All Things Newz
Law \ Legal

The Fiction, Function And Formulation Of Swiss-style Claims In New Zealand – Patent


Traditional Swiss-style claims provide a unique form of
protection for pharmaceutical patentees against the authorised use
of an active agent in the manufacture of a medicament for a new
therapeutic use. Such second-medical use claims are particularly
important in New Zealand, where methods of treating humans are
excluded from patentability.1 A number of recent
decisions issued by the New Zealand Patent Office
(IPONZ) provide useful guidance on the
allowability of Swiss-style claims that do not fit the traditional
format in New Zealand.

The fiction of Swiss-style claims

Swiss-style claims were first conceived in Europe in the 1980s
in response to a need to protect novel therapeutic uses of known
compounds in a legislative framework that excluded method of
medical treatment claims from patentability. Such claims are often
referred to as a “legal fiction” because their novelty is
derived solely from the discovery of a new therapeutic use of a
known compound; it is not necessary for the product or the process
of manufacture to be novel. While claims in Swiss-style format were
superseded by “for use” claims in Europe when major
revisions to the European Patent Convention were
implemented in 2000, they are still the preferred second medical
use format in a number of jurisdictions, including New Zealand.

The New Zealand Court of Appeals affirmed the allowability of
Swiss-style claims in Pharmac,2 stating
“there can be invention and novelty in the discovery of
unrecognised properties of known pharmaceutical compounds”.
Thus, traditional Swiss-style claims of the form “Use of
[active agent] in the manufacture of a medicament for the treatment
of [therapeutic indication]” are allowable in New Zealand
where the active agent has not previously been used to treat the
therapeutic indication. IPONZ has also found that the novelty of
Swiss-style claims can reside in new dosage forms, modes of
administration, treatment regimens or patient
groups.3

Swiss-style claims differ in scope to method of treatment
claims. Whereas method of treatment claims are directly infringed
by medical professionals in the treatment of patients, a Swiss-type
claim is “directed to the manufacture of the medicament with
the intention of a specified medical use, but does not extend to
the actual method of treatment. It is therefore limited to the
preparation and sale of a product for the purpose of carrying out a
specific medical treatment”.4 While not yet tested
before a New Zealand court, the Full Federal Court of Australia has
confirmed that Swiss-style claims are only infringed when the
medicament is manufactured for the specified therapeutic
purpose, which involves consideration of a number of factors
discussed here.5

Functional language in Swiss-style claims

A recent decision by IPONZ, Ardelyx Inc. [2022]
NZIPOPAT 7 (Ardelyx), confirmed that the
active agent in a Swiss-style claim may be defined solely in
functional terms.6 DCC represented Ardelyx Inc. before
IPONZ.

The Ardelyx decision concerned the following
Swiss-style claim:

Use of a compound in the manufacture of a medicament for
inhibiting phosphate uptake in the gastrointestinal tract of a
patient with hyperphosphatemia, wherein said compound is an
NHE3 inhibitor.
[emphasis added; proviso
omitted]

The Examiner objected to the above claim as lacking clarity and
support on the basis that the active agent was defined in a
“vague and speculative manner” and has an
“essentially unlimited scope of compounds”. However, the
Assistant Commissioner considered the claim to be “as precise
and exact as needed to clearly define the invention”.

According to the Assistant Commissioner, in addition to the
situation in Pharmac where the invention and novelty
resided in the discovery of an unrecognised property of known
pharmaceutical compounds, “there can be invention and novelty
in the discovery of an unrecognised interaction between chemical
inhibition of a particular protein present on certain cell types in
the gastro-intestinal tract and the inhibition of phosphate uptake
by those cells”. In accordance with Pharmac, such
circumstances give rise to an obligation to make patent protection
available to the extent that it is compatible with the prohibition
on methods of medical treatment.

