Case Summaries

Zyfas Medical Co (Sued as a firm) v Millennium Pharmaceuticals, Inc [2020] SGCA 84

SUPREME COURT OF SINGAPORE

27 August 2020

Case summary

CA/CA 211/2019

Zyfas Medical Co (Sued as a firm) v Millennium Pharmaceuticals, Inc [2020] SGCA 84

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Decision of the Court of Appeal (delivered by Tay Yong Kwang JA):

Outcome: Court of Appeal dismisses generic drug distributor’s appeal against declaration that it failed to disclose the existence of patents in application to register therapeutic product

Pertinent and significant points of the judgment

  • The court allowed the appellant to advance a new point on appeal given the importance of the therapeutic product regulatory regime and the lack of prejudice to the respondent
  • Process patents must be declared in an application for registration of a therapeutic product pursuant to reg 23(2) of the Health Products (Therapeutic Products) Regulations 2016 (S 329/2016)

Background

1 The appellant, Zyfas Medical Co (“Zyfas”) is a distributor of generic pharmaceutical, medicinal and healthcare products. It applied to register an anti-cancer drug known as “Myborte” with the Health Sciences Authority (“HSA”). The active ingredient in Myborte is bortezomib. Bortezomib is not protected by any product patent in Singapore but the respondent, Millennium Pharmaceuticals, Inc (“Millennium”), is the registered proprietor of three patents for the processes relating to the manufacture of bortezomib.

2 Zyfas did not declare the existence of these process patents when it applied to register Myborte. It took the position that the manufacturing process for bortezomib in Myborte did not infringe the process patents and there was no need to declare them. Millennium filed an application to the High Court seeking a declaration that Zyfas’s declaration to the HSA contained a statement that was false or misleading in a material particular or omitted to disclose a matter that was material to the application for the registration of Myborte.

3 Pursuant to reg 23(2) of the Health Products (Therapeutic Products) Regulations 2016 (S 329/2016) (“TPR”), any applicant for registration of a therapeutic product had to furnish a declaration to the HSA stating whether there was a patent under the Patents Act (Cap 221, 2005 Rev Ed) in force in respect of the therapeutic product and whether the applicant was the proprietor of the patent. Under reg 24(1)(a)(ii), where a court determined that the applicant’s declaration contained a statement that was false or misleading in a material particular or omitted to disclose any matter that was material to the application, the HSA could cancel the registration of the therapeutic product.

4 Before the High Court, Zyfas conceded that Millennium’s process patents were patents in force in respect of the therapeutic product and their existence was a matter material to its application for registration. The parties’ submissions were confined to the single issue of whether Zyfas’s omission to declare the process patents had to be done knowingly or intentionally before the court could grant a declaration under reg 24(1)(a)(ii). The High Court judge (“the Judge”) concluded that there was no such requirement. All that Millennium had to show was that Zyfas failed to disclose any matter that was material to its application. The Judge granted the declaration.

5 On appeal, Zyfas argued that process patents were not patents in force in respect of the therapeutic product and did not have to be declared.

The court's decision

6 Zyfas’s change in position was highly unsatisfactory as it was retracting from the agreed parameters of the case before the High Court. As a result, the High Court’s decision was rendered irrelevant in the appeal as its correctness was not being challenged at all. Zyfas was effectively asking the Court of Appeal to rehear the entire case on a totally different basis, thereby converting what should have been an appeal into a second trial. This “new argument” was not new but was an issue that Zyfas’s counsel had considered and conceded. Ordinarily, the court could have disallowed the new argument and dismissed the appeal (at [30] to [32]).

7 In this case, there were special features that persuaded the court to exercise its discretion to allow Zyfas to make the “new argument”. First, the issue to be canvassed was a question of law that would impact the work of the HSA in an industry that was growing increasingly important, and leaving the scope of reg 23 of the TPR unclear was not conducive to good administration. Second, the new argument would not cause any prejudice to Millennium. Third, if Zyfas had not made the concession, the Judge would in all likelihood have considered himself bound by the previous decision in Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd [2019] SGCA 31 (“Drug Houses of Australia”) (at [33] to [35]).

8 The sole issue in the appeal was whether process patents were within the the ambit of “a patent under the Patents Act… in force in respect of the therapeutic product”. The Court of Appeal had considered this issue in Drug Houses of Australia where the reasoning on this issue was necessary to the decision that was made in that appeal (at [37] and [38]).

9 It was possible for the bortezomib in Myborte to have been manufactured using the processes in Millennium’s process patents, though Zyfas took the position that this was not the case. The process patents were “in respect of the therapeutic product” because the active ingredient in that product could have been made using the patented processes. The proper procedure was to declare the existence of the process patents under reg 23(2) and then declare that the patents would not be infringed by the doing of the act for which the registration of the therapeutic product was sought. It would then be up to the HSA to decide whether to require Zyfas to serve the requisite notice under reg 23(5) on the proprietor (at [42]).

10 The purpose of reg 23 was to fulfil Singapore’s obligations under the US-Singapore Free Trade Agreement (“USSFTA”) through the patent linkage scheme. Local legislation was to be interpreted as far as possible to be consonant with Singapore’s treaty obligations. If the clear words of the legislation indicated that Singapore had done more than what its treaty obligations required, there was nothing objectionable about giving effect to the clear intent (at [44] and [45]).

11 The broad interpretation of reg 23(2) that included process patents was consonant with the legislative purpose of reg 23 as it was intended to give notice and protection to proprietors of relevant patents, whether they were product or process patents. There was no reason why product patents should be accorded more protection than process patents since a therapeutic product could infringe one or the other (at [48]).

This summary is provided to assist in the understanding of the Court’s grounds of decision. It is not intended to be a substitute for the reasons of the Court. All numbers in bold font and square brackets refer to the corresponding paragraph numbers in the Court’s grounds of decision.

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