Apotex Pty Ltd v Cipla Limited (No 2)

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FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Cipla Limited (No 2) [2018] FCA 1393

File number: VID 1229 of 2017
Judge: BEACH J
Date of judgment: 3 August 2018
Date of publication of reasons: 11 September 2018
Catchwords: PRACTICE AND PROCEDURE – discovery – patents – pharmaceutical products and formulations for nasal and ocular use – antihistamines, particularly azelastine – corticosteroids, particularly fluticasone – combination of azelastine and steroids – grounds of invalidity – lack of inventive step – related US proceedings – depositions – transcripts of trial evidence – trial exhibits – false suggestion – material of secondary significance – indirect relevance – proportionality
Legislation: Patents Act 1990 (Cth) ss 18(1)(b)(ii) and 138(3)(d)
Cases cited:

Apotex Pty Ltd v Cipla Limited [2017] FCA 1627

BlueScope Steel Limited v Dongkuk Steel Mill Co., Ltd [2017] FCA 1537

Date of hearing: 3 August 2018
Registry: Victoria
Division: General Division
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Category: Catchwords
Number of paragraphs: 45
Counsel for the Applicant / First Cross-Respondent: Mr N Murray and Mr M Fleming
Solicitor for the Applicant / First Cross-Respondent: Ashurst
Counsel for the Respondent / Cross-Claimants: Mr B Caine QC and Mr J Cooke
Solicitor for the Respondent / Cross-Claimants: MinterEllison

ORDERS

VID 1229 of 2017
BETWEEN:

APOTEX PTY LTD (ACN 096 916 148)

Applicant

AND:

CIPLA LIMITED

Respondent

AND BETWEEN:

CIPLA LIMITED (and another named in the Schedule)

First Cross-Claimant

AND:

APOTEX PTY LTD (ACN 096 916 148) (and another named in the Schedule)

First Cross-Respondent

JUDGE:

BEACH J

DATE OF ORDER:

3 AUGUST 2018

THE COURT ORDERS THAT:

1.By 4.00 pm on 19 October 2018, the Respondent/Cross-Claimants conduct an electronic search of the US Discovered Documents (as described in paragraph 18(b)(ii) of the affidavit of Shyama Jayaswal affirmed on 1 August 2018), using key words as agreed by the parties or otherwise ordered by the Court, for documents that:

(a)record or describe the research, development, testing or experimental work undertaken in the course of developing the invention claimed in the Australian patent number 2003244799 titled “Combination of azelastine and steroids” during the period 14 June 2000 to 14 June 2002; and

(b)were created during the period 14 June 2000 to 14 June 2003.

2.By 4.00 pm on 9 November 2018, the Respondent/Cross-Claimants:

(a)give discovery to the Applicant/First Cross-Respondent (Apotex) of the documents identified pursuant to Order 1 above; and

(b)produce for inspection, an electronic copy of each of the documents discovered pursuant to paragraph (a), subject to any claim for privilege.

3.Apotex’s interlocutory application dated 5 March 2018 otherwise be dismissed.

4.The Respondent’s/Cross-Claimants’ costs of and incidental to Apotex’s interlocutory application be their costs in the cause and there be no other orders as to costs in relation to the Interlocutory Application.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.


REASONS FOR JUDGMENT

BEACH J:

  1. The applicant (Apotex) has sought orders requiring the respondent/cross-claimants to discover various categories of documents…

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Details
Case
[2018] FCA 1393
Decision Date

CaseChat Overview and Summary

The parties involved in this case are Apotex Pty Ltd and Cipla Limited, who are engaged in a legal dispute concerning a patent for pharmaceutical products. Specifically, the case involves the patent numbered 2003244799, which claims a combination of azelastine and steroids for nasal and ocular use. The dispute was heard in the Federal Court of Australia. The central issue before the court was whether the Respondent/Cross-Claimants were required to conduct a detailed electronic search of documents originating from the United States, and if so, to what extent. The Applicant/First Cross-Respondent (Apotex) sought discovery of documents related to the research, development, testing, and experimental work undertaken in developing the patented invention during a specified period. The court had to determine the scope and nature of the discovery required, including the relevance and proportionality of the requested documents.

The court examined whether certain documents, which were indirectly relevant and of secondary significance, should be included in the discovery. It also considered the implications of a false suggestion made by the Respondent/Cross-Claimants regarding the relevance of the documents. The court deliberated on the balance between the need for comprehensive discovery and the potential burden on the parties. Ultimately, the court ruled that a search should be conducted, but it was limited to documents that directly pertained to the specified period and the invention in question. The court emphasised the importance of proportionality and relevance in the discovery process, ensuring that the burden on the parties was reasonable and justified.

In its judgment, the court ordered the Respondent/Cross-Claimants to perform an electronic search of the specified US documents and to provide the discovered documents to Apotex, subject to any claims for privilege. The court dismissed Apotex's broader interlocutory application and awarded costs to the Respondent/Cross-Claimants. This decision underscores the necessity for precision and proportionality in patent-related discovery proceedings, ensuring that the process remains fair and manageable for all parties involved.

Orders

Orders of the court

1. By 4.00 pm on 19 October 2018, the Respondent/Cross-Claimants conduct an electronic search of the US Discovered Documents (as described in paragraph 18(b)(ii) of the affidavit of Shyama Jayaswal affirmed on 1 August 2018), using key words as agreed by the parties or otherwise ordered by the Court, for documents that:

(a) record or describe the research, development, testing or experimental work undertaken in the course of developing the invention claimed in the Australian patent number 2003244799 titled “Combination of azelastine and steroids” during the period 14 June 2000 to 14 June 2002; and

(b) were created during the period 14 June 2000 to 14 June 2003.

2. By 4.00 pm on 9 November 2018, the Respondent/Cross-Claimants:

(a) give discovery to the Applicant/First Cross-Respondent (Apotex) of the documents identified pursuant to Order 1 above; and

(b) produce for inspection, an electronic copy of each of the documents discovered pursuant to paragraph (a), subject to any claim for privilege.

3. Apotex’s interlocutory application dated 5 March 2018 otherwise be dismissed.

4. The Respondent’s/Cross-Claimants’ costs of and incidental to Apotex’s interlocutory application be their costs in the cause and there be no other orders as to costs in relation to the Interlocutory Application.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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