A five judge bench of the Full Federal Court in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 (Besanko, Jessup, Foster, Nicholas and Yates JJ) have dismissed AstraZeneca's appeal in relation to two of its rosuvastatin (Crestor) related patents, which concern the treatment of patients with high cholesterol.
The Full Federal Court has upheld the first instance Judge's (Jagot J's) finding that the two relevant patents were invalid on the basis of entitlement or lack of novelty (AstraZeneca's earlier priority date assertions having been rejected). However, whilst the overall outcome for Watson, Ascent and Apotex (the Respondents in the case) remains unchanged, the Full Court has overturned the first instance decision in a number of ways that beg consideration.
A summary of the findings of the Full Court
The findings of the Full Court that are considered in this alert relate to inventive step, novelty and fair basis. Whilst their Honours' also provided a detailed discussion of matters relating to indirect infringement, entitlement and the priority date of one of the patents, we have not provided a detailed discussion of these points.
In relation to inventive step, the Full Court has now made it clear that statements made in a patent specification (for instance about the relevant problem that the invention is said to solve) cannot be relied upon as a substitute for information that does not otherwise form part of the common general knowledge or which was not disclosed in the prior art at the relevant date.
In relation to novelty, the Full Court appears to have taken a very narrow view of how the skilled addressee can utilise what was commonly known in the field when determining if a prior art document wholly discloses the invention.
Furthermore, their Honours have preferred to broadly construe the plain meaning of the claim language of the patent. In doing so, the claims were construed to capture subject matter which is not expressly disclosed in the specification. But in a twist the court found that the claims are wholly invalid because, notwithstanding its consistory language in relation to "comprising", the specification does not provide a real and reasonably clear disclosure of the claims when given that construction.
The Patents considered on appeal
The two patents considered by the Full Court on appeal were referred to as the:
1) "low dose patent", which generally claimed a method of treating hypercholesterolemia comprising administration as a starting dose of a single, once daily, oral dose of 5 to 10 mg of the compound; and
2) "cation patent", which generally claimed a pharmaceutical composition including rosuvastatin and an inorganic salt in which the cation is multivalent.
Inventive Step – Starting Point
At first instance, Jagot J held that it was appropriate to rely on statements in the body of the patent specification to determine what the "starting point" would be for assessment of inventiveness. In doing so, her Honour concluded that the patents in suit presupposed the existence of rosuvastatin, notwithstanding that rosuvastatin and its properties might not have been part of the common general knowledge or disclosed in any prior art document at the earliest asserted priority date. However, the Full Federal Court has categorically rejected this approach.
The majority judgment of Besanko Foster Nicholas and Yates JJ
In its majority judgment, the Full Court held that in all circumstances only common general knowledge PLUS information contained in a prior art document could be considered when assessing inventive step. It identified only one exception to this approach, namely, if the specification expressly acknowledges that particular information formed part of the common general knowledge.
Their Honours provided a number of reasons for their conclusion, including that:
1) the starting point suggested in the specification might not be one that would suggest itself to the skilled addressee;
2) the law does not require the patent specification to disclose the path taken to arrive at the invention;
3) there are still standard patents in force in Australia which were granted under former law which considered a confined prior art base only including acts done in the patent area, whereas the inventor's starting point may consist of information that was made publically available by an act outside of Australia;
4) the idea that inventiveness can be assessed on something that is not common general knowledge or information contained in a prior art document suggests that it need not be publically available, which conflicts with the basic premise of the test for inventive step being by reference to what is publically available; and
5) disputes will often arise as to what the proper construction of the starting point is based on one's reading of the specification.
Their Honours distinguished the case from the Full Court's decision (Emmett, Bennett and Middleton JJ) in Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416 (which was applied by the primary Judge in this case). It did so on the basis that, in that case, their Honours were concerned with the former 1952 Patents Act and not the current 1990 Patents Act.
Additionally, their Honours indicated that whilst the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) 212 CLR 411 (Alphapharm) took omeprazole as the relevant starting point, even though it did not form part of the common general knowledge, this did not mean that the High Court had endorsed that approach. Rather the starting point issue did not form part of the High Court appeal and the appellants in that case had conducted the appeal on the basis that the High Court should begin with that assumed knowledge.