In reaching the decision in Ardelyx, the Assistant
Commissioner took account of the state of the law in Europe in
relation to the use of functional features in second-medical use
claims. In particular, the German Federal Court of Justice
(FCJ) found a second medical use claim in
which the active agent was defined solely in functional terms
– and where the specification only provided four examples of
active agents having the recited functional feature – to be
clear and sufficiently disclosed.7 The key finding of
the FCJ, with which the Assistant Commissioner appeared to agree,
are:

  1. The applicant may claim certain generalisations of the
    exemplified embodiments, provided that doing so takes account of
    the legitimate desire to cover the invention in its entirety;

  2. The scope of protection sought should not extend beyond what
    would appear to a person skilled in the art from the specification
    as a whole to be the most generalised technical teaching by which
    the problem underlying the invention is solved; and

  3. Describing a group of compounds according to their function is
    not precluded by the fact that they may encompass compounds yet to
    be known, or that such compounds may require inventive activity to
    produce.

The formulation of Swiss-style claims

Two other recent decisions by IPONZ – Taiho
Pharmaceutical Co. Ltd
[2020] NZIPOPAT 5 (Taiho
1
) and Taiho Pharmaceutical Co., Ltd. [2022] NZIPOPAT 1 (Taiho
2
) – highlight that Swiss-style claims must be
formulated with care to ensure they are allowable in New
Zealand.

Taiho 1

Taiho 1 concerned a Swiss-style claims directed to:

Use of a combination drug comprising trifluridine (FTD) and
tipiracil hydrochloride (TPI) at a molar ratio of 1:0.5 for the
manufacture of [a medicament for the prevention or treatment of
cancer in a subject OR an antitumor effect enhancer to enhance the
antitumor effect of an antibody in a cancer patient], wherein the
medicament comprises:

the combination drug which is formulated for
co-administration
at a dose of from 35 to 70
mg/m2/day as FTD with an antibody selected from the
group consisting of bevacizumab, cetuximab and panitumumab at a
[specified dose]; and wherein the cancer is colorectal cancer or
breast cancer.
[emphasis added]

Relevantly, the use of the FTD/TPI combination drug and each of
the antibodies was separately known in the art for the treatment of
patients with either or both specified therapeutic indications.
Thus, according to the Assistant Commissioner, the “nub of the
invention” was the co-administration of all three active
agents, and “a Swiss-style claim that is commensurable with
the disclosed method of therapy should require the use of both
drugs (the combination drug and the anti-body) in the manufacture
of medicaments for the treatment of breast and colorectal
cancer”. The combination drug being “formulated for”
co-administration with the antibody was construed as the
combination merely being suitable for co-administration
with the antibody.

In contrast, the Assistant Commissioner referred to another
IPONZ decision in which the Swiss-style claims at issue recited
that the medicament was “formulated for” administration
in conjunction with the known drug ritonavir.8 In that
case, the claims were allowable because the active agent present in
the medicament was novel. However, corresponding Swiss-style claims
in which the medicament contained ritonavir and was formulated for
administration in conjunction with the new active agent, were not
allowable because they were not directed to a new use of
ritonavir.

The Assistant Commissioner also noted in Taiho 1 that
Swiss-style claims in which the medicament was for a known
therapeutic use of the active agent, but which was “adapted
for” or “formulated for” administration in a novel
dosage form, mode of administration or dosage regimen, have been
allowed where they “relate[] to more than additional
information about an existing and known medical use which could be
put into effect using known dosage forms”9 or
overcome or alleviate a problem associated with known modes of
administration or dosage regimens.10 It was also noted
that the novelty of a Swiss-style claim can reside in a specific
patient group where that group has not previously been shown to be
sensitive to the specified treatment.11

Taiho 2

Taiho 2 concerned, inter alia, the clarity of
the following Swiss-style claim:

Use of trifluridine and tipiracil hydrochloride in a molar
ratio of 1:0.5 in the preparation of an antitumor medicament for
the treatment of solid cancers,

wherein the antitumor medicament is adapted to administer
trifluridine and tipiracil hydrochloride at a dose in the range of
35 to 70 mg/m2 /day, and

wherein the antitumor medicament is adapted to
administer trifluridine and tipiracil hydrochloride in combination
with irinotecan hydrochloride hydrate
at a dose in the
range of 45 to 130 mg/m2 /day.
[emphasis added]

Relevantly, the FTD/TPI combination was known in the art for use
in the treatment of solid cancers. The invention was said to reside
in the discovery that the combination of FTD, TPI and
irinotecan hydrochloride hydrate, when administered in the recited
ratio and dosages, provides “remarkable” antitumor
effects with few side effects. The Assistant Commissioner agreed
with the Examiner that the above claim “is not clearly
directed to what the applicant has discovered” and directed
that the claim be amended to include all three active agents in the
manufacture of the medicament.

