Ranbaxy Laboratories Ltd v Warner Lambert Company

• Jurisdiction: Ireland
• Judge: O'Sullivan J.,Mr Justice McCracken
• Judgment Date: 02 December 2005
• Neutral Citation: [2005] IESC 81
• Court: Supreme Court
• Docket Number: [S.C. No. 242 of 2005]
• Date: 02 December 2005

[2005] IEHC 178

THE HIGH COURT

[Record No. 18683P/24COM/2004]

RANBAXY LABORATORIES LTD & ORS v WARNER-LAMBERT COMPANY

BETWEEN

RANBAXY LABORATORIES LIMITED, RANBAXY EUROPE LIMITED AND RANBAXY IRELAND LIMITED

PLAINTIFFS

AND

WARNER-LAMBERT COMPANY

DEFENDANT

PATENTS ACT 1992 S45

PATENTS ACT 1992 SCHED 2

EUROPEAN PATENT CONVENTION ART 69

PATENTS ACT 1977

ELECTRIC MUSICAL INDUSTRIES v LISEN LTD 1938 4 AER 221

GLAVERBEL SA v BRITISH COAL CORP & ANOR 1995 RPC 225

CATNICK v HILL & SMITH 1982 RPC 183

LUBRIZOL v ESSO PETROLEUM 1998 RPC 727

ROHM & HAAS v COLLAG LTD 2002 FSR 28

BRISTOL-MYERS SQUIBB CO v BAKER NORTON INC 1999 RPC 253

KIRIN AMGEN INC & ORS v HOECHST MARION ROUSSEL LTD & ORS 2005 1 AER 667

LIPOSOME COMPANY INC v VESTAR INC 1994 WL 738952

FURR v CO TRULINE 1985 FSR 553

CIBA-GEIGY v OTE OPTICS UNREP SUPREME 13.1.1995 (NETHERLANDS)

FESTO CORP v SHOKETU KINZOKU KOGYO KABUSHIKI CO LTD 2000 234 F 3D 558

INTELLECTUAL PROPERTY:

Patents

Evidence - Admissibility of evidence - Construction of patent - Admission against interest - Communications by patentee as to meaning of patent - Whether communications by patentee as to meaning of patent admissible to aid in construction of patent - Whether admissible where made against interest - Catnic Components Limited v Hill & Smith Ltd [1982] RPC 183, Glaverbel SA v British Coal Corporation[1995] RPC 255 and Lubrizol Corp v Esso Petroleum Co Ltd [1998] RPC 727 approved - Glaverbel SA v British Coal Corp (No 2) [1993] RPC 90 followed - Rohm and Haas Co v Collag Ltd [2002] FSR 445 distinguished - Liposome Company Inc v Vestar Inc (US District Court of Delaware, 20/12/1994) not followed - Patents Act 1992 (No 1), s 45,sch 2 - Documents found inadmissible (2004/18683P & 24 COM - O'Sullivan J -8/6/2005) [2005] IEHC 178

Ranbaxy Laboratories Ltd v Warner Lambert Co

Facts: The plaintiffs claimed a declaration that a product to be manufactured by them did not infringe the defendant’s Irish patent. In the plaintiffs’ reply to the defence, they referred to a number of communications made by the defendant with inter alia the US patent office and the European patent office. The plaintiffs applied for discovery and Finlay Geoghegan J. ordered that an issue be tried as to whether the communications set out in the reply were admissible in evidence in the proceedings. This judgment dealt only with this issue, i.e. the admissibility of the documents.

Held by O’Sullivan J. that the communications sought to be discovered were inadmissible because they were representations which came into existence and were made for the purpose of indicating the thoughts, intentions and opinions of the inventor and his agents and as such were inadmissible because they were irrelevant to the sole issue before the court in the proceedings, namely the construction of the defendant’s patent.

Reporter: R.W.

1 JUDGMENT of O'Sullivan J. delivered the 8th June, 2005

Introduction

2 The plaintiffs claim a declaration that a product to be manufactured by them does not infringe the defendant's Irish patent (No. 6014) which protects a product known as LIPITOR and is the world's most widely prescribed drug reducing the level of bad cholesterol in the blood.

3 The defendant's Irish patent has a number of corresponding foreign patents, namely, a US patent ("the 893 patent"), a European patent and a Danish patent. A further US patent ("the 995 patent") is claimed by the defendant to cover LIPITOR but is the subject of a claim of invalidity in that country. A further patent in the U.K. corresponding to the 995 patent is also the subject of an invalidity claim and an Irish patent corresponding to the 995 patent is the subject of challenge and revocation proceedings are to be commenced here.

