Patent Term Extensions

In Australia the application of the Patent Term Extension provisions of the Patents Act 1990 have been construed narrowly so that PTEs are applicable to only certain types of pharmaceutical patents.

PTEs were introduced in 1998, pursuant to the Intellectual Property Laws Amendment Act 1998 amended the Patents Act 1990 to provide for an extension of up to 5 years for a standard patent that claims a pharmaceutical substance.

Judicial interpretation of a pharmaceutical substance has been a fraught exercise, and a recent decision of the Federal Court of Australia (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129) has now ruled on the applicability of PTEs to Swiss-style claims.

In this article we discuss the Court's decision (that the Swiss-style claims cannot be the subject of PTEs in Australia) and consider the earlier judicial rulings which demark the boundaries of PTEs in Australia.

Background to PTEs

Section 70 - Extending a patent term

In order to obtain a PTE, the following requirements must be met:

a) section 70(2): the patent must, in substance, disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;

b) section 70(3):

• goods containing or consisting of that pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG); and
• the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent; and

c) section 70(4): the term of the patent must not have been previously extended.

Provided the requirements of the Act are satisfied, the term of the patent (in its entirety) may be extended.

Time for applying

Under section 71(2), an application for a PTE must be made during the term of the patent and within 6 months after the latest of the following dates:

• the date the patent was granted;
• the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, any of the pharmaceutical substances referred to in section 70(3);
• the date of commencement of the extension of term provisions (27 January 1999).

Pharmaceutical substance "per se"

The issue that has caused controversy in the construction of the Australian PTE provisions is the meaning of pharmaceutical substance "per se".

The meaning of pharmaceutical substance "per se" was comprehensively discussed by the Full Federal Court decision in Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138. This decision upheld the findings of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70.

Background

This case related to the Lundbeck Australian patent no 623144 which contains claims to the pharmaceutical substance escitalopram (the (+)-enantiomer of the compound citalopram):

Claim 1: (+)–1-(3-dimethylaminopropyl)–1-(4’-fluorophenyl)–1,3-dihydroisobenzofuran–5-carbonitrile and non-toxic acid addition salts thereof.

Citalopram is the subject of the Alphapharm Australian patent no 509445 and is a racemic mixture of the two enantiomers escitalopram and (-)-citalopram in equal proportion.

The issue in this appeal was whether escitalopram satisfied the requirement of pharmaceutical substance "per se" pursuant to section 70(2)(a).

Meaning of pharmaceutical substance "per se"

Alphapharm argued that Lundbeck’s patent was a claim in respect of the isolated or pure enantiomer (limited by a requirement of purity of manufacture), and it was not a claim to a pharmaceutical substance per se.

The Federal Court held at [65]:

the task is to construe the words of claim 1. Those words describe a product or substance. They do not suggest in any way that the product or substance must be isolated from other products or substances. There is nothing in claim 1 to suggest that the (+)-enantiomer is disclosed with a degree of purity. The racemate is no more than a mixture of the two enantiomers. Each of those two compounds is present in the racemate and can be separated. Further, at the relevant time, the relevant hypothetical skilled addressee was aware that the racemate contained both compounds and that the two compounds could be separated.

This decision was upheld on appeal by the Full Federal Court in Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138. Bennett , Nicholas and Yates JJ held at [92]:

The term “pharmaceutical substance per se” simply means the pharmaceutical substance “in itself”…

…it is clear that the claim describes a pharmaceutical substance per se. The substance was… a new chemical entity. The racemate and the (+)-enantiomer had different physico-chemical interactions manifested in different pharmacodynamics and pharmacokinetics… The claim is to (+)-citalopram, irrespective of how it is produced. The isolated (+)-enantiomer plainly qualifies as a pharmaceutical substance per se and the primary judge was correct in concluding that it satisfies s 70(2)(a) of the Act.

This decision gives important context to the most recent Full Federal Court decision of Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129, in which the proper interpretation of the term ‘pharmaceutical substance’ for the purpose of interpreting section 70(2)(b) was considered in the context of PTEs for Swiss Style Claims.

