AstraZeneca AB v Apotex Pty Ltd AstraZeneca AB v Watson Pharma Pty Ltd AstraZeneca AB v Ascent Pharma Pty Ltd
[2015] HCA 30
2 September 2015
S54/2015, S55/2015 & S56/2015
ORDER
In each matter, appeal dismissed with costs.
On appeal from the Federal Court of Australia
Representation
A J L Bannon SC with C Dimitriadis SC and C J Burgess for the appellants in each matter (instructed by Ashurst Australia)
D K Catterns QC with N R Murray for the respondent in S54/2015 (instructed by Herbert Smith Freehills)
A J Ryan SC with I P Horak for the respondents in S55/2015 and S56/2015 (instructed by Minter Ellison Lawyers)
J T Gleeson SC, Solicitor-General of the Commonwealth with F T Roughley for the Commonwealth of Australia, intervening (instructed by Corrs Chambers Westgarth)
Notice: This copy of the Court's Reasons for Judgment is subject to formal revision prior to publication in the Commonwealth Law Reports.
CATCHWORDS
AstraZeneca AB v Apotex Pty Ltd AstraZeneca AB v Watson Pharma Pty Ltd AstraZeneca AB v Ascent Pharma Pty Ltd
Intellectual property – Patents – Patents Act 1990 (Cth) – Inventive step – Obviousness – Patent disclosing method of treatment for hypercholesterolemia – Administration of rosuvastatin and its pharmaceutically acceptable salts at low dosage range in claims – Whether invention obvious in light of common general knowledge together with two prior art documents considered separately where another prior art document disclosed alternative compound – Whether prior art documents were ascertained, understood and regarded by person skilled in relevant art as relevant – Whether permissible to use information from other documents to determine relevance of information in prior art document – Use of prior art not within common general knowledge.
Words and phrases – "ascertained, understood and regarded as relevant", "considered separately", "inventive step", "obviousness", "person skilled in the relevant art".
AstraZeneca AB, the first appellant, is the registered proprietor of Australian Patent Number AU200023051 ("Patent 051") entitled "Use of Cholesterol-Lowering Agent". AstraZeneca Pty Ltd, the second appellant, is the exclusive licensee of the Patent. The term "AstraZeneca" is used in these reasons to designate either or both appellants. The term "the Agent" used in the title of Patent 051 is defined in the specification as a compound called "rosuvastatin" and its pharmaceutically acceptable salts. Rosuvastatin is one of a class of compounds called statins which can reduce health threatening cholesterol levels in the human body by blocking the action of an enzyme called HMG-CoA reductase. The enzyme binds to a substrate HMG-CoA and mediates a reaction which transforms the substrate to mevalonic acid, a precursor of cholesterol. Statins interfere with that…
Grounds of appeal
[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.
[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.
[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.
Consideration
[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.
[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.
Continue reading AstraZeneca AB v Apotex Pty Ltd
Sign in free to access the full text
Details
AGLC
AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30
Case
[2015] HCA 30
Decision Date
CaseChat Overview and Summary
AstraZeneca AB and AstraZeneca Pty Limited (together "AstraZeneca") appealed to the High Court of Australia concerning Australian Patent No 200023051. The patent, referred to as the "051 patent" or "low dose patent," claimed a method of treatment for hypercholesterolemia, hyperlipoproteinemia, and atherosclerosis by administering rosuvastatin or its pharmaceutically acceptable salts within a specific low dosage range. The dispute centred on whether this claimed invention involved an inventive step, specifically whether it was obvious in light of the prior art.
The central legal issue before the High Court was whether the invention, as defined by the claims of the 051 patent, possessed an inventive step. This required the Court to determine if the invention was obvious to a person skilled in the relevant art, considering common general knowledge and the prior art documents. Specifically, the Court had to assess whether the prior art documents were properly ascertained, understood, and regarded as relevant by such a skilled person, and whether information from different prior art documents could be used to establish the relevance of information within another.
The High Court considered expert evidence regarding the prior art, including a 1997 article by Watanabe and others which disclosed rosuvastatin (then designated S-4522) and its potent HMG-CoA reductase inhibitory activity. The Court noted that the patent specification identified the problem it sought to solve as finding alternative statins with improved efficacy and safety profiles at particular dosages. The patent claimed that at the specified low dosages of 5-10 milligrams per day, rosuvastatin lowered LDL cholesterol to an unexpectedly greater degree and without significant adverse side effects. The Court ultimately found that AstraZeneca's appeals failed on the ground of inventive step.
The appeals brought by AstraZeneca were dismissed with costs.
Orders
Orders of the court
In each matter, appeal dismissed with costs.
