3.12.1.8 First Regulatory Approval Date

In this topic:

Under sec 70(3), the period beginning on the date of the patent and ending on the first regulatory approval date for the pharmaceutical substance must be at least 5 years.  The first regulatory approval date, in relation to a pharmaceutical substance, is defined in sec 70(5) as:

• where there is no pre-TGA marketing approval in relation to the substance, the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance; or
• where there is pre-TGA marketing approval in relation to the substance, the date of the first approval.

Goods may be included in the ARTG as registered goods, provisionally registered goods, listed goods, biologicals or medical devices.  Importantly, not everything that is included in the ARTG will satisfy the other requirements of section 70 (for example, medical devices, or biologicals which are used to replace parts of the anatomy in a person, are unlikely to be considered pharmaceutical substances per se).

‘First inclusion in the ARTG’ means the first time the goods are included in the ARTG, regardless of what part of the register the goods are included in.

Note: ‘Registered goods’ are assessed by the TGA for quality, safety and efficacy.  ‘Listed goods’ are assessed for quality and safety, but not efficacy. ‘Biologicals’ comprise, contain or are derived from human cells or tissues.

According to sec 71(2) an application for an extension of term must be made within 6 months of the latest of the date of grant of the patent or the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, any of the pharmaceutical substances referred to in sec 70(3) (see 3.12.2.2).

Following Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643, the relevant goods for the purpose of sections 70, 71 and 77 are those of the patentee, rather than those of a stranger or competitor.  However, the sponsor of goods listed on the ARTG is often not the patentee.  When the patentee is not the sponsor, it will be necessary for the patentee to confirm when making the application for an extension of term that the application for inclusion in the ARTG was made with their consent.

While the pharmaceutical substance on which an application for an extension of term is based must in substance fall within the scope of a claim, where the claims encompass more than one pharmaceutical substance, the ‘first inclusion in the ARTG’ refers to the earliest date on which at least one substance falling within the scope of the claims was included in the ARTG (Bennett J clearly expressed this in Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176 at [34]).

However, this refers only to those inclusions in the ARTG made following an application by or with the consent of the patentee.  As knowledge of this lies with the patentee, when the Commissioner becomes aware of a listing which appears prima facie to be a relevant earlier listing a deficiency will be raised on the basis that the requirement of sec 71(2) is not met.  Such a deficiency will be able to be overcome by confirmation from the patentee that the application for the earlier listing was not made with their consent.

Case Law

Pfizer Corp v Commissioner of Patents [2006] FCAFC 190

The case concerned 4 patents, each relating to a pharmaceutical substance.  The term of each patent was extended on the basis that the first regulatory approval date was the date on which the relevant pharmaceutical substance was entered into the part of the ARTG relating to registered goods.  However, it was subsequently found that the pharmaceutical substances had previously been entered into the part of the ARTG relating to listed goods.  Consequently, the Commissioner altered the expiry date of the patents to reflect the date of first listing, thereby reducing the lengths of the extensions of term.

The Court considered the issue of whether the first regulatory approval date was the date on which the substance was entered into the part of the ARTG relating to registered goods, or the date on which the substance was entered into the part relating to listed goods.  It was held that the goods in question were first included in the ARTG when they were included in that part relating to listed goods.  Furthermore, there was no error on the part of the Commissioner in treating the first inclusion of the relevant goods in the part of the ARTG relating to listed goods, as the first regulatory approval date of those goods.

AbbVie Biotechnology Ltd [2015] APO 45

The earliest regulatory approval date was the date of the goods were first registered, not the date of subsequent inclusions for various different indications.  This decision was affirmed by the AAT in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 at [82]-[89].

Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643

In circumstances where two goods containing pharmaceutical substances disclosed and claimed in a patent were listed on the ARTG, the Court held that the relevant goods and pharmaceutical substance for the purpose of secs 70, 71 and 77 were those of the patentee (and not those of a third party having nothing to do with the patentee).  Accordingly, an unconnected third party’s ARTG listing will not provide the relevant date for sec 71(2) or the “earliest first regulatory approval date” in sec 77.

However, the Court accepted the position that a patentee may not “pick and choose which of its products to nominate as the substance for the purposes of s 70” (at [134], [174]).

Following this Federal Court decision, earlier Patent Office decisions regarding the earliest first regulatory approval date, such as G.D. Searle LLC [2008] APO 31, should no longer be followed.