Case Details
- Citation: [2018] SGHC 149
- Case Title: Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd
- Court: High Court of the Republic of Singapore
- Date of Decision: 27 June 2018
- Judges: Mavis Chionh Sze Chyi JC
- Case Number: Suit No 1089 of 2017
- Related Summonses: Summons No 5611 of 2017; Summons No 5650 of 2017; Summons No 1764 of 2018
- Procedural Posture: Applications for interlocutory injunction and for striking out of the Statement of Claim (with leave to appeal granted in respect of the injunction decision)
- Plaintiff/Applicant: Millennium Pharmaceuticals, Inc
- Defendant/Respondent: Drug Houses of Australia Pte Ltd
- Counsel for Plaintiff: Suhaimi bin Lazim, Chiong Song Ning and Yan Chongshuo (Mirandah Law LLP)
- Counsel for Defendant: Kang Choon Hwee Alban, Tan Lijun and Marcus Lim (Bird & Bird ATMD LLP)
- Legal Areas: Civil Procedure — Injunctions; Civil Procedure — Pleadings; Patents and Inventions — Infringement
- Key Statutory Framework: Health Products Act (Cap 122D); Health Products (Therapeutic Products) Regulations 2016 (S 329/2016); Patents Act (Cap 221)
- Appeal Note (LawNet Editorial Note): The appeal in Civil Appeal No 79 of 2018 was allowed while the appeal in Civil Appeal No 84 of 2018 was dismissed by the Court of Appeal on 30 April 2019 (see [2019] SGCA 31)
- Judgment Length: 25 pages, 14,847 words
Summary
Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd concerned a dispute arising from Singapore’s regulatory framework for therapeutic products and the patent declarations that applicants must make to the Health Sciences Authority (HSA). The plaintiff, the registered proprietor of two Singapore process patents relating to manufacturing processes for the anti-cancer drug bortezomib, sued the defendant after the defendant obtained HSA registration for its therapeutic product containing bortezomib. The plaintiff’s pleaded case included allegations that the defendant made a false or misleading declaration to the HSA in a material particular by omitting to disclose the plaintiff’s patents, and that the defendant’s registered acts would infringe the plaintiff’s patents.
At first instance, the High Court dealt with two interlocutory matters: the plaintiff’s application for an interlocutory injunction to restrain the defendant from performing the acts for which registration had been obtained, and the defendant’s cross-application to strike out parts of the plaintiff’s Statement of Claim on the basis that it disclosed no reasonable cause of action. The court dismissed the plaintiff’s application for an interlocutory injunction and allowed the defendant’s striking-out application in part, striking out certain passages of the Statement of Claim. The decision therefore turned on pleading sufficiency and the threshold for injunctive relief at an early stage, in the context of a complex regulatory-patent interface.
What Were the Facts of This Case?
The plaintiff, a US-incorporated company, is the registered proprietor of Singapore Patent Nos SG 151322 and SG 182998. These patents are process patents: they protect certain processes for manufacturing the active ingredient bortezomib, rather than the active ingredient itself. The patents were due to expire on 24 March 2025. The plaintiff had granted an exclusive licence to Johnson & Johnson Pte Ltd in Singapore, and the plaintiff’s evidence indicated that public hospitals in Singapore conduct annual tenders for the supply of bortezomib. The plaintiff asserted that Johnson & Johnson had historically been awarded the tender “by default” because it was the sole participant with an existing therapeutic product registration for bortezomib.
The defendant, a Singapore-incorporated company, obtained HSA approval for registration of a therapeutic product described as “Bortezomib – Actavis Powder for Solution for Injection 3.5mg/vial” under Therapeutic Product Registration No SIN15243P. The approval was granted on 26 May 2017. The defendant’s position was that it did not manufacture bortezomib and did not use the processes disclosed in the plaintiff’s patents in making its product. The plaintiff did not dispute that the patents relate to improvements over other processes and that other manufacturing processes for bortezomib may exist that are either not patented or involve patents that may have expired.
