To compensate patent owners for the time it takes to obtain
regulatory and marketing approval for new drugs, the Australian
Patents Act provides for patent term extensions of up to five
years. However, in order to have an extension of term granted, a
number of requirements need to be satisfied. One of these
requirements is that a patent discloses and claims a pharmaceutical
substance per se or a pharmaceutical substance produced by a
process that involves the use of recombinant DNA technology.
In ImmunoGen, Inc  APO 88 (December 19 2014), the
Patent Office considered whether a claim directed to a process for
preparing an antibody conjugate encompassed within its scope a
pharmaceutical substance produced by a process involving the use of
recombinant DNA technology in order to determine the patent's
eligibility for extension of term.
The pertinent claim made no mention of a step involving the
preparation of an antibody by recombinant DNA technology but rather
defined steps of contacting the antibody to a cross-linking agent
and chemically conjugating the antibody to a cytotoxic agent,
Relevantly, the Patent Office accepted that the
antibody-maytansinoid conjugate when produced by a process
involving the use of recombinant DNA technology fell within the
scope of the claim defining a process for preparing the
antibody-maytansinoid conjugate. Also significantly, the Patent
Office found that it is not necessary for a claim to specifically
recite recombinant methodology process steps provided a recombinant
product made by the defined process be included among the things
claimed. Accordingly, the application for an extension of term was
Notably, the patentee filed post-acceptance amendments to
include a new process claim that recited a step of humanising a
mouse monoclonal antibody by recombinant DNA methodology as well as
a product-by-process claim. While the delegate indicated that the
proposed amendments were allowable, interestingly he also noted
that they were not necessary in order for the application to comply
with the requirements for an extension of term.
The salient points of this decision for those responsible for
securing extensions of term on pharmaceutical patents are that:
a claim defining a process of producing a pharmaceutical
substance encompasses the substance made by the defined method;
it is not necessary for a relevant claim to specifically recite
recombinant methodology process steps.
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 has been awarded the MIP Global Award for
Australian IP Firm of the Year 2013.
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