Patent term extensions – Australian Federal Court says the Commissioner’s interpretation of the legislation “absurd” and third party ARTG listing dates are not relevant

The Commissioner of Patents has always taken the position that such applications require consideration of the first ARTG listing of any product that falls within the claims of the relevant patent – even if this product was a third party ARTG listing.

This was the case in Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643, where Ono had sought an extension of term of its patent directed at human monoclonal antibodies to programmed death 1 (PD-1) on the basis of a product marketed by a related entity under the name OPDIVO included on the ARTG on 11 January 2016.

In the scheme of extensions under the Patents Act, generally the later the registration of the relevant reference product on the ARTG, the longer the extension, and hence the preferred use of OPDIVO as the reference product.

A Delegate of the Commissioner held that the application did not meet the statutory requirements because the application should have been made on the basis of KEYTRUDA, a product marketed by a third party competitor, that was included earlier on the ARTG on 16 April 2015.

This decision was the subject of judicial review.

The Court found that having regard to third party ARTG listings manifested in absurd and unreasonable results having regard to the intention of the scheme, and it is for the patentee to specify the substance that is to be considered for the purpose of the extension request.

The extension of term scheme

Under the Patents Act, a patentee may obtain an extension where (emphasis added):

(a) one or more pharmaceutical substances per se (or one or pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology) are disclosed in the complete specification, and in substance fall within the scope of a claim of the patent (section 70(2)); and

(b) goods containing or consisting of the substance are included in the Australian Register of Therapeutic Goods (ARTG) (section 70(3)(a)); and

(c) the period beginning on the date of the patent (usually the filing date), and ending on the first regulatory approval date for the substance, must be at least 5 years (section 70(3)(b)).

There are timing requirements for such an application, requiring that any application for an extension be made within 6 months of the earlier of:

(a) the date that the patent was granted;

(b) the date of commencement of the first inclusion on the ARTG of goods that contain or consist of any of the pharmaceutical substances in section 70(3).

The length of the extension granted is equal to the difference between the date of the patent and the “earliest first regulatory approval date in relation to any of the pharmaceutical substances” less 5 years (such that if the period between the date of the patent and the ARTG listing date is 5 years, any extension is zero).

To date, the position of the Australian Patent Office has been that both in relation to the provisions regarding the timing of such applications, and the length of any extension, that such sections require reference to the earliest ARTG listing date that applies to the patent – and so, where there is more than one product that falls within the claims of the patent it would refer to the earliest in time ARTG listing date, regardless of whether this was the patentee’s product or another third party product. The Commissioner’s position was based on a conclusion by Bennett J in Pfizer Corporation v Commissioner of Patents (No 2) (2006) 69 IPR 525 that the calculation of time provision (section 77):

…refers to the “earliest first regulatory approval date” (emphasis added). This recognises that the patent may cover more than one pharmaceutical substance and provides that the term of the extension is based on the earliest of the approval dates that apply to the patent.

The decision

In Ono, Ono had sought an extension of term of its patent directed at human monoclonal antibodies to programmed death 1 (PD-1) on the basis of a product marketed by a related entity under the name OPDIVO, which was included on the ARTG on 11 January 2016.

A Delegate of the Commissioner held that the application did not meet the statutory requirements because the application should have been made on the basis of KEYTRUDA, a product marketed by a third party competitor, that was included on the ARTG on 16 April 2015.

There was no contest that the KEYTRUDA product also fell within claims of the Ono patent.

On judicial review of the decision, his Honour, Justice Beach, had regard to the purpose of the extension of term regime, and the fact that “it is designed to remedy the mischief of a shortened period for an effective monopoly that has been caused by delays in obtaining regulatory approval”, and that as such, he said, “a liberal, rather than a literal construction of the provisions is to be preferred”.

Before the Court, the Commissioner of Patents maintained her position that, where there were two substances entered on the ARTG that contain pharmaceutical substances that fall within the claims of the patent, the provisions required reference to the first in time inclusion date on the ARTG.

The Court found that the Commissioner’s construction lead to questions of absurdity and unreasonableness – it would require the patentee to review each and every approval granted on the ATG, and monitor regulatory approvals of third parties to try and determine if those products fell within the scope of one or more claims, which of itself is a complex task, and may require information that can only be provided to the patentee if a Court were to order discovery of relevant documents. In addition, his Honour noted that the ARTG is not a complete database of all possible “first regulatory approval dates” in existence – products are removed, and are superseded.

He said that his decision was was not inconsistent with Pfizer because her Honour, in that case, was not tasked with construing the meaning of the provisions in the context of a patent that disclosed more than once substance.

Takeaways

As a result, it is for the patentee to stipulate the pharmaceutical substance the basis for the extension of term application, and this can be any pharmaceutical substance of the patentee that is in substance disclosed and claimed in the patent (putting aside the requirements of the timing of such an application as required by the legislation).

However, we note that his Honour pointed out that it was not Ono’s position that a patentee should be permitted to wait and elect to apply for an extension based on a good that may be second, third, or last on the ARTG. Nor was it Ono’s position that a patentee should be permitted to pick and choose which of its products to nominate as the substance for the purposes.

There are decisions that are anticipated (both at the Patent Office and Federal Court level) within the next 6 months that will consider this different factual matrix, and whether, where the ARTG registered products are all the patentees, whether this yields a different result, having regard to the intention of the scheme.