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Patentability of Kit-Of-Parts Claims - The contrast between New Zealand and Australia
In combination therapy patents, the invention lies in the discovery of a particular therapeutic benefit to taking two (or more) different pharmaceutical actives together. To provide patent subject matter, the therapeutic benefit must be based on a synergistic or inter-working relationship between the actives in the body; for example, in enhanced activity or in the amelioration of side effects.
In New Zealand, patent protection is not available for the combination therapy itself, which constitutes a method of medical treatment. However, patent protection has been available for claims in the Swiss format, and claims to a pharmaceutical composition containing both actives.
Kit-of-parts claims relate to a product which provides the two actives together in a package ready for co-administration.
The recently published decision in Takeda GmbH [2013] NZIPOPAT 27 has established that kit-of-parts claims are patentable in New Zealand. This contrasts with the situation in Australia, where such claims are not considered to be patentable unless they are constrained to the inventive concept by adding the requirement that the kit is used in the inventive therapy.
Background
The Applicant, Takeda GmbH, had invented a combination therapy for inflammatory pulmonary disease, involving the drugs Roflumilast and Rosuvastatin.
On the basis that the Applicant had demonstrated that there was a synergistic relationship between these two compounds, the examiner had allowed claims to a pharmaceutical formulation containing the two compounds and at least one pharmaceutically acceptable auxiliary; in other words, a pharmaceutical composition having the two components in intimate mixture.
In contrast, claims to a combination product comprising Roflumilast and Rosuvastatin, each formulated with at least one pharmaceutically acceptable auxiliary, and adapted for administration simultaneously or sequentially (the “kit claims”), were rejected by the examiner, who cited L’Oreal’s Application [1970] RPC 565, which stated that the mere putting up of two ingredients in separate containers in one pack, the ingredients being intended to be mixed together before use to produce a known compound, cannot prima facie amount to a manner of new manufacture. The examiner also relied on Blendax-Werke [1980] RPC 491, alleging that for a kit of known integers to patentable, the elements forming the pack must be arranged physically such that the benefits arise directly from the arrangement, and the “paper bag test” discussed in the Australian decision Beecham Group Ltd’s Application (1977) AOJP at 530:
In the present case a vendor was perfectly free to sell the two known components separately. He was also perfectly free to sell those two known components at the same time. It is beyond my comprehension why the same vendor should be prevented from selling the same known components in the same paper bag. And that is what the claim to the pack seeks to prohibit. Put another way, I do not think it would be seriously disputed that there is no novelty in placing two known articles side by side. How then can there be novelty in placing the same two articles side by side in the one paper bag?”
The Applicant argued that the claims were distinguished from those in L’Oreal’s Application because, unlike L’Oreal’s combination, the Applicant’s combination involved an inventive step. The Applicant also noted that in the kit, no particular physical arrangement of the components was required to achieve the surprising synergistic effect, and pointed out that in Mannatech Inc [2000] NZIPOPAT 26, the Assistant Commissioner had found that the “paper bag test” only applies where the known components do not interact to produce a new result.
Hearing before the Commissioner
After a protracted correspondence with the examiner, the Applicant requested a hearing before the Assistant Commissioner of Patents, who agreed with the Applicant, finding that the combination product claims were distinguished from the situation in L’Oreal’s Application, because the claimed combination product provides a new, non-obvious, and surprising result. The finding in Mannatech that the paper bag test does not apply where there appears to be an unexpected result, or there is a doubt which must be given to the Applicant, was also approved by the Assistant Commissioner.
The Assistant Commissioner drew on Graham J’s statement in Blendax that there is no reason that an Applicant who has invented a valuable process should not get a monopoly for packs or other articles which are useful in that process, so that he can rely on the value of his discovery to claim something which otherwise people might think had no subject matter.
The Applicant’s position that a claim to a kit of parts should not be treated differently to any other claim to a collocation of integers was endorsed by the Assistant Commissioner. Both claims should be subjected to the same test, as set out in British Celanese Ltd v Courtaulds Ltd [1935] 52 RPC 171:
(i) whether the collocation of integers was novel at the priority date of the application (i.e. a new combination of known integers);
(ii) whether, if novel, it had subject-matter (i.e. a synergistic result or working inter-relationship between the integers); and
(iii) whether, even if novel and prima facie possessing subject-matter, it was obvious (i.e. possessed an inventive step).
These questions had been answered in the affirmative regarding the pharmaceutical composition claims, and as the kit claims contained the same integers, they were also patentable.
The situation in Australia
Several decisions have established that claims to such pharmaceutical combinations are not patentable in Australia. The case Schering Aktiengesellschaft (1990) AIPC 90–649 is an analogous example, as it related to claims to a pharmaceutical preparation for inducing abortion or labour comprising three components: a prostaglandin, an antigestagen and a glucocorticoid, which were contained in separate dosage units.
In Schering the Assistant Commissioner held that it could not be implied that the separated components of the pharmaceutical preparation have an actual working interrelationship as required by British Celanese, because the actual working interrelationship only takes place when all the components of the preparation are present in the body of the patient. It was acknowledged that the separated components of the pharmaceutical preparation may have “a potential working interrelationship”, provided that the collection of separate chemical compositions is limited to the inventive concept, which was held to be the introduction into the body of the three components. The Assistant Commissioner considered Blendax and Organon Laboratories Limited's Application [1970] R.P.C. 574, and found that as the claims, which were effectively directed to a blister pack, did not include a physical construction which ensures that in normal use the separate dosage units are applied to a single patient, they were not directed to patentable subject matter.
Summary
Gaining patents for combination therapies in New Zealand and Australia requires different strategies.
While a kit-of-parts claim is patentable in New Zealand, in Australia such a claim must be constrained to the inventive concept by adding the requirement that the kit is used in the inventive therapy, for example, by using a phrase “…when used in the treatment of [inflammatory pulmonary disease]”. A claim containing this phrase would be rejected in New Zealand as encompassing a method of medical treatment. In Australia, additional patent protection is available for a claim to the therapeutic method itself.
April 2014
