AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 has been overturned.

Summary

  • Today, the Full Federal Court set aside a decision of the Administrative Appeals Tribunal thereby making it clear that patent term extension (PTE) may not be granted on the basis of Swiss-style claims.
  • As Swiss-style claims are process claims, a pharmaceutical substance does not in substance fall within the scope of the claim. Thus the requirements of s 70(2)(b) of the Patents Act 1990 are not satisfied and Swiss-style claims cannot form valid basis for a PTE application.
  • The Court concluded that PTE is only available for pharmaceutical substances (i.e. products) and not processes involving pharmaceutical substances.

In Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129, the Full Federal Court has today set aside a previous decision of the Administrative Appeals Tribunal (AATA) that a patent term extension (PTE) may be granted on the basis of a Swiss-style claim (AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682).

Background

By way of background, the relevant requirements of s 70 of the Patents Act 1990 are as follows (emphasis added):

(2) Either or both of the following conditions must be satisfied:

(a) 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 the claim or claims of that specification;

(b) 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 of the claim or claims of that specification.

AbbVie applied for PTE on the basis of Swiss-style claims directed to the use of adalimumab in the manufacture of a medicament for the treatment of several autoimmune diseases.

Briefly, the AATA held that the requirements of s 70(2)(b) were satisfied, as Swiss-style claims are properly construed as process claims, and adalimumab is ‘produced by a process that involves the use of recombinant DNA technology’.

The AATA reasoned that the omission of ‘per se’ from s 70(2)(b) was significant and intentional, and thus s 70(2)(b) must be understood to mean that process claims (where the pharmaceutical in question is produced by recombinant DNA technology) were valid basis for a PTE application.

The Full Federal Court Decision

Conversely, the Court focussed on the definition of a ‘pharmaceutical substance’, and considered that it related solely to products, not processes. In view of this, and the Court’s review of existing case law relating to s 70, it was concluded that PTE is available only for pharmaceutical substances (i.e. products), and not methods or processes involving pharmaceutical substances. In its reading of the case law, as well as the Explanatory Memorandum, statements which made literal reference to the wording of s 70(2)(a) were interpreted by the Court as also relevant to s 70(2)(b).

The omission of ‘per se’ in s 70(2)(b) was dealt with by the observation that the phrase would be inapposite had ‘per se’ been included, as the ‘one or more pharmaceutical substances’ in s 70(2)(b) are further characterised by the requirement that they be produced by a particular process.

The Court considered that Swiss-style claims, being directed to a process for preparing a medicament from a pharmaceutical substance, were not directed to a pharmaceutical substance at all. In other words, the claims in suit were not directed to adalimumab produced by recombinant DNA technology – they were directed to a process in which adalimumab is used to produce a medicament, where that medicament is used for a specific therapeutic purpose.

In summary, the Court provided the following construction of s 70(2)(b):

…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.

A pharmaceutical substance, as a product, does not in substance fall within the scope of a Swiss-style claim. It is not ‘included amongst the things claimed’ (Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 at 42). On this basis the Court concluded that PTE may not be granted on the basis of Swiss-style claims.