In case T1673/11, an EPO Board of Appeal was asked to consider
whether a post-grant amendment of a Swiss-style claim into a second
medical use claim according to Article 54(5) EPC would constitute
added matter according to Article 123(3) EPC, which provides that
the claims of a European patent may not be amended in such a way as
to extend the protection conferred upon grant.
The patent at issue was granted with the following claim 1:
The use of human acid alpha
glucosidase in the manufacture of a medicament for the treatment of
infantile Pompe's disease, wherein the human acid alpha
glucosidase is in the 100 to 110 kD form, wherein the medicament is
to be administered intravenously, and wherein the treatment is to
be continued for at least 4 weeks.
During opposition proceedings, the Opposition Division found the
following amended claim 1 to be allowable:
Human acid alpha glucosidase in
the 100 to 110 kD form, for use in the treatment of infantile
Pompe's disease, wherein the human acid alpha glucosidase is to
be administered intravenously, and wherein the treatment is to be
continued for at least 4 weeks.
An appeal was filed by one of the opponents on the basis that
the amendment to claim 1 contravened Article 123(3) EPC.
The Board held that the amendments contravened Article 123(3)
EPC by extending the scope of protection conferred.
In its decision the Board referred to G2/88, which states that
the test to be applied under Article 123(3) EPC is whether the
subject matter defined by the claims is more or less narrowly
defined as a result of the amendment made. The same test applies to
an amendment involving a change of claim category.
In the present case, the amendment resulted in a change of claim
category from a purpose-limited process claim (a Swiss-style claim)
to a purpose-limited product claim (a second medical use claim
according to Article 54(5) EPC). Following on from G2/88 (and also
related case T1780/12), the Board reiterated the generally accepted
principle that a claim to a particular physical activity (ie
process, use etc.) confers less protection than a claim to the
physical entity per se.
The proprietor had tried to argue that Article 64(2) EPC, which
states that the protection conferred by a claim to a process
extends to the products directly obtained by that process, should
be taken into account when assessing whether the amendment added
matter. According to the proprietor, as a Swiss-style claim is
directed to a process of manufacture of a product and this process
is not limited by any technical feature, the manufacture could not
be limiting on any product obtained by it. Rather, the specific
medical use was the limiting feature and this was the same in both
the granted and amended claims. However, the Board ruled that even
if Article 64(2) EPC were to be taken into account, the two claims
still conferred differing amounts of protection.
The Board adopted the position that a medicament containing
human acid alpha glucosidase in the 100 to 110 kD form packaged and
provided with instructions for use in a treatment other than
that of infantile Pompe's disease was encompassed by the scope
of amended claim 1 when the so-packaged medicament is being
used for the treatment of infantile Pompe's disease. This was
based on the logic that amended claim 1 is a purpose-limited
product claim which confers protection whenever the relevant form
of human acid alpha glucosidase is being used for the treatment of
infantile Pompe's disease. In contrast, the Board concluded
that the protection conferred by granted claim 1 did not encompass
such a use because the direct product of the Swiss-style process
claim is a medicament which is packaged and/or provided with
instructions for use in the treatment of infantile Pompe's
disease. The patent had therefore been amended so as to extend the
protection it conferred and was revoked in its entirety.
Although the Swiss-style claim format is no longer accepted by
the EPO for new filings, a number of applications with a filing
date (or, if applicable, priority date) prior to 28 January 2011
are still likely to grant with claims in this format. European
practitioners should therefore be aware that a change of claim
category from a Swiss-style claim into a second medical use claim
according to Article 54(5) EPC, in the absence of any other basis,
is likely to constitute added matter.
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.
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1.The trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.
The UK government has not yet invoked Article 50 of the Treaty on European Union (this is likely to happen by the end of March), and the UK's actual exit from the European Union is at least two years away.
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