The recent Australian opposition decision of Merial Limited v Zoetis LLC  APO 59 highlights the differences between the Australian and New Zealand patent offices in the construction of “kit” claims in relation to the same invention. It also brings to light the question of how such differences will be addressed upon implementation of the proposed Trans-Tasman agreement, where it is contemplated that a single patent office will examine both New Zealand and Australian applications.
Recently, we reported on the outcome of an opposition proceeding before the New Zealand Patent Office, in relation to a patent application directed to a veterinary treatment of mastitis (see our article: Is inventive step in New Zealand “udderly” ridiculous?).
We indicated that we would start to see more patent cases in this area in both Australia and New Zealand. We weren’t wrong: the Australian Patent Office has now released its decision in relation to opposition proceedings for the Australian counterpart application: Merial Limited v Zoetis LLC  APO 59. While Merial Limited was unsuccessful in opposing the grant of Zoetis LLC’s New Zealand application, it has had more success before the Australian Patent Office. As we explain below, the different outcome in Australia highlights differences in the approach of the respective patent offices to claim construction.
The opposed application, AU 2003283757 relates to a veterinary composition which has application in the treatment of mastitis in dairy cattle. Claim 1 of the accepted application claims:
A veterinary composition for intra-mammary use in non-human animals comprising an oil-based antibacterial formulation and a separate oil-based seal formulation, wherein the seal formulation comprises a gel base and a non-toxic heavy salt in the base in an amount of at least 30% by weight of the gel base.
Independent claim 2 is similar to claim 1 but specifies that the antibacterial formulation and seal be provided as a single formulation. Claims dependent on claims 1 and 2 specify the components of the formulations. Dependent claims 11 and 12 are “Swiss-form” and method of treatment claims, respectively.
Claim 1 was construed by the hearing officer as defining two separate formulations per se that may be used together as a composition wherein the formulations are suitable for intra-mammary use. The hearing officer also commented that the claim is not drafted so as to require a particular outcome when it is used. Such a claim construction was not adopted by the New Zealand hearing officer – a difference which we elaborate on below.
Although it was common ground that both oil-based antibacterial formulations and oil-based seal formulations were known, the Applicant submitted that the prior art taught away from their combined use as it was understood that the oil-based antibacterial would cause disintegration of the seal. Rather, the prior art taught the combined use of an aqueous antibacterial formulation to maintain the integrity of the oil-based seal formulation. However, because of the broad claim construction outlined above, the hearing officer found that claim 1 lacked novelty over the prior art.
The hearing officer commented that although the prior art indicated that there would be seal disintegration over time, the prior art did not indicate a gross failure of the combination. Accordingly, the fact that aqueous antibiotic/seal formulations are superior does not erase the fact that the oily antibiotic/seal formulations are suitable for use in the prevention and treatment of mammary disorders in cows.
Despite the fact that the claims were found to lack novelty, the hearing officer found the claims to be inventive. This is an unusual outcome because claims lacking novelty are typically also found to lack an inventive step. However, this finding can be explained by the broad construction of claim 1 coupled with the teaching away of the prior art to combine oil-based antibiotics with oil-based sealants. Novelty was not a ground of opposition pursued in the New Zealand opposition, however, the outcome in relation to inventive step was the same in both jurisdictions.
Owing to the broad construction of claim 1, this claim (and its dependent claims) were found not to be for a manner of new manufacture because they define a mere collocation of known integers. As indicated previously, it was common ground that both integers of the composition were known, however, the outcome in the Australian proceedings highlights the different approach of the Australian Patent Office compared to other when construing claims so-called “kit claims”. Although not specifically drafted as a kit claim, claim 1 is in essence attempting to claim a kit comprising two components.
In many jurisdictions, a kit claim will be construed in such a way that it will implicitly understood that both components of the kit are required for the working of the invention. In Australia, however, a kit claim requiring two components will be construed in such a way that the components don’t necessarily need to be provided in a single entity. Rather, the scope of the claim would encompass, for example, a shop providing each component separately, potentially at opposite ends of the store. Accordingly, in Australia, it can be quite difficult to get kit claims allowed unless, for example, it can be demonstrated that at least one of the components is novel.
In Australia, if an invention consists of a collocation of known integers (as in the present case), the invention will only be patentable if a claim defines the integers to be in a physical arrangement that in ordinary use provides for a working interrelationship1. This can be quite difficult to accomplish. Clearly, in the present case the use of the word “separate formulation” in claim 1 and “single formulation in claim 2” meant that the hearing officer had no choice but to consider that claim 1 does not assure the combination of the known integers in normal use. The hearing officer also commented that claim 1 was drafted in such a way that the integers only be suitable for intra-mammary use and are not limited to any particular outcomes in use.
Under New Zealand patent law, claims to collocations of known integers will be allowed if the collocation itself is novel and if the integers, when placed together have some working interrelationship producing a new or improved result (eg a synergistic effect). If the integers of a combination are defined to be in a physical arrangement that in ordinary use provides for such a working interrelationship, then the claim will also be allowable. Often, the arguments presented to the New Zealand examiner in order to demonstrate a new or improved result will be similar to inventive step arguments. These aspects of the New Zealand law relating to collocations of known integers perhaps explain why Merial did not pursue the ground of novelty during its opposition to the New Zealand patent application.
Although Merial was successful in its opposition to the Australian application, the hearing officer has suggested that the deficiencies in the claims can be addressed by amendment. Accordingly, Zoetis may well end up with a better position in Australia than in New Zealand. This is because the Australian claims, when amended, will likely be a more robust set of claims which will be less susceptible to attack in a revocation proceeding and more easily enforced against a potential infringer.
1. Australian Patent Examiner’s Manual, at 188.8.131.52