26 July 2018

Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd
[2018] SGHC 149

In the recent decision of Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd (“Millennium Pharmaceuticals”), the Singapore High Court heard an application by the plaintiff for an interim interlocutory injunction to restrain prospective acts of patent infringement pursuant to Regulation 24 of the Health Products (Therapeutic Products) Regulations 2016 (“TPR”). The court declined to grant the injunction sought. The court also heard the defendant’s application to strike out various claims made by the plaintiff. The plaintiff has filed an appeal against this decision.

The judgment is instructive for the court’s clarification as to how the framework under Regulation 24 of the TPR operates.

Facts

The plaintiff, Millennium Pharmaceuticals, was the registered proprietor of two process patents. The defendant, Drug Houses of Australia Pte Ltd, had registered and obtained approval for the registration of a therapeutic product (“defendant’s Product”). The defendant had earlier made a declaration that no patent was in force in respect of the therapeutic product to which the application related. As such, the defendant was not required to serve the plaintiff with a notice under Regulation 23(5) of the TPR.

Regulation 23 provides a framework that is triggered when a declarant states that there is a patent in respect of a therapeutic product in issue. Upon notification, the patentee may then choose to commence an action relating to prospective acts of patent infringement for the relevant patent.

The plaintiff subsequently discovered the registration of the defendant’s Product and commenced a suit against the defendant. The defendant applied to strike out several of the plaintiff’s claims, namely:

  • That the defendant had, in omitting to declare the plaintiff’s patents when applying for and obtaining registration for its product, made a declaration that contained a false or misleading statement (“Material Falsehood Declaration Claim”); 
  • That the defendant’s performance of the acts for which registration had been obtained would infringe the plaintiff’s patents (“Prospective Infringement Declaration Claim”); 
  • The plaintiff’s application for an injunction to restrain the defendant from infringing the plaintiff’s patents (“Injunction Claim”); and
  • The plaintiff’s allegation of actual infringement by the defendant (“Actual Infringement Claim”).

Striking out the Actual Infringement Claim

As it was common ground between the parties that an infringing act had yet to take place, the plaintiff’s Actual Infringement Claim was found to be unsustainable and struck out by the court.

Striking out the Prospective Infringement Declaration Claim

The plaintiff submitted that Regulation 24 provided a cause of action to restrain prospective infringement, citing the case of AstraZeneca AB (SE) v Sanofi-Aventis Singapore Pte Ltd [2012] SGHC 16 (“AstraZeneca”) in support of this argument. The court disagreed and held that Regulation 24 of the TPR does not provide for a cause of action against prospective acts of patent infringement.

Under Regulation 24, an interested person may apply to cancel the registration of a therapeutic product if it is determined that (a) the doing of an act authorised by the registration infringes a patent under the Patents Act, or (b) the declaration made under Regulation 23 contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application.

The court distinguished the plaintiff’s claim from that in AstraZeneca and found AstraZeneca to be inapplicable on the facts of the present case. The court held that the factual framework set out in AstraZeneca fell within the purview of Regulation 23 of the TPR (which provides a separate cause of action in prospective infringement) and not Regulation 24 as the language in Regulation 24 provides only for an action under the Patents Act. Following an analysis of AstraZeneca, the court concluded that the Patents Act only provides for a cause of action relating to past, and not, prospective acts of patent infringement.

Striking out the Injunction Claim

Without a reasonable cause of action for prospective patent infringement, the court found that an injunction could not be granted in the plaintiff’s favour to restrain the defendant from acts of prospective infringement. Accordingly, the defendant was also successful in its claim to strike out the Injunction Claim. In any case, it was also found on the facts that damages would have been an adequate remedy for the plaintiff as revenue and profit losses consequent to the registration of the defendant’s Product was readily quantifiable.

Striking out the Material Falsehood Claim

The court however accepted the plaintiff’s submissions that Regulation 24 mandates that an applicant must make a truthful and accurate declaration as to the existence and validity of any patent in respect of the therapeutic product in issue.

Impact of the decision

The practical effect of Millennium Pharmaceuticals is that the declaration from an applicant for a therapeutic product may trigger the framework under Regulation 24 of the TPR and this framework precludes a patentee from maintaining an action for prospective acts of patent infringement. The patentee’s recourse under this framework is to wait for an actual act of patent infringement before a cause of action is available under the Patents Act though a patentee may still pursue a claim alleging malicious falsehood, serving as a possible check on the making of disputed declarations.

The case also determined that only Regulation 23 of the TPR provides a patentee with a cause of action relating to prospective acts of patent infringement. The court also implicitly endorsed the position in AstraZeneca that a patentee who commences an action under the framework in Regulation 23 of the TPR “should not be required to plead facts to support its allegation that its patent will be infringed”.

The case of Millennium Pharmaceuticals essentially creates two possible frameworks under the TPR. The framework under Regulation 24 arguably creates a pro-applicant regime whereby a patentee’s options are limited to waiting for an actual act of patent infringement before a cause of action is available under the Patents Act. In contrast, Regulation 23 appears to create a pro-patentee system whereby a patentee is not required to plead facts supporting its allegation that prospective acts by the applicant will lead to patent infringement.

For now, it appears that whichever framework applies is entirely dependent on the declaration made by the applicant seeking therapeutic product registration. This arguably incentivises the making of a strategic declaration.

It is also worth noting that in AstraZeneca AB (SA) v Sanofi-Aventis Singapore Pte Ltd [2013] SGHCR 7, the defendant succeeded in obtaining further and better particulars relating to alleged prospective acts of patent infringement. Hence, the question as to whether particulars supporting alleged prospective acts of patent infringement pursuant to Regulation 23 may be ordered awaits conclusive determination.

 

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