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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Actavis Group HF v Eli Lilly & Company [2012] EWHC 3316 (Pat) (27 November 2012) URL: https://www.bailii.org/ew/cases/EWHC/Patents/2012/3316.html Cite as: [2012] EWHC 3316 (Pat) |
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CHANCERY DIVISION
PATENTS COURT
Fetter Lane, London, EC4A 1NL |
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B e f o r e :
____________________
ACTAVIS GROUP HF |
Claimant |
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- and - |
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ELI LILLY AND COMPANY |
Defendant |
|
And between : |
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MEDIS EHF |
Claimant |
|
- and - |
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ELI LILLY AND COMPANY |
Defendant |
____________________
Stephen Phillips QC and Thomas Mitcheson (instructed by Hogan Lovells International LLP) for the Defendant
Hearing dates: 14-15 November 2012
____________________
Crown Copyright ©
MR JUSTICE ARNOLD :
Contents
Topic | Paragraphs |
Introduction | 1 |
Background | 2-23 |
 The parties | 2-3 |
 The Patent | 4-5 |
 The pre-action correspondence | 6-10 |
 The First Claim | 11-16 |
 The Second Claim | 17-20 |
 The German proceedings | 21 |
 France, Italy and Spain | 22 |
 European Patent Office opposition | 23 |
Matters not in dispute | 24-34 |
The issues | 35 |
Was service of the First Claim validly effected under the consent for service? | 36-60 |
 The law | 36-39 |
 Assessment | 40-60 |
Did the consent extend to a claim by Actavis Group? | 41-52 |
Did the consent extend to a claim in respect of the non-UK designations of the Patent? | 53-59 |
Conclusion | 60 |
Was service of the First Claim validly effected under CPR r.63.14(2)(a)? | 61-66 |
Was service of the First Claim validly effected under CPR r.6.9(2)? | 67-80 |
 The law | 67-71 |
 Assessment | 72-80 |
Was service of the Second Claim validly effected under the consent for service? | 81 |
Was there consent to jurisdiction? | 82 |
Forum non conveniens | 83-105 |
 The law | 84 |
 Assessment | 85-105 |
Summary of conclusions | 106 |
Introduction
Background
The parties
The Patent
"Burnside, Ivan John et al
Eli Lilly and Company Limited
European Patent Operations
Lilly Research Centre
Erl Wood Manor
Sunnighill [sic] Road
Windlesham, Surrey GU20 6PH (GB)"
"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, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-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."
The pre-action correspondence
"EP 1 313 508 ("the Patent")
We represent Actavis Group PTC ehf and its relevant national subsidiaries ("Actavis").
You are registered as the proprietor of European Patent (UK) No. 1 313 508 B1 entitled "Combination containing an antifolate and methylmalonic acid lowering agent" that is currently valid until 15 June 2021.
The purpose of this letter is to put you on notice that Actavis wishes at the expiry of SPC/GB05/011 to launch a pemetrexed product for use in the manufacture of a medicament for use in combination therapy for inhibiting tumour growth in mammals in the United Kingdom. At the same time (i.e. upon expiry of the equivalent SPCs) Actavis similarly wishes to launch such a product in other jurisdictions, including but not limited to Germany, France, Italy and Spain.
Actavis is aware of the Patent. We should be grateful if you would treat this letter as relating to the national designations of EP 1 313 508 B1 in Germany (DE60127970 (T2)), France (EP 1 313 508 B1), Italy (ES2284660 (T3)), and the United Kingdom, Actavis has no wish to engage in litigation with you about the Patent but will do so if necessary. The purpose of this letter is to attempt to avoid such litigation.
On this basis and in accordance with section 71 of the Patents Act 1977 and/or the inherent jurisdiction of the Court, our client hereby seeks a written acknowledgement from the proprietor of the Patent that each of the proposed acts alone set out below would not constitute an infringement of the Patent:
1. Actavis imports, keeps, offers for disposal and disposes of medicaments in the United Kingdom containing pemetrexed dipotassium for use in combination therapy for inhibiting tumour 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.
