Les Laboratoires Servier v Apotex Inc.

JurisdictionEngland & Wales
JudgeTHE HON MR JUSTICE ARNOLD
Judgment Date29 March 2011
Neutral Citation[2011] EWHC 730 (Pat)
Docket NumberCase No: 06C03050
CourtChancery Division (Patents Court)
Date29 March 2011
Between:
(1)les Laboratoires Servier
(2)servier Laboratories Limited
Claimants
and
(1)apotex Inc
(2)apotex Pharmachem Inc
(3)apotex Europe Limited
(4)apotex Uk Limited
Defendants

[2011] EWHC 730 (Pat)

Before:

The Hon Mr Justice Arnold

Case No: 06C03050

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Royal Courts of Justice

Strand, London, WC2A 2LL

Iain Purvis QC (instructed by Bristows) for the Claimants

Antony Watson QC and Simon Salzedo (instructed by Taylor Wessing) for the Defendants

Hearing dates: 15–16 March 2011

Approved Judgment

THE HON MR JUSTICE ARNOLD

MR. JUSTICE ARNOLD :

Introduction

1

The issue I have to decide in this case is whether a patentee who has obtained an interim injunction from this court to restrain infringement of a European patent (UK) which is subsequently held invalid should compensate the defendant for losses sustained as a result of being prevented by the injunction from selling goods manufactured by the defendant in infringement of a valid foreign patent owned by the same group of companies.

2

This is the second occasion on which I have had to consider the impact of illegality on a claim under a cross-undertaking in damages, the first being my judgment in Lilly Icos LLC v 8PM Chemists Ltd [2009] EWHC 1905 (Ch), [2010] FSR 4.

Background

The parties

3

Les Laboratories Servier is a French pharmaceutical company which was the proprietor of European Patent No. 1 296 947 ("the European Patent"). Servier Laboratories Ltd is an English company which was the exclusive licensee under the UK designation of the European Patent. Both companies are part of same group of companies. I shall refer to the group and its individual companies as "Servier" save where it is necessary to distinguish between them.

4

Apotex Inc and Apotex Pharmachem Inc are Canadian pharmaceutical companies which specialise in manufacturing and marketing generic pharmaceutical products. Apotex Europe Ltd and Apotex UK Ltd are English companies in the same group of companies. I shall refer to the group and its individual companies as "Apotex" save where it is necessary to distinguish between them.

Perindopril erbumine

5

One of Servier's products is perindopril erbumine (also known as perindopril tert-butylamine). Perindopril erbumine is a long-acting ACE (Angiotensin-Converting Enzyme) inhibitor used for treating hypertension and cardiac insufficiency. It is marketed by Servier under the trade mark COVERSYL. Servier discovered perindopril and its tert-butylamine salt, and obtained patent protection for them in many countries. It has been both therapeutically and commercially a very successful product.

Servier's European patents

6

In Europe, Servier's first and basic patent covering perindopril erbumine was European Patent No. 0 049 658 ("658"), which had a priority date of 2 October 1980. 658 expired on 29 September 2001. The protection conferred by 658 was extended by a supplementary protection certificate which expired on 21 June 2003.

7

Servier also obtained a number of further patents relating to perindopril erbumine. European Patent No 0 380 341 ("341"), which was filed on 16 September 1988 and expired on 16 September 2008, covered a process for making perindopril erbumine. On 6 July 2000 Servier filed priority applications for three patents each of which covered one of the three crystalline forms of perindopril erbumine (a, b and ?) which had been discovered. The European Patent was subsequently granted in respect of the a form, European Patent No. 1 294 689 in respect of the B form and European Patent No. 1 296 948 in respect of the ? form.

8

The European Patent was granted on 4 February 2004. It was opposed by ten opponents, but not by Apotex. At the hearing of the opposition on 27 July 2006 the Opposition Division decided to maintain the European Patent for reasons which it gave on 21 September 2006. Most of the opponents appealed. By a decision dated 6 May 2009 T1753/06 the Technical Board of Appeal revoked the European Patent. That was over 5 years after the European Patent had been granted. As will appear, the events with which I am concerned occurred during that interval.

The English infringement proceedings

9

On 1 March 2006 Apotex's solicitors wrote to Servier's patent attorneys notifying them that Apotex intended to start marketing generic perindopril erbumine in June 2006. This led to correspondence between the parties' solicitors. During the course of that correspondence, on 26 April 2006 Apotex's solicitors sent Servier's solicitors a confidential description of Apotex's process for manufacturing perindopril erbumine. This stated that the finished product was manufactured by Apotex Pharmachem Inc. On 9 May 2006 Apotex's solicitors sent Servier's solicitors samples of tablets containing 2 mg, 4 mg and 8 mg of perindopril erbumine and of the active pharmaceutical ingredient ("API").

10

On 13 June 2006 Servier's solicitors wrote to Apotex's solicitors asking for further information on a number of points. This letter included the following paragraph:

"Your client's samples also appear to have originated in Canada, and the chemistry described by Section D of your client's Confidential Process Description dated 26 April 2006 (the 'Process Description') is stated to be carried out at Apotex Pharmachem Inc. As your client will be aware, our client has a product patent on perindopril erbumine in Canada that does not expire until 2018. For this reason also we doubt that the sample you have provided is a product of your client's industrial manufacturing line. Please would you clarify the situation."

11

Apotex's solicitors replied on 20 July 2006 saying:

"We do not see the relevance of the points raised in relation to where the product is manufactured or our client's regulatory position. As stated above, we can confirm that the samples are a product of our client's industrial manufacturing line."

