After the Administrative Appeals Tribunal of Australia (AATA) decision in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682, patentees were hopeful of wider grants of patent term extensions (PTEs) in Australia. The AATA ruled in that case that a PTE could be granted for Humira where the patent claim was a Swiss-style claims.

A recent decision in the Full Federal Court of Australia (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129) has reversed the decision ruling that Swiss-style claims can not be the subject of PTEs in Australia. Against the vexed PTE provisions in Australia, this decision further narrows the scope of extensions of patent terms for pharmaceutical products in Australia.

Background

By way of background, AbbVie Biotechnology Ltd (AbbVie) owns a number of Australian patents relating to a pharmaceutical substance known as adalimumab (Humira). Adalimumab is produced by a process of recombinant DNA technology. Adalimumab was originally included in the ARTG in 2003 for treatment of rheumatoid arthritis. Subsequently, adalimumab was demonstrated to be effective for other diseases and AbbVie obtained three additional patents covering these further medical uses, each of which includes ‘Swiss-style’ claims.

PTEs in Australia are limited to circumstances where one or both of these conditions are satisfied:

  • One or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of a claim
  • One or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope a claim.

On 3 October 2014, AbbVie applied to the Patents Office for a PTE of each patent, relying on s 70(2)(b) of the Patents Act, submitting that the patents involve the use of recombinant DNA technology; and the patents are in substance disclosed in the specifications.

Patent Office decision

The Delegate in AbbVie Biotechnology Ltd [2015] APO 45 determined that patents containing Swiss-style claims were not eligible for PTEs under section 70(2)(b) of the Patents Act, stating [at 13]: I do not find that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of the claims. I must therefore refuse the application for an extension of term.

The AATA decision

The AATA overturned the Patent Office decision, finding [at 71] that 'the only requirement, for extension of a patent for a substance produced by recombinant DNA technology, is that it be disclosed in the complete specification of the patent and falls within the scope of the patent'.

Full Federal Court – the decision

The Commissioner of Patents appealed the AATA decision to the Full Federal Court (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129).

The ultimate decision of the Full Federal Court came down to:

  • the proper interpretation of the term ‘pharmaceutical substance’ for the purpose of interpreting section 70(2)(b) of the Patents Act; and
  • whether, based on this interpretation, patents containing Swiss-style claims could satisfy s 70(2)(b) of the Act.

The Court held that a ‘pharmaceutical substance’ related solely to a pharmaceutical substance (ie product) and not the processes involving pharmaceutical substances:

…even though produced by a process involving recombinant DNA technology, the pharmaceutical substance must also, in substance, fall within the scope of the claim or claims of the specification in suit. Properly construed, this means that it is the pharmaceutical substance that must be the subject matter of the claim or claims, not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance.

The Court found that Swiss-style claims, being directed to a process for preparing a medicament from a pharmaceutical substance, were not directed to a pharmaceutical substance and therefore did not satisfy the requirements of s 70(2)(b).

In applying this provision to the facts, the Court stated that [at 58-59]:

With specific reference to the present case, adalimumab is a pharmaceutical substance produced by a process that involves recombinant DNA technology. However, the claims in suit are not directed to adalimumab produced by recombinant DNA technology. They are directed to different subject matter. First, they are directed to a method or process in which adalimumab is used to produce a medicament. Secondly, they are directed to a medicament containing adalimumab that is to be used for specific therapeutic purposes…. These claims do not meet the requirements of s 70(2)(b). In our respectful view, the Tribunal erred in concluding otherwise.

Lesson from the case

The recent decision of the Full Federal Court provides more clarity on the interpretation of the PTE provisions in Australia. This decision narrows the scope for PTEs in Australia for second generation patents such as method of treatment claims or Swiss style.