The Intellectual Property Office of New Zealand (IPONZ) has updated its guidelines for Swiss-type claims. The update provides a more comprehensive and clear explanation of the form, and IPONZ’s construction, of Swiss-type claims, including helpful examples of common claims and comparing New Zealand patent law with other jurisdictions. The Guidelines are available from IPONZ's website.
Why Swiss-type claims?
Claims encompassing methods of medical treatment of humans or methods of medical diagnosis performed on humans are not patentable in New Zealand under s16(2) or s16(3) of the Patent Act 2013. However, medical uses can be protected using the Swiss-type claim format.
Format of a Swiss-type claim
The general form of a Swiss-type claim is:
Use of [substance or composition] in the [manufacture of a medicament] for [new medical use].
A Swiss-type claim must recite a medical use. This can be either a therapeutic or diagnostic use. In addition, Swiss-type claims may cover surgical methods that involve a new use of a substance or composition.
The substance or composition may be new or known in the art. Functional definitions of the substance or composition are allowable, provided the person skilled in the art would know what substances or compositions are within the scope of the claim, either because of their common general knowledge and/or through routine testing.
The medical use can be defined by reciting, for example:
- a recognised disease or disorder;
- an underlying pathological mechanism of a disease or disorder; or
- a mechanism of action used to treat a disease or disorder.
The medical use recited in a Swiss-type claim must also be clearly understood by the person skilled in the art.
Finally, the “manufacture of a medicament” in a Swiss-type claim is not mandatory, and other wording such as “preparation of a pharmaceutical composition” or “manufacture of a composition” can be used.
Examining Swiss-type claims
Novelty and inventive step
Novelty and inventiveness of Swiss-type claims may derive, for example, from treatment of a different condition, a new mode of administration, a new patient group, or a novel and inventive dosage regime. If novelty resides in the mode of administration or dosage regime, IPONZ considers the claimed subject matter must also overcome a disadvantage or provide an advantage over the prior art to be inventive. For new patient groups, IPONZ considers the new patient group must be clearly distinguished from the previous group and the choice of group must not be arbitrary.
Support and enablement
The specification as filed must disclose the invention in a clear enough and complete enough manner for the invention to be performed by the person skilled in the art and the Swiss-type claims must be supported by the specification as filed. The scope of the claims should be commensurate with the applicant’s contribution to the art. The disclosure should enable the skilled person to perform the invention as claimed without undue experimentation or further inventiveness being required.
Other medical use format claims can be converted to Swiss-type claims. If the original medical use format claim (e.g. first medical use, or method of treatment claim) is supported and enabled by the specification, then a corresponding Swiss-type claim will also be considered supported and enabled.
Avoid active language
IPONZ will object to a Swiss-type claim that uses active language such as “is administered”, “is used”, “is provided”, and “when used”. The wording “is to be administered” or “treatment comprises administration of” is not considered active language. The wording “formulated for” or “adapted for” may be construed as merely “suitable for” unless there is a physical difference in the substance or composition over the prior art disclosed in the specification.
Limit to humans
A notable difference between New Zealand practice and European practice, for example, is that methods of veterinary treatment are patentable in New Zealand.
IPONZ will object to Swiss-type claims that are not clearly limited to the treatment of humans, or which reference non-human animals. IPONZ’s position is that methods of treatment of non-human animals are not excluded under the Patents Act 2013, so protection is available for this subject matter via method claims in which the treatment subject is appropriately limited.
Swiss-type claims that refer to a “subject” or “patient” will typically be considered as limited to humans. However, a “mammal” in a Swiss-type claim will generally be construed as including both humans and non-human mammals.
Do not claim non-therapeutic uses
Non-therapeutic uses that are allowable in method claims should not be claimed in Swiss-type claims unless the non-therapeutic use, such as cosmetic use, cannot be separated from a therapeutic use.
Device or apparatus
Claims to the use of an apparatus or device are not Swiss-type claims. However, Swiss-type claims may include an apparatus or device if it is part of the manufacture of a medicament or the medical use.
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