A loophole allowing patent term extensions in Australia for certain Swiss-style claims has been closed

by FPA Patent Attorneys
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The Australian Administrative Appeals Tribunal opened the door for patent term extensions based on a Swiss-form claim which enlarged the scope of applications of patent term extensions considerably. Recently, the Full Federal Court has reversed that decision.

Patent term extensions continue to be available for product claims and claims to processes of preparing a product that use recombinant DNA technology. However, other method and Swiss-form claims cannot support a patent term extension. Purpose-limited product claims are yet to be considered in this context.

Patent term Extensions

Patent term extension is available in Australia for patents covering pharmaceutical products that are registered on the Australian Register of Therapeutic Goods where the registration, and consequently sale, of the pharmaceutical product occurs more than 5 years after filing of the patent. One of the requirements for patent term extension in Australia is that either:

  1. a 'pharmaceutical substance per se…in substance fall within the scope of the claim or claims” of the relevant patent; or
  2. a 'pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology…in substance fall within the scope of the claim or claims' of the relevant patent.

Option 1 has been judicially considered and determined to allow the extension of product claims but not method claims because a pharmaceutical substance per se does not in substance fall within the scope of a method claim. Option 2 had little judicial consideration prior to this series of cases.

Swiss-form claims and use of recombinant DNA technology

The present case involved the product adalimumab, which is prepared using recombinant DNA technology. There were several patents of interest all of which included exclusively “Swiss-form” claims. Attorneys commonly use the term “Swiss-form claim” to refer to claims of the following structure “use of compound [X] in the manufacture of a medicament for [a new therapeutic use]”. In Australia, Swiss-form claims are for methods of making medicaments which are purpose limited not methods of medical treatment as they were understood in Europe (see our related articles here for further information on the construction of Swiss-form claims and here for information on infringement of Swiss-form claims). Therefore, while the claims were for processes of preparing a pharmaceutical product using recombinant DNA technology, the claims also required that the product was for a specific therapeutic use.

Earlier decisions

The Patent Office found that the Swiss-form claims were characterised by a therapeutic use and therefore the pharmaceutical product prepared using recombinant DNA technology did not in substance fall within the scope of the Swiss-form claims. This decision was overturned on appeal at the Administrative Appeals Tribunal (AAT), where it was reasoned that the removal of the phrase “per se” from option 2 above meant that the option was not limited to product claims alone. The AAT decision indicated that it was enough if one of the features of the claim was the preparation of a pharmaceutical product using recombinant DNA technology and found that a request for patent term extension is not disqualified because the relevant claims are in the Swiss-form claim style. In the view of some commentators, the AAT decision had significant impact because it had the potential to apply to method claims and significantly extend the number of patents for which a patent term extension was available where a product was produced by recombinant DNA technology.

This decision

The Full Federal Court disagreed with the AAT. The Full Federal Court found that, as a pharmaceutical substance is a product, the patent term extension provisions are concerned with inventions that are products, not inventions that are methods or processes. The court cited the comments in Prejay Holdings that:

It is not enough that the substance appears in a claim in combination with other integers or as part of the description of a method (or process) that is the subject of a claim. The policy adopted in s 70 was to confine extensions to patents that claim invention of the substance itself.

The only exception is where a process involves recombinant DNA technology but that exception is limited to claims for the pharmaceutical substance so produced and not extended to other methods or processes involving the substance. The Court considered that the Swiss-form claims were not directed to adalimumab produced by recombinant DNA technology but were directed to different subject matter because of the aspect of the claims referring to the therapeutic use of adalimumab. Consequently, the pharmaceutical substance prepared by recombinant DNA technology did not in substance fall within the scope of the Swiss-form claims.

Status of patent term extension in Australia

Patent term extension continues to be available for product claims for a pharmaceutical substance per se. Product and process claims can support a patent term extension for a pharmaceutical substance produced using recombinant DNA technology so long as the process steps are limited to the preparation of the pharmaceutical substance using recombinant DNA technology. However, Swiss-form claims cannot be used to support patent term extension and claims for methods of use of a product, such as methods of medical treatment, also cannot support a patent term extension. There has been little judicial consideration of purpose-limited product claims in Australia so it is not yet clear whether these will be considered product or method claims in this context. That said, under current practice the Patent Office will construe purpose-limited product claims as method claims and refuse to grant patent term extension of such claims until there is judicial consideration of this issue.

 

References

[1] Subsection 70(2) of the Patents Act 1990.

[2] AbbVie Biotechnology Ltd (2015) 115 IPR 398 (Patent Office decision).

[3] Re AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 (AAT decision).

[4] Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 at [49] (This decision).

[5] Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IRP 424 at [24] (Prejay Holdings).

[6] Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 at [55] (This decision).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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