Case Details
- Citation: [2020] SGHC 28
- Case Title: Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm)
- Court: High Court of the Republic of Singapore
- Decision Date: 07 February 2020
- Originating Process: Originating Summons No 1034 of 2019
- Judge: Dedar Singh Gill JC
- Plaintiff/Applicant: Millennium Pharmaceuticals, Inc
- Defendant/Respondent: Zyfas Medical Co (sued as a firm)
- Counsel for Plaintiff/Applicant: Suhaimi bin Lazim and Yan Chongshuo (Mirandah Law LLP)
- Counsel for Defendant/Respondent: Wong Siew Hong and Kuek Kai Liang (Eldan Law LLP)
- Legal Area: Statutory Interpretation — Construction of statute
- Statutes Referenced: Interpretation Act (Cap 1), including s 9A; Interpretation Act provisions on subsidiary legislation; Health Products Act (Cap 122D); Health Products (Therapeutic Products) Regulations 2016 (S 329/2016); Medicines Act (Cap 176, 1985 Rev Ed); Patents Act (Cap 221, 2005 Rev Ed)
- Key Regulations/Provisions: Regulation 23(2) and Regulation 24(1)(a)(ii) of the Health Products (Therapeutic Products) Regulations 2016
- Related Appellate Note: The appeal in Civil Appeal No 211 of 2019 was dismissed by the Court of Appeal on 14 August 2020 (see [2020] SGCA 84).
- Judgment Length: 6 pages; 2,691 words
Summary
In Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm) [2020] SGHC 28, the High Court considered the statutory consequences of an omission in a regulatory declaration made to the Health Sciences Authority (HSA) under the Health Products (Therapeutic Products) Regulations 2016. The case arose because the defendant, a distributor of generic pharmaceutical products, obtained registration for a therapeutic product containing the active ingredient bortezomib without disclosing certain patents held by the plaintiff.
The court granted the plaintiff a declaration that the defendant’s declaration under reg 23(2) of the Therapeutic Products Regulations omitted to disclose matter that was material to its application. Crucially, the High Court held that, for the purposes of reg 24(1)(a)(ii), the operative omission did not require proof that the defendant knowingly or intentionally omitted to disclose the relevant patents. The court adopted a purposive approach to statutory interpretation, focusing on the regulatory scheme’s objective of enabling the HSA to assess patent status at the time of marketing approval decisions.
What Were the Facts of This Case?
The plaintiff, Millennium Pharmaceuticals, Inc, is a Delaware-incorporated company. The defendant, Zyfas Medical Co (sued as a firm), is a Singapore-registered partnership and a distributor of generic pharmaceutical, medicinal and healthcare products, including products used for cancer treatment. The dispute concerned the registration of a therapeutic product with the HSA and the accuracy and completeness of the patent-related declarations made in the course of that regulatory process.
The plaintiff was the registered proprietor of three patents relating to the manufacture of bortezomib, a cancer drug used to treat multiple myeloma and mantle cell lymphoma. The patents included Singapore publication and application rights: Singapore Publication No SG 151322, Singapore Publication No SG 182998, and Singapore Application No SG 10201600029P. These were process patents, meaning they protected methods of manufacturing bortezomib rather than a product patent covering bortezomib itself.
On 1 February 2018, the defendant applied to register a therapeutic product sold under the name “Myborte” with the HSA. The Myborte product contained bortezomib as its active ingredient. The plaintiff later discovered, around July 2019, that the defendant had obtained registration for the Myborte product. At the time of the defendant’s declaration to the HSA, bortezomib itself was not covered by any existing product patent in Singapore. However, the plaintiff’s process patents were in force.
The defendant took the position that only product patents “in force in respect of a therapeutic product” needed to be declared, and therefore it did not disclose the plaintiff’s process patents. When the plaintiff’s solicitors requested a copy of the defendant’s declaration on 11 July 2019, the defendant’s solicitors responded on 24 July 2019 that there was no infringement of the patents and, therefore, no need to declare them in the HSA declaration. This response prompted the plaintiff to commence the present proceedings seeking a declaration that the defendant’s regulatory declaration omitted material patent information.
What Were the Key Legal Issues?
The central legal issue was the proper construction of reg 24(1)(a)(ii) of the Health Products (Therapeutic Products) Regulations 2016. Specifically, the court had to decide whether an “operative omission” under reg 24(1)(a)(ii)—an omission to disclose “any matter that is material to the application”—requires that the defendant knowingly or intentionally omitted to state the existence of relevant patents.
While the defendant’s omission was not seriously disputed in substance, the parties differed on the mental element, if any, required by the regulatory text. The plaintiff argued that the statute did not impose a requirement of knowledge or intention for the omission to be operative. The defendant submitted that the court must examine the defendant’s knowledge or intention at the time the declaration was made, effectively reading in a fault element into the regulatory consequence.
A related interpretive question was how the court should approach the statutory scheme as a whole, including the purpose of the declaration requirement and the role of the HSA in managing patent disputes through the regulatory framework. The court also considered how earlier authority had interpreted the declaration requirement, including the Court of Appeal’s approach to the relevance of process patents in the HSA declaration context.
How Did the Court Analyse the Issues?
The court began by setting the regulatory framework. Under reg 23(2) of the Therapeutic Products Regulations, an applicant for registration of a therapeutic product must furnish to the HSA, in its declaration, information including whether a patent under the Patents Act is in force in respect of the therapeutic product. The HSA uses this information to determine how to proceed with the application and, where appropriate, to trigger mechanisms for patent dispute handling.
