As previously reported, the Australian Patent Office issued two decisions in August 2015 in which it found that Swiss-style claims (which are of the general type “Use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use”) cannot be used to support a patent term extension (PTE). However, this finding has been recently overturned by the Administrative Appeals Tribunal of Australia (AATA) in AbbVie Biotechnology Ltd Commissioner of Patents [2016] AATA 682.

Background

In light of patent office decisions which established that claims directed to processes of producing compositions that involve the use of recombinant DNA technology in some way are sufficient to confer eligibility for an extension of term (ImmunoGen Inc. [2014] APO 88 and Novartis Vaccines and Diagnosis S.r.l. [2015] APO 2), ThromboGenics NV and AbbVie Biotechnology Ltd separately sought to obtain PTEs for patents containing Swiss-style claims on the basis that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of such claims.

However, in ThromboGenics NV [2015] APO 44 and AbbVie Biotechnology Ltd [2015] APO 45 the Delegate found that, while a pharmaceutical substance produced by a recombinant process was disclosed in the specification, it did not in substance fall within the scope of the claims. Consequently, the Delegate refused the PTE applications.

As we noted in our reporting article, the distinction between the Patent Office’s decisions in ThromboGenics NV and AbbVie Biotechnology Ltd and its earlier decisions ImmunoGen Inc. and Novartis Vaccines and Diagnosis S.r.l is a fine one. Having found that a product can fall “in substance” within the scope of a process claim, we considered it arguable that a product, when intended for a specific therapeutic use, could fall in substance within the scope of a relevant Swiss style claim. Accordingly, it is not surprising that AbbVie Biotechnology Ltd appealed the Patent Office decision to the AATA.

The AATA decision

In overturning the Patent Office decision, the AATA found that the relevant section of the Patent Act (section 70(2)(b)) only requires that the pharmaceutical substance be produced by recombinant DNA technology, and that an interpretation excluding Swiss style claims based upon a substance produced by recombinant DNA technology is unwarranted. The AATA found that if the legislature intended to exclude such claims, then the plain reading of the subsection does not achieve this object. The only requirement for a PTE for a pharmaceutical substance produced by recombinant DNA technology, is that it be disclosed in the complete specification of the patent and fall within the scope of the patent. The AATA found that the patents in suit satisfy such criteria and should not be disqualified because the claims are drafted in the Swiss style format.

Despite finding that the Swiss style claims of the patents confer PTE eligibility, the AATA held that the PTE applications were not based on the first listing in the Australian Register of Therapeutic Goods (ARTG) of goods containing, or consisting of, the pharmaceutical substance. The AATA found that the therapeutic effect of the pharmaceutical substance is to be ignored when considering the date of first ARTG listing and that AbbVie Biotechnology Ltd had relied on the wrong ARTG listing (which related to a subsequent indication). Abbvie can apply to correct the error.

Conclusions

As a result of the AATA decision, the following claims may render a patent eligible for a PTE:

  1. claims to a pharmaceutical composition per se; and
  2. claims encompassing pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology in some way (including process claims and Swiss-style claims), even if the use of recombinant DNA technology is not recited in the claims.

However, it is important to note that the date of the first ARTG listing for (2) above is not related to the therapeutic indication recited in the Swiss style claim, it is the date of the first listing of any goods containing, or consisting of, the pharmaceutical substance.

The AATA decision is appealable to the Federal Court and we will keep you informed of any developments in this regard.