking position letter three months before the Sixth Action. I do not agree that this relieves Actavis from the obligation to demonstrate that they have made serious and effective preparations, however. In my judgment the evidence demonstrates that Actavis had made serious and effective preparations to manufacture and market each of the products, and particularly the diacid, by 20 December 2013 and certainly by the time of the trial. By 20 December 2013 Actavis had concrete and well-developed plans to manufacture and market each of the products, had taken a number of steps towards implementing those plans and had invested a certain amount of time, effort and money in doing so. By the trial Actavis had taken further steps and invested a lot more money. By 20 December 2013, and still more so by the trial, Actavis had a developed formulation of each product which they could be reasonably confident would receive regulatory approval and which they could manufacture on an industrial scale, although further work remained to be done. This was particularly true of the diacid. Accordingly, I conclude that Actavis are entitled to a DNI pursuant to art.L.615-9 IPC. Even if Published by Oxford University Press for the Intellectual Property Office 324 325 326 327 328 329 only the intended manufacturer can obtain a DNI, Actavis Italy is the intended manufacturer and will, if necessary, import the product into France. Route 2. For the purpose of considering route 2, I shall assume that Lilly is correct that Actavis cannot circumvent the requirement of art.L.615-9 IPC for a taking position letter by relying upon Lilly’s statements in these proceedings because Lilly has not positively asserted infringement by Actavis. Actavis contend that, by the date of the Sixth Action, more than three months had elapsed since Actavis’ taking position letter dated 16 September 2013, and accordingly Actavis had fully complied with the requirements of art.L.615-9. Lilly does not concede that the letter dated 16 September 2013 satisfied the requirements of art.L.615-9 IPC, but in my judgment it did. In closing submissions counsel for Lilly raised a new argument that Actavis could not rely upon this letter since it was sent during the currency of earlier actions, in particular the First and Third Actions, but this point is unpleaded and unsupported by the expert evidence. More than three months elapsed between the date of the letter and the date the Sixth Action was commenced. I have already held that Actavis had made serious and effective preparations to manufacture and market each of the products, and particularly the diacid, by 20 December 2013, and certainly by the date of the trial. Accordingly, I conclude that Actavis are also entitled to a DNI pursuant to art.L.615-9 IPC on this basis. Route 3. Although my conclusion in relation to routes 1 and 2 makes it strictly unnecessary to consider route 3, I shall do so because it is relied upon by Actavis as one of their answers to Lilly’s abuse of process argument (as to which, see below). Route 3 is essentially the same as route 2, except it relies upon the First and Third Actions and the contention that Actavis can rely upon a taking position letter sent during the pendency of those proceedings. I have concluded that Actavis are right about that. I have already held that Actavis had made serious and effective preparations to manufacture and market each of the products, and particularly the diacid, by 20 December 2013, and certainly by the date of the trial. Accordingly, I conclude that Actavis are also entitled to a DNI pursuant to art.L.615-9 IPC on this basis. DNI in respect of the Italian designation applying Italian law Italian law Article 100 of the Code of Civil Procedure (“CCP”) provides: “In order to state a claim or to oppose the same, the claimant and the opponent must have a legitimate interest.” It is common ground that this applies to claims for DNIs. It is also common ground that the test for a legitimate interest in relation to a claim for a DNI is that there is an objective uncertainty giving rise to a present, concrete prejudice to the claimant which the judgment of the court is capable of curing. It is also common ground that there is no need for a cease-and-desist letter to have been sent. Prof Gugliemetti considers that there must be some form of actual, articulated objection (“contestazione”) from the patentee in order for the required uncertainty to exist. Prof Franzosi does not agree with this, although he does agree that the [2015] R.P.C., Issue 2 330 331 332 333 334 uncertainty must not be academic or hypothetical. Both experts have referred to a number of cases as supporting their respective positions. Prof Franzosi’s position is supported by some decisions of the Supreme Court in non-patent cases, and in particular Case 17026 VS v TA of 26 July 2006, in which the Court stated: “The most recent case law of the Supreme Court has in fact broadened the scope of enforceability of declaratory actions or of actions of mere declaratory assessment, observing that the interest in bringing forth a lawsuit for a mere declaratory judgment does not necessarily imply the actual occurrence of an infringement on a right or a dispute (contestazione) as a state of objective uncertainty is sufficient with regards to the exact scope of rights and mutual obligations arising from any legal transaction as in the present case.” Prof Franzosi’s position is also supported by some recent decisions of the lower courts in patent cases, in particular three decisions of the Ordinary Court of Milan (Case 77566/2011 Medexpo International Srl v Medel Group SpA (1 February 2012), Case 89281/2012 Ranbaxy UK Ltd v AstraZeneca AB (12 February 2013) and Case 11770/2011 Mylan SpA v AstraZeneca AB (2 April 2013)) and one of the Court of Appeal of Milan (Case 4074/2009 