Part 2 - Extensions of Term for Pharmaceutical Patents - application based on "first regulatory approval date"

Mykenzie Johnson - Unsplash

In a previous article published here we discussed a recent decision of the Full Federal Court in Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39.

In this follow up article, we outline another decision of the Full Federal Court in Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40.

In this case the Court had to consider a patent claiming two pharmaceutical substances and whether a patentee may base an extension of term application on a later registration of one of the substances in the ARTG either: a) as a matter of choice by the patentee; or b) by default if the earlier registration occurred less than 5 years from the date of the patent and would thus not qualify for an extension.

Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022]FCAFC 40

This case commenced as a result of an infringement claim by Merck Sharp & Dohme against Sandoz Pty Ltd for infringement of its patent for the type 2 diabetes treating pharmaceutical substance sitagliptin, which is a competitive inhibitor of the enzyme dipeptidyl peptidase 4 (DPP-4), and the combination pharmaceutical substance sitagliptin/metformin.

Sandoz filed a cross-claim for rectification of the patent term to cancel a patent term extension granted by the Commissioner of Patents at the request of Merck.

The Patent Term Extension

An ARTG registration was obtained by Merck for sitagliptin under the brand name JANUVIA, however, the registration was dated less than 5 years from the date of the patent.  

s 77(1) provides that the term of the extension is equal to the period beginning on the date of the patent and “the earliest first regulatory approval date” in relation to any pharmaceutical substances disclosed and claimed in the patent, minus 5 years.

Accordingly, Merck sought and obtained a patent term extension based on a later ARTG registration of the combination sitagliptin/metformin under the brand name JANUMET, which was registered more than 5 years after the date of the patent.

s 70(3) states that two conditions must be satisfied in relation to at least one of those pharmaceutical substances:

(a)goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.

The dispute centred on the proposition argued by Merck that as only sitagliptin/metformin satisfied s 70(3), because the ARTG registration was more than five years from the date of the patent, it was the only pharmaceutical substance of the two alternatives that could form the basis of an extension of term application.

“the earliest first regulatory approval date”

MSD argued that “the earliest first regulatory approval date” in s 77(1) includes any or all pharmaceutical substances disclosed and claimed in the patent and registered in the ARTG satisfying s 70(3).

 Sandoz and the Commissioner of Patents argued that the words “the earliest first regulatory approval date” mean what they say, namely that the basis for any extension of term application must be the earliest and first ARTG registration of any pharmaceutical substance disclosed and claimed in the patent.

If this happens to be less than 5years after the date of the patent then this unfortunately means that no term extension is available even if another pharmaceutical substance of the patent is registered on the ARTG more than 5 years after the date of the patent.

First Court Decision – Patent Term Extension Cancelled

The primary judge in the Court of first instance dismissed the infringement claim and made orders to cancel the patent term extension granted by the Commissioner of Patents under s 70(3).

The primary judge agreed with Sandoz and the Commissioner that the earliest first regulatory approval date within s 77(1) does not permit the patentee to nominate which ARTG registered pharmaceutical substance it will use as the basis for a term extension. Accordingly, the first ARTG registration, whether it be less than 5years from the date of the patent or not, must be the basis for any patent term extension application.

The ARTG registration for sitagliptin was less than 5 years after the date of the patent which gives a term extension of zero. In other words, the patent is not eligible for any term extension.

Full Court Appeal

On appeal, the Full Court upheld the primary judge’s decision to cancel the term extension to the Full Federal Court.  The Full Court held that:

“Where, as in the present case, more than one pharmaceutical substance per se is in substance disclosed and claimed in the relevant patent and there are multiple regulatory approvals for goods that contain or consist of those substances, the length of the extension is to be calculated from the earliest first inclusion in the ARTG of goods relating to any of those substances. That is in accordance with a policy objective of achieving a balance between the competing interests of a patentee of a pharmaceutical substance whose exploitation of monopoly has been delayed, and the public interest in unrestricted use of the pharmaceutical invention.” [79]

Take Aways

This decision confirms that in a case where more than one pharmaceutical substance is disclosed and claimed in a patent and there are multiple regulatory approvals for goods that contain or consist of those substances the patentee may not choose which ARTG registration they want to form the basis for an extension application. Rather, the extension must be based on the pharmaceutical substance that is registered in the ARTG first even if the registration occurred less than 5 years after the date of the patent such that no patent term extension is available.

For more information about patent term extensions please contact Daniel McKinley or Kelly Foskett.

Further reading
Broadly Speaking - Breadth of Goods and Services Specifications in AU and NZ Trade Marks
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