[authors: Adrian M Trioli* & Noelene Treloar**]

The Australian Full Federal Court's recent decision in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 confirms that an extension of patent term for pharmaceutical substances does not extend to Swiss type claims.

The decision highlights that Swiss type claims do not fall within the relevant legislative provisions for patent term extensions under (i) section 70 (2)(a) for a pharmaceutical substance per se, or (ii) section 70 (2)(b) for a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.

Background:

Section 70(2)(b) of the Patents Act 1990 (Cth) (the Patents Act) allows for the term of a standard patent to be extended in circumstances where 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 Biotechnology Ltd (AbbVie) is the patentee of three (3) Australian patents directed to use of its blockbuster drug adalimumab, marketed under the brand name Humira™.  The drug has been successful in the treatment of diseases including rheumatoid arthritis, rheumatoid spondylitis, Chrone's disease and ulcerative colitis.

AbbVie sought an extension of term to its Australian patents in accordance with section 70(2)(b) of the Patents Act.  In August 2015, the Deputy Commissioner of Patents denied the extension of term request on the basis that the condition in section 70(2)(b) had not been satisfied as the relevant patent claims were directed to a therapeutic use of adalimumab, and not directed to the pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.

AbbVie appealed the decision to the Administrative Appeals Tribunal, and the Tribunal set-aside the Deputy Commissioner's decision.  The Deputy Commissioner appealed to the Full Federal Court.

Full Federal Court Decision:

The Full Federal Court of Australia held that adalimumab is a pharmaceutical substance produced by recombinant DNA technology.  However, the relevant patent claims were Swiss type claims directed to (i) a method or process in which adalimumab is used to produce a medicament, and (ii) a medicament containing adalimumab that is to be used for specific therapeutic purposes.  As such, the Swiss type claims were use claims (or characterised as method or process claims) and therefore did not meet the requirements of section 70(2)(b) that require product claims.  The extension of patent term from 20 years to 25 years in Australia was thereby denied.

* Adrian M Trioli, Principal, Adrian M Trioli Patent and Trade Mark Attorney
** Noelene Treloar, Of Counsel, Adrian M Trioli Patent and Trade Mark Attorney