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.
construction would render the patent
wrongfully extended under the PTE
scheme as there was no claim to a
substance per se. But for the PTE,
the patent would have expired in 2019.
...this case serves as a
warning to all actual or
likely PTE applicants to
keep a close eye on the
claims of any patents
covering potentially
registrable medicines.
The Court’s decision
and reasoning
The reasons advanced in favour
of a purpose-limited construction,
and the reasons Rofe J was prepared
to accept it “at least on a provisional
view”, included:
(a) The description disclosed that
dialkyl fumarates per se were not
new, as they were to be prepared
by processes known in the art;
(b) The specification discussed
the invention and its objectives
Key issue: was the
and aspects as tied to use in
PTE valid?
transplantation medicine or
therapy of autoimmune diseases
Pharmacor conceded that its generic
in all but two paragraphs; and
DMF product would fall within the
(c) 209 of the 211 claims in the
scope of the relevant claim, and thus
patent made express reference
if the claim were extant and valid,
to use of the preparations in
Biogen’s prima facie infringement
transplantation medicine or
case was strong. However, Pharmacor
therapy of autoimmune diseases,
submitted the strength of its case
and the two remaining claims
on invalidity and wrongful PTE
were omnibus claims.
qualified Biogen’s infringement case
sufficiently such that the preliminary
Rofe J also drew some parallels
injunction should be refused.
between EPC 2000 claims and Swiss-
style claims, in that both feature a
Pharmacor put to the Court that the
“for the prevention/treatment”/“for
relevant claim should be construed
the therapy of”-type integer. Her
as a purpose-limited product
Honour noted that in Swiss-style
claim because “it claims an actual
claims, this integer has the effect
achievement of a therapeutic act
of purpose-limiting the claim (per the
being a functional technical feature
Full Court in Mylan v Sun Pharma). 4
of the claim”. 3 If accepted, this
It therefore seemed to her Honour
that the therapeutic purpose should
be considered an essential integer
of the relevant claim in the present
case and that use of DMF micro-
tablets/pellets for any non-recited
therapeutic uses would fall outside
the scope of the claim. Her Honour
concluded that the relevant claim
was not a claim to a substance per
se and that there was “a sufficiently
strong prospect that the extension of
the patent may have been wrongly
granted”. The preliminary injunction
was denied.
Conclusions Although the wrongly granted PTE
was the key determining factor for
denying an injunction in this case, for
completeness, Rofe J also looked at
the “basket of discretionary factors”,
such as the adequacy of damages.
Her Honour considered most of
these factors to be quite evenly
balanced between the parties. The
one exception was launch of Biogen’s
new MS therapy, Vumerity, into the
DMF market, which was predicted to
have a profound impact on DMF sales
and act as a factor tending against the
granting of the interim injunction.
As noted above, this case serves as
a warning to all actual or likely PTE
applicants to keep a close eye on
the claims of any patents covering
potentially registrable medicines.
It is also a timely reminder of the
importance of monitoring claim
scope across jurisdictions and,
where possible, leveraging broad
claims. In this case, claims to
pharmaceutical products per se
without the ‘for use’ limitation were
being pursued in at least Europe
prior to acceptance of the Australian
patent, and were ultimately granted
there. It would thus appear that
there was scope to pursue at least
one claim excluding the “for use”
integer in Australia, either in this
application or in a divisional.
9 1
Dr Jessica Chadbourne | Associate
2 MIP, PhD, BSc (Adv) (Hons&UM), JP
Biogen International GmbH v Pharmacor Pty Ltd [2021] FCA 1591
T he only exception to this rule is that patents to pharmaceutical substances
when produced by a process that involves the use of recombinant
DNA technology are also eligible for PTEs in Australia.
3 Biogen v Pharmacor, [108].
4 Mylan Health Pty Ltd & Anor v Sun Pharma ANZ Pty Ltd & Anor [2020] FCAFC 116.
Inspire March 2022
It is relevant in the present case
that Australia’s statutory patent
term extension (PTE) provisions only
allow for extensions to be granted in
respect of pharmaceutical substances
per se, where the substance is both
disclosed in the specification and
in substance falls within the scope
of at least one claim of the patent.
In practice, a patent must contain a
product claim to a substance per se to
qualify for a PTE. 2 Patents containing
only method of treatment claims and
Swiss-style use claims, for example,
are not eligible to be extended under
the PTE scheme as they are not
considered to disclose and claim a
pharmaceutical substance per se.
Presumably due to the practice noted
above of construing ‘substance
for use’ claims as claims to the
substance per se, Biogen was
successful before the Patent Office in
obtaining a PTE based on DMF being
in substance within the scope of the
relevant claim. However, interestingly,
and perhaps in something of a
contradiction, the Australian Patent
Examiner’s manual now and at the
date of the patent specifically states
that claims in the format “substance
X for use…” are not considered
directed to substances per se and
therefore cannot form the basis of
a PTE request. This creates some
ambiguity around the PTE eligibility
of ‘substance for use’ claims which,
until the present case, has not been
considered by an Australian Court.
jessica.chadbourne@pof.com.au