M.E.P. Maccine Elettroniche Piegatrici SpA v Titanfer Srl (19 May 2011)). Of these cases, I find the analysis in Ranbaxy v AstraZeneca the most comprehensive, helpful and persuasive. In this judgment the Court is explicit that it is not necessary for an objection already to have been made. Thus Italian law on this question appears to be evolving in the same direction as English law has evolved. Accordingly, I accept Prof Franzosi’s opinion on this issue. It does not appear to be disputed that, as stated by Prof Franzosi, legitimate interest is to be assessed at the date of the court’s decision and therefore events after the issue of the claim can be taken into account. Prof Gugliemetti does say that a subordinate counterclaim under Italian procedure cannot give rise to a legitimate interest. Prof Franzosi disagrees with this, but in my view it does not matter who is right, because these proceedings have not been conducted in accordance with Italian procedure and Lilly has not made a subordinate counterclaim. Actavis contend that they have a legitimate interest in obtaining a DNI in respect of the Italian designation of the Patent because there is an objective uncertainty giving rise to a present, concrete prejudice to Actavis which the declaration of the court is capable of curing. I agree with this. Actavis are well advanced with plans to manufacture and market a generic pemetrexed product. They contend that none of pemetrexed diacid, dipotassium or ditromethamine fall within the scope of the claims of the Italian designation of the Patent. Lilly disputes this. This means that, objectively viewed, there is uncertainty. That gives rise to present, concrete prejudice to Actavis, because they need a determination of the issue in order to know whether they will be safe to launch their product. In short, the uncertainty affects their business. A declaration of the court will cure this uncertainty. If, contrary to the conclusion I have reached above, an objection from Lilly is required, I consider that there has been an objection by Lilly for this purpose. Lilly has expressly alleged that pemetrexed diacid, dipotassium or ditromethamine fall within the scope of the claims of the Italian designation of the Patent and has Published by Oxford University Press for the Intellectual Property Office adduced evidence and arguments in support of that allegation. Indeed, para.88 of Lilly’s combined defence alleges in relation to the Italian designation of the Patent that “There is infringement by equivalence . . . .”. It is immaterial that Lilly has not expressly alleged that Actavis have committed or threaten to commit any infringing acts. Again, it is clear that the only reason why Lilly has not done so is because it would prefer Actavis to have to bring their claim in the Italian courts. DNI in respect of the Spanish designation applying Spanish law Spanish law 335 Article 127 of the Spanish Patents Act 1986 (“SPA”) provides as follows: “1. Any interested person may file an action against the owner of the patent so that the competent judge may declare that a particular act does not constitute infringement of the patent. 2. Before filing the action, the interested person shall, through notarial channels, demand that the patent owner make known his position on the opposability of the patent to the industrial exploitation carried out in Spain by the claimant or serious and effective preparations being made for that purpose. The person making the demand may file the action provided for in the preceding paragraph if the patent owner has not replied within one month of the date of the demand, or if he does not agree with the reply. 3. The action specified in paragraph 1 above may not be filed by any person against whom a claim for infringement of the said patent has been brought. Where the claimant proves that the act referred to in the claim does not constitute infringement of the patent, the judge shall grant the declaration that was demanded. 5. The claim shall be notified to all persons owning rights in the patent who are duly entered in the Register, so that they may appear and take part in the proceedings. Nevertheless, holders of contractual licenses may not appear in the proceedings where their license contracts so specify. 6. The action referred to in the present Article may be brought jointly with an action to declare the invalidity of the patent.” 336 There are a considerable number of issues between the parties with regard to this provision, and there is a great deal of expert evidence on those issues (and not merely because of Lilly’s use of two experts to address some of them). I shall confine my attention to the issues which matter and deal with them as concisely as I can. In particular, I do not propose to enter into the debate between the experts as to whether art.127 is procedural or substantive as a matter of Spanish law. Nor, to the extent that it is a separate question, do I propose to enter into the question of whether art.127 is a provision as to standing as a matter of Spanish law. Nor, to the extent that it is a separate question, do I propose to enter into the debate as to the relationship between art.127.1 and art.127.2. In so far as these matters relate to the issue over the [2015] R.P.C., Issue 2 Crown Copyright interpretation of Rome II, as I have already said, they are not determinative. While it is fair to say that the debates over these issues are linked with debates over the issues considered below, it does not appear to me that it is essential to resolve them in order to resolve the issues considered below. The first issue is whether it is necessary for the claimant to comply with the requirement of art.127.2 for a demand through notarial channels one month before filing the action if the patentee has already clearly taken a position on the opposability of its