A central factual feature was the regulatory declaration process. Under the Health Products (Therapeutic Products) Regulations 2016, an applicant seeking to register a therapeutic product must make a declaration at the time of application about whether a patent under the Patents Act is in force in respect of the therapeutic product and, if so, whether the applicant is the patent proprietor. Where the applicant is not the proprietor, the applicant must further state, among other things, whether the proprietor has consented to or acquiesced in the registration, or whether, in the applicant’s opinion and to the best of its belief, the patent is invalid or will not be infringed by the doing of the act for which registration is sought. The regulations also contemplate that the HSA may require the applicant to serve a specified notice on the patent proprietor in certain circumstances.
In this case, the plaintiff alleged that it was not served with any notice under reg 23(5) of the therapeutic product regulations. The plaintiff also stated that it had not seen the defendant’s declaration made under reg 23(2) and therefore did not know what the declaration said. The defendant’s declaration was not produced in evidence at the interlocutory hearing. The plaintiff only discovered the defendant’s registration sometime in June 2017 and, on 4 July 2017, wrote to the defendant seeking confirmation whether it had declared the plaintiff’s patents and requesting a copy of the defendant’s declaration. The defendant responded that the plaintiff’s patents were “not relevant” because the defendant’s product did not use the processes disclosed in the patents, and it asserted that there was no necessity to provide the plaintiff with a copy of the declaration.
What Were the Key Legal Issues?
The first major issue was whether the plaintiff could obtain an interlocutory injunction restraining the defendant from performing the acts for which registration had been obtained. Injunctive relief in patent-related disputes typically requires the court to assess, at an early stage, the strength of the plaintiff’s case on infringement, the adequacy of damages, and the balance of convenience. Here, the plaintiff’s case was intertwined with the regulatory declaration regime: the plaintiff sought to restrain the defendant’s registered acts based on allegations that the defendant made a false or misleading declaration to the HSA and that those acts would infringe the plaintiff’s process patents.
The second issue was pleading sufficiency. The defendant applied to strike out the plaintiff’s Statement of Claim on the ground that it disclosed no reasonable cause of action. This required the court to determine whether the pleaded allegations—particularly those relating to false or misleading declarations and patent infringement—were legally and factually coherent enough to survive at the interlocutory stage. The court also had to consider how the process-patent nature of the plaintiff’s rights affected the infringement analysis, given the defendant’s assertion that it did not use the patented processes.
Finally, the case raised a broader interpretive question about the relationship between regulatory compliance and patent enforcement. The plaintiff’s pleaded declarations to the HSA were not merely regulatory technicalities; they were framed as part of the cause of action. The court therefore had to consider how far the plaintiff could rely on the regulatory declaration framework to support civil claims for infringement and injunctive relief, and whether the pleadings properly connected the regulatory conduct to the patent rights asserted.
How Did the Court Analyse the Issues?
The High Court began by setting out the statutory framework governing therapeutic product registration. The court emphasised that successful registration indicates that the HSA has evaluated the product for compliance with statutory requirements relating to quality, safety, efficacy, and presentation, and that the HSA must be satisfied that overall intended benefits outweigh overall risks. This framework matters because the declaration regime is designed to assist the HSA in assessing compliance, including the patent-related disclosures required by the regulations.
Within that framework, the court focused on the declaration requirements under reg 23 of the therapeutic product regulations. The court explained that applicants must declare whether a patent is in force and whether the applicant is the proprietor. If the applicant is not the proprietor, the applicant must either indicate consent/acquiescence or make a further declaration about invalidity or non-infringement “in its opinion and to the best of its belief.” The court also described the four categories of declarations (A1, A2, A3, and B) and the regulatory consequences that may follow, including the HSA’s discretion to require notice to the patent proprietor under reg 23(5) in certain circumstances.
Turning to the interlocutory injunction, the court dismissed the plaintiff’s application. While the extract provided does not reproduce the full injunctive analysis, the court’s approach at this stage would necessarily involve assessing whether the plaintiff had shown a sufficiently strong prima facie case on infringement and whether the other requirements for an interlocutory injunction were met. The court was also likely influenced by the evidential difficulties inherent in process patent infringement disputes. The defendant asserted that it did not use the patented processes, and the plaintiff did not have access to the defendant’s declaration or the underlying process documentation at the time of the interlocutory hearing. This gap in evidence affects the court’s ability to conclude that infringement was likely, which in turn affects the likelihood of obtaining injunctive relief.
