In a previous article published here, we discussed the requirements for Patent Term Extensions (PTE) of pharmaceutical patents and summarised the recent guidance provided by the Federal Court in interpreting the PTE requirements.

In this follow up article, we provide a brief overview of the PTE application process and discuss a recent Australian Patent Office decision in Banki Haddock Fiora v Glaxo Group Limited [2024] APO 20, which considered a PTE opposition.

PTE Application Process

Application

An application for a PTE of a standard patent must be made by the patentee (s 70(1)) within 6 months after the later of the patent grant date or the ARTG listing date (s 71(2)).

As outlined in section 71(1)(a), an application for a PTE must be in the approved form. Relevantly, IP Australia’s Patent Manual of Practice and Procedure specifies that the approved form requires:

• applicant (patentee) and patent details;

• information regarding the pharmaceutical substance on which the application for an extension of term is based and the goods containing, or consisting of, the substance;

• information regarding whether the inclusion of the goods in the ARTG was made following an application by the patentee, or with their consent;

• information to the best of the patentee’s knowledge about the first regulatory approval date relating to the substance and the earliest first regulatory approval date applying to the patent;

• information concerning the inclusion of the goods in the ARTG; and

• statement that there are no relevant proceedings in relation to the patent, or details of the relevant proceedings.

Furthermore, as outlined in section 71(1)(b)-(c) and the regulations, the application must be accompanied by the following documents:

• information showing that goods containing, or consisting of, the substance are currently included in the ARTG (reg 6.8(2));

• information identifying the substance, as it occurs in those goods, in the same way (as far as possible) as the substance is identified in the complete specification of the patent (reg 6.8(3)); and

• for a pharmaceutical substance for which pre-TGA marketing approval has not been given:

a certificate under the Therapeutic Goods Act 1989 (Cth) stating the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance; or if the patentee does not have such a certificate, information showing the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance (reg 6.9); or

• for a pharmaceutical substance for which pre-TGA marketing approval has been given:

a written statement by the person who gave the relevant marketing approval showing that approval has been given and the date of the first approval, or if the patentee does not have a written statement,  information showing that approval has been given; and the date of the first approval (reg 6.10).

If, after an application has been filed, the Commissioner requires further information in order to decide if the application satisfies the requirements of section 70 (eligibility requirements) and section 71 (timing and form of application) and the PTE should be granted, the Commissioner may give the applicant a notice requesting the further information and allow the applicant a period of time of between two and six months to comply with the request (reg 6.11(1)-(3)).

Acceptance to Grant

If the Commissioner determines that the application meets the requirements of section 70 and section 71, the application must be accepted (sec 74). Once accepted, a notice of acceptance is published in the Official Journal and third parties have three months from the date of publication of the notice of acceptance to file a notice of opposition to the extension of term (sec 75 and reg 5.4(2)). The only permissible grounds of opposition are that application does not satisfy the requirements of section 70 or section 71. Where a decision to grant or refuse an extension of term is issued following an opposition, the decision can be appealed to the Federal Court (sec 75(4)).

Under section 76(1), the extension of term will be granted if there is no opposition to the grant, or in spite of opposition, the Commissioner's decision, or the decision on appeal, is that the extension should be granted. On granting the extension, the Commissioner will publish a notice of the grant in the Official Journal and the Register will be updated to include the new expiry date.

Banki Haddock Fiora v Glaxo Group Limited [2024] APO 20

In a recent decision of the Australian Patent Office in Banki Haddock Fiora v Glaxo Group Limited [2024] APO 20, Banki Haddock Fiora (the Opponent) opposed Glaxo Group Limited’s application to extend the term of Australian Patent No. 2018282427 based on the inclusion of TRELEGY ELLIPTA in the ARTG.

This decision highlights that the relevant specification to consider in determining compliance with the PTE requirements is that subsisting at the time of making the decision of compliance with the requirements. Furthermore, that the goods included in the ARTG, as supplied, must consist or contain the pharmaceutical substance per se claimed and disclosed in the patent.

