Patent Opposition Fails to Block Patent Term Extension for COPD and Asthma Drug

Banki Haddock Fiora v Glaxo Group Limited [2024] APO 20 (28 May 2024)

Date of decision: 28 May 2024

Body: Patent Office

Adjudicator: Delegate of the Commissioner or Patents – Dr S J Smith

28 May 2024

Patent Office

Delegate of the Commissioner or Patents – Dr S J Smith

Background

Glaxo Group Limited (Glaxo) applied for an extension of term of Australian Patent No. 2018282427 (AU2018282427) based on the product TRELEGY ELLIPTA, first listed on the Australian Register of Therapeutic Goods (ARTG) on 16 January 2018 (extension application).

Before deciding on the extension application, the Commissioner re-examined AU2018282427, considering it not to meet certain requirements of the Patents Act 1990 (the Act).  Glaxo proposed amendments limiting the claims of AU2018282427 to an admixture composition, which, once allowed, overcame the invalidity issues raised during re-examination.

Banki Haddock Fiora (Banki) opposed the accepted extension application on the ground that it incorrectly treated the first regulatory approval date as the inclusion of TRELEGY ELLIPTA on the ARTG, rather than that of ANORO ELLIPTA on 4 July 2014.  Banki also contended that the relevant specification for determining the extension application should be the specification as it stood at the time the extension application it was made, that is, the specification prior to amendment when the claims defined a composition, not an admixture.

Key Issues and Findings

We previously reported on the regime governing patent term extensions under Australian law here.

Briefly, under Australian law, patents that cover pharmaceutical inventions are eligible for an extension of term of up to five years if:

• The patent relates to a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology;
• The pharmaceutical is included on the ARTG before the 20-year term of the patent expires and the entry is current at the time of the application for an extension; and
• At least five years have elapsed between the effective filing date of the patent and the first inclusion of the pharmaceutical on the ARTG.

The opposition focused on determining the date of first inclusion of the pharmaceutical substance per se on the ARTG for the extension application.  However, it was first necessary for the Delegate to assess which version of the specification was relevant to the extension application.

The Delegate concluded that the relevant version of the specification for the analysis of the extension application was AU2018282427 as amended to address the invalidity issues raised during re-examination, reasoning that a patentee may seek an amendment under s104 of the Act at any time, and if allowable, the patent no longer subsists in its unamended form.

The Delegate also found that the TRELEGY ELLIPTA goods were the correct pharmaceutical substance per se, being an admixture composition as approved for supply; the ANORO ELLIPTA goods, while an admixture composition in use, were not supplied in that form.

The extension of term has been granted, subject to appeal.  Costs were awarded against Banki.

Takeaways

This decision makes it clear that the relevant version of the specification for analysis of an extension of term application is that subsisting at the time the Commissioner decides the application, which in this case, was the specification as found allowable after re-examination.  As re-examination of Australian pharmaceutical patents by the Commissioner now occurs routinely, particularly where there are differences in scope between the claims as granted in Australia versus those granted in corresponding foreign patents, any necessary specification amendments should be made before filing an extension of term application, or at the very least, before the application is considered.

This decision also clarifies that assessment of the pharmaceutical substance per se is made on the product form as approved for supply, and not in use.

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