Millennium Pharmaceuticals v Zyfas Medical: Statutory Interpretation & Patent Disclosure

In Millennium Pharmaceuticals, Inc. v Zyfas Medical Co, the High Court of Singapore addressed whether Zyfas Medical Co omitted to disclose relevant patents in its application for registration of a therapeutic product, Myborte, to the Health Sciences Authority (HSA). Millennium Pharmaceuticals sought a declaration that Zyfas Medical had violated regulation 23(2) of the Health Products (Therapeutic Products) Regulations 2016 by omitting to disclose the existence of certain patents. The court granted the declaration, finding that the omission was a material violation of the regulations.

1. Case Overview

1.1 Court

High Court of the Republic of Singapore

1.2 Outcome

Declaration granted to the plaintiff that the defendant's declaration omitted to disclose matter that is material to its application for registration of its therapeutic product.

1.3 Case Type

Civil

1.4 Judgment Type

Grounds of Decision

1.5 Jurisdiction

Singapore

1.6 Description

The court ruled Zyfas Medical omitted material information by not disclosing relevant patents when registering a therapeutic product, violating health regulations.

1.7 Decision Date

2. Parties and Outcomes

Party NameRoleTypeOutcomeOutcome TypeCounsels
Millennium Pharmaceuticals, IncPlaintiffCorporationDeclaration GrantedWon
Zyfas Medical Co (sued as a firm)DefendantPartnershipDeclaration Granted AgainstLost

3. Judges

Judge NameTitleDelivered Judgment
Dedar Singh GillJudicial CommissionerYes

4. Counsels

Counsel NameOrganization
Suhaimi Bin LazimMirandah Law LLP
Yan ChongshuoMirandah Law LLP
Wong Siew HongEldan Law LLP
Kuek Kai LiangEldan Law LLP

4. Facts

  1. The plaintiff is the registered proprietor of process patents relating to the manufacture of bortezomib.
  2. The defendant applied to register a therapeutic product containing bortezomib.
  3. The defendant did not disclose the existence of the plaintiff's patents in its declaration to the HSA.
  4. The defendant believed that only product patents had to be declared.
  5. The plaintiff sought a declaration that the defendant's declaration omitted to disclose material information.

5. Formal Citations

  1. Millennium Pharmaceuticals, IncvZyfas Medical Co (sued as a firm), Originating Summons No 1034 of 2019, [2020] SGHC 28

6. Timeline

DateEvent
Defendant applied to register a therapeutic product with the HSA.
Plaintiff discovered that the defendant had obtained registration for the Myborte product.
Plaintiff’s solicitors requested a copy of the defendant’s declaration to the HSA.
Defendant’s solicitors replied stating that there was no infringement of the Patents and therefore no need to declare the existence of the Patents in the HSA declaration.
Court granted the declaration sought by the plaintiff.
Hearing
Grounds of decision issued.

7. Legal Issues

  1. Omission of Patent Disclosure
    • Outcome: The court held that the defendant's omission to disclose the existence of relevant patents was a material omission under regulation 24(1)(a)(ii) of the Health Products (Therapeutic Products) Regulations 2016.
    • Category: Substantive
    • Sub-Issues:
      • Failure to disclose process patents
      • Materiality of omitted information

8. Remedies Sought

  1. Declaration that the defendant's declaration omitted to disclose matter that is material to its application

9. Cause of Actions

  • Violation of Health Products (Therapeutic Products) Regulations 2016

10. Practice Areas

  • Pharmaceutical Law
  • Intellectual Property Litigation

11. Industries

  • Pharmaceuticals

12. Cited Cases

Case NameCourtAffirmedCitationJurisdictionSignificance
Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd and another appealCourt of AppealYes[2019] SGCA 31SingaporeCited for the principle that applicants must declare relevant patents to the HSA, even if they believe the patents are invalid or not infringed.
Zainudin bin Mohamed v Public ProsecutorN/AYes[2018] 1 SLR 449SingaporeCited for the governing provision on the interpretation of statutes.
Attorney-General v Ting Choon Meng and another appealN/AYes[2017] 1 SLR 373SingaporeCited for the principle that a provision is to be interpreted in relation to the context of the provision within the written law as a whole.

13. Applicable Rules

Rule Name
No applicable rules

14. Applicable Statutes

Statute NameJurisdiction
Health Products Act (Cap 122D, 2008 Rev Ed)Singapore
Patents Act (Cap 221, 2005 Rev Ed)Singapore
Interpretation Act (Cap 1, 2002 Rev Ed)Singapore

15. Key Terms and Keywords

15.1 Key Terms

  • Therapeutic product
  • Patent disclosure
  • Health Sciences Authority
  • Process patent
  • Material omission
  • Bortezomib
  • Myborte

15.2 Keywords

  • Therapeutic product registration
  • Patent disclosure
  • Health Sciences Authority
  • Material omission

17. Areas of Law

Area NameRelevance Score
Pharmaceutical Law90
Patents85
Therapeutic Products Registration75
Statutory Interpretation70
Administrative Law60

16. Subjects

  • Therapeutic Products
  • Patent Law
  • Statutory Interpretation