Pharmaceutical extensions: a listing in the ARTG is an inclusion

Pharmaceutical extensions: a listing in the ARTG is an inclusion

Pharmaceutical extensions: a listing in the ARTG is an inclusion

The Full Federal Court has affirmed the previous findings of the Commissioner of Patents and a single judge of the Federal Court that, where no pre-TGA marketing approval was given, an export listing in the Australian Register of Therapeutic Goods (ARTG), prior to registration to permit marketing in Australia, is to be considered as the first inclusion in the ARTG for the purpose of determining the first regulatory approval date in calculating a patent extension term.

The issues under consideration in this case concerned four patents relating to Norvasc (amlodipine) and Replax (eletriptan hydrobromide) which had all been granted an extension of patent term under the provisions of the Patents Act 1990 (Cth) (“the Patents Act”). The extensions varied from approximately 5 months to almost 5 years and were calculated on the first regulatory approval date supplied by Pfizer, being the date the goods containing the substance were first included in the ARTG as registered goods. These extensions were recorded in the Patents Register.

In order for a patent to qualify for an extension, goods containing or consisting of the pharmaceutical substance (as disclosed and claimed in the patent) must be included in the ARTG, and 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 (s 70(3)). The first regulatory approval date is given by s 70(5) and is:

a) if no pre-TGA marketing approval was given 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
b) if pre-TGA marketing approval was given in relation to a substance – the date of the first approval. In this particular instance, as no pre-marketing approval had been given, the issue turned on the date defined by (a). The extension term is then calculated according to s 77, being the period beginning on the date of the patent and ending on the earliest first regulatory approval date, less five years. The extension period so calculated cannot be less than zero but is capped at a maximum of five years.

In 2005, the Patent Regulations were amended to prescribe that if the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance is earlier than that supplied with the application for extension, then the Commissioner must amend the entry in the Patent Register (r 10.7(7)). Having become aware that the goods containing Norvasc or Replax had previously been included in the ARTG as listed (for export only) goods, the Commissioner notified Pfizer that she intended to amend the patent Register to reflect a shorter extension term based on the earliest first regulatory approval date being the date of inclusion in the ARTG as listed goods.

We recently reported (September 2006) the decision of a Delegate of the Commissioner of Patents, and on appeal that of Bennett J, that an export only listing in the ARTG is an inclusion for the purpose of s 70(5) of the Patents Act and that where that inclusion precedes registration that permits marketing in Australia, and no pre-TGA marketing approval was given, it is the earliest first regulatory approval date for the purpose of calculating the extension of term as set out s 77. Pfizer sought leave to appeal the decision to the Full Federal Court, contending that the Commissioner misconstrued s 70 of the Patents Act in directing the amendment to the Patent Register and that, in any event, the provision that authorised the amendment is invalid.

In determining the question of whether r 10.7(7) is ultra vires, the Full Court considered the purpose of the regulation – being to ensure that particulars entered into the Register are not false. It noted that if an extension were granted that should not have been granted, such that the entry ought not to have been made, there ought to be a mechanism to correct that entry, and that r 10.7(7) does no more than do so. Whilst acknowledging that provisions which grant power to make regulations (s 228(2) of the Patents Act) must not vary or depart from the positive provisions and purpose of the statute, it held that the Commissioner should be authorised to amend the Patent Register to reflect the extensions that were authorised by the Patents Act in lieu of extensions that were not authorised. Regulation 10.7(7) was therefore held to be a valid exercise of the power conferred by s 228(2).

Having determined that r 10.7(7) was not ultra vires, the Court then turned its attention to the question of whether a listing, for export only, in the ARTG can be taken as the first inclusion therein for the purpose of s 70(5)(a). In support of their proposition that the date on which goods were entered into the ARTG as registered goods is the first inclusion in the ARTG, Pfizer argued essentially on three fronts: by reference to extrinsic materials, the purpose of the relevant provisions was to provide the patentee with an effective patent term to exploit the invention by restoring time lost in gaining marketing approval, the higher degree of scrutiny required for registered goods relative to listed goods, and consistency with s 70(5)(b).

However, in rejecting these submissions, the Court looked at the ordinary English meaning of the language of s 70(5)(a) and concluded that the words first inclusion in means the first time the goods are included in the ARTG. The Court held that there was nothing in s 70(5)(a) to indicate that there should be any qualification of the clear and unequivocal words that are to be found in the provision and pointed out that, notwithstanding the greater onus in securing registration of the goods rather than listing, if they are included in either part of the register, they are included in the ARTG. The Court in turn also referred to a number of extrinsic materials which made no reference to marketing approval but which made it “tolerably clear” that the purpose of the provisions was to provide an effective patent life, i.e. an extended period in which the invention can be exploited. It observed that the listing of goods in the ARTG does allow the patentee to exploit the invention by exporting the goods and thus fulfils the purpose of the provisions. It was therefore held that the goods containing the pharmaceutical substances were first included in the ARTG within the meaning of s 70 when they were included in the part relating to listed goods and that there had been no error on the part of the Commissioner or the primary judge.

Pfizer had also argued for conformity of language between s 70(5)(a) and s 70(5)(b) which both refer to “pre-TGA marketing approval”. Pre-TGA marketing approval, in relation to a substance, is defined by s 70(6) as an approval (however, described) by a Minister, or a Secretary to a Department to: (a) market the substance, or a product containing the substance, in Australia; or import into Australia the substance, or a product containing the substance. Pfizer contended that the expression “pre-TGA” was shorthand for “preTherapeutic Goods Act”. On this basis it was argued that as a first regulatory approval date before the commencement of the TGA, under which the ARTG was established, referred to marketing approval, then where “no-pre-TGA marketing approval” had been given, i.e. after the commencement of the TGA, s 70(5)(a) must be read so as to include the words “for marketing in Australia”.

However, the Court did not agree with this interpretation, observing that the TGA also provides for certain exemptions and approvals to permit marketing of the goods in Australia prior to inclusion in the ARTG. These may be given in certain, situations, for example, to allow stockpiling to deal with a potential or actual threat to public health or for sole experimental purposes in humans. Such circumstances, although within the regime of the TGA, were considered by the Court to be examples of preTGA marketing approval, “in the sense that it would be an approval given before the regime of the TGA is complied with in respect of the goods in question”.

This is an interesting conclusion as Pfizer’s interpretation that “pre-TGA” was shorthand for “pre-Therapeutic Goods Act” was one which had, up until now, been commonly accepted. Whilst the Court’s finding on this point is merely obiter, and it is likely to be a rare occurrence where such circumstances might apply, patentees seeking an extension of patent term should be mindful of any such exemptions or approvals which may have been granted before an inclusion of the goods in the ARTG as this may bring forward the timing of their application for an extension.