2. Actavis imports, keeps, offers for disposal or disposes of medicaments in the United Kingdom containing pemetrexed dipotassium for use in combination therapy for inhibiting tumour 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 hydroxocobalmin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin and a folic binding protein binding agent selected from folic acis, (6R)-5-methly-5,6,7,8-tetrahydrofolic acid and (6R)-5-forinyl-5,6,7,8-tetrahydrofolic acid of a physiologically available salt or ester thereof.
We consider that the answer to the proposed acts should be the same across Europe in relation to the acts specified in the national provisions equivalent to section 60 of the Patents Act. Accordingly, we assume that if you are prepared to provide the declarations sought in accordance with section 71 of the Patents Act that you will also be willing to provide such an acknowledgement that such acts in each and all of the jurisdictions where the Patent is in force or where the national patents specified above are registered would not infringe such patents. We should be grateful if you would also provide us with such a written acknowledgement.
For the avoidance of doubt and given other relevant constraints, Actavis is not planning an imminent launch of such a product.…"
"We consider that your client is, and has been since 12 July 2012, in possession of all the facts that it needs in order to provide the written acknowledgements sought by our client. If the acknowledgments have not been provided to us by 4:00 pm on Tuesday 31 July 2012, our client intends to serve proceedings on your client seeking appropriate declarations from the Court. We should be grateful if you would inform us by return whether or not you are instructed to accept service of such proceedings."
"We confirm that we are instructed to accept service on behalf of our client."
The First Claim
"In your letter of 31 July 2012, you confirmed that you were instructed to accept service on behalf of your client (Eli Lilly & Company). As you are aware, the proprietor of the Patent is Eli Lilly & Company. You will also be aware that the proprietor of the Related Patents is the same Eli Lilly & Company. Accordingly, upon receipt by you of this letter and the enclosures Eli Lilly & Company has been served in relation to the action as a whole and that [sic] there is no requirement for our client to go to the time and expense of serving these same proceedings on the addresses for service for the Related Patents."
The Second Claim
The German proceedings
France, Italy and Spain
European Patent Office opposition
Matters not in dispute
The issues
i) Was service of the First Claim validly effected:
a) under the consent for service contained in Hogan Lovells' letter dated 31 July 2012,
b) under CPR r. 63.14, and/or
c) under CPR r. 6.9?
ii) Was service of the Second Claim validly effected under the consent for service? (The issues under CPR rr. 63.14 and 6.9 are identical for the Second Claim.)
iii) If the consent for service covers the First (or Second) Claim, was it also a consent to jurisdiction?
iv) If service has been validly effected, but there has been no consent to jurisdiction, should the Court decline to exercise its jurisdiction on the ground of forum non conveniens?
Was service of the First Claim validly effected under the consent for service?
The law
"The meaning of words, as they would appear in a dictionary, and the effect of their syntactical arrangement, as it would appear in a grammar, is part of the material which we use to understand a speaker's utterance. But it is only a part; another part is our knowledge of the background against which the utterance was made. It is that background which enables us, not only to choose the intended meaning when a word has more than one dictionary meaning but also, in the ways I have explained, to understand a speaker's meaning, often without ambiguity, when he has used the wrong words."
"The 'rule' that words should be given their 'natural and ordinary meaning' reflects the common sense proposition that we do not easily accept that people have made linguistic mistakes, particularly in formal documents. On the other hand, if one would nevertheless conclude from the background that something must have gone wrong with the language, the law does not require judges to attribute to the parties an intention which they plainly could not have had."
Assessment
Was service of the First Claim validly effected under CPR r. 63.14(2)(a)?
"(1) Subject to paragraph (2), Part 6 applies to service of a claim form and any document in any proceedings under this Part."
(2) A claim form relating to a registered right may be served–
(a) on a party who has registered the right at the address for service given for that right in the United Kingdom Patent Office register, provided the address is within the United Kingdom; or
(b) in accordance with rule 6.32(1), 6.33(1) or 6.33(2) on a party who has registered the right at the address for service given for that right in the appropriate register at—
(i) the United Kingdom Patent Office; or
(ii) the Office for Harmonisation in the Internal Market."
