Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd

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FEDERAL COURT OF AUSTRALIA

Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44

File number(s): NSD 172 of 2024
Judgment of: DOWNES J
Date of judgment: 5 February 2025
Catchwords:

PATENTS – patent for controlled release aripiprazole formulations and methods for preparing and using such formulations – validity of extension of term of patent – validity of claims – whether pharmaceutical substance per se – whether pharmaceutical substance can include formulations – whether formulations can only include substances which have therapeutic use – whether pharmaceutical substances fall within scope of claims within meaning of s 70(2) Patents Act 1990 (Cth) – whether goods on the Australian Register of Therapeutic Goods take all of the features of the pharmaceutical substance as required by s 70(3) Patents Act 1990 (Cth)

PATENTS – whether claims limited by result – validity of claims – whether claims should be revoked for lack of clarity and lack of definition – s 40(2)(b) Patents Act 1990 (Cth) – s 40(3) Patents Act 1990 (Cth)
Legislation:

Competition and Consumer Act 2010 (Cth) Sch 2 (Australian Consumer Law) s 18

Patents Act 1990 (Cth) ss 40(2)(b), 40(3), 70, 70(2), 70(3), 78, 192

Cases cited:

Albany Molecular Research Inc v Alphapharm Pty Ltd (2011) 90 IPR 457; [2011] FCA 120

Alphapharm Pty Ltd v H Lundbeck A/S (2014) 254 CLR 247; [2014] HCA 42

Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag (2008) 77 IPR 229; [2008] FCAFC 121

Axent Holdings Pty Ltd t/a Axent Global v Compusign Australia Pty Ltd (2020) 154 IPR 431; [2020] FCA 1373

BlueScope Steel Ltd v Dongkuk Steel Mill Co, Ltd (No 2) (2019) 152 IPR 195; [2019] FCA 2117

Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595; [2001] FCA 647

Boehringer Ingelheim International v Commissioner of Patents (2000) AIPC 91-670; [2000] FCA 1918

Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414

Commissioner of Patents v AbbVie Biotechnology Ltd (2017) 253 FCR 436; [2017] FCAFC 129

Commissioner of Patents v Ono Pharmaceutical Company Ltd (2022) 291 FCR 1; [2022] FCAFC 39

Flexible Steel Lacing Company v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890

General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd (1971) 1A IPR 121

GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Ltd v Apotex Pty Ltd (2016) 119 IPR 1; [2016] FCA 608

H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151; [2009] FCAFC 70

Hicks v Minister for Immigration & Multicultural & Indigenous Affairs [2003] FCA 757

Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461

Meat & Livestock Australia Ltd v Cargill, Inc (2018) 129 IPR 278; [2018] FCA 51

Merck Sharp & Dohme Corp v Sandoz Pty Ltd (2022) 291 FCR 26; [2022] FCAFC 40

Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Limited (1980) 144 CLR 253

Nesbit Evans Group Australia Pty Ltd v Impro…

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Details
Case
[2025] FCA 44
Decision Date

CaseChat Overview and Summary

The case of Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd was heard in the Federal Court of Australia. The dispute between the parties centred on the validity of a patent for controlled release aripiprazole formulations and methods for preparing and using such formulations. Otsuka Pharmaceutical Co Ltd, the patent holder, alleged that Sun Pharma ANZ Pty Ltd had threatened to infringe its patent and extend the term of the patent in breach of the Patents Act 1990 (Cth). The court was required to determine whether the pharmaceutical substances per se could include formulations and whether these substances fell within the scope of the claims as defined by section 70(2) of the Patents Act. Additionally, the court had to decide if the claims were limited by result and if they complied with sections 40(2)(b) and 40(3) of the Patents Act.

The court found that the patent extension term (PTE) claims were invalid due to their failure to define the invention and lack of clarity, as required by sections 40(2)(b) and 40(3) of the Patents Act. The court determined that the asserted pharmaceutical substances per se did not meet the requirements of section 70 of the Patents Act because the substances did not contain the relevant feature contained in the PTE claims and the claims were invalid. As a result, the pharmaceutical substances did not fall within the scope of the claims as required by section 70(2)(a) of the Patents Act. Consequently, the cross-claim based on threatened infringement of the patent also failed because no valid patent was found.

The court ordered that the unredacted text of the reasons for judgment be restricted to the external legal representatives of the parties until further order of the court. The parties were directed to confer and provide a draft order to the chambers of Downes J by a specified date. If the parties were unable to reach an agreement on the form of orders, they were to notify chambers and provide their own version of a draft order with the areas of disagreement set out in mark-up.

Orders

Orders of the court

1. Pursuant to ss 37AF(1)(b) and 37AG(1)(a) of the Federal Court of Australia Act 1976 (Cth), access to and disclosure (by publication or otherwise) of the unredacted text of the reasons for judgment delivered today be restricted to the external legal representatives of the parties until further order of the Court.

2. By 7 February 2025, the parties confer to determine whether any paragraphs of these reasons require redaction before being publicly released and provide a draft order to the chambers of Downes J concerning the publication of these reasons.

3. The parties are directed to confer and provide a draft order giving effect to these reasons to the chambers of Downes J by 12 February 2025.

4. If the parties are unable to reach agreement about the form of orders, then the parties are to notify chambers and provide their own version of a draft order, with the areas of disagreement set out in mark-up.

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

For these reasons, the PTE Claims are invalid because they fail to define the invention and lack clarity, as required by ss 40(2)(b) and 40(3) of the Patents Act. It follows that they should be revoked. 7. CONCLUSION ON VALIDITY OF EXTENSION In summary, the asserted pharmaceutical substances per se do not meet the requirements of s 70 of the Patents Act for the following reasons:(1)Substances I–IV and VI–IX do not contain the Relevant Feature which is contained in each of the PTE Claims with the consequence that they do not in substance fall within the scope of the claim or claims as required by s 70(2)(a) of the Patents Act.(2)Substances I–X do not in substance fall within the scope of the claim or claims as required by s 70(2)(a) because the PTE Claims are invalid as they fail to comply with ss 40(2)(b) and 40(3) of the Patents Act.8. CROSS-CLAIM As observed, Sun Pharma has applied to register and intends to sponsor and supply products registered on the ARTG which are a generic version of the ABILIFY MAINTENA (400 mg) powder and solvent for injection, and it wishes to launch those products on 1 April 2025. By reference to the proposed Sun Pharma products, it is common ground that the Cross-Claim based on threatened infringement of the Patent must succeed in the event that the Patent and the Extension are found to be valid to any extent. As that has not occurred, this claim must fail. Otsuka also claims that Sun Pharma has threatened to contravene s 18(1) of the ACL. Otsuka’s case relies on the Court’s finding of threatened infringement of the Patent, at least in part. As no finding of threatened infringement of the Patent has been made, this claim must also fail.9. DISPOSITION I will direct the parties to confer and either provide my chambers with an agreed form of order which reflects these reasons, or with their own version of a proposed order.

Ratio Decidendi

Legal Principle Established

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