Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd

• Jurisdiction: Singapore
• Judge: Mavis Chionh Sze Chyi JC
• Judgment Date: 27 June 2018
• Neutral Citation: [2018] SGHC 149
• Court: High Court (Singapore)
• Docket Number: Suit No 1089 of 2017 (Summonses Nos 5611 and 5650 of 2017)
• Published date: 07 May 2019
• Year: 2018
• Hearing Date: 28 March 2018,05 April 2018
• Plaintiff Counsel: Suhaimi bin Lazim, Chiong Song Ning and Yan Chongshuo (Mirandah Law LLP)
• Defendant Counsel: Kang Choon Hwee Alban, Tan Lijun and Marcus Lim (Bird & Bird ATMD LLP)
• Subject Matter: Civil Procedure,Injunctions,Pleadings,Striking out,Patents and Inventions,Infringement,Health Products (Therapeutic Products) Regulations 2016 (S 329/2016)
• Citation: [2018] SGHC 149

Mavis Chionh Sze Chyi JC: Introduction

By Suit No 1089 of 2017 (“Suit 1089”), Millennium Pharmaceuticals, Inc (“the Plaintiff”), which is the registered proprietor of Singapore Patent Nos SG 151322 and SG 182998 (“the Plaintiff’s Patents”), brings an action against Drug Houses of Australia Pte Ltd (“the Defendant”) seeking, among other things: (a) a declaration that the Defendant had, in omitting to declare the Plaintiff’s Patents when applying for and obtaining registration of its therapeutic product under Therapeutic Product Registration No SIN15243P (“the Defendant’s Product”), made a declaration to the Health Sciences Authority (“the HSA”) that contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to its application to register its product; (b) a declaration that the Defendant’s performance of the acts for which registration of the Defendant’s Product has been obtained would infringe the Plaintiff’s Patents; and (c) an injunction to restrain the Defendant from infringing the Plaintiff’s Patents.¹

In Summons No 5611 of 2017 (“SUM 5611”), the Plaintiff applied for an interlocutory injunction to restrain the Defendant from performing any of the acts for which the Defendant had obtained registration of its product.² In Summons No 5650 of 2017 (“SUM 5650”), the Defendant cross-applied to strike out the Plaintiff’s Statement of Claim on the ground that it disclosed no reasonable cause of action.³ I heard both summonses on 28 March 2018. On 5 April 2018, I dismissed the Plaintiff’s application in SUM 5611 for an interlocutory injunction, and allowed the Defendant’s striking-out application in SUM 5650 in part, striking out certain passages in the Statement of Claim. On 26 April 2018, I granted the Plaintiff’s application in Summons No 1764 of 2018 (“SUM 1764”) for leave to appeal against my decision in SUM 5611.⁴ The Plaintiff has appealed against my decision in both SUM 5611 and SUM 5650. Accordingly, I set out below the grounds of my decision.

Background

As the statutory framework for the registration of therapeutic products forms an important part of the background to these proceedings, I will first summarise the key components of this framework before setting out the facts leading to the dispute.

The statutory framework for the registration of therapeutic products

Therapeutic products are one of the categories of health products regulated under the Health Products Act (Cap 122D, 2008 Rev Ed) (“the HPA”): see para 3 of the First Schedule to the HPA. The system of registration put in place for health products generally is set out in Part VII of the HPA, with the detailed requirements in relation to the registration of therapeutic products being set out in Part 5 of the Health Products (Therapeutic Products) Regulations 2016 (S 329/2016) (“the TPR”). The HSA is the agency responsible for overseeing the registration process.

In gist, successful registration of a therapeutic product with the HSA indicates that the HSA has evaluated the product for compliance with the statutory requirements for, (inter alia) the quality, safety and efficacy of the product and the presentation of the product in the light of its formulation, composition or design specification and intended purpose: see s 33(2) of the HPA. The HSA must in particular be satisfied that the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with its use; and that based on the formulation, manufacturing process controls, specifications and shelf life of the product, and its stability under the recommended storage conditions, the product is suitable for its intended purpose, and any risk associated with its use is minimised: reg 22 of the TPR.

Under reg 23(2) of the TPR, unless the HSA otherwise determines, the applicant seeking to register a therapeutic product must at the time of the application make a declaration stating (a) whether a patent under the Patents Act (Cap 221, 2005 Rev Ed) (“the PA”) is in force in respect of the therapeutic product; and (b) whether the applicant is the proprietor of the patent. If the applicant is not the proprietor of the patent in respect of the therapeutic product and there is such a patent in force, the applicant must further state in its declaration, inter alia, whether the proprietor has consented to or has acquiesced in the grant of the registration of the applicant’s therapeutic product; or 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: reg 23(3)(b) of the TPR.

