Case Details
- Citation: [2020] SGCA 84
- Title: Zyfas Medical Co (Sued as a firm) v Millennium Pharmaceuticals, Inc.
- Court: Court of Appeal of the Republic of Singapore
- Date of Decision: 27 August 2020
- Civil Appeal No: Civil Appeal No 211 of 2019
- Originating Summons: Originating Summons No 1034 of 2019
- High Court Application: HC/OS 1034/2019
- Judges: Andrew Phang Boon Leong JA, Tay Yong Kwang JA and Woo Bih Li J
- Presiding/Delivering Judge: Tay Yong Kwang JA (delivering the grounds of decision)
- Plaintiff/Applicant (in OS): Millennium Pharmaceuticals, Inc
- Defendant (in OS): Zyfas Medical Co (Sued as a firm)
- Appellant (in CA): Zyfas Medical Co (Sued as a firm)
- Respondent (in CA): Millennium Pharmaceuticals, Inc
- Legal Area: Patents and Inventions; Therapeutic product registration; Statutory interpretation
- Statutes Referenced: Patents Act (Cap 221); Health Products Act (Cap 122D); Therapeutic Products (III) Regulations 2016 (S 329/2016) (“TPR”)
- Key Regulation: Regulation 23(2)(a) of the TPR
- Related/Previously Considered Case: Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another [2020] SGCA 84
- Judgment Length: 26 pages; 7,130 words
- Cases Cited (as provided): [2019] SGCA 31; [2020] SGCA 68; [2020] SGCA 84; [2020] SGHC 28
Summary
This Court of Appeal decision concerns the statutory patent-disclosure regime that applies when a party applies to register a therapeutic product with Singapore’s Health Sciences Authority (“HSA”). The appellant, Zyfas Medical Co (“Zyfas”), was a distributor of generic pharmaceutical products. It applied to register an anti-cancer drug, “Myborte”, containing the active ingredient bortezomib. Although bortezomib itself was not protected by a product patent in Singapore, the respondent, Millennium Pharmaceuticals, Inc (“Millennium”), held valid and subsisting patents covering the manufacturing processes for bortezomib (the “process patents”). Zyfas did not disclose these process patents in its declaration to the HSA.
Millennium commenced proceedings in the High Court seeking a declaration that Zyfas’s declaration under reg 23(2) of the Therapeutic Products (III) Regulations 2016 (S 329/2016) (“TPR”) contained a false or misleading statement in a material particular or omitted to disclose a matter that was material to the application. The High Court granted the declaration. Zyfas appealed to the Court of Appeal, and the appeal was dismissed with costs.
At the appellate level, Zyfas attempted to advance a legal argument that it had conceded below. The Court of Appeal granted leave in the special circumstances, but ultimately rejected the appeal. Substantively, the Court affirmed the interpretation and operation of the TPR’s disclosure scheme, emphasising the purpose of the regime and the materiality of patent information in the registration process.
What Were the Facts of This Case?
Zyfas is a distributor of generic pharmaceutical, medicinal and healthcare products. On 2 February 2018, it applied to register an anti-cancer drug known as “Myborte” with the HSA. The active ingredient in Myborte is bortezomib, which is used in the treatment of multiple myeloma and mantle cell lymphoma.
It was undisputed that bortezomib was not protected by any product patent in Singapore. However, Millennium was the registered proprietor of three patents relating to processes for manufacturing bortezomib. These process patents were valid and subsisting at the material time. Importantly, Zyfas did not declare the existence of these process patents when it applied to register Myborte as a therapeutic product.
After Zyfas’s application was approved by the HSA on 5 July 2019, Millennium discovered that Zyfas had obtained registration for Myborte. Millennium then contacted Zyfas and requested a copy of Zyfas’s declaration made in the HSA application. Zyfas’s position was that the manufacturing process for bortezomib in Myborte did not infringe the process patents, and therefore Zyfas contended there was no need to declare the process patents.
On 19 August 2019, Millennium filed OS 1034 in the High Court. The application sought a declaration that Zyfas’s declaration under reg 23(2) of the TPR contained a false or misleading statement in a material particular or omitted to disclose a matter that was material to the application for registration. Millennium also sought costs. The High Court granted the declaration, and Zyfas appealed to the Court of Appeal.
What Were the Key Legal Issues?
The central legal issue concerned the proper interpretation of reg 23(2)(a) of the TPR and the consequences of non-disclosure. Specifically, the Court had to determine whether Zyfas’s failure to disclose the existence of Millennium’s process patents in its declaration amounted to a false or misleading statement in a material particular, or an omission of a material matter, within the meaning of the TPR scheme.
A second issue arose procedurally and concerned Zyfas’s attempt to raise a legal argument on appeal that it had conceded during the High Court hearing. The Court of Appeal addressed whether it should grant leave to advance this new point, and if so, whether the argument could succeed on the merits.
More broadly, the case required the Court to consider how the patent-disclosure regime under the TPR interacts with the Patents Act framework. The Court needed to assess the purpose of the disclosure obligations and the extent to which the HSA and the regulatory scheme rely on the applicant’s declaration, rather than conducting substantive patent infringement or validity inquiries at the registration stage.
How Did the Court Analyse the Issues?
