In Takeda GmbH ( NZIPOPAT 27) the New Zealand Assistant Commissioner of Patents has confirmed that kit of parts claims should be considered using the same test as for any other alleged mere collocation objection.
In addition, the Assistant Commissioner helpfully confirmed that the Intellectual Property Office of New Zealand (IPONZ) should be consistent with its own previous practice, including following Hearings Office decisions and taking a consistent approach where claims with similar subject matter have previously been allowed.
With respect to the kit of parts matter, the claims at issue were directed to a combination product comprising two active ingredients, roflumilast (A) and rosuvastatin (B). During examination, IPONZ had objected to the claims on the basis that, because they were directed to a combination product and could encompass separate dosage forms, the claims related to a mere kit of parts.
IPONZ relied heavily on L’Oreal’s Application  RPC 565, asserting that this decision confirms that packaging known compounds in a pack is not a new manner of manufacture and that people should not be restricted from purchasing the two known compounds and wrapping them together (i.e. the so-called “‘paper bag’ test”).
The Assistant Commissioner, however, held that the combination product claims should not be treated any differently than, for example, claims directed to a pharmaceutical composition comprising (A) and (B). The Assistant Commissioner also held that, regardless of whether the objection is raised as a “mere kit of parts” or “mere collocation” objection, the correct test for patentability is the test set out inBritish Celanese v Courtaulds Ltd  52 RPC 171. In that decision, the Judge set out three questions that arise in the case of an alleged mere collocation:
(i) Whether the collocation of integers was novel at the earliest priority date of the application;
(ii) Whether, if novel, it had subject-matter, and
(iii) Whether, even if novel and prima facie possessing subject-matter, it was obvious at the priority date.
The Assistant Commissioner relied on the earlier IPONZ decision in GD Searle & Co.  NZIPOPAT 17. In that decision, the Commissioner stated that the British Celanese questions “…still provide a useful test for the presence of ‘mere collocation’…” when considering if such a claim meets the definition of “invention”.
When considering the impact of the “‘paper bag’ test”, the Assistant Commissioner relied on the earlier IPONZ decision in Mannatech Inc  NZIPOPAT 26, which states (at page 8) that the so-called “‘paper bag’ test “…can only apply where the known components do not interact to produce a new result.” The Mannatech decision makes it clear that a patentable combination is one where the two components, even if separate, interact to produce a new result.
The Assistant Commissioner stated (at ) that:
“…in using the ‘kit of parts’ analogy, the examiner is focusing on the proximity of the components to each other and not looking at the alleged invention…[t]he examiner is not applying Mannatech”
and that the examiner was ignoring
“…the collocation aspect of the present invention, which is [that] the combination is delivered to the patient in a way that will produce a synergistic effect. The fact that it may be necessary to keep the two components separate does not detract from the allowability of the invention being claimed” (at ).
It is particularly pleasing that the Assistant Commissioner has clarified that IPONZ must be consistent with its own previous practice, including following Hearings Office decisions, and that IPONZ should take a consistent approach where claims with similar subject matter have previously been allowed.While both points may appear to be self-evident, this clarification will result in greater consistency and predictability of IPONZ examination.This can only be a benefit to New Zealand patent applicants.