According to the Plaintiff (and the Defendant does not dispute this), an applicant seeking to register a therapeutic product may make one of the following four types of declarations:⁵ A “Category A1” declaration, which means that no patent is in force in respect of the therapeutic product to which the application relates. A “Category A2” declaration, which means that a patent is in force in respect of the therapeutic product to which the application relates, and the applicant is either the proprietor of the patent, or if it is not the proprietor of the patent, the proprietor has consented to or acquiesced in the grant of the registration. A “Category A3” declaration, which means that a patent is in force in respect of the therapeutic product to which the application relates, the applicant is not the proprietor of the patent, the proprietor has not consented to nor acquiesced in the grant of the registration, and the applicant is requesting for registration to be granted after the patent expires. An application with a Category A3 declaration may not be made earlier than 18 months before the patent expires. A “Category B” declaration, which means that a patent is in force in respect of the therapeutic product to which the application relates, the applicant is not the proprietor of the patent, the proprietor has not consented to nor acquiesced in the grant of the registration, and in the applicant’s opinion and to its best belief, the patent is invalid or will not be infringed by the doing of the act for which registration is sought.

Under reg 23(5) of the TPR, where the applicant is not the proprietor of a patent under the PA that is in force in respect of the therapeutic product, the HSA “may require the applicant to serve … on the proprietor of the patent, a notice in the form specified on the [HSA’s] website” if: the applicant has declared that, in its 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; or the HSA considers it appropriate in any particular case for the applicant to do so.

Anyone seeking to manufacture, import or supply a therapeutic product is also required to apply to the HSA for the appropriate licence, as the licensing system is activity-based, and the type of licence issued by the HSA depends on the specific type of activity the applicant seeks to carry out: see, eg, Parts 2 and 3 of the TPR for the requirements in relation to the manufacture and import as well as the supply of therapeutic products respectively.

The dispute

The Plaintiff is a company incorporated and based in the United States of America, whereas the Defendant is a company incorporated in Singapore.⁶

The Plaintiff’s Patents, which expire on 24 March 2025, are process patents which relate to certain processes for the manufacture of the active ingredient Bortezomib, an anti-cancer drug.⁷ They are not patents in respect of the active ingredient Bortezomib itself.⁸ The Defendant has asserted (and the Plaintiff does not dispute) that the specifications for the Plaintiff’s Patents make it clear that the protected inventions are an improvement over other processes, and that apart from the processes disclosed in the Plaintiff’s Patents, there exist other processes for the manufacture of Bortezomib which may either not be patented or for which patents may have expired.⁹

The Plaintiff does not manufacture, market or supply Bortezomib in Singapore. It has granted an exclusive licence to Johnson & Johnson Pte Ltd (“Johnson & Johnson”) in Singapore. The terms of this licence agreement were not put in evidence in the hearing before me. The Plaintiff has asserted – and the Defendant has not denied – that the public hospitals in Singapore hold an annual tender for the supply of Bortezomib, and that up until now, Johnson & Johnson has been awarded the tender “by default as it would be the sole participant in the tender with an existing Therapeutic Product Registration No. in respect of Bortezomib”.¹⁰

On 26 May 2017, the Defendant obtained approval from the HSA for the registration of a therapeutic product described as “Bortezomib – Actavis Powder for Solution for Injection 3.5mg/vial” under Therapeutic Product Registration No SIN15243P (ie, the Defendant’s Product).¹¹ According to the Defendant, it “does not manufacture Bortezomib or utilise the processes disclosed in [the Plaintiff’s] Patents” in the making of its product.¹²

The Plaintiff was not served with any notice under reg 23(5) of the TPR.¹³ The Plaintiff has also not seen the declaration made by the Defendant under reg 23(2) (“the Defendant’s Declaration”), and does not know what the declaration says. The Defendant’s Declaration was not produced in evidence in the hearing before me.

Sometime in June 2017, the Plaintiff found out about the Defendant’s registration of its therapeutic product. On 4 July 2017, the Plaintiff’s lawyers wrote to the Defendant asking the Defendant to confirm whether it had declared the Plaintiff’s Patents in making the application for registration, and also requesting a copy of the Defendant’s Declaration.¹⁴

On 31 July 2017, the Defendant’s lawyers replied, stating that the Plaintiff’s...