patent to the product. Prof Desantes considers that it is not, relying in particular on the decision of the Court of First Instance of Bilbao in Judgment 156/02 Teodosio v Metro Bilbao SA of 24 June 2012 concerning a dispute as to whether the domain name metrobilboa.com registered and used by the claimant infringed the defendant’s trade mark METRO BILBAO. In that case the Court rejected the defendant’s argument that the claimant had not complied with art.127.2 (which the Spanish trade mark law applies to trade marks) because the purpose of the notarised request was to allow the trade mark owner to take a position with regard to the activity in question, but there was no need for this in the instant case because the trade mark owner had already filed a complaint against the claimant with the World Intellectual Property Organisation’s Arbitration and Mediation Centre. Prof Bercovitz accepts in para.143 of his first report that this decision showed that “under exceptional circumstances, where the purpose of such requisites had been deemed to have been fulfilled”, it was not necessary to send a notarial request and wait for a month as required by art.127.2. In para.118 of his second report he states that art.127.2 has not been dispensed with in any other case and the decision “cannot be extrapolated to any de facto circumstance imaginable in which there has been no notarial request”. In para.30 of his third report, he points out that there was no appeal, and so one does not know what the position of the higher courts would have been. He does not go so far as to say that the decision is wrong, however. Similarly, Prof Arenas states in para.57 of his second report that in that case “the purpose sought by the notarial request had been achieved by an equivalent channel: (i) the trademark holder was aware of the claimant’s activity; (ii) the trademark holder had ‘sufficient time’ to assess the infringement . . .; (iii) the trademark holder had an opportunity to file an infringement complaint”. Accordingly, the experts are agreed that there can be circumstances in which it is not necessary for the party seeking a DNI to comply with the requirement in art.127.2 for a prior demand through notarial channels. The dispute is as to what circumstances suffice for this purpose. In my judgment, the evidence demonstrates that compliance with this requirement in art.127.2 can be dispensed with, but only if the purposes which it serves have already been achieved before commencement of the claim for DNI. This will be the case if the patentee has been made aware of the product in question, has had at least a month to consider its position and has clearly taken a position on the opposability of its patent to the product. I do not consider that this conclusion is contradicted by the decision of the Court of Appeal of Navarre in Judgment 130/2011 Laboratorios Cinfa SA v Novartis AG of 27 May 2011 which was relied on by counsel for Lilly. In that case Cinfa had sent a letter dated 16 April 2008 to Novartis stating that it had made serious and effective preparations to market generic valsartan in Spain and asserting that its product did not infringe Novartis’ patent. It does not appear that this letter identified the manufacturer of the active ingredient. Novartis replied asserting that the patent covered the marketing of such a product and formally requesting Cinfa not to Published by Oxford University Press for the Intellectual Property Office market the product. On 3 June 2008 Cinfa commenced a claim under art.127 requesting a declaration that valsartan manufactured by Qu´ımica Sinte´tica SA did not infringe the patent. Novartis objected that Cinfa had not complied with the requirements of art.127. Prior to the trial, Cinfa sought to amend its claim to seek a declaration in respect of its own marketing of valsartan made by Qu´ımica Sinte´tica, but this application was refused and there was no appeal. The first instance court agreed with Novartis, holding that Cinfa only had locus standi to request a DNI in respect of its own activities and not in respect of manufacture by a different company. Cinfa’s appeal was dismissed. Among Cinfa’s arguments on appeal was that Novartis had given it locus standi by its subsequent actions and statements, namely, bringing infringement proceedings against Cinfa. The Court of Appeal rejected this argument on the ground that “The requirements for locus standi as claimant must exist on the date the complaint is filed, and this cannot be remedied subsequently . . . .”. It does not follow that a prior taking of position cannot be relied upon. The second issue is whether, if the patentee has stated its position clearly, this also removes the need for the claimant to show that it has made serious and effective preparations. Prof Desantes considers that this is the case, while Prof Bercovitz and Prof Arenas do not. In my judgment the logic which I have identified in the decision in Teodosio v Metro Bilbao for dispensing with the requirement for a notarial request one month before the claim where the purposes of that requirement have already been achieved does not justify dispensing with the requirement for serious and effective preparations. This conclusion receives some slight support from the judgment in Cinfa v Novartis, in which the Court of Appeal held that, if Cinfa had wanted to obtain a DNI in respect of its marketing of the product “it should have been expressly requested in the petition section of the complaint, specifying the ‘serious and effective preparations’ in its complaint and accrediting the reality of the same at the evidentiary stage”. The third issue concerns the requirement for a demand through notarial channels (“requerira´ notarialmente”), assuming that it is not sufficient for the patentee to have clearly stated his position on the opposability of