Take home messages

A very recent decision of the Australian Patent Office has upheld the current application of the law in relation to extensions of term in Australia, i.e., the following type of claims may be extended:

• Claims defining the pharmaceutical substance per se; and
• Claims encompassing products of recombinant DNA techniques (including process claims resulting in such products), even if the recombinant DNA technique is not recited in the claims

Background

The Australian Patents Act 1990 currently provides for the extension of term of certain patents claiming pharmaceutical substances for a period of up to five years. Extensions are currently available only for patents that disclose and claim a pharmaceutical substance per se or a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology.

It is this latter class of compounds that is of particular interest to makers of biotherapeutics and has been subject of recent consideration by the Australian Patents Office. To obtain a patent term extension for such a patent

“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” (emphasis added)

Recent decisions of the Patent Office have held that patents claiming methods for producing a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology are eligible for a patent term extension (see ImmunoGen, Inc. [2014] APO 88 and Novartis Vaccines and Diagnostics S.r.l. [2015] APO 2.

AbbVie Biotechnology recently tested this aspect of Australian law by applying for extensions of term to its Australia Patents 2012261708, 2013203420 and 2013257402. The patents included “Swiss-type” claims characterised by manufacture of a medicament comprising a human antibody (which is recombinant) for use in the treatment of ankylosing spondylitis, Crohns disease or ulcerative colitis. AbbVie argued that the “claims expressly require the human antibody be produced by a process that involves the use of recombinant DNA technology”. On this basis, a “Swiss-style claim, directed to the manufacture of a medicament intended to be used for a particular therapeutic purpose, in substance includes within its scope the medicament”. AbbVie sought the extensions on the basis of approvals in Australia for Humira (adalimumab) for the conditions (as opposed to the first approval of the drug) and argued that the approval includes both adalimumab and each condition. Essentially, Abbvie argued that each condition is a separate approved product.

Decision

In a decision on 4 August 2015, the Patent Office rejected Abbvie’s arguments.

Subject matter of an extendable patent

Dealing with the subject matter claimed, the Patent Office held that “Swiss-type claims are purpose limited, they are not directed to substances when produced by a process that involves the use of recombinant DNA technology”. This is consistent with earlier decisions of the office. In handing down the decision, the Patent Office held that whilst the specification may disclose a pharmaceutical substance, it does not in substance fall within the scope of the claims because

• “while notionally directed to a method or process of manufacturing a medicament, the claims are characterised by a therapeutic use” and
• “that patents covering new therapeutic uses of old substances produced by old processes should not be extended even if they involve recombinant DNA technology”.

The Patent Office also highlighted that the extension provisions are intended to “exclude therapeutic methods and to provide extensions only for new and inventive pharmaceutical substances per se and, as an exception, substances produced by new and inventive process involving recombinant technology”. The provisions are not intended to provide extensions for methods of treatment that are “in some way associated with recombinant techniques” as argued by AbbVie.

Approval date for an extension

The Patent Office also highlighted that the applications did not refer to the correct approval date [December 2003] for adalimumab. The office held that there is nothing in Australian legislation to suggest that reference to a pharmaceutical substance should be taken to include its use. Rather, while a pharmaceutical substance may be approved for different indications, this does not mean that the composition of that substance is necessarily different. The Office took the position that they need only look at the approved drug (adalimumab) and, on this basis, Abbvie relied on the incorrect approval for their application for an extension of term.

Summary

Abbvie’s applications for an extension of term were rejected. Thus, the current state of play in relation to extensions of term in Australia remains, i.e., the following type of claims may be extended:

• Claims defining the pharmaceutical substance per se; and
• Claims encompassing products of recombinant DNA techniques (including process claims resulting in such products), even if the recombinant DNA technique is not recited in the claims.

If the applications were allowed, this may have paved the way for manufacturers of biotheraputics to obtain rolling patent term extensions based on new indications added to the label of a drug. At this stage, this does not appear to be a viable opportunity in Australia.

The decisions may be appealed.