Federal Court of Australia
Federal Court of Australia
AUPharma Pty Limited v Mundipharma Pty Limited [2023] FCA 330 File number: NSD 1009 of 2022
Judgment of: YATES J
Date of judgment: 5 April 2023
Catchwords: PRACTICE AND PROCEDURE – patents – application for an order that the respondent produce certain modules provided to the Therapeutic Goods Administration – whether modules relevant to applicant's challenges to validity and extensions of term of the respondent's patents
Legislation: Federal Court Rules 2011 (Cth) rr 1.32, 30.28 Patents Act 1990 (Cth) ss 40, 70
Cases cited: Re Application by LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12; 57 IPR 104 Re LTS Lohmann Therapie Systeme AG & Schwartz Pharma Ltd and Commissioner of Patents [2010] AATA 809; 118 ALD 425
Division: General Division
Registry: New South Wales
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Number of paragraphs: 50
Date of hearing: 5 April 2023
Counsel for the Applicant: Mr J Cooke SC
Solicitor for the Applicant: Maddocks
Counsel for the Respondent: Mr P Flynn SC and Ms C Cunliffe
Solicitor for the Respondent: Corrs Chambers Westgarth
ORDERS NSD 1009 of 2022
BETWEEN: AUPHARMA PTY LIMITED (ACN 132 146 313) Applicant
AND: MUNDIPHARMA PYT LIMITED (ACN 081 322 509) Respondent
order made by: YATES J DATE OF ORDER: 5 APRIL 2023
THE COURT ORDERS THAT:
1. The respondent produce to the applicant electronic copies of the following modules from the dossier provided to the Therapeutic Goods Administration in relation to each of the respondent's TARGIN® products: (a) module 3.2.P.1 titled "Description and Composition of the Drug Product"; (b) section 3.2.P.2.1 titled "Components of the Drug Product"; (c) section 3.2.P.2.2 titled "Drug Product"; (d) section 3.2.P.2.3 titled "Manufacturing Process Development"; and (e) module 3.2.P.3.3 titled "Description of Manufacturing Process and Process Controls". 2. The respondent pay the applicant's costs of the interlocutory application dated 23 March 2023. 3. The interlocutory application dated 30 March 2023 be dismissed, with no order as to costs. 4. The proceeding be listed for case management on 21 April 2023 at 9.30 am. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
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