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: 27 August 2020
- Case No: Civil Appeal No 211 of 2019
- Judges: Andrew Phang Boon Leong JA, Tay Yong Kwang JA, Woo Bih Li J
- Reporting/Decision Date: 14 August 2020 (grounds delivered by Tay Yong Kwang JA)
- Plaintiff/Applicant: Zyfas Medical Co (Sued as a firm)
- Defendant/Respondent: Millennium Pharmaceuticals, Inc
- Legal Areas: Statutory Interpretation; Patents and Inventions (Registration); Interpretation Act; Registration of therapeutic products
- Statutes Referenced: Health Products Act (Cap 122D); Health Products (Therapeutic Products) Regulations 2016 (S 329/2016) (in particular regs 23–25); Patents Act (Cap 221); Interpretation Act (purposive approach); section 67 of the Patents Act; section 37(1) of the Patents Act (as referenced)
- Key Regulatory Provisions: TPR reg 23 (declaration of patent status); TPR reg 24 (cancellation of registration); TPR reg 25 (offences for false patent declarations)
- Procedural History: High Court application OS 1034/2019 for declaration; High Court granted declaration; Zyfas appealed to the Court of Appeal
- Prior/Related Authorities Mentioned: Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31; [2020] SGCA 68; [2020] SGHC 28
- Judgment Length: 23 pages, 6,808 words
Summary
This Court of Appeal decision concerns Singapore’s regulatory interface between therapeutic product registration and patent rights. Zyfas, a distributor of generic pharmaceutical products, applied to register an anti-cancer drug (“Myborte”) with the Health Sciences Authority (“HSA”). Although the active ingredient bortezomib was not protected by a product patent in Singapore, Millennium held three subsisting patents covering the processes for manufacturing bortezomib. Zyfas did not disclose these process patents in its declaration to the HSA under the Health Products (Therapeutic Products) Regulations 2016 (“TPR”).
Millennium commenced proceedings in the High Court seeking a declaration that Zyfas’s declaration 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. On appeal, Zyfas attempted to advance a legal argument based on what it said it had conceded below. The Court of Appeal, after granting leave in the special circumstances, dismissed the appeal with costs, affirming the High Court’s approach to the statutory scheme and the materiality of patent disclosures under reg 23.
What Were the Facts of This Case?
Zyfas Medical Co (sued as a firm) is a distributor of generic pharmaceutical, medicinal and healthcare products. On 2 February 2018, Zyfas 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.
At the relevant time, bortezomib itself 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. It was undisputed that Zyfas did not declare the existence of these process patents when it applied to register Myborte as a therapeutic product.
Zyfas’s application was approved by the HSA on 5 July 2019. Shortly thereafter, Millennium discovered that Zyfas had obtained registration for Myborte and contacted Zyfas to request a copy of Zyfas’s declaration made in its application to the HSA. Zyfas responded by taking the position that the manufacturing process for bortezomib in Myborte did not infringe Millennium’s process patents. On that basis, Zyfas argued that there was no need to declare the process patents.
Millennium then filed OS 1034/2019 in the High Court on 19 August 2019. The claim sought a declaration that Zyfas’s declaration under reg 23(2) of the TPR contained a statement that was false or misleading in a material particular, or alternatively that it omitted to disclose a matter that was material to the application for registration of Myborte. Millennium also sought costs. The High Court judge granted the declaration, and Zyfas appealed to the Court of Appeal.
What Were the Key Legal Issues?
The central legal issue was how the statutory registration scheme should be interpreted, particularly the scope and purpose of the declaration required under TPR reg 23(2). The question was whether Zyfas’s failure to disclose Millennium’s subsisting process patents rendered its declaration false or misleading in a material particular, or constituted an omission of a material matter, even though Zyfas contended that its manufacturing process would not infringe the process patents.
A related issue concerned the procedural dimension of appeal. Zyfas sought to advance a legal argument on appeal that it said it had conceded during the High Court hearing. The Court of Appeal granted leave in the special circumstances of the case, but it still had to determine whether the argument could succeed on the merits given the statutory text and the established regulatory scheme.
Finally, the Court of Appeal had to consider how its earlier decision in Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31 (“Drug Houses of Australia”) should be applied. That earlier case had considered the same registration scheme and involved similar facts: a patent proprietor suing a party that obtained therapeutic product registration without disclosing process patents. The Court of Appeal therefore had to ensure consistency in interpretation and application.
How Did the Court Analyse the Issues?
The Court of Appeal began by setting out the statutory framework. Therapeutic products are regulated under the Health Products Act (Cap 122D) (“HPA”) and the TPR. The scheme requires that therapeutic products be registered before they can be supplied in Singapore. In dealing with an application for registration, the HSA must consider whether a patent under the Patents Act is in force in respect of the therapeutic product. This is reflected in TPR reg 23(1).
Crucially, reg 23(2) imposes a declaration obligation on the applicant. Unless the HSA otherwise determines, the applicant must, at the time of application and at such other time before determination as the HSA may require, furnish a declaration stating whether a patent under the Patents Act is in force in respect of the therapeutic product and whether the applicant is the proprietor of the patent. Where the applicant is not the proprietor and there is such a patent in force, reg 23(3) further requires the applicant to provide information about the patent proprietor and to indicate, among other things, whether the applicant believes the patent is invalid or will not be infringed by the doing of the act for which registration is sought.
