Swiss style claims and patent term extension

David Tso

Dr David Tso

Under Australian patent law, the term of a pharmaceutical patent may be extended if certain criteria are met. In this regard, a patent term extension (PTE) of up to five years may be obtained for pharmaceutical products per se. In order to be eligible for a PTE, section 70(2) of the Patents Act 1990 (Cth) states:

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.

A recent Federal court decision, Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129, has provided more clarity on PTE’s in Australia.

Declan McKeveney

For more information about patent term extensions, contact Dr Declan McKeveney.

Background

AbbVie Biotechnology Ltd (AbbVie) owns a number of Australian patents relating to the pharmaceutical substance adalimumab (the blockbuster drug marketed under the name ‘Humira’). Adalimumab is produced by a process of recombinant DNA technology and was originally used in the treatment of rheumatoid arthritis. Subsequently, adalimumab was found to be effective for other diseases.

AbbVie filed three patent applications directed to these further medical uses. These applications were subsequently granted, and included ‘Swiss-style’ claims. A Swiss-style claim takes a typical format of “Use of substance X in the manufacture of a medicament for the treatment of condition Y” and, while directed to manufacture of a medicament, relies on the condition to be treated for novelty and inventiveness. AbbVie filed PTE applications asserting that the patents involved the use of recombinant DNA technology, and as such satisfied requirement 70(2)(b) mentioned above. The Examiner responsible for reviewing the request disagreed and the matter was set down for a hearing.

Patent Office Decision

The Delegate, in AbbVie Biotechnology Ltd [2015] APO 45, found that Swiss-style claims were not eligible for PTE’s under section 70(2)(b) of the Patents Act 190 (Cth). In short, the Delegate determined that a substance when produced by recombinant DNA technology does not fall within the scope of a Swiss-style claim in the same way that a pharmaceutical substance per se does not fall within the scope of such a claim. In other words, a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, does not fall within the scope of a therapeutic use-limited Swiss-style claim. As such, the Delegate found that the AbbVie patents were not eligible for PTE.

Administrative Appeals Tribunal Decision

AbbVie appealed the Patent Office decision to the Administrative Appeals Tribunal (the AAT) (AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682). Surprisingly, the AAT overturned the Patent Office decision in part. The AAT ruled that the relevant requirement for a PTE based on Swiss-Style claims is that the substance produced by recombinant DNA technology is disclosed in the complete specification and falls within the scope of the claims. As such, the AAT found that the AbbVie patents were eligible for PTE.

Full Federal Court Decision

The Commissioner of Patents appealed the Administrative Appeals Tribunal decision to the Full Federal Court (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129). However, AbbVie did not contest this matter and so no contradictory view was heard.

The Court came to the conclusion that ‘pharmaceutical substance’, in section 70(2) of the Patents Act 1990 (Cth), must relate solely to a pharmaceutical substance and not methods or processes concerning or involving the pharmaceutical substance. In this regard, the Court stated:

…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.

The Court found that Swiss-style claims are directed towards a method or process of preparing a medicament for a specific disorder, and were not directed to the pharmaceutical substance itself. As such, the Court found that the AbbVie patents did not satisfy the requirements of section 70(2)(b) of the Patents Act 1990 (Cth). The Court has therefore found that the scope of a Swiss-style claim is fundamentally different to the scope of the claims required by section 70(2) of the Patents Act 1990 (Cth) to be the subject of a PTE.

Succinctly, the Court summarised its findings and stated:

With specific reference to the present case, adalimumab is a pharmaceutical substance produced by a process that involves recombinant DNA technology. However, the claims in suit are not directed to adalimumab produced by recombinant DNA technology. They are directed to different subject matter. First, they are directed to a method or process in which adalimumab is used to produce a medicament. Secondly, they are directed to a medicament containing adalimumab that is to be used for specific therapeutic purposes…. These claims do not meet the requirements of s 70(2)(b).

Conclusion

In light of this ruling, a patent is only entitled to a PTE if it contains a claim(s) to a pharmaceutical substance per se. Claims directed to a medical use of a pharmaceutical substance or to a use of the pharmaceutical substance in the preparation of a medicament are not entitled to PTE regardless of whether the substance is produced by a process involving recombinant DNA technology. Fisher Adams Kelly Callinans would be happy to assist you in relation to PTE advice. Contact us on +61 7 3011 2200 or mail@fak.com.au. You can also follow all of our IP updates at www.linkedin.com/company/fisher-adams-Kelly.