In light of patent office decisions which established that
claims directed to processes of producing compositions that involve
the use of recombinant DNA technology in some way are sufficient to
confer eligibility for an extension of term (ImmunoGen
Inc.  APO 88 and Novartis
Vaccines and Diagnosis S.r.l.  APO 2), ThromboGenics
NV and AbbVie Biotechnology Ltd separately sought to obtain PTEs
for patents containing Swiss-style claims on the basis that a
pharmaceutical substance, when produced by a process that involves
the use of recombinant DNA technology, in substance falls within
the scope of such claims.
As we noted in our reporting article, the distinction between
the Patent Office's decisions in ThromboGenics NV and
AbbVie Biotechnology Ltd and its earlier decisions
ImmunoGen Inc. and Novartis Vaccines and Diagnosis
S.r.l is a fine one. Having found that a product can fall
"in substance" within the scope of a process claim, we
considered it arguable that a product, when intended for a specific
therapeutic use, could fall in substance within the scope of a
relevant Swiss style claim. Accordingly, it is not surprising that
AbbVie Biotechnology Ltd appealed the Patent Office decision to the
The AATA decision
In overturning the Patent Office decision, the AATA found that
the relevant section of the Patent Act (section 70(2)(b)) only
requires that the pharmaceutical substance be produced by
recombinant DNA technology, and that an interpretation excluding
Swiss style claims based upon a substance produced by recombinant
DNA technology is unwarranted. The AATA found that if the
legislature intended to exclude such claims, then the plain reading
of the subsection does not achieve this object. The only
requirement for a PTE for a pharmaceutical substance produced by
recombinant DNA technology, is that it be disclosed in the complete
specification of the patent and fall within the scope of the
patent. The AATA found that the patents in suit satisfy such
criteria and should not be disqualified because the claims are
drafted in the Swiss style format.
Despite finding that the Swiss style claims of the patents
confer PTE eligibility, the AATA held that the PTE applications
were not based on the first listing in the Australian Register of
Therapeutic Goods (ARTG) of goods containing, or consisting of, the
pharmaceutical substance. The AATA found that the therapeutic
effect of the pharmaceutical substance is to be ignored when
considering the date of first ARTG listing and that AbbVie
Biotechnology Ltd had relied on the wrong ARTG listing (which
related to a subsequent indication). Abbvie can apply to correct
As a result of the AATA decision, the following claims may
render a patent eligible for a PTE:
claims to a pharmaceutical composition per se; and
claims encompassing pharmaceutical substances when produced by
a process that involves the use of recombinant DNA technology in
some way (including process claims and Swiss-style claims), even if
the use of recombinant DNA technology is not recited in the
However, it is important to note that the date of the first ARTG
listing for (2) above is not related to the therapeutic indication
recited in the Swiss style claim, it is the date of the first
listing of any goods containing, or consisting of, the
The AATA decision is appealable to the Federal Court and we will
keep you informed of any developments in this regard.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Shelston IP ranked one of Australia's
leading Intellectual Property firms in 2015.
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