FEDERAL COURT OF AUSTRALIA

Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC [2006] FCA 1353

RANBAXY AUSTRALIA PTY LTD (ACN 110 871 826) v WARNER-LAMBERT COMPANY LLC AND COMMISSIONER OF PATENTS

VID 926 OF 2005

YOUNG J

10 OCTOBER 2006

MELBOURNE

RULING ON EVIDENCE

1                     Warner‑Lambert Company LLC (‘Warner-Lambert’) has objected to the admissibility of passages in three affidavits of Gregory Ralph Tye dated 22 June 2006, 24 July 2006 and 18 September 2006 respectively. After some discussion and some concessions by Ranbaxy Australia Pty Ltd (‘Ranbaxy’), the objections were narrowed to the following paragraphs: paras 4, 6 and 7 of the affidavit of 22 June 2006 (‘the first affidavit’), paras 20 to 28 of the affidavit of 24 July 2006 (‘the second affidavit’), and paras 5 to 7 of the affidavit of 18 September 2006 (‘the third affidavit’).

2                     Mr Tye is a partner at Norman Waterhouse, the solicitors acting for Ranbaxy in these proceedings. In the paragraphs to which objection has been taken, Mr Tye seeks to tender documents that fall into two broad categories. The first category concerns communications between Warner‑Lambert, or its patent attorneys or other agents, and the Danish Patent Directorate and the European Patent Office: see paras 4, 6 and 7 of Mr Tye's first affidavit, paras 20 to 23 and 27 of his second affidavit and paras 5 and 6 of his third affidavit. The nature of these communications is sufficiently indicated by Exhibit GRT3, which is a letter from Warner‑Lambert's patent attorney to the Danish Patent Directorate dated 18 May 1993. That letter responded to certain objections and queries raised by the Danish Patent Office. In the letter, Warner‑Lambert's patent attorney said that to comply with European nomenclature rules concerning stereochemistry, all references to ‘trans’ in the patent application had been changed to ‘trans (±)’. Ranbaxy contends that the symbol (±) indicates that the compound in question is a racemate. The second category comprises communications between Warner-Lambert or its agents and the United States Patent Office concerning the United States enantiomer patent. This category of communications is referred to in Mr Tye's second affidavit at paras 24 to 26.

3                     Ranbaxy argued that these documents are relevant and admissible because they provide part of the context for the construction of Australian Letters Patent No 601981 (‘the Basic Patent’). The equivalent United States patent was filed on 30 May 1986 and all of the communications in question post date that application. Ranbaxy contends that, on its proper construction, the Basic Patent is confined to a racemic mixture and does not claim the individual trans enantiomers. Ranbaxy seeks to rely upon the documents in support of that construction. It contends that the documents provide evidence that, from the perspective of a skilled person in the field, it would have been reasonable to register a patent for the racemic mixture only, stopping short of claiming the individual trans enantiomers.

4                     Ranbaxy argued that the reasonableness of such a registration is directly contested by evidence that Warner‑Lambert proposes to lead from Professor Christopher Easton and Professor Peter Scammells. That evidence is found in paras 5.5 and 8 of Professor Easton's affidavit of 18 September 2006, and paras 2.9(c) and 3.20 of Professor Scammells' second affidavit, sworn 14 September 2006. The broad thrust of the evidence in these paragraphs is adequately conveyed by para 8 of Professor Easton's affidavit of 18 September 2006, which states (inter alia) that:

‘Further, in the wider context which would inform my understanding at the relevant dates in my first affidavit, I would not have understood structural formula 1 [of the Basic Patent] to be limited to racemic mixtures only. In particular, to confine the subject of the ‘981 [Basic] Patent to racemic mixtures makes no sense to me, because it would exclude the very thing, the more active enantiomer, that I and any person working in the Field would expect to be key to the useful activity of the compounds.’

5                     Ranbaxy argued that it wishes to use the documentary evidence it seeks to tender to rebut evidence of this kind from Professor Easton and Professor Scammells, and not as evidence of Warner‑Lambert's subjective intentions as to the meaning of the Basic Patent.

6                     In my opinion, the evidence sought to be relied upon by Ranbaxy is not admissible as an aid to the construction of the Basic Patent.

