Case Details
- Citation: [2020] SGHC 28
- Title: Millennium Pharmaceuticals, Inc. v Zyfas Medical Co (sued as a firm)
- Court: High Court of the Republic of Singapore
- Originating Process: Originating Summons No 1034 of 2019
- Date of Decision: 7 February 2020
- Judge: Dedar Singh Gill JC
- Hearing Dates Mentioned: 23 October 2019 (decision granted ex tempore); 7 February 2020 (grounds of decision)
- Plaintiff/Applicant: Millennium Pharmaceuticals, Inc.
- Defendant/Respondent: Zyfas Medical Co (sued as a firm)
- Legal Area(s): Statutory interpretation; regulatory law; patent-related regulatory declarations
- Statutes Referenced: Health Products Act (Cap 122D, 2008 Rev Ed) (“HPA”); Health Products (Therapeutic Products) Regulations 2016 (S 329/2016) (“TPR”); Patents Act (Cap 221, 2005 Rev Ed); Interpretation Act (as to subsidiary legislation made under an Act)
- Key Regulations: Regulations 23(2), 23(3), 23(5), and 24(1)(a)(ii) of the TPR
- Related Statutory Provision (historical): Section 12A(2) of the Medicines Act (Cap 176, 1985 Rev Ed) (“MA”)
- Cases Cited: [2019] SGCA 31; [2020] SGHC 28
- Judgment Length: 12 pages; 2,864 words
Summary
Millennium Pharmaceuticals, Inc. v Zyfas Medical Co (sued as a firm) concerns the patent-declaration regime under Singapore’s therapeutic product regulatory framework. The plaintiff, a patent proprietor, sought a declaration that the defendant’s declaration to the Health Sciences Authority (“HSA”) under reg 23(2) of the Health Products (Therapeutic Products) Regulations 2016 (“TPR”) omitted to disclose certain patents that were in force at the time of the defendant’s application to register a therapeutic product containing bortezomib.
The High Court (Dedar Singh Gill JC) granted the plaintiff the declaration, and the defendant appealed. In the grounds of decision, the court focused on the proper construction of reg 24(1)(a)(ii) of the TPR—specifically whether an “operative omission” under that provision requires proof that the applicant knowingly or intentionally omitted to disclose the relevant patents. The court held that the omission analysis did not turn on the defendant’s knowledge or intention; it was sufficient that the declaration omitted material information required by reg 23(2).
What Were the Facts of This Case?
The plaintiff, Millennium Pharmaceuticals, Inc., is a Delaware-incorporated company. The defendant, Zyfas Medical Co, is a Singapore-registered partnership and a distributor of generic pharmaceutical and healthcare products, including products for cancer treatment. The dispute arose from the defendant’s regulatory steps to obtain registration for a therapeutic product containing bortezomib.
The plaintiff is the registered proprietor of three Singapore patent publications/applications relating to process patents for the manufacture of bortezomib. These patents were: (a) Singapore Publication No SG 151322; (b) Singapore Publication No SG 182998; and (c) Singapore Application No SG 10201600029P. The patents protected processes used to manufacture bortezomib, a drug used for multiple myeloma and mantle cell lymphoma.
On 1 February 2018, the defendant applied to register a therapeutic product sold under the name “Myborte” with the HSA. The Myborte product contained the active ingredient bortezomib. At the time of the defendant’s declaration to the HSA, bortezomib itself was not covered by any existing product patent in Singapore. The defendant took the position that only product patents “in force in respect of” the therapeutic product needed to be declared, and therefore it did not disclose the plaintiff’s process patents.
In or around July 2019, the plaintiff discovered that the defendant had obtained registration for the Myborte product. The plaintiff’s solicitors requested a copy of the defendant’s declaration to the HSA on 11 July 2019. On 24 July 2019, the defendant’s solicitors replied that there was no infringement of the plaintiff’s patents and therefore no need to declare their existence in the HSA declaration. This prompted the plaintiff to file the present originating summons seeking a declaration that the defendant’s reg 23(2) declaration omitted material matters required by the TPR.
