Zyfas Medical v Millennium Pharmaceuticals: Patent Declaration & Therapeutic Product Registration
Zyfas Medical Co appealed against the High Court's decision, which declared that Zyfas had omitted to disclose certain patents to the Health Sciences Authority (HSA) when applying to register a therapeutic product. Millennium Pharmaceuticals, Inc. filed the original action. The Court of Appeal dismissed Zyfas's appeal, holding that Zyfas was required to declare the existence of process patents when applying to register its therapeutic product.
1. Case Overview
1.1 Court
Court of Appeal of the Republic of Singapore1.2 Outcome
Appeal Dismissed
1.3 Case Type
Civil
1.4 Judgment Type
Grounds of Decision
1.5 Jurisdiction
Singapore
1.6 Description
Appeal regarding Zyfas's failure to disclose patents when registering a therapeutic product. The court dismissed the appeal, requiring disclosure.
1.7 Decision Date
2. Parties and Outcomes
| Party Name | Role | Type | Outcome | Outcome Type | Counsels |
|---|---|---|---|---|---|
| Millennium Pharmaceuticals, Inc | Respondent, Plaintiff | Corporation | Appeal Upheld | Won | |
| Zyfas Medical Co (sued as a firm) | Appellant, Defendant | Partnership | Appeal Dismissed | Lost |
3. Judges
| Judge Name | Title | Delivered Judgment |
|---|---|---|
| Andrew Phang Boon Leong | Judge of Appeal | No |
| Tay Yong Kwang | Judge of Appeal | Yes |
| Woo Bih Li | Judge | No |
4. Counsels
4. Facts
- Zyfas applied to register an anti-cancer drug, Myborte, with the HSA.
- Myborte's active ingredient is bortezomib.
- Millennium is the registered proprietor of three process patents for manufacturing bortezomib.
- Zyfas did not declare the existence of Millennium's process patents in its application to the HSA.
- HSA approved Zyfas's application on 5 July 2019.
- Millennium sought a declaration that Zyfas's declaration to the HSA omitted material facts.
- Zyfas conceded that process patents were patents in force in respect of the therapeutic product.
5. Formal Citations
- Zyfas Medical Co (Sued as a firm) v Millennium Pharmaceuticals, Inc, Civil Appeal No 211 of 2019, [2020] SGCA 84
6. Timeline
| Date | Event |
|---|---|
| Zyfas applied to register Myborte with the HSA. | |
| HSA approved Zyfas’s application. | |
| Millennium filed OS 1034. | |
| Zyfas was awarded a tender to supply bortezomib to public hospitals in Singapore. | |
| Zyfas filed this appeal. | |
| Millennium and J&J filed HC/SUM 430/2020 in Suit 817 seeking an interlocutory injunction. | |
| Millennium filed CA/SUM 30/2020 to expedite the present appeal. | |
| The Judge granted the application for the interlocutory injunction only in part. | |
| Millennium’s application for leave to appeal to the Court of Appeal was refused by the Judge. | |
| Millennium's further application to the Court of Appeal for leave to appeal was dismissed. | |
| Hearing date. | |
| Grounds of decision. |
7. Legal Issues
- Patent Declaration Requirements
- Outcome: The court held that process patents must be declared under reg 23(2)(a) of the TPR.
- Category: Substantive
- Sub-Issues:
- Omission to disclose material information
- Interpretation of 'patent' under reg 23(2)(a) of the TPR
- Statutory Interpretation
- Outcome: The court applied the purposive approach to interpret reg 23(2)(a) of the TPR.
- Category: Procedural
- Sub-Issues:
- Purposive approach to statutory interpretation
8. Remedies Sought
- Declaration that Zyfas’s declaration to the HSA contained a statement that was false or misleading or omitted to disclose a matter that was material
- Costs
9. Cause of Actions
- Omission to disclose material information in a declaration to the HSA
10. Practice Areas
- Intellectual Property Law
- Pharmaceutical Law
11. Industries
- Pharmaceuticals
12. Cited Cases
| Case Name | Court | Affirmed | Citation | Jurisdiction | Significance |
|---|---|---|---|---|---|
| Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appeal | Court of Appeal | Yes | [2019] SGCA 31 | Singapore | Cited for the principle that process patents fall within the description set out in reg 23(2)(a) of the TPR and must be declared. |
| Tan Cheng Bock v Attorney-General | N/A | Yes | [2017] 2 SLR 850 | Singapore | Cited for the purposive approach to statutory interpretation. |
| JWR Pte Ltd v Edmond Pereira Law Corporation and another | Court of Appeal | Yes | [2020] SGCA 68 | Singapore | Cited for guidance on the relevant principles when applying for leave to introduce a new point on appeal. |
| Abhilash s/o Kunchian Krishnan v Yeo Hock Huat and another | N/A | Yes | [2019] 1 SLR 873 | Singapore | Cited for principles governing the granting of leave to raise new points on appeal. |
| Grace Electrical Engineering Pte Ltd v Te Deum Engineering Pte Ltd | N/A | Yes | [2018] 1 SLR 76 | Singapore | Cited for factors to consider when granting leave to introduce new points on appeal. |
| Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm) | High Court | Yes | [2020] SGHC 28 | Singapore | Cited for the High Court's conclusion that there was no requirement of mental elements of knowledge or intention under reg 24(1)(a)(ii). |
13. Applicable Rules
| Rule Name |
|---|
| Rules of Court (Cap 322, R 5, 2014 Rev Ed) |
14. Applicable Statutes
| Statute Name | Jurisdiction |
|---|---|
| Health Products Act (Cap 122D, 2008 Rev Ed) | Singapore |
| Patents Act (Cap 221, 2005 Rev Ed) | Singapore |
15. Key Terms and Keywords
15.1 Key Terms
- Therapeutic product
- Process patent
- Patent declaration
- Health Sciences Authority
- Registration
- Bortezomib
- Patent linkage scheme
15.2 Keywords
- Patent
- Therapeutic product
- Registration
- Health Sciences Authority
- Process patent
- Declaration
- Omission
- Material fact
17. Areas of Law
| Area Name | Relevance Score |
|---|---|
| Patents | 90 |
| Therapeutic Products Registration | 85 |
| Statutory Interpretation | 70 |
| Appellate Practice | 60 |
16. Subjects
- Patent Law
- Pharmaceutical Regulation
- Statutory Interpretation