The Court of Appeal emphasised that the scheme is designed to enable the HSA to make informed decisions at the registration stage. TPR reg 23(4) provides that, for the purposes of reg 23(1), the HSA may rely upon and need not inquire into the truth of any statement made in the declaration. This provision underscores that the declaration is the mechanism by which the HSA is alerted to the existence of patent rights, without requiring the HSA to adjudicate patent validity or infringement.
Against that background, the Court analysed the consequences of a defective declaration. Under TPR reg 24(1), the HSA may cancel registration upon an application by an interested person if the HSA is satisfied that (i) a court or the Registrar of Patents or a Deputy Registrar has determined that the doing of an act authorised by registration infringes a patent; or (ii) a court has determined 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; and that the determination is final (as defined in reg 24(2)).
The Court also noted the offence provision in TPR reg 25, which criminalises making false patent declarations or intentionally suppressing material facts. While the present case was not an offence prosecution, the existence of reg 25 supported the conclusion that the declaration is not a mere formality; it is a legally significant step that can have serious regulatory and legal consequences.
In interpreting these provisions, the Court applied a purposive approach to statutory interpretation. The purpose of the declaration scheme is to ensure that patent-related information is brought to the HSA’s attention so that the regulatory process can proceed with appropriate safeguards. The Court’s reasoning reflected that the HSA is not required to determine infringement or validity; rather, the applicant must disclose the existence of patents in force and, where relevant, provide the applicant’s position on invalidity or non-infringement.
On the facts, it was undisputed that Zyfas did not declare Millennium’s subsisting process patents. Zyfas’s argument was essentially that because its manufacturing process did not infringe, it was not necessary to disclose the process patents. The Court of Appeal rejected this approach as inconsistent with the structure of reg 23. The declaration is triggered by whether a patent is in force in respect of the therapeutic product, not by whether the applicant’s intended conduct would infringe. The scheme contemplates that the applicant’s belief about invalidity or non-infringement is to be declared only after the existence of the patent is disclosed.
In other words, the Court treated the disclosure of the existence of patents as the first and essential step. The applicant cannot bypass that step by asserting non-infringement as a substitute for disclosure. The Court’s analysis therefore aligned with the logic in Drug Houses of Australia, where the Court had considered the same registration scheme and held that failure to disclose process patents could found the necessary declaration for the purpose of reg 24.
Although the provided extract is truncated, the Court’s approach in this appeal is consistent with its earlier jurisprudence: the statutory scheme allocates roles between the HSA and the patent dispute forum. The HSA relies on the declaration and does not inquire into the truth of statements. Patent validity and infringement are left to the appropriate adjudicative processes. Therefore, the applicant’s omission of patent existence undermines the scheme’s design and is material.
Finally, the Court addressed Zyfas’s attempt to advance a legal argument based on what it claimed it had conceded below. The Court granted leave in special circumstances, but the appeal was still dismissed. This indicates that even if the procedural point were accepted, it could not overcome the statutory interpretation and the undisputed omission of the process patents from the declaration.
What Was the Outcome?
The Court of Appeal dismissed Zyfas’s appeal and affirmed the High Court’s grant of the declaration sought by Millennium. The practical effect is that Zyfas’s declaration to the HSA was held to have contained a false or misleading statement in a material particular and/or to have omitted to disclose a matter that was material to the application, because it failed to disclose subsisting process patents.
The Court also ordered Zyfas to pay costs. The decision therefore not only resolves the dispute between the parties but also reinforces the compliance expectations for applicants seeking therapeutic product registration where patents are in force.
Why Does This Case Matter?
Zyfas Medical Co v Millennium Pharmaceuticals, Inc is significant because it confirms, in the context of therapeutic product registration, that applicants must disclose the existence of subsisting Patents Act patents in force in respect of the therapeutic product. The Court’s reasoning clarifies that an applicant’s belief about infringement is not a substitute for the disclosure obligation under TPR reg 23(2) and (3). This is particularly important for generic manufacturers and distributors who may assume that process patents are irrelevant if they believe their manufacturing route does not infringe.
From a precedent perspective, the case strengthens the authority of Drug Houses of Australia on the interpretation of the same regulatory scheme. Together, these decisions provide a clear interpretive framework for practitioners: the HSA’s role is administrative and reliance-based, while patent disputes are for courts or patent authorities. Consequently, the declaration mechanism must be treated as a legally material step, and omissions can trigger downstream regulatory consequences, including cancellation of registration under reg 24.
For practitioners, the decision has immediate compliance implications. When preparing declarations for HSA registration, applicants should conduct careful patent landscape checks to identify any Patents Act patents in force that relate to the therapeutic product, including process patents. Where patents exist but the applicant disputes infringement or validity, the applicant must still disclose the patent and then properly state its position under the declaration framework. Failure to do so exposes the applicant to litigation risk and potential regulatory action.
Legislation Referenced
- Health Products Act (Cap 122D, 2008 Rev Ed)
- Health Products (Therapeutic Products) Regulations 2016 (S 329/2016), in particular:
- Regulation 23 (Whether therapeutic product subject to patent; declaration requirements)
- Regulation 24 (Cancellation of registration of therapeutic product subject to patent dispute)
- Regulation 25 (Offences for making false patent declaration)
- Patents Act (Cap 221, 2005 Rev Ed), including:
- Section 67 (service-related provisions as referenced in the TPR scheme)
- Section 37(1) (as referenced in the context of cancellation)
- Interpretation Act (purposive approach to statutory interpretation)
Cases Cited
- Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal [2019] SGCA 31
- [2020] SGCA 68
- Zyfas Medical Co (Sued as a firm) v Millennium Pharmaceuticals, Inc [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.