The Court of Appeal began by situating the dispute within the statutory design of therapeutic product registration. Therapeutic products are regulated under the Health Products Act (Cap 122D, 2008 Rev Ed) (“HPA”) and the TPR. Under the scheme, therapeutic products must be registered before they can be supplied in Singapore. The TPR establishes a structured process for the HSA to consider whether patents under the Patents Act are in force in respect of the therapeutic product.
Regulation 23(1) requires the HSA, when dealing with an application for registration, to consider whether a patent under the Patents Act is in force in respect of the therapeutic product. Regulation 23(2) then imposes a disclosure obligation on the applicant: unless the HSA otherwise determines, the applicant must make and furnish a declaration at the time of the application (and at other times as required) stating (a) whether a patent under the Patents Act is in force in respect of the therapeutic product, and (b) whether the applicant is the proprietor of the patent. Where the applicant is not the proprietor, reg 23(3) requires further information, including the proprietor’s details and 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 Court’s analysis emphasised that the scheme is not designed to turn the HSA registration stage into a full patent infringement or validity adjudication. Regulation 23(4) expressly provides that, for the purposes of reg 23(1), the HSA may rely upon, and need not be concerned to inquire into the truth of, any statement made in the declaration furnished under reg 23(2). This legislative choice is significant: it indicates that the applicant’s declaration is the primary mechanism by which the HSA is informed about the existence and status of relevant patents.
Against this background, the Court considered the meaning of “false or misleading” or “omits to disclose” a material matter. The Court’s reasoning, consistent with the purposive approach to statutory interpretation, treated the disclosure of patents as central to the regulatory scheme. Where a patent is in force in respect of the therapeutic product, the applicant must declare its existence. The applicant’s belief about infringement (for example, that its manufacturing process does not infringe) does not negate the obligation to disclose the patent’s existence. Instead, the scheme provides a structured pathway for patent disputes to be addressed through subsequent mechanisms, including the possibility of court or patent office proceedings and the cancellation of registration where the statutory conditions are met.
In particular, the Court referred to reg 24(1)(a)(ii), which empowers the HSA to cancel registration upon a final determination by a court that the declaration under reg 23(2) contains a false or misleading statement in a material particular or omits to disclose a matter that is material to the application. This reinforces that the legal consequence of non-disclosure is not merely regulatory; it can lead to cancellation of registration, but only after the statutory determination process is satisfied.
On the procedural point, Zyfas sought to advance a legal argument on appeal that it had conceded below. The Court of Appeal granted leave in the special circumstances of the case. However, after hearing the parties, it dismissed the appeal with costs. While the judgment extract provided does not set out the precise content of the conceded argument, the Court’s ultimate dismissal indicates that the argument could not overcome the statutory text, purpose, and the established interpretation of the disclosure regime.
Finally, the Court’s approach aligned with its earlier consideration of the same registration scheme in related appellate authority, including Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another. By treating the TPR as a coherent system with clear disclosure duties and defined dispute-resolution pathways, the Court maintained consistency in how reg 23(2) is applied across cases involving process patents and generic therapeutic product registration.
What Was the Outcome?
The Court of Appeal dismissed Zyfas’s appeal and affirmed the High Court’s declaration. The practical effect was that Zyfas’s failure to disclose Millennium’s process patents in its reg 23(2) declaration was legally significant under the TPR scheme, and the declaration obtained by Millennium stood.
In addition, the Court ordered Zyfas to pay costs of the appeal. This outcome underscores that, even where a generic applicant believes it does not infringe a process patent, the statutory disclosure obligation remains mandatory and is assessed according to the declaration regime rather than the applicant’s infringement position.
Why Does This Case Matter?
This decision is important for practitioners because it clarifies the operation of Singapore’s therapeutic product patent-disclosure regime. For generic manufacturers and distributors, the case confirms that the obligation under reg 23(2) is triggered by the existence of a patent “in force” under the Patents Act in respect of the therapeutic product. The applicant cannot avoid disclosure by asserting that it does not infringe the patent. Instead, the TPR contemplates that infringement and validity disputes are to be addressed through the statutory processes that follow registration.
For patent proprietors and brand-name companies, the case supports the effectiveness of the disclosure regime as an enforcement tool. By enabling a court determination that a declaration is false or misleading or omits material information, the regime provides a pathway to cancellation of registration under reg 24(1)(a)(ii). This enhances the strategic value of monitoring declarations and acting promptly once non-disclosure is discovered.
From a statutory interpretation perspective, the Court’s reliance on a purposive approach and the legislative design of reg 23(4) (permitting the HSA to rely on declarations without truth inquiry) provides a strong interpretive framework. Lawyers advising clients on compliance should treat the declaration as a critical legal instrument. Any omission of patent information that is material to the application can expose the applicant to adverse declarations and downstream regulatory consequences.
Legislation Referenced
- Health Products Act (Cap 122D, 2008 Rev Ed)
- Therapeutic Products (III) Regulations 2016 (S 329/2016), in particular:
- Regulation 23 (including reg 23(2)(a) and reg 23(4))
- Regulation 24 (cancellation of registration)
- Regulation 25 (offences for making false patent declarations)
- Patents Act (Cap 221, 2005 Rev Ed)
Cases Cited
- [2019] SGCA 31
- [2020] SGCA 68
- [2020] SGCA 84
- [2020] SGHC 28
Source Documents
This article analyses [2020] SGCA 84 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the full judgment for the Court's complete reasoning.