The Abbvie decision

No patent extensions for Swiss Style Claims in Australia

After the Administrative Appeals Tribunal of Australia (AATA) decision in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682, patentees were hopeful of wider grants of PTEs in Australia. The AATA ruled in that case that a PTE could be granted for certain patents concerning its Humira product where the patent claim was a Swiss-style claims (ie the use of the pharmaceutical product in the manufacture of a medicament for the treatment of a specified indication).
A recent decision in the Full Federal Court of Australia (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129) has reversed the decision ruling that Swiss-style claims cannot be the subject of PTEs in Australia.

This ruling meant that PTEs have been disallowed for AbbVie's patents directed to use of Humira to treat ulcerative colitis, Chrohn's disease and rheumatoid spondylitis, and each Such patent therefore expired on 10 February 2017.

Against the vexed application of the PTE provisions in Australia, this decision further narrows the scope of PTEs by narrowing the extensions of patent terms for pharmaceutical products in Australia.

Background

By way of background, AbbVie Biotechnology Ltd (AbbVie) owns a number of Australian patents relating to a pharmaceutical substance known as adalimumab (Humira).

Adalimumab is produced by a process of recombinant DNA technology. Adalimumab was originally included in the ARTG in 2003 for treatment of rheumatoid arthritis. Subsequently, adalimumab was demonstrated to be effective for other diseases and AbbVie obtained three additional patents covering these further medical uses, each of which includes ‘Swiss-style’ claims.

On 3 October 2014, AbbVie applied to the Patents Office for a PTE of each patent, relying on section 70(2)(b) of the Patents Act. Humira was first listed on the ARTG on 10 December 2003, indicated for rheumatoid arthritis. The further indications the subject of the patents sought to be extended (ulcerative colitis, Chrohn's disease and rheumatoid spondylitis) were ARTG listed in 2006, 2007 and 2013 respectively.

The PTE provisions allow a maximum 5 years PTE (the length of the PTE is equal to the period between the date of the patent and the date of the earliest first regulatory approval, reduced (but not below zero) by 5 year).

The PTEs in this case would have delivered extensions to the AbbVie patents to 2021 and 2022.

Patent Office decision

The Delegate in AbbVie Biotechnology Ltd [2015] APO 45 determined that patents containing Swiss-style claims were not eligible for PTEs under section 70(2)(b) of the Patents Act, stating [at 13]:

While notionally directed to a method or process of manufacturing a medicament, the claims are characterised by a therapeutic use….I do not find that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of the claims. I must therefore refuse the application for an extension of term.

The AATA decision

The AATA overturned the Patent Office decision, finding [at 71] that 'the only requirement, for extension of a patent for a substance produced by recombinant DNA technology, is that it be disclosed in the complete specification of the patent and falls within the scope of the patent'.

Full Federal Court – the decision

The Commissioner of Patents appealed the AATA decision to the Full Federal Court (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129).

The ultimate decision of the Full Federal Court came down to:

• the proper interpretation of the term ‘pharmaceutical substance’ for the purpose of interpreting section 70(2)(b) of the Patents Act; and
• whether, based on this interpretation, patents containing Swiss-style claims could satisfy section 70(2)(b) of the Act.

The Court held that a ‘pharmaceutical substance’ related solely to a pharmaceutical substance (ie product) and not the processes involving pharmaceutical substances:

…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, being directed to a process for preparing a medicament from a pharmaceutical substance, were not directed to a pharmaceutical substance and therefore did not satisfy the requirements of section 70(2)(b). This is consistent with recent a finding that under Australian law Swiss style claims are characterised as "process or method" claims (Otsuka v Generic Health (No 4) (2015) 113 IPR 191.

In applying this provision to the facts, the Court stated that [at 58-59]:

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). In our respectful view, the Tribunal erred in concluding otherwise.

Status of patent term extension in Australia

After the Abbvie decision, the availability of PTEs in Australia is now clearer. It is now settled that:

1. Patent term extension continues to be available for product claims for a pharmaceutical substance per se.
2. Product and process claims can support a PTE for a pharmaceutical substance produced using recombinant DNA technology so long as the process steps are limited to the preparation of the pharmaceutical substance using recombinant DNA technology, for therapeutic use.
3. Swiss-style claims and method of treatment claims cannot be used to support PTEs.