7                     This conclusion follows as a matter of basic principle. The construction of a patent is a question of law. Direct evidence of the patentee as to what he or she intended the patent to mean, or what he or she subsequently thought it meant, is not admissible. Nor is evidence that seeks to prove the same matters indirectly by adducing evidence of documentation brought into existence prior to the relevant patent application or subsequent to it: see Glaverbel SA v British Coal Corporation [1995] RPC 225 at 268 per Staughton LJ. Thus, documentary evidence disclosing the intentions, opinions or submissions of the patentee, such as that which might be found in communications with the patent office where the patent was granted or in subsequent communications with foreign patent offices, is not admissible: see Kirin-Amgen Inc v Hoechst Marion Roussel Ltd[2005] 1 All ER 667 (‘Kirin-Amgen’) at 681-682 [35] per Lord Hoffmann and Baygol Pty Ltd v Foamex Polystyrene Pty Ltd (2005) 64 IPR 437 (‘Baygol’) at 442 [21] per Tamberlin J.

8                     This conclusion is also consistent with general principles of contract law. Evidence of pre-contractual negotiations is inadmissible insofar as it is relied upon to show the actual subjective intentions of the contracting parties: Codelfa Construction Pty Ltd v State Rail Authority of NSW (1982) 149 CLR 337 at 352 per Mason J. And the conduct of contracting parties subsequent to the making of the contract is not admissible as an aid to construction of the contract: FAI Traders Insurance Co Ltd v Savoy Plaza Pty Ltd [1993] 2 VLR 437.

9                     Senior counsel for Warner‑Lambert referred me to several interlocutory decisions which are directly in point. Those decisions arose in the course of litigation in the United Kingdom and Ireland concerning the equivalents of the patents in suit in this case. The English litigation has resulted in two final decisions: the decision of Pumfrey J at trial, see Ranbaxy UK Limited v Warner‑Lambert Company [2005] EWHC 2142, and on appeal, the decision of the Court of Appeal in Ranbaxy UK Limited v Warner‑Lambert Company [2006] EWCA Civil 876.

10                  In the English litigation, Ranbaxy sought to tender documents that were identical or substantially similar to the documents it seeks to tender in evidence in this proceeding. The documents were ruled inadmissible by Pumfrey J. I have been supplied with the transcript of Pumfrey J’s ruling. Pumfrey J rejected the tender of the documents on essentially two grounds. The first was that, as a matter of basic principle, the documents were irrelevant and inadmissible as an aid to the construction of the specification. The second and broader ground was the principle that has been adopted in the courts of the United Kingdom that a patent office file is not to be used in aid of the construction of a patent. To do so really invites the introduction into evidence of what are essentially submissions and, in the words of Pumfrey J, it would open up a field of investigation which is too long, too detailed and of limited assistance.

11                  In the Irish litigation, the Irish Supreme Court affirmed the decision at first instance of O'Sullivan J in the High Court to refuse to order discovery of documents of essentially the same character as the documents in issue before me: see Ranbaxy Laboratories Ltd v Warner-Lambert Company [2005] IEHC 178 per O’Sullivan J, affirmed on appeal in Ranbaxy Laboratories Ltd v Warner-Lambert Company [2005] IESC 81 per McCracken, Macken and Kearns JJ.

12                  I agree with the reasoning and conclusions reached by Pumfrey J and by the judges in both the Irish High Court and the Irish Supreme Court.

13                  In my opinion, the admissibility of the material is not demonstrated by Ranbaxy’s submission that it wishes to use the evidence to contest or contradict the evidence of Professor Easton and Professor Scammells. That objective does not render the documents admissible as evidence in Ranbaxy's case. To be admissible in its case, the documents would have to go to a relevant issue. The only issue identified was that of construction of the Basic Patent and, in my opinion, the documents are not admissible on that issue.

14                  The reality of the situation, it seems to me, is that Ranbaxy is attempting to tender opinions or submissions of the patentee or its agents, or documentary evidence of their intentions, because they are consistent with Ranbaxy’s submissions on the question of construction. The cases are clear that such evidence is not admissible for that purpose. However, nothing in this ruling is intended to address the broader question of whether, in cross‑examination, it is open to Ranbaxy to put questions to Professor Easton or Professor Scammells that challenge the evidence they propose to give in the paragraphs of the affidavits that I have mentioned.

15                  Lastly, even if a case could be made out for the tender of this material, I would reject it in the exercise of my discretion under s 135(c) of the Evidence Act 1995 (Cth). I take the view that the evidence opens up what is essentially a collateral issue and the pursuit of that issue would be likely to result in an undue waste of Court time for little or no reward. In forming this view, I have taken into account the observations of Lord Hoffmann in Kirin-Amgen and Tamberlin J in Baygol, with which I agree.

16                  For the foregoing reasons, I rule that paras 4, 6 and 7 of Mr Tye's first affidavit, paras 20 to 28 of his second affidavit and paras 5 to 7 of his third affidavit, and the documents referred to therein, are inadmissible.

Associate:

Dated: 13 October 2006