No patent extensions for Swiss Style Claims in Australia
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…