12

On 24 July 2006 Apotex received marketing authorisations enabling it to market tablets containing 2mg, 4 mg and 8 mg perindopril erbumine in the United Kingdom. These authorisations specified that the API was manufactured by Apotex Pharmachem Inc in Canada and then formulated into tablets by Apotex Inc also in Canada, but that information was not publicly available. On 28 July 2006 Apotex UK Ltd started selling in the United Kingdom perindopril erbumine tablets imported from Canada. Apotex was the first supplier to market a generic version of perindopril erbumine in the United Kingdom. Between 28 July 2006 and 3 August 2006 Apotex made sales worth over £4.1 million.

13

On 1 August 2006 Servier commenced proceedings against Apotex Inc, Apotex Pharmachem Inc and Apotex Europe Ltd for infringement of the European Patent by importing, keeping, offering to dispose of and disposing of perindopril erbumine, alternatively threatening to do such acts. In its Particulars of Infringement Servier pleaded, on the basis of the statements made in the Process Description and in Apotex's solicitors' letter dated 20 July 2006, that the product was made by Apotex Pharmachem Inc on behalf of and under the control of Apotex Inc.

14

On 2 August 2006 Servier applied without notice to Mann J for an interim injunction to restrain Apotex from marketing perindopril erbumine. This application was prompted by Servier's discovery that day that Apotex was already selling generic perindopril erbumine. Mann J declined to grant relief without notice to Apotex. On 3 August 2006 Servier renewed its application on notice to Apotex, and Mann J granted a short-term injunction until a hearing on 7 August 2006. He also granted Servier permission to join Apotex UK Ltd as an additional defendant.

15

By the hearing on 7 August 2006 the parties had exchanged evidence. In paragraph 16 of his first witness statement, Dr Eric Falcand, the Chief Executive Officer of Servier Laboratories Ltd, drew attention to the fact that the patient information leaflet ("PIL") accompanying the Apotex product stated that the marketing authorisation holder was Apotex Europe Ltd, the manufacturer was Katwijk Farma BV (with an address in the Netherlands) and the distributor was Apotex UK Ltd. In paragraph 32 of the same statement Dr Falcand stated that "if Apotex are prevented from continuing to supply the market but are ultimately successful at trial, I believe that the damage suffered by Apotex could be adequately compensated by damages" and in paragraph 33 he said that "Servier offers an undertaking to pay any damages which the Court orders to compensate Apotex for losses due to the granting of an injunction to restrain generic entry which the Court later determines should not have been granted". Apotex served a first witness statement from Colin Darroch, the managing director of Apotex UK Ltd, replying to Dr Falcand's evidence, but he did not comment on the accuracy or otherwise of the statements to which Dr Falcand had drawn attention in paragraph 16 of his statement.

16

It does not appear to have been drawn to Mann J's attention during the course of argument that Apotex was (contrary to the statement in the PIL) manufacturing perindopril erbumine in Canada or that Servier had asserted that the manufacture of perindopril erbumine in Canada would infringe a Canadian patent owned by it.

17

Following the hearing on 7 August 2006, Mann J granted an interim injunction until trial for the reasons given in his judgment dated 8 August 2006 ([2006] EWHC 2137 (Pat)). In his judgment he considering the adequacy of damages for each side at [20]-[23]. He summarised Apotex's case on this question at [20] and that of Servier at [21]-[22]. As part of the latter, he recorded at [22] Servier's...

To continue reading

Request your trial
12 cases
  • Twentieth Century Fox Film Corporation and Others v David Harris and Others
    • United Kingdom
    • Chancery Division
    • 5 February 2013
    ...on innovation and creativity. 20 Section 18 of the Copyright Act 1956 is noteworthy in this context. As Arnold J explained in Les Laboratoires Servier v Apotex Inc [2011] EWHC 730 (Pat), [2011] RPC 20 (at paragraph 67): "S.18 of the 1956 Act created a statutory fiction that infringing copi......
  • Les Laboratoires Servier v Apotex Inc.
    • United Kingdom
    • Court of Appeal (Civil Division)
    • 3 May 2012
  • Les Laboratoires Servier v Apotex Inc.
    • United Kingdom
    • Supreme Court
    • 29 October 2014
    ...to take the public policy point having given an undertaking in damages? 10 Arnold J gave judgment on these questions on 29 March 2011: [2011] RPC 574. He decided all three points in favour of Servier. On the first point, he held that a relevant illegality was one which was sufficiently ser......
  • Marvalyn Taylor-Wright v Sagicor Bank Jamaica Ltd
    • Jamaica
    • Court of Appeal (Jamaica)
    • 1 July 2016
    ...v Bridges (1854) 118 ER 1283, Mahonia Limited v JP Morgan Chase Bank and another [2003] EWHC 1927 (Comm) and Les Laboratoires Servier and another v Apotex Inc and others [2011] EWHC 730 (Pat), Mr Braham contended that if the instrument upon which the claim was brought is illegal, then it ca......
  • Request a trial to view additional results
1 firm's commentaries
  • IP Snapshot April 2011
    • United Kingdom
    • Mondaq United Kingdom
    • 3 May 2011
    ...engaged in litigation. For the full text of the decision, click here. Les Laboratoires Servier and another v Apotex Inc and others [2011] EWHC 730 (Pat), 29 March The High Court has held that a defendant must repay damages paid to it resulting from a cross-undertaking in the context of an i......
1 books & journal articles
  • The ex turpi causa principle in Hounga and Servier
    • United Kingdom
    • The Modern Law Review No. 78-5, September 2015
    • 1 September 2015
    ...such that production of the compound would have been lawful, and that43 Les Laboratoires Servier and another v Apotex Inc and others [2011] RPC 574.44 n 3 above at [10] (summarised by Lord Sumption).45 Les Laboratoires Servier and another v Apotex Inc and others [2013] Bus LR 80.46 ibid at ......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT