In a recent decision, Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129, the Full Court of the Federal Court of Australia has set aside an earlier decision of the Administrative Appeals Tribunal and affirmed the original decision of the Patent Office that patent term extension (PTE) is not available based on Swiss-style medical use claims. The Full Court has confirmed that a PTE is only available based on claims to pharmaceutical substances. A patent including only Swiss-style claims (directed to use of a pharmaceutical substance in the preparation of a medicament for a specified therapeutic purpose) cannot be the subject of a valid PTE, even if the substance has been produced by a process that involves the use of recombinant DNA technology.

Application for PTE Refused by Patent Office

AbbVie Biotechnology Ltd markets the pharmaceutical substance adalimumab under the name Humira for treatment of certain inflammatory diseases. Adalimumab is a genetically engineered human monoclonal antibody which is a produced by recombinant DNA technology.

AbbVie filed applications for PTE of three patents at the Australian Patent Office. All of the claims in each of the three patents were Swiss-style medical use claims directed to the use of adalimumab in the manufacture of a medicament for treatment of specified diseases. The PTE applications were supported by regulatory approval for the specific therapeutic indication issued by the Australian Register of Therapeutic Goods. Each PTE application was refused on several grounds. Notably, the Deputy Commissioner of Patents determined that s 70(2)(b) of the Patents Act 1990 had not been satisfied (AbbVie Biotechnology Ltd (2015) 115 IPR 398; [2015] APO 45).

The term of a patent can be extended provided that either or both of the conditions identified in s 70(2) are 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.

The Deputy Commissioner considered 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. Accordingly, the Deputy Commissioner found that the three patents involving only Swiss-style claims were not eligible for PTE and the PTE applications were refused.

Review of Decision

AbbVie applied to the Administrative Appeals Tribunal for review of the refusal decisions.

In AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682, the Tribunal focussed on the differing language in s 70(2)(a) and s 70(2)(b). It considered that the absence of the term "per se" in s 70(2)(b) was significant and that it follows that s 70(2)(b) should be interpreted to allow process claims, where the pharmaceutical substance is produced by recombinant DNA technology, to be a valid basis for PTE. The Tribunal set aside the Deputy Commissioner's finding and substituted a decision that a pharmaceutical substance when produced by a process involving recombinant DNA technology falls within the scope of the claims under s 70(2)(b) when the claims are directed to a specified therapeutic indication.

The Commissioner of Patents appealed the decision to the Full Federal Court on a question of law regarding the proper construction of s 70(2)(b).

Full Federal Court Considers "Pharmaceutical Substance"

In Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 the Full Federal Court set aside the finding by the Administrative Appeals Tribunal that a PTE may be based on a Swiss-style claim. Significantly, AbbVie did not participate in the proceedings.

In reaching the decision the Court considered the interpretation of "pharmaceutical substance" in s 70(2), referring to existing case law and the Explanatory Memorandum for the Intellectual Property Laws Amendment Bill 1997 (Cth) for guidance. The Court concluded that the language “pharmaceutical substance” requires that a patent which is the subject of a PTE must include a claim or claims directed only to products, and not to methods or processes. To meet the requirement of s 70(2)(b) this product must have been produced by recombinant DNA technology. Therefore, the claim may, but need not necessarily, be directed to the product when produced by recombinant DNA technology (i.e. product-by-process claim).

The Full Court confirmed that Swiss-style claims are to be interpreted as method or process claims. Such claims are construed as being directed to a method or process through which a pharmaceutical substance is used to produce a medicament, where there is an additional method or process element relating to the specific purpose for which the medicament is to be used. The scope of a Swiss-style claim was therefore considered by the Court to be fundamentally different to the scope of claims as required by s 70(2) of the Patents Act.

The Court found, at paragraph [60], that the Tribunal's error was that it had, with regard to s 70(2)(b), considered that production of the pharmaceutical substance by a process involving recombinant DNA technology was enough to invoke operation of this provision with regard to PTE. According to the Full Court the Tribunal had “overlooked the requirement in s 70(2)(b) that, 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”.

Conclusion

As a consequence of the finding of the Full Court, a patent can only be extended if it includes a claim or claims directed to a pharmaceutical substance or such substance when produced using recombinant DNA technology. Claims directed to a second (or subsequent) medical use of a pharmaceutical substance will not support a valid pharmaceutical patent term extension in Australia. This applies regardless of whether the substance was produced by a process involving recombinant DNA technology.

However, it is important to bear in mind that AbbVie did not contest this matter in the Federal Court; accordingly there was no contradictor present at the hearing to provide argument in support of why the three patents should have been extendible. Thus, the final outcome of this matter is disappointing as, in the absence of a contradictor, the Court did not have the opportunity to consider the applicant’s arguments that were persuasive to the Tribunal.

The current Full Court decision will now stand unless and until another Full Court can be convinced to consider the question anew, on the basis that the Full Court in the present case did not have the benefit of a contradictor.