What Were the Key Legal Issues?
The central legal issue was statutory construction: when an interested person applies to cancel a therapeutic product registration under reg 24(1)(a)(ii) of the TPR, does the court require proof that the applicant knowingly or intentionally omitted to disclose the relevant patents? Put differently, is the operative omission under reg 24(1)(a)(ii) a purely objective omission of required information, or does it incorporate a mental element?
Related to this was the scope of what must be disclosed under reg 23(2). Although the defendant’s position was that only product patents need to be declared, the court noted that the defendant’s solicitor conceded that the requirement under reg 23(2)(a) to state whether a patent is in force in respect of the therapeutic product includes the disclosure of existing process patents relating to the therapeutic product. That concession aligned with the Court of Appeal’s approach in Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31.
Accordingly, the dispute narrowed to a single interpretive question: whether the omission must be accompanied by knowledge or intention at the time the declaration was made, or whether it is enough that the declaration omitted a matter that is “material to the application” as required by reg 23(2).
How Did the Court Analyse the Issues?
The court began by placing the TPR within the broader legislative scheme. The TPR were made under ss 71 and 72 of the Health Products Act (Cap 122D, 2008 Rev Ed) (“HPA”). The HPA regulates different types of health products with different regulatory requirements. The court observed that the patent-declaration requirement in reg 23(2) was substantially similar to the former s 12A(2) of the Medicines Act (Cap 176, 1985 Rev Ed) (“MA”). This similarity mattered because it allowed the court to consider the legislative purpose behind the earlier provision.
To ascertain purpose, the court referred to parliamentary materials. The Minister for Health, Mr Khaw Boon Wan, explained that s 12A of the MA was introduced to fulfil Singapore’s obligation under the US-Singapore Free Trade Agreement: marketing approval for a generic product should not be granted before the expiration of the relevant patent unless the patent owner consents. Section 12A enabled the HSA to consider the patent status of the product when deciding whether to grant marketing approval.
By analogy, the court reasoned that reg 23(2) of the TPR serves the same function. Regulation 23(2) requires an applicant, at the time of application and at other times as the HSA may require, to make and furnish a declaration stating, among other things, whether a patent under the Patents Act is in force in respect of the therapeutic product. The court treated this as a prescribed requirement that supports the HSA’s ability to manage patent disputes and regulatory decisions.
The court then examined the enforcement mechanism. Under s 37(1) of the HPA, the HSA may suspend or cancel registration if it has reasonable grounds to believe, inter alia, that the registrant was obtained by fraud or misrepresentation, or that the registrant contravened “any other prescribed requirement”. Regulation 23(2) is one such prescribed requirement. The TPR also contain further procedural safeguards: under reg 23(3), if the applicant is not the proprietor of the patent in respect of the therapeutic product, it must provide further information such as whether the patent proprietor has consented. Under reg 23(5), the HSA may require the applicant to serve a notice on the patent proprietor in certain circumstances, including where the applicant declares that the patent is invalid or will not be infringed.
Against that background, the court considered reg 24(1)(a)(ii), which provides a cancellation pathway upon an application by any interested person. The HSA may cancel registration if it 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”. The court emphasised that the plaintiff’s case proceeded on the omission limb, not on whether the declaration was false or misleading.
Crucially, the defendant’s argument sought to import a mental element into the omission requirement. The defendant submitted that, in determining whether the declaration omitted to disclose a material matter, the court must examine the defendant’s knowledge or intention at the time the declaration was made. The plaintiff contended that the TPR did not require such a mental element; the focus was on whether the declaration omitted material information required by the regulation.
The court’s analysis turned on the text and structure of the provisions. Regulation 24(1)(a)(ii) is triggered by a court determination that the declaration contains a false or misleading statement in a material particular or omits to disclose any matter that is material to the application. The language is framed in terms of the content of the declaration and the materiality of the omitted matter. The court did not treat the provision as expressly requiring proof of knowledge or intention for an omission to be “operative”.