the patent. Prof Bercovitz considers that this means that there must be a notarial summons (“acta de requiriminto”) in accordance with art.202 of the Notary Rules and Regulations, although he accepts that a foreign notary, rather than a Spanish notary, can be employed for this purpose where the patentee is based outside Spain. Prof Desantes disagrees, and considers that art.127.2 merely requires a notarial notification (“acta de notificacio´n”). On this point I find Prof Desantes’ reasoning in paras.21–24 of his fourth report convincing. Even if a notarial summons is required, Prof Desantes considers that proof of transmission of the demand through notarial channels is not required where the patentee has acknowledged receipt of the demand. Prof Bercovitz and Prof Arenas disagree with this. Again, I find Prof Desantes’ reasoning convincing. It seems clear that the purpose of requiring the demand to be sent through notarial channels is to ensure that the claimant can prove transmission and receipt. If the patentee has acknowledged receipt, proof by notarial means is not required. As the decision in Teodosio v Metro Bilbao shows, the Spanish courts will not insist upon compliance with pointless formalities. The fourth issue is what constitutes “serious and effective preparations”. It is not disputed that “industrial exploitation” includes marketing a product. Prof Bercovitz considers that “serious and effective preparations” requires the preparations to have reached the point that the claimant has the capacity to proceed imminently with the [2015] R.P.C., Issue 2 Crown Copyright exploitation. In support of his opinion, Prof Bercovitz argues that “serious and effective preparations” in art.127 should be interpreted in the same way as those words have been interpreted in the context of a prior use defence to infringement under art.54 SPA (similar to s.64 of the UK Patents Act 1977). This argument receives some support from the decision of the Court of Appeal of Barcelona in Judgment 375/06 Rolabo SL v Medichem SA of 20 July 2006. That was a case concerning the interpretation of art.54. In the course of its judgment, the court referred to a number of other provisions of the SPA, including art.127. On the other hand, art.127 was not itself in issue in that case. More significantly, in Cinfa v Novartis the Court of Appeal of Navarre adopted the judgment in Rolabo v Medichem to the extent it held that “experimental acts” were not sufficient to constitute “serious and effective preparations”. On the other hand, that passage was what an English court would regard as obiter, although I appreciate that Spanish courts do not make the same distinction between ratio and obiter. Against this, Prof Desantes argues that, while it is justified to interpret the words narrowly in the context of the art.54 defence to infringement, the purpose of art.127 is different and so it does not follow that they should be interpreted in the same way in that context. Prof Desantes points out that art.127 is based on s.162 of the BIRPI (the predecessor to WIPO) Model Law for Developing Countries on Inventions. The commentary to s.162 states: “The purpose of this Section is to avoid future infringement proceedings in borderline cases. It is possible that a person’s present or future activity may perhaps be an infringement, but that the person is not certain. In order to clarify the matter, he may avail himself of the procedure provided for in this Section. If the outcome is favourable to him, in other words, if the court’s finding is that the performance of the act in question does not infringe the patent, the person may engage in (or continue) his activity without risk, whereas he will discontinue (or forgo) the activity if the court’s finding is unfavourable to him.” Furthermore, Prof Bercovitz, who was the draftsman of the bill which introduced art.127, himself stated in an article introducing the new law: “When starting or continuing a particular industrial activity it is of extreme relevance to have the assurance that no other’s patents are violated. Consider, in fact, that for any productive activity it is necessary to make investments that may be lost if later that activity cannot be developed because it infringes a patent. This unfortunate situation can be avoided if in cases of doubt the action for declaration of non-infringement is filed, avoiding therefore the invidious position of a defendant accused of having infringed the rights arising from a patent.” 346 347 Prof Desantes also points out that other commentators have interpreted “serious and effective preparations” in art.127 more broadly. One suggests that merely experimental acts are not enough, but not a requirement of immediacy of exploitation. Another suggests that serious and effective preparations “may consist of tests following the trial period and technical and economical studies making this operation visible”. Prof Desantes considers even these approaches are too restrictive, however. Accordingly, Prof Desantes considers that “serious and effective preparations” is a broad concept which is for the overall factual assessment of the court, and that it could Published by Oxford University Press for the Intellectual Property Office 348 349 350 351 352 353 354 include (but would not necessarily require): (a) laboratory tests; (b) business plans to launch after a future marketing authorisation; (c) commencement of industrial scaling up; (d) preparation of a marketing authorisation dossier; or (e) starting preparations in order to be in a position to launch after expiry of SPCs. In my judgment, the decision in Cinfa v Novartis and the weight of the commentary indicates that mere experimental acts will not suffice for “serious and effective preparations”. I am not persuaded that it is necessary for the claimant to demonstrate that exploitation