"(1) This Part applies to all intellectual property claims including-
(a) registered intellectual property rights such as
(i) patents;
…
(2) In this Part –
(a) 'the 1977 Act' means the Patents Act 1977;
…
(e) 'patent' means a patent under the 1977 Act …
…"
Was service of the First Claim validly effected under CPR r. 6.9(2)?
The law
"… in practice a real problem will normally only arise where the corporation's business is alleged to be carried on by a representative or agent, who is not an officer or employee of the corporation, and who may act as a representative or agent for other corporations in addition. Service may be effected on the representative or agent if the business is that of the corporation, and not solely the business of the representative or agent who acts for it in England. Where the representative or agent has power to make contracts on behalf of the foreign corporation and displays its name on his premises, there will be little difficulty in establishing that the place of business is that of the corporation"
"(a) whether or not the fixed place of business from which the representative operated was originally acquired for the purpose of enabling him to act on behalf of the corporation; (b) whether the corporation had directly reimbursed him for (i) the cost of his accommodation at the fixed place of business; (ii) the cost of his staff; (c) what other contribution, if any, the overseas corporation made to the financing of the business carried on by the representative; (d) whether the representative was remunerated by reference to transactions, e.g. by commission, or by fixed regular payments or in some other way; (e) what degree of control the corporation exercised over the running of the business conducted by the representative; (f) whether the representative reserved part of his accommodation or part of his staff for conducting business related to the corporation; (g) whether the representative displayed the corporation's name at his premises or on his stationery, and if so, whether he did so in such a way as to indicate that he was a representative of the corporation; (h) what business, if any, the representative transacted as principal exclusively on his own behalf; (i) whether the representative made contracts with customers or other third parties in the name of the corporation, or otherwise in such manner as to bind it; (j) if so, whether the representative required specific authority in advance before binding the corporation to contractual obligations."
Assessment
"Ivan Burnside is Sr. Director-Assistant General Patent Counsel at Eli Lilly and Company. … He trained in a London Private Practice firm before joining Eli Lilly and Company in January 2001. … Ivan is based in the United Kingdom and reports to Vice President-Deputy General Patent Counsel, located in the United States of America. He is head of European Patent Operations Department covering prosecution, oppositions, appeals, defense and enforcement (litigation) of patents in the European region, IP aspects of parallel trade in Europe, customs and excise procedures and IP advocacy activities. "
"Authority to approve and execute for and on behalf of the Company, documents in connection with patent matters in Europe relating to:
(i) the institution, prosecution, and completion of proceedings directed towards the issuance of patents;
(ii) the amendment, restriction, renewal, reissue, revival, maintenance, restoration, cancellation, extension and abandonment of patents and applications for patents;
(iii) the institution, prosecution, and termination of proceedings of opposition, revocation, and nullification, including the filing of preliminary statements, concessions of priority, disclaimers, abandonments of the contents, and abandonments of the invention, the institution of any revocation or nullification being subject to prior approval by the Senior Vice President and General Counsel of the Company;
(iv) the institution, prosecution, and termination of proceedings of enforcement of patents, including the filing of applications for interim, interlocutory and preliminary injunctions, and all other proceedings for infringement of patents, the initiation of such proceedings being subject to prior approval by the Senior Vice President and General Counsel of the Company;
(v) the settlement of patent proceedings of opposition, revocation, nullification and enforcement, subject to prior approval by the Senior Vice President and General Counsel of the Company;
(vi) the filings of statutory disclaimers;
(vii) the institution, prosecution, and termination of appellate proceedings; and
(viii) the granting and the revocation of powers of attorney in connection with any of the foregoing."
a) The Lilly Research Centre was set up in 1967. It is not clear how long the European Patent Operations Department has been based there, but it does not appear that the premises were acquired by Lilly UK for the purpose of housing the Department.