In addition, the court’s approach was consistent with the concession made by the defendant’s solicitor during the hearing. The solicitor accepted that the existence of the patents was a “matter” material to the defendant’s application under reg 24(1)(a)(ii). The only remaining issue was therefore whether the omission required a mental element. The court treated the omission as established on the objective basis that the declaration failed to disclose the patents that were in force and that were required to be declared under reg 23(2).
The court also relied on the Court of Appeal’s ex tempore reasoning in [2019] SGCA 31. In that case, the Court of Appeal rejected the notion that an applicant could avoid disclosure by arguing that its product would not infringe the patent. The Court of Appeal held that the applicant must declare the patents and then state, among several possibilities, that the patents are invalid and will not be infringed; it is then for the HSA to decide whether to invoke reg 23(5) to require notice to the patent proprietor. This reinforced the regulatory design: disclosure is the gateway to the patent dispute mechanism, and the applicant cannot unilaterally decide that disclosure is unnecessary based on its view of infringement.
Accordingly, the High Court concluded that an operative omission under reg 24(1)(a)(ii) does not require proof that the applicant knowingly or intentionally omitted to disclose the relevant patents. The court’s focus remained on whether the declaration omitted material matters required by reg 23(2). The court also noted that it had made no finding on whether the declaration was false or misleading; the declaration’s omission of required patent information was sufficient for the declaration sought.
What Was the Outcome?
The court granted the plaintiff the declaration that the defendant’s declarations made under reg 23(2) of the TPR omitted to disclose matter that was material to its applications for registration of its therapeutic product (SIN15736P). This declaration supported the plaintiff’s ability to pursue cancellation under the TPR framework, because reg 24(1)(a)(ii) requires a court determination that the declaration omitted material matters.
Practically, the decision clarified that the omission analysis is not dependent on the defendant’s state of mind. The defendant’s appeal was therefore not successful on the key interpretive issue, and the court’s construction of reg 24(1)(a)(ii) stands as guidance for future patent-declaration disputes in therapeutic product registrations.
Why Does This Case Matter?
This case is significant for practitioners because it provides authoritative guidance on how Singapore courts will interpret the patent-declaration regime in the TPR. In particular, it confirms that where a declaration required by reg 23(2) omits material information, the regulatory consequence does not hinge on whether the applicant knowingly or intentionally made the omission. This reduces the scope for applicants to defend non-disclosure by framing it as a mistake or misunderstanding about what must be declared.
For patent owners and generic applicants alike, the decision reinforces the regulatory design: the HSA’s decision-making process depends on receiving complete patent-status declarations. The applicant’s view on infringement is not a substitute for compliance with the declaration requirement. Instead, the applicant must declare the relevant patents and then use the TPR’s procedural mechanisms (including the possibility of notice to the patent proprietor) to manage the patent dispute.
From a litigation strategy perspective, the case also illustrates how disputes may be narrowed. Here, the defendant conceded that process patents were within the scope of disclosure under reg 23(2)(a), and that materiality was satisfied. That left only the interpretive question about mental element. The court’s resolution of that question will likely streamline future applications for declarations under reg 24(1)(a)(ii), focusing attention on objective compliance with the declaration form and content requirements.
Legislation Referenced
- Health Products Act (Cap 122D, 2008 Rev Ed) (“HPA”)
- Health Products (Therapeutic Products) Regulations 2016 (S 329/2016) (“TPR”): regs 23(2), 23(3), 23(5), 24(1)(a)(ii)
- Patents Act (Cap 221, 2005 Rev Ed)
- Interpretation Act (as to subsidiary legislation made under an Act)
- Medicines Act (Cap 176, 1985 Rev Ed) (“MA”)—historical s 12A(2) (for legislative purpose)
Cases Cited
- [2019] SGCA 31
- [2020] SGHC 28
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.