is imminent, which would be contrary to the purpose of art.127 as explained by Prof Bercovitz in his article. Thus if there are concrete and well developed plans for industrial exploitation and preparations have been made to implement those plans extending beyond mere experimental acts, that will suffice. The fifth issue is whether the serious and effective preparations must be in Spain. Prof Desantes considers that this is not necessary. As counsel for Actavis pointed out, Prof Bercovitz and Prof Arenas do not take issue with this, as opposed to emphasising that the serious and effective preparations must be for industrial exploitation in Spain. Prof Desantes accepts the latter point. It is common ground that the question whether the claimant has made serious and effective preparations is to be assessed as at the date the claim was commenced. The sixth issue is whether it is possible for the claimant in a claim under art.127 to remedy deficiencies in his claim, such as a failure to send a demand through notarial channels one month before the claim, during the course of the proceedings. Prof Desantes considers that this is possible, relying upon various provisions of the Spanish Code of Civil Procedure. Prof Bercovitz and Prof Arenas disagree. For reasons that will appear, I do not consider it necessary to resolve this dispute. The seventh issue is whether it is possible for the claimant in a claim under art.127 to remedy deficiencies in his claim, such as a failure to send a demand through notarial channels one month before the claim, by starting a further action during the pendency of the first action. Again, Prof Desantes considers that this is possible, while Prof Bercovitz and Prof Arenas disagree. Again, I do not consider it necessary to resolve this dispute. Assessment Actavis rely upon no less than seven alternative “routes to admissibility” of their claim for a DNI in respect of the Spanish designation. Lilly again contends that all seven routes fail for one or more of four reasons: (i) art.127.2 SPA must always be complied with; (ii) Actavis have not given Lilly one month’s notice through notarial channels; (iii) Actavis had not at the relevant dates, and still have not, carried out the necessary serious and effective preparations; and (iv) it is not possible for Actavis to cure defects within an existing action, but only by starting again and commencing a new action. I shall confine my attention to routes 1, 2, 3 and 5. Route 1. Actavis contends that, by the time the Sixth Action was commenced, Lilly had clearly taken a position as to the opposability of the Spanish designation of the Patent to the products. As with France, Actavis rely in particular on the recital to the order dated 17 October 2013, Lilly’s Statement of Case and the letter dated 10 December 2003. Lilly again relies on the same points as with France. Again, I conclude that Lilly had clearly taken a position on the opposability of the Spanish designation of the Patent to the products by 20 December 2013. Again, the only reason why Lilly had not positively alleged infringement of the Spanish designation was that it wanted, so far as possible, to preserve its position that Actavis should have [2015] R.P.C., Issue 2 355 brought the claim in Spain in accordance with Spanish procedure rather than in England in accordance with English procedure, and thereby make it more difficult for Actavis to obtain a DNI even if they were right on the merits. Accordingly, I agree with Actavis that it does not matter whether they had properly complied with the requirement to send a taking position letter through notarial channels one month before the Sixth Action. I do not agree that this relieves Actavis from the obligation to demonstrate that they had made serious and effective preparations, however. In my judgment the evidence demonstrates that Actavis had made serious and effective preparations to manufacture and market each of the products, and particularly the diacid, by 20 December 2013 for similar reasons to those I have given in relation to the French designation. Accordingly, I conclude that Actavis are entitled to a DNI pursuant to art.127 SPA. Route 2. For the purpose of considering route 2, I shall assume that Lilly is correct that Actavis cannot circumvent the requirement of art.127.2 SPA for a letter to be sent through notarial channels one month prior to the action by relying upon Lilly’s statements in these proceedings. Actavis contend that, by the date of the Fifth Action, more than one month had elapsed since Actavis’ taking position letter dated 16 September 2013, and accordingly Actavis had fully complied with the requirements of art.127.2. The same goes for the later actions. Lilly does not concede that the content of the letter dated 16 September 2013 satisfied the requirements of art.127.2, but in my judgment it did. Lilly contends that the letter was not sent through notarial channels as required. As is common ground, however, Lilly acknowledged receipt of the letter. Thus there is no doubt that the letter was both sent and received. I therefore conclude that the sending of the letter did comply with art.127.2. I have already found that Actavis had made serious and effective preparations to manufacture and market each of the products, and particularly the diacid, by the date of the Sixth Action. Accordingly, I conclude that Actavis are also entitled to a DNI pursuant to art.127 SPA on this basis. Route 3. Route 3 again relies upon the letter dated 16 September 2013. I shall nevertheless consider it because it is relied upon by Actavis as one of their answers to Lilly’s abuse of process argument. The difference from route 2 is that, instead of relying on the starting of the Fifth Action more than one month after that letter, Actavis rely upon the amendments which Actavis made to the First