Millennium Pharmaceuticals v. Drug Houses of Australia: Patent Infringement & Therapeutic Product Registration
Millennium Pharmaceuticals, Inc. sued Drug Houses of Australia Pte Ltd in the High Court of Singapore, alleging potential patent infringement related to the defendant's therapeutic product registration. The plaintiff sought declarations and an injunction. The defendant applied to strike out the plaintiff's statement of claim. The court partially allowed the defendant's striking-out application and dismissed the plaintiff's application for an interlocutory injunction. The court found that the claim for a declaration of material falsehood disclosed a reasonable cause of action, but the claims for prospective infringement, an injunction, and actual infringement did not.
1. Case Overview
1.1 Court
High Court of Singapore1.2 Outcome
Defendant's striking-out application allowed in part; Plaintiff's application for interlocutory injunction dismissed.
1.3 Case Type
Intellectual Property
1.4 Judgment Type
Grounds of Decision
1.5 Jurisdiction
Singapore
1.6 Description
Millennium Pharmaceuticals sues Drug Houses of Australia for potential patent infringement related to therapeutic product registration. The court partially grants the striking-out application.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Millennium Pharmaceuticals, Inc | Plaintiff | Corporation | Striking-out application partially allowed against, Application for Interlocutory Injunction Dismissed | Partial, Lost | Suhaimi bin Lazim, Chiong Song Ning, Yan Chongshuo |
| Drug Houses of Australia Pte Ltd | Defendant | Corporation | Striking-out application allowed in part | Partial | Kang Choon Hwee Alban, Tan Lijun, Marcus Lim |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| Mavis Chionh Sze Chyi | Judicial Commissioner | Yes |
4. Counsels
| Counsel Name | Organization |
|---|---|
| Suhaimi bin Lazim | Mirandah Law LLP |
| Chiong Song Ning | Mirandah Law LLP |
| Yan Chongshuo | Mirandah Law LLP |
| Kang Choon Hwee Alban | Bird & Bird ATMD LLP |
| Tan Lijun | Bird & Bird ATMD LLP |
| Marcus Lim | Bird & Bird ATMD LLP |
4. Facts
- Plaintiff owns Singapore Patent Nos SG 151322 and SG 182998, process patents related to manufacturing Bortezomib.
- Defendant obtained approval from the HSA for a therapeutic product described as “Bortezomib – Actavis Powder for Solution for Injection 3.5mg/vial”.
- Plaintiff alleges Defendant omitted to declare Plaintiff's Patents when applying for registration of its therapeutic product.
- Defendant claims its product does not use the processes disclosed in Plaintiff's Patents.
- Plaintiff sought an interlocutory injunction to restrain the Defendant from performing any acts for which registration was obtained.
- Defendant cross-applied to strike out the Plaintiff’s Statement of Claim on the ground that it disclosed no reasonable cause of action.
- Plaintiff has granted an exclusive license to Johnson & Johnson Pte Ltd to manufacture, market, and supply Bortezomib in Singapore.
5. Formal Citations
- Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd, Suit No 1089 of 2017 (Summonses Nos 5611 and 5650 of 2017), [2018] SGHC 149
6. Timeline
| Date | Event |
|---|---|
| Defendant obtained approval from the Health Sciences Authority for registration of a therapeutic product. | |
| Plaintiff's lawyers wrote to the Defendant regarding the declaration of Plaintiff's Patents. | |
| Defendant's lawyers replied, stating that the Plaintiff's Patents were 'not relevant'. | |
| Plaintiff and Defendant signed a non-disclosure agreement. | |
| Plaintiff commenced Suit 1089 against the Defendant. | |
| Plaintiff brought Summons No 5611 seeking an interlocutory injunction. | |
| Defendant brought Summons No 5650 seeking to strike out the Statement of Claim. | |
| Court heard both summonses. | |
| Court dismissed the Plaintiff’s application for an interlocutory injunction and allowed the Defendant’s striking-out application in part. | |
| Court granted the Plaintiff’s application for leave to appeal against the decision in Summons No 5611. |
7. Legal Issues
- Patent Infringement
- Outcome: The court found that there was no reasonable cause of action for prospective infringement.
- Category: Substantive
- Sub-Issues:
- Prospective Infringement
- Actual Infringement
- False Declaration in Therapeutic Product Registration
- Outcome: The court found that the claim for a declaration of material falsehood disclosed a reasonable cause of action.
- Category: Substantive
- Interlocutory Injunction
- Outcome: The court dismissed the plaintiff's application for an interlocutory injunction.