b) It appears that the day to day operations of the Department are funded by Lilly UK, and in particular that Lilly UK pays the salaries of the employees, but it is not clear whether or not Lilly UK receives any reimbursement from Lilly.
c) It is not clear whether or not Lilly makes any other contribution to the financing of the Department.
d) It does not appear that the Department is remunerated by Lilly for its work whether by commission or otherwise.
e) It appears that Lilly does exercise overall management control over the Department, while allowing the Department a fair degree of autonomy as shown by Dr Burnside's authority.
f) Part of the Centre and the whole of the Department are reserved for conducting Lilly's European patent business (although the Department also handles the European patent business of other Lilly subsidiaries).
g) Dr Burnside's business card, email signature and speaker biography present him as representing Lilly, albeit that the first two also give Lilly UK as part of his address.
h) The Department does not appear to transact much business on behalf of Lilly UK as distinct from Lilly (or other Lilly subsidiaries).
i) The Department does make contracts in the name of Lilly, as discussed above.
j) Dr Burnside requires approval in relation to some matters, but not others.
Was service of the Second Claim validly effected under the consent for service?
Was there consent to jurisdiction?
Forum non conveniens
The law
"(a) The basic principle is that a stay will only be granted on the ground of forum non conveniens where the court is satisfied that there is some other available forum, having competent jurisdiction, which is the appropriate forum for the trial of the action, i.e. in which the case may be tried more suitably for the interests of all the parties and the ends of justice.
…
(d) Since the question is whether there exists some other forum which is clearly more appropriate for the trial of the action, the court will look first to see what factors there are which point in the direction of another forum. These are the factors which Lord Diplock described, in MacShannon's case [1978] A.C. 795, 812, as indicating that justice can be done in the other forum at 'substantially less inconvenience or expense.' … Lord Keith of Kinkel, in The Abidin Daver [1984] A.C. 398, 415, … referred to the 'natural forum' as being 'that with which the action had the most real and substantial connection.' So it is for connecting factors in this sense that the court must first look; and these will include not only factors affecting convenience or expense (such as availability of witnesses), but also other factors such as the law governing the relevant transaction …, and the places where the parties respectively reside or carry on business.
(e) If the court concludes at that stage that there is no other available forum which is clearly more appropriate for the trial of the action, it will ordinarily refuse a stay …
(f) If however the court concludes at that stage that there is some other available forum which prima facie is clearly more appropriate for the trial of the action, it will ordinarily grant a stay unless there are circumstances by reason of which justice requires that a stay should nevertheless not be granted. In this inquiry, the court will consider all the circumstances of the case, including circumstances which go beyond those taken into account when considering connecting factors with other jurisdictions. One such factor can be the fact, if established objectively by cogent evidence, that the plaintiff will not obtain justice in the foreign jurisdiction …"
Assessment
"For myself I would not welcome the task of having to decide whether a person had infringed a foreign patent. Although patent actions appear on their face to be disputes between two parties, in reality they also concern the public. A finding of infringement is a finding that a monopoly granted by the state is to be enforced. The result is invariably that the public have to pay higher prices than if the monopoly did not exist. If that be the proper result, then that result should, I believe, come about from a decision of a court situated in the state where the public have to pay the higher prices. One only has to imagine a decision of this court that the German public should pay to a British company substantial sums of money to realise the difficulties that might arise. I believe that, if the local courts are responsible for enforcing and deciding questions of validity and infringement, the conclusions reached are likely to command the respect of the public. Also a conclusion that a patent is infringed or not infringed involves in this country a decision on validity as in this country no man can infringe an invalid patent. In the present case the plaintiffs admit the validity of the patent and therefore there is no dispute upon the matter. However, it will be implicit in the judgment of this court that there has been infringement, and that, between the parties, the patent is valid. Thus, I believe it is at least convenient that infringement, like validity, is decided in the state in which it arises."