The proceedings

4 These proceedings commenced by plenary summons dated 2nd September, 2004, and by order of 8th September, they were entered in the commercial list.

5 In the statement of claim the plaintiffs allege that the defendant's Irish patent covers only certain (50/50) mixtures of the relevant chemical compounds. This is contested in the defence which asserts protection for a wider range of mixtures. In reply the plaintiffs refer to a number of communications made by the defendant including with the United States patent and trade marks office, the European patent office, the Danish patent office and to averments made by the defendant's own employees in patent litigation in the United States where the language used supports the plaintiff's interpretation of the scope of the Irish patent. In a rejoinder to that reply the defendant pleads that those latter matters are not relevant to the issues before the court and in particular not relevant to the correct construction of the Irish patent and are inadmissible in the present proceedings.

6 The plaintiffs submitted a request for voluntary discovery (as did the defendant) which was rejected by the defendant on the ground that the documents sought were irrelevant to the sole issue before the Irish court which, they agreed was "…he interpretation of the patent and the scope of the claims…".

7 The dispute on discovery came before Finlay Geoghegan J. on 8th April, 2005 when she made an order that an issue be tried as to whether the matters set out at

8 para. 7 of the reply or other evidence of a similar type is admissible in evidence in these proceedings. The learned judge also made an order that the plaintiffs write a further letter setting out their request for discovery.

9 I understand that the second of those orders referred to the fact that when the matter was debated before Finlay Geoghegan J. a point was made on behalf of the defendant that the then current plaintiffs' request for discovery gave as a typical reason for requesting the documents sought that the sole issue in the case had been the subject of representations (recorded in the documents sought) by the patentee on that very issue, but that in the course of argument the plaintiffs sought to rely, in addition, on the principle that the documents sought might put them on a legitimate train of enquiry and also upon the principle that the documents contained admissions against interest made by the defendant. Because these latter two grounds were not included in the first request I understand an order was made directing a further request and this was made on 22nd April, 2005 and is the request for discovery under consideration in this judgment. The reasons now relied on do contain reference both to admissions or statements against interest and also reference to the train of inquiry principle.

10 Before proceeding to describe more closely the factual (stereochemical) context in which the revised request for discovery is made I should make it clear what this judgment does and more particularly what it does not do. In it I am dealing only with the question of admissibility of the documents sought by the plaintiff and not with other issues, such as necessity, which will arise when the full question of discovery will be dealt with.

Factual context

11 In an affidavit sworn by Patricia McGovern, solicitor on behalf of the plaintiffs, the factual background is set out, the deponent having taken her client's instructions and having been informed that the account is accurate. This contention was not challenged in the hearing before me. The following is her description:-

"Stereochemistry is an important subfield in the broader field of chemistry, which focuses on the three dimensional structure of organic molecules in space. An Isomer is one of several species, or molecular entities, that have the same atomic composition (molecular formula) but different stereochemical formulae and hence different physical and/or chemical properties. Stereoisomers are compounds that have the same atoms and the same connectivity pattern of the atoms or groups of atoms, but are different in the way the atoms or group of atoms are arranged in three-dimensional space. An asymmetric or chiral centre is an atom, such as a carbon atom, which has four distinct groups bounded to it…

One asymmetric centre in a molecule gives rise to two possible enantiomers. Enantiomers are stereoisomers that are non super-imposable mirror images or each other. Enantiomers have identical physical properties, including solubilities and melting points, with the exception of their interactions with chiral matter and plane-polorised light. A racemate is a one to one mixture of two enantiomers, such that it contains 50% of one enantiomer and 50% of its opposite enantiomer. Racemates and enantiomers are distinct compounds and, in general, have different physical properties, such as solubilities and melting points. Optical activity is the ability of a compound to rotate plane-polarised light. A pure enantiomer rotates plane-polarised light in only one direction to the maximal amount permitted by that molecule. An unequal mixture of two opposite enantiomers is optically active and the degree of optical rotation will reflect the percentage of each enantiomer present in the mixture.

In a racemate, which is an equal mixture of two opposite enantiomers, the optical rotations of the enantiomers cancel each other out and the compound is not optically active.

There are a set of rules that are accepted by chemists for naming and describing racemates and enantiomers. In a molecule containing one asymmetric centre, one enantiomer is designated the R-enantiomer, and its opposite enantiomer is designated the S-enantiomer. Because a racemate contains equal amounts of the R and S-enantiomers, the racemate is designated the R S structure.

There are other accepted ways by which chemists designate racemates and enantiomers. Single enantiomers are optically active compounds in that they rotate...