- Category: Procedural
8. Remedies Sought
- Declaration of False Declaration
- Declaration of Patent Infringement
- Injunction to Restrain Infringement
- Delivery Up or Destruction of Infringing Articles
- Inquiry as to Damages or Account of Profits
9. Cause of Actions
- Patent Infringement
- False Declaration
10. Practice Areas
- Intellectual Property Litigation
- Pharmaceutical Law
11. Industries
- Pharmaceuticals
12. Cited Cases
| Case Name | Court | Affirmed | Citation | Jurisdiction | Significance |
|---|---|---|---|---|---|
| American Cyanamid Co v Ethicon Ltd | House of Lords | Yes | [1975] AC 396 | United Kingdom | Cited for the test to determine whether to grant an interlocutory injunction. |
| AstraZeneca AB (SE) v Sanofi-Aventis Singapore Pte Ltd | High Court | Yes | [2012] SGHC 16 | Singapore | Cited regarding the issue of prospective patent infringement and the interpretation of the Medicines Act. |
| Gouriet v Union of Post Office Workers and Others | Unknown | Yes | [1978] AC 435 | Unknown | Cited for the principle that a party applying for declaratory relief need not have a subsisting cause of action. |
| Nokia Corp v Interdigital Technology Corp | Unknown | Yes | [2007] FSR 23 | Unknown | Cited as establishing that the court has inherent jurisdiction in patent cases to grant declarations of infringement or non-infringement pertaining to prospective events. |
| Wyko Group Plc v Cooper Roller Bearings Co Ltd | Unknown | Yes | [1996] FSR 126 | Unknown | Cited as establishing that the court has inherent jurisdiction in patent cases to grant declarations of infringement or non-infringement pertaining to prospective events. |
| Nation Fittings (M) Sdn Bhd v Oystertec plc and another suit | High Court | Yes | [2006] 1 SLR(R) 712 | Singapore | Cited for the purposive approach to statutory interpretation. |
| Wee Soon Kim Anthony v Law Society of Singapore | Unknown | Yes | [2001] 2 SLR(R) 821 | Unknown | Cited for the principle that the 'essential touchstone' for any exercise of the court's inherent jurisdiction is that of 'need'. |
| Roberto Building Material Pte Ltd and others v Oversea-Chinese Banking Corp Ltd and another | Unknown | Yes | [2003] 2 SLR(R) 353 | Unknown | Cited for the courts' repeated reminder that the 'circumstances must be special' to justify the exercise of inherent jurisdiction. |
| Siskina (Owners of cargo lately laden on board) and Others v Distos Compania Naviera SA | Unknown | Yes | [1979] AC 210 | Unknown | Cited for the principle that a right to obtain an interlocutory injunction is not a cause of action. |
| Associated Newspapers Group Plc v Insert Media Ltd and Others | Unknown | Yes | [1988] 1 WLR 509 | Unknown | Cited for the principle that a right to obtain an interlocutory injunction is not a cause of action. |
| The Upjohn Company v T Kerfoot & Co Ltd | Unknown | Yes | [1988] FSR 1 | Unknown | Cited for the principle that the making of an application for registration per se is not an infringing act. |
| Wellmix Organics (International) Pte Ltd v Lau Yu Man | Unknown | Yes | [2006] 2 SLR(R) 117 | Unknown | Cited for the 'most exceptional' nature of the court's inherent jurisdiction. |
| Leo Pharma A/S and Another v Sandoz Ltd | England and Wales Court of Appeal (Civil Division) | Yes | [2008] EWCA Civ 850 | United Kingdom | Cited as an authority where an interim injunction was granted based on the finding that damages would be an inadequate remedy. |
| SmithKline Beecham Plc v Generics UK Ltd | England and Wales High Court (Patents Court) | Yes | [2001] EWHC 563 (Pat) | United Kingdom | Cited as an authority where an interim injunction was granted based on the finding that damages would be an inadequate remedy. |
| SmithKline Beecham Plc and Another v Apotex Europe Limited and Others | England and Wales Court of Appeal (Civil Division) | Yes | [2003] EWCA Civ 137 | United Kingdom | Cited as an authority where an interim injunction was granted based on the finding that damages would be an inadequate remedy. |
| Merck Sharp & Dohme Corporation and another v Glenmark Pharmaceuticals | High Court of Delhi | Yes | FAO (OS) 190/2013 | India | Cited as an authority where an interim injunction was granted based on the finding that damages would be an inadequate remedy. |
| Cephalon, Inc and Others v Orchid Europe Limited and Generics (UK) Ltd (t/a Mylan) | England and Wales High Court (Patents Court) | Yes | [2010] EWHC 2945 (Pat) | United Kingdom | Cited as an authority where the court declined to find that a generic's entry presaged an irreversible price crash. |
| Royal Insurance Co Ltd v Midland Insurance Co Ltd | Unknown | Yes | (1908) 26 RPC 95 | Unknown | Cited for the principle that a plaintiff who seeks a quia timet injunction takes upon himself the burden of proving that it is reasonably certain that what the defendant is threatening and intending to do will cause imminent and substantial damage to the plaintiff. |
13. Applicable Rules
| Rule Name |
|---|
| Rules of Court (Cap 322, R 5, 2014 Rev Ed) |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Health Products Act (Cap 122D, 2008 Rev Ed) | Singapore |
| Patents Act (Cap 221, 2005 Rev Ed) | Singapore |
| Civil Law Act (Cap. 43) | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- Bortezomib
- Therapeutic Product Registration
- Patent Infringement
- Interlocutory Injunction
- Striking Out
- Health Sciences Authority
- Prospective Infringement
- Material Falsehood
- Process Patents
15.2 Keywords
- patent infringement
- therapeutic product
- injunction
- striking out
- pharmaceuticals
- bortezomib
16. Subjects
- Intellectual Property
- Patent Law
- Civil Procedure
- Pharmaceuticals
- Therapeutic Products
17. Areas of Law
- Patent Law
- Civil Procedure
- Injunctions
- Therapeutic Product Registration