"108. There is no doubt that the modern trend is in favour of the enforcement of foreign intellectual property rights. First, article 22(4) of the Brussels I Regulation only assigns exclusive jurisdiction to the country where the right originates in cases which are concerned with registration or validity of rights which are 'required to be deposited or registered' and does not apply to infringement actions in which there is no issue as to validity. This can rarely, if ever, apply to copyright. Second, the Rome II Regulation also plainly envisages the litigation of foreign intellectual property rights and, third, the professional and academic bodies which have considered the issue, the American Law Institute and the Max Planck Institute, clearly favour them, at any rate where issues of validity are not engaged.
109. There are no issues of policy which militate against the enforcement of foreign copyright. States have an interest in the international recognition and enforcement of their copyrights …. Many of the points relied on by the Court of Appeal to justify the application of the Moçambique rule in this case as a matter of policy would apply to many international cases over which the English court would have jurisdiction and would in principle exercise it, especially the suggestion that questions of foreign law would have to be decided. It was also said by the Court of Appeal that enforcement of foreign intellectual property law might involve a clash of policies such that a defendant may be restrained by injunction from doing acts in this country which are lawful in this country. But such an injunction will be granted only if the acts are anticipated to achieve fruition in another country, and there is no objection in principle to such an injunction. Nor is there any objection in principle, as the Court of Appeal thought, to a restraint on acts in another country. Extra-territorial injunctions are commonly granted here against defendants subject to the in personam jurisdiction. …"
"21. … No doubt it is convenient and generally speaking desirable that, say, the law of Denmark should be considered and applied by Danish courts. For that purpose the foreign court would be the forum conveniens. But the courts here frequently have to determine issues of foreign law. The choice would appear to be between one action here with evidence relating to the law in 12 countries or separate actions in each of thirteen countries (assuming, of course, that under the Brussels Convention each and all of the foreign courts would be permitted to accept jurisdiction). If the former course is taken, although there may be separate issues relating to the law of joint tortfeasance in each country, it is likely that the law of infringement and validity will be in nearly all respects identical since each country has tried to implement the provisions of the EPC. On the other hand if the latter course is taken, in each of thirteen countries the national courts will be asked to determine the same issues of infringement and validity. This will involve preparing and producing evidence in each countries and 26 teams of lawyers will have to be instructed.
22. I have no doubt that one action would be quicker, cheaper and more convenient. It will reduce the possibility of conflicting decisions on the same EPC issues. In addition the Convention is designed to produce a uniform international code in accordance with which litigation is directed to specified national courts. It is well known and established that considerations of forum conveniens is not a relevant consideration under the Convention. I can think of no circumstances which would justify me exercising any discretion I may have so as to make an order which prevents a party from litigating in a court in which, in accordance with the provisions of the Convention, he is entitled to sue."
"Both parties provided expert evidence on the relevant German law, that evidence being given by Mr Peter Von Rospatt for the claimant and by Mr Matthias Brandi-Dohrn for the defendant. Although those witnesses disagreed on a few important issues, the parties agreed to forego the right to cross-examine. Their position is that the relevant German case law has been identified and they are content that I should read that for the purpose of resolving relevant areas of dispute."
Furthermore, it is increasingly common in intellectual property cases for the courts of this country to apply case law from other EU Member States when deciding questions of European Union law or national law based on European conventions such as the CPC: see, for example, Grimme Landmaschinenfabrik GmbH & Co KG v Scott [2010] EWCA Civ 1110, [2011] FSR 7.
Summary of conclusions
i) Lilly consented to service of the First Claim, and thereby consented to the jurisdiction of this Court over it.
ii) The First Claim was not validly served pursuant to CPR r. 63.14(2)(a).
iii) The First Claim was validly served pursuant to CPR r. 6.9(2).
iv) Lilly did not consent to service of the Second Claim. Otherwise, the conclusions with regard to service of the First Claim also apply to the Second Claim.
v) If Lilly did not consent to service, but the First Claim was validly served pursuant to either CPR r. 63.14(2)(a) or CPR r. 6.9(2), no stay of Actavis' claims under the non-UK designations of the Patent should be granted on forum non conveniens grounds.