and Third Actions on 22 October 2013 pursuant to the order dated 17 October 2013. The effect of the amendments was to introduce claims in relation to pemetrexed diacid and ditromethamine into the First Action and pemetrexed dipotassium into the Third Action more than one month after the letter dated 16 September 2013. This raises the question of whether Actavis had made serious and effective preparations by 22 October 2013. With slightly more hesitation than in the case of 20 December 2013, I consider that they had. Lilly also advances an argument in relation to route 3 of abuse of process under English law, which I shall consider below. Route 5. For the purpose of considering route 5, I shall assume that Actavis fail on routes 1, 2 and 3 and that Actavis must prove transmission of a taking position letter through notarial channels. In my judgment Actavis has complied with all the notarial requirements relied on by Lilly with respect to the letter dated 4 April 2014. The Ninth Action was issued more than one month after that. Furthermore, even if Actavis had not made serious and effective preparations by the dates of the Sixth Action, I consider that they had done so by the date of the Ninth Action, having continued to progress Published by Oxford University Press for the Intellectual Property Office their plans. Accordingly, I conclude that Actavis are also entitled to a DNI pursuant to art.127 SPA on this basis. Lilly’s abuse of process argument in relation to the French and Spanish designations Lilly contends that, if (i) on the proper interpretation of the Rome II Regulation the law applicable to the non-contractual obligation includes the rules with regard to interest and pre-notification under French and Spanish law on which Lilly relies, (ii) the First and Third Actions were not well founded due to non-compliance by Actavis with those rules at the dates of those actions, but (iii) the Fourth or any of the subsequent Actions was well founded because by the date of those actions Actavis had complied with the relevant rules, the Fourth and subsequent Actions should be struck out as an abuse of the process in so far as they relate to the French and Spanish designations (“the Main Abuse Argument”). Lilly also contends that, if Actavis is correct that the First and Third Actions were well founded in relation to the Spanish designation as from the date of the amendments on 22 October 2013 even if not originally, the making of those amendments was an abuse of process (“the Amendment Abuse Argument”). Given my earlier conclusions, I need to make clear the bases upon which I shall consider these arguments. So far as the French and Spanish designations are concerned, I have concluded that (i) Actavis will not infringe those designations applying the lex loci protectionis, (ii) on a proper interpretation of the Rome II Regulation the other conditions which must be satisfied for the making of a DNI are governed by the lex fori and (iii) applying English law Actavis are entitled to a DNI. It follows that Actavis succeed in the First and Third Actions, and the later actions were unnecessary. Even if I am wrong on point (ii), I have held that, applying French law, Actavis succeed on route 3. Again it follows that Actavis succeed in the First and Third Actions, and the later actions were unnecessary. If I am wrong about that, but right that Actavis succeed on routes 1 or 2, it follows that Actavis succeed in the Sixth Action, but not in the First and Third Actions. I shall therefore consider Lilly’s contention that the Sixth Action is an abuse of process on that assumption. Applying Spanish law, I have held that (subject to the Amendment Abuse Argument) Actavis succeed on route 3. If I am wrong about that, but right that Actavis succeed on routes 1, 2 or 5, it follows that Actavis succeed in the Fifth, Sixth or Ninth Actions, but not in the First and Third Actions. I shall therefore consider Lilly’s contention that the Fifth, Sixth and Ninth Actions are an abuse of process on that assumption. It should be noted before proceeding further that Lilly advances these arguments in reliance upon the English law of abuse of process i.e. the lex fori. Lilly does not rely upon the laws of France or Spain for this purpose. It must therefore be assumed that the Fourth and subsequent Actions would not be struck out or dismissed as an abuse of process or on an equivalent ground applying French and Spanish law. As I understand it, the reason why Lilly contends that the relevant law is English law is because the court whose process Lilly claims is being abused is the English court. I am unable to understand why, if Lilly is correct that the relevant rules are substantive rules governed by the lex loci protectionis, the question whether it is legitimate for Actavis to try to ensure compliance with those rules by starting fresh actions during the pendency of earlier actions or by amending pending actions should be judged by [2015] R.P.C., Issue 2 reference to the lex fori. Be that as it may, I will consider the merits of Lilly’s arguments on the assumption that it is correct as to the applicable law for this purpose. It is convenient first to consider the Amendment Abuse Argument. This relates to route 3 in respect of the Spanish designation. As I have explained, route 3 relies upon the amendments to the First and Third Actions made on 22 October 2013. Counsel for Lilly submitted that route 3 failed because the amendments were an abuse of process. I do not consider that this argument is open to Lilly for the following reasons. First, the order giving Actavis permission to make those amendments provided that the amendments would be made “without prejudice to Lilly’s or Actavis’ ability to argue such points as they may have as to the effect of those amendments in respect of the Fourth Action”. Lilly’s