Case Details
- Citation: [2018] SGHC 149
- 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
- Case Number: Suit No 1089 of 2017 (Summonses Nos 5611 and 5650 of 2017)
- Coram: Mavis Chionh Sze Chyi JC
- Plaintiff/Applicant: Millennium Pharmaceuticals, Inc
- Defendant/Respondent: Drug Houses of Australia Pte Ltd
- Procedural Posture: Plaintiff sought an interlocutory injunction (SUM 5611). Defendant cross-applied to strike out the Statement of Claim (SUM 5650). The Plaintiff also obtained leave to appeal (SUM 1764) against the interlocutory decision.
- Judicial Outcome (at High Court level): SUM 5611 dismissed; SUM 5650 allowed in part (certain passages struck out).
- Related Court of 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).
- Representing Counsel (Plaintiff): Suhaimi bin Lazim, Chiong Song Ning and Yan Chongshuo (Mirandah Law LLP)
- Representing Counsel (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/Regulatory Framework: Health Products Act (Cap 122D); Health Products (Therapeutic Products) Regulations 2016 (S 329/2016); Patents Act (Cap 221); and related provisions on declarations to the Health Sciences Authority (HSA).
- Judgment Length: 25 pages, 14,847 words
Summary
Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd concerned a dispute at the intersection of Singapore’s therapeutic product regulatory regime and patent enforcement. 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 a 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 when applying for registration, and that the Defendant’s registered acts would infringe the Plaintiff’s patents.
At the interlocutory stage, the High Court addressed two procedural questions: first, whether an interlocutory injunction should be granted to restrain the Defendant from performing the acts for which registration had been obtained; and second, whether the Plaintiff’s Statement of Claim should be struck out for disclosing 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 reflects the Court’s careful approach to (i) the evidential threshold for injunctions and (ii) the limits of pleadings where the pleaded case is insufficiently particularised or legally untenable.
What Were the Facts of This Case?
The Plaintiff, Millennium Pharmaceuticals, Inc, is incorporated and based in the United States. It 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. Importantly, the patents do not claim the active ingredient itself. The patents were stated to expire on 24 March 2025. The Plaintiff’s position was that its protected processes represent improvements over other known manufacturing processes, and that other processes may exist which are either not patented or may relate to expired patents.
The Defendant, Drug Houses of Australia Pte Ltd, is incorporated in Singapore. The Defendant obtained approval from the Health Sciences Authority (HSA) 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 Plaintiff alleged that the Defendant’s registration and subsequent performance of the registered acts would infringe the Plaintiff’s process patents. The Defendant asserted that it did not manufacture bortezomib and did not utilise the processes disclosed in the Plaintiff’s patents in making its product.
Singapore’s therapeutic product registration framework requires applicants to make declarations to the HSA regarding relevant patents. Under the Health Products Act and the Health Products (Therapeutic Products) Regulations 2016, the applicant must declare whether a patent under the Patents Act is in force in respect of the therapeutic product and whether the applicant is the proprietor of that patent. Where the applicant is not the proprietor and a patent is in force, the applicant must further state whether the proprietor has consented to or acquiesced in the grant of registration, or (alternatively) 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 different “categories” of declarations (A1, A2, A3, and B) depending on the patent status and the applicant’s position.
In this case, the Plaintiff stated that it was not served with any notice under the relevant regulatory provision that would have required the applicant to notify the patent proprietor where the applicant’s declaration indicates that the patent is invalid or will not be infringed. The Plaintiff also stated that it had not seen the Defendant’s declaration and did not know its contents. When the Plaintiff discovered the Defendant’s registration in June 2017, it wrote to the Defendant seeking confirmation of whether the Plaintiff’s patents were declared 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 Plaintiff’s patents, and it asserted there was no necessity to provide the declaration. The parties later entered into a non-disclosure agreement in October 2017, under which the Defendant provided documentation to allow the Plaintiff to assess whether the Defendant’s process infringed the patents.
What Were the Key Legal Issues?
The first key issue was whether the Plaintiff was entitled to an interlocutory injunction restraining the Defendant from performing the acts for which registration had been obtained. Injunctions in patent and regulatory-adjacent disputes require the applicant to establish, at least at the interlocutory stage, a sufficiently strong case on infringement (or other pleaded wrongdoing), and to satisfy the balance of convenience and the risk of irreparable harm. The Court also had to consider how the regulatory context—HSA registration and the declarations made to it—interacted with the patent infringement claim.
The second key issue concerned the Defendant’s striking-out application. The Defendant sought to strike out the Statement of Claim on the basis that it disclosed no reasonable cause of action. This required the Court to assess whether the pleadings were legally sustainable and sufficiently particularised. In particular, the Court had to examine whether the Plaintiff’s allegations—especially those relating to the content and alleged falsity or misleading nature of the Defendant’s declaration to the HSA—could properly ground a cause of action in the form pleaded, and whether the infringement allegations were framed in a manner that could proceed to trial.
