Apotex Pty Ltd v Les Laboratoires Servier

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FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Les Laboratoires Servier [2012] FCA 359

Citation: Apotex Pty Ltd v Les Laboratoires Servier [2012] FCA 359
Parties: APOTEX PTY LTD ACN 096 916 148 v LES LABORATOIRES SERVIER; LES LABORATOIRES SERVIER and SERVIER LABORATORIES (AUST) PTY LTD ACN 004 838 500; APOTEX PTY LTD and SYMBION PTY LTD ACN 000 875 034
File number: NSD 51 of 2012
Judge: BENNETT J
Date of judgment: 5 April 2012
Catchwords:

PRACTICE AND PROCEDURE – Federal Court Rules 2011 – Division 20.3 and rule 30.28 – Application to set aside Notice to Produce – relevance to issues in proceedings – allegations of authorisation of infringement of patent, joint tortfeasorship and common design – breadth of categories sought – commercially sensitive documents

COSTS – costs of application to set aside Notice to Produce – changing basis upon which Notice to Produce pressed

Legislation: Patents Act 1990 (Cth) s 13
Federal Court Rules 2011, rules 7.22, 10.43, 20.33, 20.35, 30.28
Cases cited: Apotex Pty Ltd v Les Laboratoires Servier (No 4) (2010) 89 IPR 274 cited
Construction, Forestry, Mining and Energy Union v BHP Coal Pty Ltd (No 3) [2012] FCA 61 cited
GarnetInternational Resources Pty Ltd v Barton International Inc [2005] FCA 93 cited
Morton-Norwich Products Inc. v. Intercen Ltd. [1978] RPC 501 cited
Date of hearing: 22 March 2012
Place: Sydney
Division: GENERAL DIVISION
Category: Catchwords
Number of paragraphs: 49
Counsel for the Applicant: Ms S. Goddard SC
Counsel for the Respondent: Mr A.J.L. Bannon SC
with Mr A.R. Lang  
Solicitor for the Applicant: Freehills
Solicitor for the Respondent: Allens Arthur Robinson

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 51 of 2012

BETWEEN:

APOTEX PTY LTD ACN 096 916 148
Applicant

LES LABORATOIRES SERVIER
First Cross-Claimant

SERVIER LABORATORIES (AUST) PTY LTD
ACN 004 838 500
Second Cross-Claimant

AND:

LES LABORATOIRES SERVIER
Respondent

APOTEX PTY LTD
First Cross-Respondent

SYMBION PTY LTD ACN 000 875 034
Second Cross-Respondent

JUDGE:

BENNETT J J

DATE OF ORDER:

5 APRIL 2012

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:

1.These reasons be kept confidential to the legal advisers for the parties until further order.

2.Counsel consult as to any matters within these reasons for which confidentiality is asserted and notify my Associate of any proposed redactions on or before 12 April 2012.

3.The application to set aside the Notice to Produce be dismissed.

4.Apotex produce to the Court at the hearing of the application dated 15 March 2012 for leave to serve the Third to Sixth Cross-Respondents out of the jurisdiction:

(a)the sale or supply agreement for the Generic Perindopril Arginine Products or the active pharmaceutical ingredient perindopril arginine for the Generic Perindopril Arginine Products (the API) between Apotex and any of the Third to Sixth Cross-Respondents, redacted to identify the parties to the agreement;

(b)the dossier (being the document in “Common Technical Document” format) in support of Apotex Pty Ltd’s application for registration on the Australian Register of Therapeutic Goods…

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Details
Case
[2012] FCA 359
Decision Date

CaseChat Overview and Summary

Apotex Pty Ltd was engaged in a patent infringement dispute with Les Laboratoires Servier before the Federal Court of Australia. Servier sought to enforce a patent against Apotex and others, alleging infringement of its patent. As part of the proceedings, Servier issued a notice to produce certain documents from Apotex, which were sought on the basis that they were relevant to the issues in the proceedings. Apotex sought to set aside the notice, arguing that the documents sought were overly broad, commercially sensitive, and not relevant to the issues at hand. The court was required to determine whether the notice to produce was valid and whether it could be set aside. The court considered the scope and relevance of the documents sought and whether the notice was within the proper scope of the rules governing the production of documents in the Federal Court.

The court found that Servier was entitled to the production of specified documents under the relevant rules. The court held that the notice to produce was within the proper scope of the rules, as it was addressed to issues arising from the cross-claim and related to documents in Apotex's control. The court also found that Servier was entitled to rely on rule 20.35 of the Federal Court Rules, which allowed for the production of documents relating to an issue in the proceedings, even if the issue was not directly between the parties to the notice. The court dismissed the application to set aside the notice to produce, finding that the documents sought were relevant to the issues in the proceedings and that the notice was not overly broad. The court ordered Apotex to produce certain documents to the court at the hearing of the application and made orders as to costs.