purpose in seeking this qualification was, as counsel for Lilly made clear at the hearing on 17 October 2013, to ensure that it was not prevented by the amendments from arguing that the Fourth (or any later) Action was an abuse of process. Lilly did not resist the amendments on the ground that they were in and of themselves an abuse of process. Secondly, Lilly has not appealed or applied to set aside that part of the order of 17 October 2013. Thirdly, Lilly has not pleaded that the amendments were an abuse of process. Even if the argument is open to Lilly, I do not accept it. As I have pointed out, Actavis were given permission to make the amendments by an order of this Court. There is no dispute that this Court had power under the Civil Procedure Rules to give Actavis permission to make the amendments. Furthermore, viewed from the perspective of English procedural law, there was nothing abusive about Actavis’ application for permission to make the amendments, which is precisely why Lilly did not in the end resist it provided that permission was qualified in the way that I have described. Even if Lilly is right that no such amendment could be made under Spanish procedural law, and the claimant would have to start a new action, that is immaterial. I turn to consider the Main Abuse Argument. The applicable principles can be summarised as follows. In Hunter v Chief Constable of the West Midlands [1982] AC 529 at p.536, Lord Diplock referred to: “. . . the inherent power which any court of justice must possess to prevent misuse of its procedure in a way which, although not inconsistent with the literal application of its procedural rules, would nevertheless be manifestly unfair to a party to litigation before it, or would otherwise bring the administration of justice into disrepute among right–thinking people. The circumstances in which abuse of process can arise are very varied . . . . It would, in my view, be most unwise if this House were to use this occasion to say anything that might be taken as limiting to fixed categories the kinds of circumstances in which the court has a duty (I disavow the word discretion) to exercise this salutary power.” As Lord Bingham of Cornhill explained in Johnson v Gore Wood & Co [2002] 2 AC 1 at p.31, this involves: “. . . a broad, merits–based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court. . .” In the context of the Civil Procedure Rules, assessment of whether there is an abuse of process is inseparably bound up with the question of what the overriding objective Published by Oxford University Press for the Intellectual Property Office “An abuse of process is of concern not merely to the parties but to the court. It is no longer the role of the court simply to provide a level playing field and to referee whatever game the parties choose to play upon it. The court is concerned to ensure that judicial and court resources are appropriately and proportionately used in accordance with the requirements of justice.” Furthermore, even where the claimant has been guilty of an abuse of process, it does not necessarily follow that his claim must be struck out if that would be a disproportionate sanction in the circumstances: see Summers v Fairclough Homes Ltd [2012] UKSC 26, [2012] 1 WLR 2004. As the decision of the Supreme Court in that case indicates, this is particularly true where there has been a fair trial of the merits of the claim and the claim has been upheld at least to some extent. As was indicated in the Hunter case, the categories of abuse of process are not closed. There are a number of established situations in which abuse of process may be recognised. One is where the court’s process is being used for an improper or collateral purpose: see in particular Goldsmith v Sperrings Ltd [1977] 1 WLR 478, [1977] 2 All ER 566. Another is re-litigation of matters that could and should have been litigated previously: see in particular Johnson v Gore Wood. A third is where it is plain that the litigation is pointless and wasteful: see in particular Jameel v Dow Jones. A fourth is where the claimant advances a false case and/or relies upon false evidence: see in particular Summers v Fairclough. The particular form of abuse which Lilly invokes is that which can arise where the claimant has framed its claim in such a manner as to attempt to circumvent a time restriction. Counsel for Lilly relied, in particular, upon the decision of Jackson J. (as he then was) in Carter Commercial Developments v Bedford Borough Council [2001] EWHC 669 (Admin) applying the judgment of the Court of Appeal in Clark v University of Lincolnshire and Humberside [2000] 1 WLR 1988, [2000] 2 All ER 752. In Carter, the gravamen of the complaint of abuse of process was concisely identified by the judge at [30] as follows: “The issues which the claimant seeks to raise are plainly public law issues and should properly be dealt with by judicial review proceedings under Part 54. The reason why the claimant has resorted to the Part 8 procedure is obvious. The claimant is seeking to circumvent the time limits contained in Part 54.” As will be clear from that quotation, the claimant was well out of time for an application for judicial review under Part 54 and was, therefore, seeking to bring private law proceedings under Part 8 instead. That was held to be an abuse of process because the claimant should have proceeded by way of judicial review. Thus the claimant was clearly using the procedures of the court in an improper way. As counsel for Actavis submitted, however, it is not an abuse of process to bring a further claim on the same cause of action during the pendency of an existing claim if there is a good reason for doing so and case management tools like consolidation are used to avoid unnecessary duplication of effort and cost: see Rosenberg v Nazarov [2008] EWHC 812 (Ch) at [71]–[77] (Thomas Ivory Q.C. sitting as a Deputy High Court Judge). A common example of this in the intellectual property field is where the claimant is relying upon a cause of action, such as secondary infringement of copyright, which requires knowledge or reason for belief on the part of the [2015] R.P.C., Issue 2 Crown Copyright defendant. Prior to the CPR, it was common for claimants, where there was doubt that the defendant had the requisite knowledge or reason for belief as at the date of the writ, but it was clear that the defendant did have it at a later date, to issue a second writ and apply to consolidate the two actions or to have them heard together. Under the CPR it is possible to take the simpler course of pleading facts arising after the date of the claim form. If there was doubt about that, however, it would not be an abuse of process for the claimant to issue a second claim form in order to ensure that it was able to rely upon the defendant’s knowledge or reason for belief as at the date of the second claim form in the alternative to the date of the first claim form and then to apply for the two claims to be heard together on the same evidence. In my judgment what Actavis have done in the present case is no different in principle to what I have just described. Lilly contends that it is different because the lis pendens effect of the First and Third Actions deprived it of the opportunity of responding to Actavis’ later taking position letters by bringing infringement proceedings in France and Spain. As to that, my view remains as stated in my judgment dated 27 November 2013 at [33]: “. . . the problem which Lilly says exists is one which exists, to the extent that it does, by virtue of the First and Third Actions and the consequences of the pendency of those actions. There is, and can be, no dispute that the First and Third Actions are properly constituted actions over which it has been decided that this court has jurisdiction. Those actions have whatever consequences in terms of lis pendens that they have. If Lilly is correct in saying that the lis pendens consequences of those actions is to prevent Lilly from bringing actions in France and Spain and thus of depriving Lilly of the procedural protections to which it claims to be entitled under French and Spanish law, as to which I express no view, then that is a natural consequence of the existence of the First and Third Actions. It is not a consequence of the bringing of the Fourth and Fifth Actions. In those circumstances, I cannot see that the Fourth and Fifth Actions are an abuse. Actavis are simply taking ordinary procedural steps to overcome procedural obstacles raised by Lilly.” Lilly argues that this is wrong because Actavis should have discontinued the First and Third Actions before commencing the later Actions, and even before writing the letters upon which those Actions are founded. I see no reason, however, why Actavis should have been obliged to discontinue claims which were properly constituted, jurisdictionally well founded and had a perfectly good prospect of success. Even if Actavis should have discontinued the First and Third Actions because they were destined to fail, that would at best found an argument that maintaining the First and Third Actions was an abuse. It would not follow that bringing the Fourth and subsequent Actions was an abuse. So Lilly’s argument has to be that, given that the First and Third Actions were maintained, it was an abuse to bring the later Actions. But that simply amounts to saying that it was an abuse for Actavis to pursue an alternative case while maintaining their primary case, which is commonplace in English litigation (and in litigation in many other legal systems). I would add two points. The first is that Lilly’s argument makes it clear that what Lilly is really complaining about is not the bringing of the Fourth and subsequent Actions during the pendency of the First and Third Actions, but the fact that Actavis have brought these proceedings before this Court. That complaint is not open to Lilly, however, because its jurisdictional challenge to the First and Second Published by Oxford University Press for the Intellectual Property Office 375 Actions failed and it has rightly accepted that this Court has jurisdiction over the Third and subsequent Actions. Furthermore, it is not an abuse of process for a claimant to bring a claim before a forum which he perceives to be more advantageous (e.g. because it is quicker) in order to forestall the defendant from bringing proceedings in a forum which the claimant perceives to be less advantageous (e.g. because it is slower) provided that the first forum is one which properly has jurisdiction in respect of the claim: see Research In Motion UK Ltd v Visto Corp [2008] EWCA Civ 153, [2008] F.S.R. 20 at [12]–[17] (Jacob L.J.) and Pell Frischmann Consultants Ltd v Prabhu [2013] EWHC 2203 (Ch), [2013] ICR 153. The second point is that Lilly can only complain that it has been the victim of an abuse of process in this respect if it has been prevented by Actavis’ conduct from bringing infringement actions against Actavis in France and Spain that it would otherwise have brought. Lilly has not adduced any evidence, nor even asserted through counsel’s submissions, that it would have brought such actions but for Actavis’ conduct, however. By contrast, Lilly has brought and pursued a claim in Germany even though this Court was first seized. Lilly’s stance with regard to France and Spain is simply obstructive. 376 requires. Thus, as Lord Phillips of Worth Matravers M.R. said in Jameel v Dow Jones & Co Inc [2005 ] EWCA Civ 75 , [2005] QB 946 at [54]:


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ACTAVIS UK LTD v ELI LILLY & CO 1, Reports of Patent, Design and Trade Mark Cases, 2015, 73-173, DOI: 10.1093/rpc/rcv017