Les Laboratoires Servier v Apotex Pty Ltd - [2009] FCA 1097

FEDERAL COURT OF AUSTRALIA
Les Laboratoires Servier v Apotex Pty Ltd [2009] FCA 1097
PRACTICE AND PROCEDURE – discovered documents redacted to keep third party identity confidential – discovered documents provided voluntarily by overseas third party on basis of identity confidentiality – access to unredacted documents to obtain identity of third party
Gray v Associated Publishers (Aust) Pty Limited [2002] FCA 1045 followed
Mackay Sugar Co-operative Association Limited v CSR Limited (1996) 63 FCR 408 cited
Sabre Corporation Pty Ltd v Russ Kalvin's Hair Care Company (1993) 46 FCR 428 cited
Science Research Council v Nasse [1980] AC 1028 at 1065 cited
LES LABORATOIRES SERVIER and SERVIER LABORATORIES (AUST) PTY LTD (ACN 004 838 500) v APOTEX PTY LTD (ACN 096 916 148), SYMBION PHARMACY SERVICES PTY LTD (ACN 000 875 034), CHEM MART PTY LIMITED (ACN 001 235 374), PHARMACOR LIMITED (ACN 121 020 835), GENEPHARM (AUSTRALIA) LIMITED (ARBN 003 854 626) (FORMERLY GENEPHARM LIMITED) and SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD (ACN 004 118 594)
VID 139 of 2007
BENNETT J
29 SEPTEMBER 2009
SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY

GENERAL DIVISION

VID 139 of 2007

BETWEEN:
LES LABORATOIRES SERVIER
First Applicant

SERVIER LABORATORIES (AUST) PTY LTD
(ACN 004 838 500)
Second Applicant

AND:
APOTEX PTY LTD (ACN 096 916 148)
First Respondent

SYMBION PHARMACY SERVICES PTY LTD
(ACN 000 875 034)
Second Respondent

CHEM MART PTY LIMITED (ACN 001 235 374)
Third Respondent

PHARMACOR LIMITED (ACN 121 020 835)
Fourth Respondent

GENEPHARM (AUSTRALIA) LIMITED (ARBN 003 854 626) (FORMERLY GENEPHARM LIMITED)
Fifth Respondent

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD (ACN 004 118 594)
Sixth Respondent

JUDGE:

BENNETT J

DATE OF ORDER:

29 SEPTEMBER 2009

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:
1.The first respondent provide to the applicants all identifying details relating to the third party supplier or its employees, agents and/or representatives redacted for “confidentiality” in the documents set out in the Schedule within 7 days of the date of this Order.
2.The identifying details of the third party supplier or its employees, agents and/or representatives referred to in paragraph 1 above be marked as confidential and dealt with in accordance with the confidentiality orders in these proceedings dated 2 November 2007 (‘the Confidentiality Orders’).
3.For the purposes of paragraph 4(a)(vii) of the Confidentiality Orders, Ms Sylvie Jaguelin, Patent Director at the First Applicant, is a person to whom, upon her signing the undertakings titled “Annexure A” annexed to Servier’s email dated 25 August 2009, the information referred to in paragraphs 1 and 2 may be disclosed.
4.Costs reserved.
Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

The text of entered orders can be located using eSearch on the Court’s website.

Schedule
List of Documents dated 3 October 2008

Apotex Doc ID Date Type Title

PHA.001.002.0001 17/06/2004 Document QA testing for 3^rd party batch # A3200DX401; receiving batch # 040635

PHA.001.002.0056 3/04/2006 Document QA testing for 3^rd party batch # A3200DZ601; receiving batch #…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2009] FCA 1097
Decision Date: 29 SEPTEMBER 2009

CaseChat Overview and Summary

In the Federal Court of Australia, Les Laboratoires Servier sued Apotex Pty Ltd over a patent infringement claim. The dispute centred around the identity of a third-party supplier that Apotex used in the synthesis of Intermediate B. Servier sought to discover documents from Apotex that would reveal the supplier's identity, as it believed this information would be crucial to its infringement claim. Servier argued that certain documents provided by the supplier, through API and Apotex, did not adequately explain the use of solvents in the synthesis process, particularly the use of Solvent 1. Servier contended that the supplier might hold additional information or documents that could support its claim, and thus sought to compel Apotex to disclose the supplier's identity.

The court had to determine whether Apotex was required to disclose the identity of the supplier under the circumstances presented. It also had to assess whether the redactions and assurances provided by API were sufficient to protect the supplier's confidentiality. Additionally, the court needed to weigh Servier's interest in obtaining the supplier's identity against the potential prejudice that such disclosure might cause the supplier and API. The court found that while the documents produced by the supplier were redacted to protect the supplier's identity, it was crucial for Servier to ascertain whether the supplier held additional information that could impact the outcome of the infringement claim. The court concluded that Apotex must disclose the supplier's identity to Servier, subject to confidentiality orders, to enable Servier to pursue its claim effectively.

The court ordered that Apotex must provide Servier with all identifying details of the supplier, redacted for confidentiality, within seven days of the order. The identifying details were to be marked as confidential and handled in accordance with the existing confidentiality orders in the case. The order also specified that the information could be disclosed to Ms. Sylvie Jaguelin, Patent Director at Les Laboratoires Servier, upon her signing the necessary undertakings. Costs were reserved for later determination.