Another aspect of the Taiho 2 decision relating to
double patenting was discussed in our article here.

Key takeaways

The Ardelyx decision is good news for pharmaceutical
applicants as it establishes that unduly restricting the scope of
Swiss-style claims by defining the active agent in structural terms
is improper where the invention legitimately resides in a newly
discovered connection between a biological function and a
therapeutic outcome.

The Taiho 1 and Taiho 2 decisions highlight
the importance of careful claim drafting to obtaining allowable
Swiss-style claims in New Zealand. For non-traditional Swiss-style
claims it is important to consider what the “nub of the
invention” is. For example, where the invention resides in a
particular active agent or a combination of known active agents,
the Taiho decisions suggest those active agents should be
included in the manufacture of the medicament. This is inconsistent
with the purpose for which Swiss-style claims were introduced and
how they have been construed in other jurisdictions.

In particular, the Taiho decisions may be problematic
for applicants seeking to protect combination therapies where the
active agents are provided in separate dosage forms. This could
give rise to a situation where the applicant’s claims do not
adequately protect their invention or where their invention cannot
be protected in New Zealand because one or more of the dosage forms
is manufactured by a third party (e.g., because one of the actives
is protected by a third party patent).

There is also an inconsistency between the Taiho
decisions, in which the terms “formulated for” and
“adapted for” were considered non-limiting, and the
earlier decisions by IPONZ in which the thing the medicament was
formulated for was the “nub of the invention” and the
novelty conferring feature, such as a new dosage form, mode of
administration or dosage regimen that provides a surprising result
or overcomes or alleviates a problem associated with existing drugs
for the same therapeutic use. In such circumstances, our usual
practice to avoid potentially non-limiting terms like
“formulated for” and “adapted for” is to
recite, for example, “wherein treating [therapeutic
indication] comprises [new dosage form, mode of administration or
dosage regimen]
“.

Whether such language would also be effective in limiting the
invention to co-administration of combinations of known active
agents without requiring each active agent to be used in the
manufacture of the medicament remains to be seen and it is likely
the New Zealand courts will need to deal with this issue at some
stage in the future.

Footnotes

1. Patents Act 2013, s 16(2)

2. Pharmaceutical Management Agency Ltd v The
Commissioner of Patents
[1999] NZCA 330

3. Merck & co. Inc. v Arrow Pharmaceuticals (NZ)
Limited
[2006] NZIPOPAT 3 (31 January 2006); Genetech Inc
and Washington University
[2007] NZIPOPAT 1; Epicept
Corporation
[2007] NZIPOPAT 29; Astrazeneca AB [2007]
NZIPOPAT 23

4. Distillers Co Ltd’s Application (1953) 70
RPC 221

5. Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd
[2020] FCAFC 116

6. DCC represented the applicant, Ardelyx, Inc., before
IPONZ.

7. German Federal Court of Justice decision X ZB
8/12

8. Abbott Laboratories [2003] NZIPOPAT
16

9. Merck & co. Inc. v Arrow Pharmaceuticals (NZ)
Limited
[2006] NZIPOPAT 3

10. Genetech Inc and Washington University
[2007] NZIPOPAT 1

11. Astrazeneca AB [2007] NZIPOPAT
23

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.



Source link

Related posts

상표등록허가를 받은 후, 권리자가 등록 상표를 사용시 주의할 점 – Trademark

How to apply for an annulment application in NSW: Everything you need to know – Court Procedure

Public Finance Impact Of The Inflation Reduction Act’s New Corporate Alternative Minimum Tax – Financial Services