In doing so, their Honours held that the cation patent (assuming it had the earliest priority date) was inventive because rosuvastatin was not part of the common general knowledge or disclosed in the prior art at the relevant date.
The minority judgment of Jessup J
Jessup J delivered a single judgment with different reasoning to the other four judges in relation to inventive step. However, his Honour agreed that it was impermissible to determine what was claimed using the specification as the primary point of reference.
Contrary to the majority, his Honour sought to make a distinction between claims that were for a product invention versus a combination invention. His Honour considered that if the claim relates to a combination, then the skilled addressee would have each of the integers before him irrespective of whether they formed part of the common general knowledge or were disclosed in the prior art because the question was whether the combination of those integers was inventive.
Applying his preferred test, his Honour came to the view that the claims of the low dose patent did not claim rosuvastatin in combination with other integers and therefore required rosuvastatin to form part of the common general knowledge or be disclosed in the prior art. In contrast, his Honour held that the cation patent claims were expressed as a combination of integers being (1) rosuvastatin or a pharmaceutically acceptable salt and (2) an inorganic salt in which the cation is multivalent. As a consequence, his Honour held that the cation patent claims were obvious (without referring to any prior art documents), in part, because rosuvastatin was not required to form part of the common general knowledge or be disclosed in the prior art.
Level of inventiveness required
Whilst their Honours' comments in relation to starting point arguably make it harder to satisfy the inventive step test in some circumstances, they have made some favourable comments in relation to the level of inventiveness required under the test. Jessup J (with whom the majority agreed on this point) reiterated that the test from Alphapharm allows for further work towards the invention to be done. In this case, their Honours all agreed that whilst neither of the prior art documents for the low dose patent contained safety data from animal (or indeed data from human trials), the evidence made it quite clear that such trials would conventionally be carried out. Their Honours applied similar reasoning in making their conclusions regarding Novelty and Entitlement (namely that the threshold for "method of treating" is not so high that it requires the prior art to disclose (or the inventor to demonstrate) a method that is sufficiently safe and efficacious to be administered by medical practitioners to patients requiring treatment for that condition).
Novelty
The Full Court also overturned Jagot J's finding in relation to the novelty of the low dose patent.
Whilst their Honours acknowledged that in considering sufficiency of the prior art disclosure, the skilled addressee is assumed to construe the prior art in the light of the common general knowledge, their Honours held that it was not permissible to use common general knowledge to add an integer that is otherwise not disclosed in the prior art. Based on their Honours' reasoning in relation to the low dose patent, it appears that the Full Court has taken a very narrow approach, when applying this principle, to the construction of the prior art in the light of the common general knowledge.
Fair Basis
The Full Court also overturned the Trial Judge's finding in relation to fair basis of the cation patent.
The parties appear to have agreed that the patent only referred to the salt being mixed or blended with rosuvastatin (rather than being applied solely to a coating on the tablet) and the only theory advanced in the specification to explain how the multivalent cation improved the stability of rosuvastatin was that it stabilised its structure, required intimate mixing according to the experts in the case. However, AstraZeneca pointed to the 'consistory clause', ie the statement that "'comprising' will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps" as the basis for the real and reasonably clear disclosure of the invention as per the claims.
The Full Court upheld the Primary Judge's finding that the patent claims extended to a formulation where rosuvastatin was contained in the tablet and the inorganic salt was contained within a coating on the tablet, rather than mixed in the tablet with rosuvastatin. However, the Full Court went on to find that the claims lacked fair basis (and were therefore wholly invalid) because there was no real and reasonably clear disclosure in the specification of a pharmaceutical composition that did not involve the mixture of the active ingredient directly with an inorganic salt in the core.
Their Honours said that a consistory clause appearing in the specification will only satisfy the test for fair basis if the specification, when the specification read as a whole, corresponded with that consistory clause. As a consequence, the Full Court preferred to construe the claims broadly (but consequently find them invalid), rather than construe the claims narrowly to ensure they were valid but with a narrower scope.