Orders

Orders of the court

1. The first respondent provide to the applicants all identifying details relating to the third party supplier or its employees, agents and/or representatives redacted for “confidentiality” in the documents set out in the Schedule within 7 days of the date of this Order.

2. The identifying details of the third party supplier or its employees, agents and/or representatives referred to in paragraph 1 above be marked as confidential and dealt with in accordance with the confidentiality orders in these proceedings dated 2 November 2007 (‘the Confidentiality Orders’).

3. For the purposes of paragraph 4(a)(vii) of the Confidentiality Orders, Ms Sylvie Jaguelin, Patent Director at the First Applicant, is a person to whom, upon her signing the undertakings titled “Annexure A” annexed to Servier’s email dated 25 August 2009, the information referred to in paragraphs 1 and 2 may be disclosed.

4. Costs reserved.

Note:

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

BENNETT J

Full text does not contain this section.

Ratio Decidendi

Legal Principle Established

Established by: BENNETT J

Apotex agreed to discover documents constituting or recording the process description for the synthesis of Intermediate B and the operating procedure for that process. While API is not subject to the obligation of discovery, Servier had raised with Apotex the possibility of a Sabre order (Sabre Corporation Pty Ltd v Russ Kalvin's Hair Care Company (1993) 46 FCR 428). API then voluntarily provided the documents to Apotex, redacted to remove information that would identify the supplier. This provision was on the basis that the supplier’s identity would be protected. Apotex produced documents provided to it by API with the name, address and contact details of the supplier redacted (‘API documents’). From the correspondence between the parties, it does not seem to be in dispute that Freehills (Apotex’s solicitors) have in their possession documents disclosing the identity of the supplier. Freehills has stated in correspondence that it caused the documents to be redacted in accordance with instructions that the supplier does not wish to be identified. In no document provided to Servier has the identity of the supplier been revealed. API had requested documents, relevant to the discovery categories, from the supplier. For some time no documents were received from the supplier and Servier asked Apotex for the name, address and contact details of the supplier in order to pursue an application under the Hague Convention. Apotex indicated in correspondence that it could not provide the identity of the supplier as that was the confidential information of API and API did not consent to its disclosure. Eventually, the supplier provided two documents to API, which were produced by Apotex on discovery to Servier (‘supplier documents’). Both of those documents were provided on a confidential basis and on the assurance by API that the supplier’s identity would be kept confidential. Any redactions on the supplier documents were made by the supplier before they were provided to API. Subsequently, in response to Servier’s requests, API made further approaches to the supplier for documents. At one stage, the supplier expressed a willingness to cooperate in providing further documents but subsequently informed API that no further documents will be provided. When the matter first came before the Court, I requested Apotex to make one further request of the supplier for ten batch records for Intermediate B which the supplier had previously indicated it would review and provide. Apotex was also given the opportunity to make contact with the supplier to advise it of Servier’s application to obtain its identity and to determine whether any further documentation or information would be provided in the absence of an order of the Court. To date, no further documentation or information has been produced by the supplier. Servier’s reasons for seeking the identity of the supplier Servier seeks information as to the identity of the supplier because it believes that the supplier may be in possession of information or documents important for its infringement claim, particularly concerning the solvent used by the supplier in the synthesis of Intermediate B. Servier refers to two sets of documents produced on discovery which, it says, suggest that Solvent 1 was not used in the synthesis of Intermediate B, as claimed by Apotex:1.An email dated 4 May 2004 from API to a party whose name has been redacted, presumably the supplier, asked for a list of solvents used in the synthesis of Intermediate B. The reply email, dated 21 May 2004, stated that the solvents being used for Intermediate B were what I will call Solvent 2 and Solvent 3 (which are different to Solvent 1). The reply does not mention Solvent 1. Solvent 2 and Solvent 3 appear to fall within the solvents specified in the claimed process of Servier’s patent. Servier says that it is not satisfied with the documents that have been produced by the supplier through API and Apotex, in the light of the emails. There is no explanation for the statement in the emails that Solvent 2 and Solvent 3 (rather than Solvent 1) are used as the solvents for the preparation of Intermediate B. While, as Apotex points out, the emails were sent in 2004, there is no evidence to explain whether there has been a change in solvent since 2004, or the length of time that Solvent 2 and 3 (within the claims of the patent) may have been used. 2.One of the sets of documents within the supplier documents provides for “deviations/remarks” concerning the process adopted by the supplier in the synthesis of Intermediate B. The document produced is a standard form and there is no entry under this heading. Servier submits that the supplier has not provided sufficient documentation to explain whether or not the deviations provided for in its standard form allow for a departure from the standard process to permit the substitution of Solvent 1 by another solvent.

IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY
GENERAL DIVISION	VID 139 of 2007

JUDGE:	BENNETT J
DATE OF ORDER:	29 SEPTEMBER 2009
WHERE MADE:	SYDNEY

Apotex Doc ID	Date	Type	Title
PHA.001.002.0001	17/06/2004	Document	QA testing for 3^rd party batch # A3200DX401; receiving batch # 040635
PHA.001.002.0056	3/04/2006	Document	QA testing for 3^rd party batch # A3200DZ601; receiving batch #…