Patent extension of term available for second indications for pharmaceutical substances produced with recombinant DNA

The Administrative Appeals Tribunal (AAT) has overturned a decision of the Commissioner of Patents and found that Swiss-style claims can form the basis for a patent term extension when the production of the pharmaceutical substance involves the use of recombinant DNA technology. The decision was made by the deputy president of the AAT in AbbVie Biotechnology Limited v The Commissioner of Patents.

For most pharmaceuticals, an extension of term is available only if a relevant claim of a patent covers pharmaceutical substances per se. In other words, a new use of a known pharmaceutical substance protected by a patent claim is generally not extendible beyond the standard 20 year term. Under s.70(2)(b), an extension is also available where a claim or claims of a patent disclose a pharmaceutical substance ‘when produced by a process that involves the use of recombinant DNA technology’. Swiss-style claims that, in the form, ‘the use of a compound X for the preparation of a medicament Y for the treatment of a disease/condition Z’ are generally not amenable to patent term extensions and for many years, these claims were not permissible in Australia at all.

In AbbVie Biotechnology, the relevant patents each related to a pharmaceutical substance sold under the brand name Humira. Humira is produced by a process of recombinant DNA technology. AbbVie sought an extension of the term for three patents, each for the treatment of different conditions using Humira. The Commissioner argued that to extend the three AbbVie patents would be anomalous as pharmaceutical substances not produced using recombinant DNA are not extendible for new uses. In rejecting this argument, the Tribunal noted that the words ‘per se’ were not found in s.70(2)(b) which related to recombinant DNA technology. The tribunal found that the only requirement for the extension of a patent for a pharmaceutical substance produced by recombinant DNA technology is that it is to be disclosed in the complete specification and fall within the scope of the claims. It mattered not that the particular patents in question were for new uses of a known pharmaceutical substance.

After applying a strict reading to s.70(2)(b), which worked to the benefit of the patentee, the tribunal then took a strict reading to the question of when an application for extension of term needed to be filed. Under s.71(1), an application for an extension of term is to be made within six months of the date a patent was granted, or six months from the first inclusion of the pharmaceutical substance in the Australian Register of Therapeutic Goods. In this case, Humira had been first registered for the treatment of other conditions from a time well before the applications for extension of term that had been filed by AbbVie. AbbVie had filed applications within six months of the specific Therapeutic Goods Administration (TGA) registrations for the treatment of the respective conditions covered by the patents. The tribunal found that this was too late.

As a result of the decision, the current structure of s.70 of the Patents Act 1990 gives preferred status to pharmaceutical substances produced by processes which involve the use of recombinant DNA. Swiss-style claims covering the use of such substances for the treatment of different conditions can be extended by up to five years beyond the standard 20 year patent term. However, an application for an extension of term must be made within six months of the original TGA registration in which the pharmaceutical substance was disclosed for any condition, not the registration relevant to the particular condition addressed in the patent.

The Commissioner of Patents has filed an appeal against the decision of the AAT.


Greg was the Chairman of the Phillips Ormonde Fitzpatrick Board and has been with the firm since 1985. Greg initially worked in the industry as a corporate patent and trade marks adviser, and later worked with a general legal practice in Melbourne. He was a founding partner of Phillips Ormonde Fitzpatrick Lawyers in 1996, and is the firm’s senior litigator.