Basis for opposition

The only ground of opposition is that the PTE application incorrectly identified the earliest first regulatory date as 16 January 2018 for the inclusion of TRELEGY ELLIPTA, when it should have been 4 July 2014 when ANORO ELLIPTA was first included in the ARTG.

The Opponent, therefore, contended that the application failed to satisfy the requirement of section 71 that the application be in the approved form, which requires an indication of, to the best of the patentee’s knowledge, the earliest first regulatory approval date in relation to goods containing, or consisting of, any pharmaceutical substance that is, in substance disclosed and claimed in the patent.

Reasoning and Decision

Since the specification was amended after the application for PTE was filed but before it was considered, the Delegate had to first determine the version of the specification relevant to the opposition.

The Opponent contended that the relevant specification is that at the time of the PTE application (i.e. specification prior to amendments) since the application is made at a fixed point in time and the assessment of whether the section 70 requirements are satisfied is made in the context of the application. However, the Delegate considered that this approach could be problematic and noted that “if amendments were made, … such that all claims were directed to methods of treatment and a pharmaceutical substance per se no longer in substance fell within the scope of any claims, it would seem perverse for the Commissioner to be obliged to grant an extension of term of the patent on the basis of claims that no longer subsisted.”

The Delegate also noted that since a patentee is able to seek an amendment under section 104 at any time subject to the allowability requirements of section 102 and, once an amendment is made, the patent no longer subsists in its unamended form, the relevant specification to consider is that subsisting at the time of making the decision of compliance with the requirements. As such, the Delegate held that the relevant specification is the amended specification.

In determining whether the PTE application incorrectly identified the earliest first regulatory date as that of TRELEGY ELLIPTA instead of ANORO ELLIPTA, the Delegate focused on main issue which centred on whether ANORO ELLIPTA contained the same pharmaceutical substance per se as that disclosed and claimed in the patent.

In the decision, the Delegate identified that the relevant pharmaceutical substance per se disclosed and claimed in the patent is an admixture of a pharmaceutically acceptable salt of umeclidinium and vilanterol (or a pharmaceutically acceptable salt thereof), which is consistent with the pharmaceutical substance identified in the PTE application.

TRELEGY ELLIPTA includes one strip wherein the blisters contain a combination of umeclidinium and vilanterol and a second strip wherein the blisters contain fluticasone furoate (at [37]). The Delegate therefore concluded that TRELEGY ELLIPTA clearly contains an admixture of umeclidinium bromide and vilanterol trifenatate as the two components are combined within single blisters.

On the other hand, ANORO ELLIPTA contains two strips of blisters with one containing umeclidinium and the other containing vilanterol, and that the two blisters are combined in the inhaler before administration and cannot be separately inhaled (at [40]). That is, ANORO ELLIPTA is a single self-contained product which, at point of supply, contains the separate components of an admixture as disclosed and defined in the patent, but it does not include an admixture until it is activated at the point of use.

The Opponent advanced that since the plain language of section 70 does not provide any temporal restriction on the assessment of whether the goods included on the ARTG contain or consist of the pharmaceutical substance per se, it does not matter when the admixture is contained in the ANORA ELLIPTA (e.g. as supplied or at the point of use).

However, the Delegate disagreed and noted that “the inclusion of goods in the ARTG is intrinsically connected with the supply of therapeutic goods. … the supply of goods is distinct from the subsequent use of the goods”.

The Delegate therefore held that since the ANORO ELLIPTA goods, as supplied, do not contain or consist the admixture composition, the ANORO ELLIPTA goods do not contain or consist the pharmaceutical substance per se defined and disclosed in the patent. As a result, the PTE application did not incorrectly identify the earliest first regulatory approval date and the opposition to the grant of the PTE is unsuccessful.

For more information on the process for applying for a PTE in Australia, please contact Daniel or Catrina.

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