Actavis Group HF v Eli Lilly and Company

Hearing dates: 14–15 November 2012

Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

Contents

Introduction

Pemetrexed is a cancer treatment which has been marketed by the Defendant ("Lilly") or its subsidiaries under the brand name Alimta since 2004. It was protected by a basic patent that has been extended by Supplementary Protection Certificates ("the SPCs") which will expire in December 2015. Lilly also owns European Patent No. 1 313 508 ("the Patent"), which will not expire until June 2021, for the use of pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof. The Claimants (whom I will refer to as "Actavis" save when it is necessary to distinguish between them) contend that dealings in pemetrexed dipotassium will not infringe the Patent. Lilly disputes this. Actavis would like a resolution of this issue in good time for them to enter the market on expiry of the SPCs. Furthermore, Actavis would like the issue to be determined with respect to the French, German, Italian, Spanish and United Kingdom designations of the Patent, which cover the major pharmaceutical markets in Europe, in a single trial. Accordingly, Actavis have commenced these proceedings seeking declarations of non-infringement of each of those designations of the Patent. Actavis do not challenge the validity of the Patent in these proceedings. By the applications which are now before the Court, Lilly seeks declarations that this Court does not have, alternatively should not exercise, jurisdiction in respect of the French, German, Italian and Spanish designations of the Patent. Lilly does not contest the Court's jurisdiction with regard to the UK designation.

Background

The parties

The Actavis group of companies is a well-known multinational supplier of generic pharmaceuticals. The Actavis group presently has its headquarters in Switzerland, having moved there from Iceland in 2009. Watson Pharmaceuticals is currently in the process of acquiring the Actavis group, and as a result certain changes have recently been made to the corporate structure of the Actavis group, but for the purposes of the present applications these can be ignored. The ultimate holding company of the Actavis group is Actavis Equity S.àr.l, a company incorporated in Luxembourg. The parent operating company is a company which in July 2012 was called Actavis Group hf ("Actavis Group"), a company incorporated in Iceland. Actavis Group has a considerable number of subsidiaries incorporated in different countries which are responsible for selling the group's products. These include Actavis France, Actavis Deutschland GmbH & Co KG ("Actavis Deutschland"), Actavis Italy SpA, Actavis Spain SA and Actavis UK Ltd. Actavis Group PTC ehf ("Actavis PTC"), a company incorporated in Iceland, is another subsidiary of Actavis Group. Actavis PTC has a number of subsidiaries, including Actavis hf and Medis ehf ("Medis"), both companies incorporated in Iceland; but these do not include the national sales subsidiaries for France, Germany, Italy, Spain or the UK.

Lilly is incorporated in the State of Indiana, United States of America. Lilly has a considerable number of subsidiaries, including Eli Lilly and Company Ltd ("Lilly UK"), which is incorporated in England.

The Patent

The Patent has an earliest claimed priority date of 30 June 2000, a filing date of 15 June 2001 and a date of grant of 18 April 2007. The specification is entitled "Combination containing an antifolate and methylmalonic acid lowering agent". The representative identified on the first page of the specification is as follows:

"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)"

The only independent claims are claim 1 and 12, which are 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, 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

On 12 July 2012 Actavis' solicitors Bird & Bird wrote to Lilly at "C/O Ivan J. Burnside, Lilly Research Centre, Erl Wood Manor, Windlesham, Surrey GU20 6PH". This is Lilly's address for service registered with the Intellectual Property Office in respect of the UK designation of the Patent pursuant to rule 103 of the Patents Rules 2007. It may be noted that the addresses for service in respect of the French, German, Italian and Spanish designations are the addresses of local patent attorneys in the respective jurisdictions.

Given the importance of the terms of this letter to the issues on the present application, it is necessary to set out almost all of it:

" 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...