The court noted that reg 23(2) operates within a broader statutory scheme under the Health Products Act. Under s 37(1) of the Health Products Act, the HSA may suspend or cancel registration if it has reasonable grounds to believe the registration was obtained by fraud or misrepresentation, or if the registrant contravened any other prescribed requirement. Regulation 23(2) is one such prescribed requirement. The consequence for non-compliance is addressed in reg 24, which provides for cancellation upon an application by an interested person if the HSA is satisfied that a court has determined that the declaration made under reg 23(2) contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application.
Importantly, the defendant conceded that the requirement to disclose whether a patent is in force in respect of the therapeutic product includes disclosure of existing process patents relating to the therapeutic product. This concession was consistent with the Court of Appeal’s reasoning in Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31, where the Court of Appeal rejected the notion that an applicant could avoid declarations by asserting non-infringement. The Court of Appeal emphasised that the applicant must declare the patents and then state, among other possibilities, that the patents are invalid and will not be infringed, leaving it to the HSA to decide whether to invoke reg 23(5) to require notice to the patent proprietor.
With the scope of disclosure clarified, the remaining interpretive dispute concerned the mental element for an omission. The court applied the purposive approach to statutory interpretation mandated by s 9A of the Interpretation Act. Under s 9A, an interpretation that promotes the purpose or object underlying the written law is preferred to one that does not. The court also relied on the fact that the purposive approach extends to subsidiary legislation made under an Act, meaning the Therapeutic Products Regulations should be interpreted in light of their regulatory objectives.
In analysing the text of reg 24(1)(a)(ii), the court focused on the language of “omits to disclose any matter that is material to the application”. The court treated the omission itself as the operative event. The statutory trigger for cancellation is not framed in terms of whether the applicant intended to mislead or whether it acted with knowledge; rather, it is framed in terms of whether the declaration omitted material information. The court therefore considered that reading in a knowledge or intention requirement would be inconsistent with the structure and wording of the provision.
The court also examined the legislative purpose behind the declaration requirement. It was helpful, the judge observed, to consider parliamentary debates on the earlier equivalent provision in the Medicines Act. The declaration requirement was introduced to fulfil Singapore’s obligations under the US-Singapore Free Trade Agreement, specifically to ensure that marketing approval for generic products is not granted before patent expiry unless the patent owner consents. The declaration requirement enables the HSA to consider patent status when deciding whether and how to grant marketing approval, and to manage patent disputes through subsequent procedural steps.
Against this background, the court reasoned that the regulatory scheme depends on accurate and complete patent disclosures at the time of application. The HSA’s ability to perform its statutory role would be undermined if applicants could avoid the consequences of omission by arguing that they did not know the patents were relevant or that they did not intend to omit them. The purpose of the scheme is to ensure that patent status information is placed before the HSA so that the regulatory process can proceed with appropriate safeguards.
Accordingly, the court concluded that an operative omission under reg 24(1)(a)(ii) does not require proof that the defendant knowingly or intentionally omitted to disclose the relevant patents. The court’s approach treated the omission as objective non-compliance with a prescribed requirement, rather than a fault-based concept requiring evidence of intention or knowledge.
What Was the Outcome?
The High Court granted the plaintiff the declaration sought, limited to the omission aspect. The court declared that the defendant’s declaration(s) made under reg 23(2) omitted to disclose matter that was material to its application(s) for registration of its therapeutic product (SIN15736P). The court did not make findings on whether the declaration contained a statement that was false or misleading in a material particular, because the plaintiff accepted that it was sufficient to establish violation of reg 23(2) through omission alone.
Practically, the decision confirmed that, for cancellation applications under reg 24(1)(a)(ii), an interested person can rely on the fact of omission of material patent information without needing to prove a mental element such as knowledge or intention. This strengthens the enforcement mechanism for patent-related declarations in the HSA regulatory process.
Why Does This Case Matter?
This case is significant for practitioners because it clarifies the evidential and interpretive threshold for regulatory non-compliance under the Therapeutic Products Regulations. By holding that an operative omission under reg 24(1)(a)(ii) does not require proof of knowledge or intention, the High Court reduced the scope for applicants to defend omissions by characterising them as inadvertent or based on a mistaken understanding of what must be declared.
For patent owners and generic applicants alike, the decision reinforces that the HSA declaration regime is designed to be information-forward and compliance-focused. Applicants must disclose relevant patents—whether product or process patents—so that the HSA can decide how to manage patent disputes. The case therefore supports a strict approach to disclosure obligations and aligns with the Court of Appeal’s earlier emphasis that applicants cannot unilaterally decide that patents are irrelevant based on infringement assessments.
From a statutory interpretation perspective, the case demonstrates the application of the purposive approach under s 9A of the Interpretation Act to subsidiary legislation. It shows how courts will use legislative history and regulatory objectives to determine whether a provision should be read as requiring a fault element. Practitioners should take note that, where the regulatory scheme is aimed at enabling administrative decision-making, courts are less likely to imply subjective mental requirements into operative provisions.
Legislation Referenced
- Health Products Act (Cap 122D, 2008 Rev Ed), in particular s 37(1)
- Health Products (Therapeutic Products) Regulations 2016 (S 329/2016), in particular regs 23(2), 23(3), 23(5), and 24(1)(a)(ii)
- Interpretation Act (Cap 1, 2002 Rev Ed), in particular s 9A (purposive interpretation) and provisions defining “written law” to include subsidiary legislation
- Patents Act (Cap 221, 2005 Rev Ed)
- Medicines Act (Cap 176, 1985 Rev Ed), in particular former s 12A(2)
Cases Cited
- Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31
- Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm) [2020] SGCA 84 (appeal dismissed; referenced in LawNet editorial note)
- Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm) [2020] SGHC 28
- Zainudin bin Mohamed v Public Prosecutor [2018] 1 SLR 449
Source Documents
This article analyses [2020] SGHC 28 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the full judgment for the Court's complete reasoning.