Inspire March 2022
‘For use’ not always suitable
for use: injunction denied due
to wrongly granted PTE
8 In the recent interlocutory decision in Biogen v Pharmacor 1 , the Federal
Court has denied patentee Biogen a preliminary injunction to restrain
generic manufacturer Pharmacor from selling a generic version of its
successful multiple sclerosis drug, Tecfidera ® . Key to Pharmacor’s success
was its case that the term of Biogen’s patent was invalidly extended based
on a claimed invention in the format “Substance X for use in treatment Y”.
Pharmacor’s success demonstrates
the advantages of pressing a
strong wrongful term extension
and invalidity case at the early,
interlocutory stage of pharmaceutical
litigation in addition to the usual
submissions regarding quantification
of damages. The decision stands
out amongst the many recent cases
where the balance of convenience
has favoured the patentee, and a
preliminary injunction has been
granted. It also stands as a lesson
to all patent practitioners to pay close
attention to the format of claims
upon which an actual or likely patent
term extension will be sought.
Background Biogen is the patentee of AU
752733 entitled “Utilisation of dialkyl
fumarates” and proprietor of the
product Tecfidera ® , a dimethyl
fumarate (DMF) medication
prescribed for the treatment of
multiple sclerosis (MS).
Biogen obtained an extension
of the term of this patent based
on the following claim:
“A pharmaceutical preparation
in the form of micro-tablets or
micro-pellets… consisting of one or
more dialkyl fumarates… for use in
transplantation medicine or for the
therapy of autoimmune diseases…”
Claims to a substance ‘for use’
in treatment such as that above
are usually construed during
prosecution as claims to a substance
merely ‘suitable for use’ in the
recited treatment but not limited
to that treatment, i.e., as claims to
a substance per se. This is notably
different from interpretation of these
claims in Europe, where they are
known as ‘EPC 2000’ claims and
are considered purpose-limited
product claims capable of protecting
new therapeutic uses of known
substances.