On the striking-out application, the court allowed it in part and struck out certain passages of the Statement of Claim. The court’s reasoning would have required it to examine whether the pleaded allegations disclosed a reasonable cause of action and whether the claims were legally sustainable. In patent disputes, courts are cautious about allowing pleadings to proceed where the pleaded case is conclusory, fails to identify material facts, or does not properly articulate the legal basis for the relief sought. Here, the plaintiff’s claims included declarations that the defendant made a false or misleading statement to the HSA and that the defendant’s performance of acts for which registration was obtained would infringe the plaintiff’s patents. The court’s partial striking out indicates that some parts of the pleaded case did not meet the threshold for a reasonable cause of action, whether due to deficiencies in the pleading of material facts, the legal framing of the regulatory declaration allegations, or the connection between the declaration and the infringement claim.
Although the extract is truncated, the court’s overall analysis reflects a careful separation between (i) the regulatory process of therapeutic product registration and (ii) the civil enforcement of patent rights. Even where regulatory declarations are alleged to be false or misleading, the plaintiff still must plead and establish a civilly actionable basis for the relief sought. Likewise, for process patents, the infringement inquiry is not simply whether the product contains the relevant active ingredient; it is whether the defendant performs the patented process (or performs acts that fall within the statutory infringement provisions for the relevant patent type). The defendant’s assertion that it did not use the patented processes would therefore be a significant factor in assessing whether the plaintiff’s pleadings and evidence were sufficient at the interlocutory stage.
What Was the Outcome?
The High Court dismissed the plaintiff’s application for an interlocutory injunction in Summons No 5611 of 2017. Practically, this meant that the defendant was not restrained at that stage from performing the acts associated with its HSA registration, pending the final determination of the suit.
In addition, the court allowed the defendant’s striking-out application in Summons No 5650 of 2017 in part, striking out certain passages of the plaintiff’s Statement of Claim. This narrowed the scope of what could proceed in the action, requiring the plaintiff to reformulate or abandon the struck portions of its pleaded case. The plaintiff subsequently obtained leave to appeal against the injunction decision in Summons No 1764 of 2018, and the LawNet editorial note indicates that the Court of Appeal later allowed one appeal and dismissed another on 30 April 2019 (see [2019] SGCA 31).
Why Does This Case Matter?
This decision is significant for practitioners because it sits at the intersection of Singapore’s therapeutic product regulatory regime and patent enforcement. The case illustrates that patent proprietors seeking urgent relief against competitors who have obtained therapeutic product registration may face substantial evidential and pleading hurdles, particularly where the asserted patents are process patents and the alleged infringement depends on how the competitor manufactures or otherwise performs the relevant processes.
From a civil procedure perspective, the partial striking out underscores the importance of drafting pleadings that clearly articulate the legal basis for each head of claim and the material facts supporting it. Courts will not necessarily allow regulatory-related allegations to proceed as a matter of course; the pleadings must connect the alleged regulatory conduct to a legally cognisable cause of action and to the specific patent rights asserted.
Finally, the case is useful for understanding how the declaration categories under the therapeutic product regulations may become relevant in patent disputes. While the regulatory framework is designed to inform the HSA’s assessment, it can also become a factual battleground in civil litigation. Lawyers advising either patent proprietors or therapeutic product applicants should therefore consider, at an early stage, how declarations made to the HSA are documented, what notices are served (or not served), and how the civil pleadings will be framed to satisfy the threshold for injunctive relief and for survival against striking-out applications.
Legislation Referenced
- Civil Law Act (Cap 43)
- First Schedule to the Supreme Court of Judicature Act
- Health Products Act (Cap 122D)
- Health Products (Therapeutic Products) Regulations 2016 (S 329/2016)
- Patents Act (Cap 221)
- Medicines Act
- Interpretation Act
- Injunction Claim and the Act (as referenced in the judgment’s metadata)
Cases Cited
- [2012] SGHC 16
- [2018] SGHC 149
- [2019] SGCA 31
Source Documents
This article analyses [2018] SGHC 149 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the full judgment for the Court's complete reasoning.