In summary, the court found that Servier was entitled to the production of specified documents from Apotex as part of the patent infringement proceedings. The court dismissed Apotex's application to set aside the notice to produce and made orders as to the production of documents and costs.

Orders

Orders of the court

1. These reasons be kept confidential to the legal advisers for the parties until further order.

2. Counsel consult as to any matters within these reasons for which confidentiality is asserted and notify my Associate of any proposed redactions on or before 12 April 2012.

3. The application to set aside the Notice to Produce be dismissed.

4. Apotex produce to the Court at the hearing of the application dated 15 March 2012 for leave to serve the Third to Sixth Cross-Respondents out of the jurisdiction:

(a) the sale or supply agreement for the Generic Perindopril Arginine Products or the active pharmaceutical ingredient perindopril arginine for the Generic Perindopril Arginine Products (the API) between Apotex and any of the Third to Sixth Cross-Respondents, redacted to identify the parties to the agreement;

(b) the dossier (being the document in “Common Technical Document” format) in support of Apotex Pty Ltd’s application for registration on the Australian Register of Therapeutic Goods (ARTG) of each of APO-Perindopril Arginine, Terry White Chemists Perindopril Arginine, Chemmart Perindopril Arginine, Apotex-Perindopril Arginine and GenRx Perindopril Arginine (the Generic Perindopril Arginine Products) to the extent that reference is made to the Third to Sixth Cross-Respondents;

(c) a sample invoice for the Generic Perindopril Arginine Products or the API between Apotex and any of the Third to Sixth Cross-Respondents, redacted to identify the manufacturer, importer, supplier and/or sponsor of each product; and

(d) letters of access in support of the application for registration on the ARTG of each of the Generic Perindopril Arginine Products provided by any of the Third to Sixth Cross-Respondents, redacted to identify the manufacturer, importer, supplier and/or sponsor of each product.

5. The proceeding be listed for directions at 9:30 a.m. on 20 April 2012.

6. Apotex’s costs in relation to the notice to produce thrown away to 1 March 2012 be Apotex’s costs in the cause.

7. Servier pay Apotex’s costs in relation to the notice to produce thrown away from 1 March 2012 to 16 March 2012.

8. Otherwise, no order is made as to the costs of the application to set aside the notice to produce.

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

Servier accepts that its case against the Foreign Respondents is necessarily one of inference and says that the Notice can be expected to provide documentary evidence of their involvement in Apotex’s infringing conduct, either by authorising that conduct or as a joint tortfeasor with Apotex. It relies on evidence of the relationship between the Foreign Respondents and Apotex and on information from various websites, in particular concerning the manufacturing activities of some of the Foreign Respondents. Servier submits that the documents sought will be of relevance and importance to the Service Application. Consideration The Service Application relates to Servier’s cross-claim. It is not the case that the validity of the Servier Patent is the only issue in the proceedings. The Notice is addressed to the issues arising from the cross-claim. Notices to produce are dealt with in the Rules. Rule 20.31 deals with a notice to produce documents mentioned in a pleading or affidavit filed by a second party. Rule 20.32 deals with the production for inspection of a document included in a second party’s list of documents. Rule 20.33 deals with the situation where a non-party ordered to give discovery does not do so. Those rules do not seem to be presently applicable. Rule 30.28 relevantly provides:(1)A party may serve on another party a notice, in accordance with Form 61, requiring the party served to produce any document or thing in the party’s control:(a) at any trial or hearing in the proceeding; or(b)at any hearing before a Registrar or any examiner or other person having authority to take evidence in the proceeding.(2)If the document or thing required to be produced under subrule (1) is not produced, the party serving the notice may lead secondary evidence of the contents or nature of the document or thing.… Servier seeks the production of the documents at the hearing of the Service Application. The Notice seeks documents that are in Apotex’s control. Within the proper scope of a notice to produce, Servier is entitled to production of specified documents under rule 30.28. If the documents are not produced, Servier may avail itself of the right to lead secondary evidence. Servier also relies on r 20.35 of the Rules which relevantly provides:(1)A party may apply to the Court for an order that another party produce to the Court a document in the party’s control relating to an issue in the proceeding.(2)The Court may inspect a document to decide the validity of an objection to production, including a claim that the document is privileged from production. This rule requires production by a party to the Court of a document relating to an issue in the proceedings. It is not limited to an issue as between the applicant for the order and that party against whom the order is sought. For the purposes of this case, it may extend to a document in Apotex’s control relating to an issue as between Servier and the Foreign Respondents. In any event, the issues relied on by Servier for the purposes of r 20.35 can each be said to include Apotex. For example, Servier relies on the involvement of the manufacturers of Generic Perindopril products in the registration of those products with the TGA as evidence that the manufacturers are knowingly involved in Apotex’s conduct alleged to be infringing conduct.