The Full Federal Court has unanimously held that patent term extensions are not available for second medical use claims involving the use of recombinant DNA technology. This decision overturns a controversial finding of the Administrative Appeals Tribunal last year and means that any patent term extensions granted on the basis of the AAT decision are now invalid. Associate Claire Gregg reports.
The appeal decision of the Full Federal Court (Justices Besanko, Yates and Beach) was unanimous. It overturns last year's controversial findings of the Administrative Appeals Tribunal (the AAT) in AbbVie Biotechnology Ltd v Commissioner of Patents  AAT 682, and confirms that it is not enough to show that a pharmaceutical substance, which has been produced by a process involving recombinant DNA technology, is an integer of the claim(s) upon which the patent term extension (PTE) application is based. Rather, the pharmaceutical substance 'must be the subject matter of the claim or claims, not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance'.
Subsection 70(2) of the Patents Act 1990 (Cth) (the Act) provides that a patent may be eligible for a PTE of up to five years where one or more of the following substances is in substance disclosed in the complete specification and falls within the scope of the claims:
(a) a pharmaceutical substance per se (s 70(2)(a)); or
(b) a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology (s 70(2)(b)).
Goods containing or consisting of the pharmaceutical substance must also be included in the Australian Register of Therapeutic Goods (ARTG), and at least five years must have elapsed between the date of the patent and the 'first regulatory approval date' of such goods.
The three patents in suit (the Patents) included Swiss-style claims directed to the use of adalimumab, an antibody produced by recombinant DNA technology, in the manufacture of a medicament for the treatment of rheumatoid spondylitis, Crohn's disease, and ulcerative colitis, respectively.
Adalimumab is marketed in Australia under the brand name HUMIRA®, and was first included in the ARTG on 10 December 2003 for the treatment of rheumatoid arthritis.
The patentee, AbbVie Biotechnology, applied to extend the term of the Patents on the basis of the subsequent regulatory approval of HUMIRA® for new therapeutic indications covered by the claims of the respective patents, ie rheumatoid spondylitis (regulatory approval granted 10 August 2006), Crohn's disease (regulatory approval granted 29 June 2007), and ulcerative colitis (regulatory approval granted 23 July 2013).
Historically, the Patent Office has interpreted section 70(2)(b) as applying to product claims per se, or a product produced by a process involving the use of recombinant DNA technology. Accordingly, the Commissioner of Patents refused to grant AbbVie's PTE applications on the basis that the Patent claims were characterised by a new therapeutic use and a product per se did not fall within the scope of those claims. The Commissioner also held that the PTE applications were not allowable because they were not based on the first regulatory approval date for HUMIRA® (10 December 2003), regardless of the therapeutic indication.
AbbVie appealed the Commissioner's decision at the AAT.
Somewhat controversially, the AAT held that an interpretation which would incorporate into the plain reading of s70(2)(b) an exclusion of Swiss-style claims based upon a substance produced by recombinant DNA technology was unwarranted, and the only qualification for extension present in s70(2)(b) was the requirement that the substance be produced by recombinant DNA technology. As s70(2)(b) does not explicitly include the words 'per se', the AAT considered that it is not restricted to 'new and inventive substances' and does not exclude method claims from its scope.
Thus, the AAT interpreted s70(2)(b) to encompass any 'process', 'method', 'application' or 'use' claims (which the AAT referred to collectively as 'Swiss-style' claims) involving pharmaceutical substances that were produced by a process involving recombinant DNA technology.
Nonetheless, the Commissioner's decision to refuse the PTE applications was ultimately upheld because the PTE applications were not based on the first regulatory approval date of HUMIRA®.
The Commissioner appealed the AAT's decision in relation to the eligibility of 'Swiss-style' claims for PTE to the Full Federal Court. Since the Full Court's decision would not change the finding that the PTE applications were based on the incorrect regulatory approval date, AbbVie took no active role in the appeal, and no other contradictor was forthcoming.
While there was no doubt that the active ingredient in HUMIRA® (adalimumab) is produced by a process involving recombinant DNA technology, and that adalimumab is in substance disclosed in the complete specification of the Patents, the Full Court held that the AAT erred in failing to look beyond whether the pharmaceutical substance was produced by a process involving recombinant DNA technology to whether the pharmaceutical substance actually falls within the scope of the claims.
The Full Court considered that, although s70(2)(b) does not expressly include the term 'per se', it addresses the same issue as s70(2)(a), namely: 'extensions of term in relation to claims directed to pharmaceutical substances, not methods or processes involving pharmaceutical substance'. Although s70(2)(b) represents an exception where pharmaceutical substances can be produced by a process that involves recombinant DNA technology, their Honours stated that, properly construed, it is the pharmaceutical substance(s) so produced, not other methods or processes involving those substances, 'that must be the subject matter of the claim or claims' in order to be eligible for PTE.
The Full Court then noted that second medical use claims are not claims to pharmaceutical substances at all. Rather, they are characterised as method or process claims. In relation to Swiss-style claims of the general form 'use of [compound X] in the manufacture of a medicament for the treatment of [condition Y]', the Full Court stated that these claims exhibit dual character:
First, they are directed to a method or process in which a substance is used to produce a medicament. Secondly, they have an additional method or process element constituted by a specific purpose to which the medication is to be used. Thus, the scope of Swiss type claims is fundamentally different to the scope of the claims addressed by s 70(2) of the Patents Act.
Accordingly, it was held that a patent cannot be extended on the basis of second medical use claims involving recombinant DNA technology because they necessarily fall outside the ambit of s70(2)(b) of the Act.
Barring a successful appeal to the High Court (which seems highly unlikely in view of the fact that the patentee took no active role in the Full Court appeal), any PTEs granted on the basis of second medical use claims in light of the AAT decision are now invalid. For pending PTE applications not yet considered by the Patent Office, it may be possible to recover a portion of the official fees.
Although this is the first time s70(2)(b) has been interpreted by the courts, previous Patent Office decisions have provided some guidance on the scope of s 70(2)(b). Thus, in considering whether to apply for PTE for a pharmaceutical patent involving recombinant DNA technology, the following should be kept in mind:
- The relevant claims need not specifically recite recombinant process steps, provided that the pharmaceutical substance that is the subject of the claim can only be produced using recombinant DNA technology.
- The claims need not necessarily be in 'product-by-process' format; a claim to a process involving recombinant DNA that would inevitably produce a pharmaceutical substance may suffice.
- The specific recombinant DNA process need not be the novel and inventive.
If you are unsure whether a patent may be eligible for PTE in Australia, please contact us.