Related to both issues was the broader question of how process patents are to be approached in infringement analysis at an early stage. Because the patents protected manufacturing processes rather than the product itself, the Plaintiff’s case necessarily depended on what processes the Defendant used (or caused to be used) in relation to the registered therapeutic product. The Court therefore had to consider whether the Plaintiff’s pleadings and evidence at the interlocutory stage sufficiently addressed the factual and legal requirements for a process-patent infringement claim.
How Did the Court Analyse the Issues?
The Court began by setting out the statutory framework governing therapeutic product registration. This was not merely background: it shaped the Court’s understanding of what declarations are required, the categories of declarations, and the regulatory consequences of those declarations. 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. The HSA must be satisfied that intended benefits outweigh risks, and that the product is suitable for its intended purpose based on formulation, manufacturing controls, specifications, and shelf life.
Within that framework, the Court focused on the declaration regime. Under the regulations, an applicant must declare whether a patent is in force and whether the applicant is the patent proprietor. Where the applicant is not the proprietor and a patent is in force, the applicant must state either consent/acquiescence or, alternatively, that the patent is invalid or will not be infringed by the acts for which registration is sought. The Court also noted the regulatory mechanism allowing the HSA to require notice to the patent proprietor in certain circumstances. This regulatory architecture was central to the Plaintiff’s allegation that the Defendant made a false or misleading declaration in a material particular or omitted to disclose material matters.
Turning to the interlocutory injunction, the Court’s analysis reflected the need for a clear evidential basis at the interim stage. While the Plaintiff alleged that the Defendant’s registration and performance would infringe the process patents, the Defendant’s position was that it did not manufacture bortezomib and did not use the patented processes. The Court therefore had to consider whether the Plaintiff had shown a sufficiently strong prima facie case of infringement, given that process patents require attention to the actual process steps used. The Court also considered the practical effect of granting an injunction in a context where the Defendant’s product had been registered by the HSA, and where the Plaintiff’s claim depended on contested technical and factual matters about manufacturing processes.
On the striking-out application, the Court applied the well-established principle that pleadings should not be struck out unless the claim is clearly unsustainable. However, the Court retained a gatekeeping role to ensure that claims without a reasonable cause of action do not proceed. In allowing the Defendant’s striking-out application in part, the Court indicated that certain passages in the Statement of Claim could not stand. Although the extract provided does not reproduce the struck-out text, the Court’s approach suggests that it scrutinised whether the Plaintiff’s pleaded allegations were framed with sufficient legal coherence and whether they disclosed a cause of action capable of being tried. This included assessing whether the Plaintiff’s declaration-related allegations were properly connected to a legally actionable claim, and whether the infringement allegations were sufficiently particularised to meet the threshold for a claim to proceed.
Finally, the Court’s reasoning implicitly addressed the relationship between regulatory declarations and patent rights. Even where a declaration to the HSA is alleged to be false or misleading, the Court would still require a legally cognisable basis for relief and a coherent linkage to patent infringement. Similarly, for infringement, the Court would require that the pleaded acts correspond to the acts protected by the patents and that the Plaintiff’s case addresses the process nature of the patents. The Court’s decision therefore demonstrates a disciplined separation between (i) the regulatory process and (ii) the substantive patent infringement inquiry, while recognising that the regulatory declarations may be relevant to the factual matrix.
What Was the Outcome?
The High Court dismissed the Plaintiff’s application for an interlocutory injunction (SUM 5611). Practically, this meant that the Defendant was not restrained on an interim basis from performing the acts for which its therapeutic product registration had been obtained, pending the resolution of the substantive dispute.
In addition, the Court allowed the Defendant’s striking-out application (SUM 5650) in part. Certain passages of the Plaintiff’s Statement of Claim were struck out, narrowing the issues that would remain for determination at trial. The Plaintiff subsequently obtained leave to appeal against the interlocutory decision, 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 case is significant for practitioners because it illustrates how Singapore courts manage patent disputes that arise alongside the therapeutic product registration regime. The decision underscores that, even where a patent proprietor alleges that a regulatory declaration was false or misleading, the claimant must still satisfy the procedural and substantive requirements for interim relief and for pleadings that disclose a reasonable cause of action. The Court’s refusal of an interlocutory injunction signals that interim patent relief will not be granted merely by asserting infringement; the applicant must show a sufficiently strong prima facie case, particularly where infringement depends on contested technical facts about manufacturing processes.
For process patents in particular, the case highlights the importance of aligning pleadings with the nature of the protected invention. Because process patents require proof of the use of the patented process (or steps) rather than merely the presence of a product, claimants must carefully plead and evidence how the defendant’s acts correspond to the patented process. The Defendant’s assertion that it did not use the patented processes was a central feature of the dispute, and the Court’s interlocutory approach reflects the need for careful scrutiny of such assertions.
Finally, the case matters as a procedural reference point. The partial striking out demonstrates that courts will remove legally untenable or insufficiently framed allegations, thereby shaping the litigation’s trajectory. For law students and litigators, the decision provides a useful example of how courts apply the gatekeeping function in striking-out applications and how they evaluate injunction applications in complex regulatory and technical contexts.
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)
- Injunction Claim and the Act (as referenced in the metadata)
- Interpretation Act (as referenced in the metadata)
- Medicines Act (as referenced in the metadata)
- Patents Act (Cap 221)
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.