The method disclosed in the six-page specification of preparing
perindopril arginine was limited to a single sentence that
generically referred to "a classical method of salification of
organic chemistry". At the time of filing, however,
Servier had prepared perindopril arginine by two specific methods,
the "1986 method" and the "1991 method", the
latter of which was used to prepare the perindopril arginine that
formed the basis of the stability study of the patent.
In the initial Federal Court decision, the primary Judge
considered that the disclosure of classical salification was
"pregnant with ambiguity" and ultimately found that
Servier had failed to describe the best method known to it of
performing the invention as required under s 40(2)(a) of the
Patents Act 1990.
In the Full Federal Court appeal, Servier relied on the lenient
sufficiency requirement under the relevant Australian law, which is
satisfied by a disclosure that would enable the production of one
thing within each claim. Servier argued that the best method
requirement is a subset of sufficiency and therefore was satisfied
because there was no challenge to the patent in relation to
sufficiency. The Court, however, found that the sufficiency
and best method obligations are separate requirements reasoning
that if additional information regarding the best method is not
included in a specification it could place the patentee in an
advantageous commercial position, relative to competitors, for
example when the patent expires.
Servier also argued that the best method requirement was
satisfied simply by the identification of the claimed compound and
that a best method of producing perindopril arginine was not
essential. The Full Court disagreed citing the nature of the
invention, namely the increased storage ability of perindopril
arginine, which the experts on both sides agreed could vary
depending on the nature of the salt formed – that being
method dependent. Thus, the Court found that there is an obligation
on the patentee to provide the best method for producing a form of
perindopril arginine that would best fulfil the promise of
The Court also reasoned that disclosure of the 1986 or 1991
methods would have saved the skilled addressee from possible
"dead ends and false starts" risked in attempting to make
the salt by "a classical method of salification" as
disclosed in the patent. Thus, the Full Court dismissed
Servier's appeal and found that Servier had failed to describe
the best method known to it of performing the invention.
Amendment of the patent
Following the initial Federal Court decision in relation to best
method, Servier sought to amend the patent to introduce the 1986
and 1991 methods of making perindopril arginine. The
allowance of such an amendment is at the discretion of the Court
and the primary Judge exercised this discretion against Servier and
refused to allow the amendment.
The salient issue considered by the Full Court in relation to
whether the proposed amendment should be allowed was the content of
correspondence between Servier and their Australian patent attorney
during prosecution of the application. Specifically,
Servier's patent attorney made a recommendation to Servier to
include a method for the manufacture of perindopril arginine, even
if the method was well known in the art, so as to satisfy the
written description requirement. In response, Servier
expressed concerns because the method was confidential and did not
heed their patent attorney's advice.
The Full Court held that Servier erred in forming the view that
the proposed amendment was unnecessary and that Servier's
decision to ignore the advice of their Australian patent attorney
was not reasonable. Accordingly, the Full Court refused the
application to amend the patent.
This Full Court decision clearly puts Australian patentees on
notice to include the best method known to them of performing an
invention. It will also, no doubt, motivate patent litigators to
seek discovery in relation to methods known by a patentee but not
included in a patent specification.
Servier has applied for special leave to appeal the Full Court
decision to the High Court and Shelston IP will keep you promptly
informed of developments.
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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