Legislation Update - Changes to patent linkage system in Singapore

A number of amendments have been made to the implementing regulations relating to Singapore’s patent linkage system, which are found in Regulation 23 of the Health Products (Therapeutic Products) Regulations 2016 (the “Regulations”), with effect from 1 August 2024. This follows a public consultation that the Singapore Health Sciences Authority (“HSA") had conducted in relation to the proposed amendments earlier this year.

The most important amendment clarifies the types of patents that must be declared when applying for registration of a therapeutic product in Singapore (a.k.a. “marketing approval or MA application”). Additionally, changes have also been made to the steps which the patent owner must take to trigger the 30-month stay on the grant of an MA application.

The amendments lend much needed clarity to the Regulations, which had previously been criticised by some as being unclear and favouring patent owners. However, this is unlikely to be the final word on the topic as there could still be some uncertainty as to the interpretation of the amended Regulations. Also, HSA has announced that it is reviewing other suggestions it has received on possible additional changes to be made to the patent linkage system. As such, this remains a somewhat fluid space.

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The Amendments

Clarity on patents to be declared

Previously, under the Regulations, all “[patents] in force in respect of the therapeutic product” had to be declared. It was not fully clear from this wording whether process patents were covered, and this issue arose in a number of lawsuits before the Singapore courts.

One argument, amongst others, that process patents need not be declared was that Singapore’s patent linkage system was implemented to fulfil our obligation under the US-Singapore Free Trade Agreement, and the US system did not involve process patents being listed in the “Orange Book” (which contained an exhaustive list of the patents that need to be declared when applying for registration of a generic drug). Indeed, in most of the jurisdictions around the world which have implemented patent linkage systems, process patents do not play a role.

In August 2020, the Singapore Court of Appeal in Zyfas Medical Co v Millennium Pharmaceuticals, Inc. [2020] SGCA 84 held that process patents fell within the broad wording of the previous Regulations and had to be declared. Moreover, the court suggested that a process patent must be declared as long as the active ingredient in the therapeutic product which is the subject of the MA application could have been made using the patented process. (See our article on the decision here.) Whilst this decision confirmed that process patents need to be declared, there remained uncertainty given the lack of guidance as to how relevant process patents should be identified in the first place.

Under the amended Regulations, only patents containing the following types of claims need to be declared:

(i)    a claim for an active ingredient of the therapeutic product for which registration is sought;

(ii)   a claim for a formulation or composition of that therapeutic product; and

(iii) a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.

(each a “restraining patent”).

The amended Regulations also specify, for the avoidance of doubt, patents which do not ned to be declared, namely:

-      a process patent (other than a process patent that contains a claim mentioned in (iii) above);

-      a patent that contains only claims relating to packaging;

-      a patent that contains only claims relating to metabolites; and

-      a patent that contains only claims relating to intermediates.

This amendment brings Singapore’s patent linkage system one step closer to that in the US, where only patents that claim the active pharmaceutical ingredient, drug formulation or composition, and method of use of a compound can be included in the Orange Book. However, since method of use claims are not allowed in Singapore, one notable difference is that this category of claims has been substituted with so-called “Swiss style” claims.

Applications for a declaration of patent validity and infringement can only be made to the High Court

When a patent is declared to the HSA at the time a MA application is made, HSA may (and will most likely) direct the MA applicant to notify the patent owner of his application. The patent owner then has 44 days after receiving such notification to apply for an injunction and/or a declaration that the patent is valid and is infringed by the doing of the act for which registration of the therapeutic product is sought, and to notify HSA of its application. This will trigger a 30-month stay on the grant of the MA application.

Previously, an application for an injunction had to be made to the Singapore High Court, but an application for a declaration could be made either to the High Court or the Patents Registry. Currently, under the amended Regulations, both applications can only be made to the High Court.

This amendment is not expected to have a significant practical impact as patent owners have been bringing their applications to the High Court, in order to be able to apply for both an injunction and a declaration.

New requirement for a patent owner to declare to HSA that any court application relates to a restraining patent

To trigger the operation of a 30-month stay, patent owners previously only had to notify HSA that an application for an injunction and/or declaration has been made and furnish evidence of the application. Currently, the patent owner also has to provide to HSA a declaration on a prescribed form that its court application “relates to a [restraining patent]”.

The rationale for this amendment was not articulated in the public consultation paper. However, there have been instances in the past where patent owners have been accused of abusing the system by including, in their court applications, patents which had not been declared by the MA applicant, to add pressure on the MA applicant. The new requirement goes some way in preventing this by indirectly imposing a requirement that only restraining patents can be the subject of any court application brought under the amended Regulations.

However, provided that a patent qualifies as a “restraining patent”, a patent owner is not prevented from relying on claims which are not mentioned in the amended Regulations to support its application for an injunction or declaration. Indeed, in HSA's announcement following its public consultation, HSA has confirmed that a patent which contains a “mixture of claims” - for example, claims for both an active ingredient of that therapeutic product and its metabolites, needs to be declared.

What’s next? Further changes possible

HSA has reported that in response to its public consultation, it has received suggestions on additional amendments to be made to Singapore’s patent linkage system and will review the same taking into account “the applicability of the measures in [Singapore’s] local context while ensuring that Singapore’s international obligations continue to be met”.

Some features in patent linkage systems around the world which are still not found in our system include the maintenance and publication of the equivalent of the US’s Orange Book (which would provide even more clarity on the patents to be declared), and the provision of a “generic exclusivity period” whereby the first generic drug manufacturer to successfully challenge the validity of a relevant patent is rewarded with a market exclusivity period of between 180-days (for the US) and 12 months (China and Taiwan).

Additionally, in Singapore, a notification by the patent owner to HSA of its court application will trigger an automatic, fixed 30-month stay on product registration. This can be contrasted with the US system where the courts have a discretion to vary the moratorium period if either party does not conduct the proceedings reasonably and expeditiously; and the shorter moratorium periods elsewhere (e.g., 9 months in China and South Korea, 12 months in Taiwan and 24 months in Canada).

These could be some of the suggestions that the HSA is reviewing. As such, this is unlikely be the last word on Singapore’s patent linkage system, and further amendments to the Regulations could be on the cards.

This article is produced by our Singapore office, Bird & Bird ATMD LLP. It does not constitute legal advice and is intended to provide general information only. Information in this article is accurate as of 8 August 2024.