Background
Background to the litigation
Full text does not contain this section.
Evidence
Evidence Before The Court
The Watanabe Article was published in 1997. It was co-authored by Masamichi Watanabe and others. Watanabe's affiliation was described as Shionogi Research Laboratories, Shionogi and Company Ltd. The title of the article referred to the synthesis and biological activity of a series of compounds identified as HMG-CoA reductase inhibitors. In the introductory section, mention was made of lovastatin, pravastatin and fluvastatin as potent hypocholesterolemic agents widely used clinically. Much effort was said to have been expended to obtain more potent reductase inhibitors. The article reported on the synthesis and biological activity of particular compounds, one of which was rosuvastatin, designated not by that name but as S-4522. The authors stated:"During this study, we found that [rosuvastatin] possesses greater enzyme inhibitory activity than lovastatin (1a) and pravastatin (1b)."S-4522 was tested for its ability to inhibit cholesterol biosynthesis in hepatocytes isolated from rat livers. It was approximately 100-fold more potent than pravastatin sodium salt. The results of testing on cultured human hepatoma cells suggested it could lead to a greater decrease in serum cholesterol than pravastatin. As a liver-selective HMG-CoA reductase inhibitor, it indicated a potent cholesterol lowering and reduced side effects in clinical use because the liver is a major site of cholesterol biosynthesis. It reduced the plasma cholesterol levels of beagle dogs by 26 per cent, compared with 18 per cent for pravastatin at a repeated dose for 14 days of 3 mg/kg per day. It also reduced the plasma cholesterol levels of the cynomologus monkey by 22 per cent at a dosage of 12.5 mg/kg whereas pravastatin reduced them by 19 per cent at a dosage of 50 mg/kg. It was said to be approximately four times more potent than lovastatin sodium salt in inhibiting HMG-CoA reductase in-vitro and was the most potent cholesterol biosynthesis inhibitor in isolated rat liver hepatocytes. The article noted that a clinical trial of S-4522 was in progress.Expert evidence — ascertainment of relevant prior art information The expert evidence relevant to inventive step, which was the focus of attention in this Court, was that of the respondents' witnesses, Dr Reece and Professor O'Brien. Their expertise was not in issue. Prior to trial Dr Reece had been instructed as follows in relation to the preparation of his opinion:"You are given a new statin and are told that it is useful in the treatment of hypercholesterolemia, hyperlipoproteinemia and atherosclerosis. HMG‑CoA reductase inhibitors are the most widely used prescription medication for the treatment of hypercholesterolaemia. A number of HMG-CoA reductase inhibitors are marketed, namely lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin and cerivastatin, and are collectively referred to as 'statins'. Despite the benefits of statin therapy, less than optimal results may be achieved in patients, due to the level of efficacy and safety achieved at the recommended dosages of the currently marketed statins. Accordingly it is important to find dosages of alternative statins which beneficially alter lipid levels to a significantly greater extent than similar dosages of currently used statins and which have a similar or improved safety profile."
Decision
Reasons for decision
FRENCH CJ
KIEFEL J
GAGELER AND KEANE JJ
NETTLE J
In dealing with the substantial commercial success of the drug in which rosuvastatin was the active ingredient administered conformably with claim 1 in Patent 051, the primary judge had said[86]:"The problem with this approach in the present case is that the commercial success of AZ's rosuvastatin product, on the evidence, is due to its potency at lower doses than other statins. But as the generic parties pointed out, these are qualities of the compound rosuvastatin. AZ did not invent rosuvastatin. As Apotex put it, 'the commercial success of Crestor is due to the quality of the drug itself, not to the entirely conventional doses of 5 mg and 10 mg'."The treatment of the "secondary evidence" in this case was tied to the particular statutory context of the alternative operation of s 7(2) and the efficacy of the drug itself. No error is disclosed in the reasoning of Jessup J in this respect.[86](2013) 100 IPR 285 at 375 [332].Conclusion For the preceding reasons AstraZeneca's appeals fail on the first ground and must be dismissed. It is therefore not necessary to consider the questions raised on the notices of contention. In particular, it is not necessary to consider the question on which the Commonwealth was granted leave to intervene, namely, the correctness of the decision of the Full Court of the Federal Court in Apotex Pty Ltd v Sanofi-Aventis[87]. The appeals should be dismissed with costs.[87](2009) 82 IPR 416. For some time, HMG-CoA reductase inhibitors, which are referred to as "statins", have been prescribed by medical practitioners for the treatment of conditions such as hypercholesterolemia and for the lowering of low density lipoprotein ("LDL") cholesterol. The statins are typically taken once a day as tablets. The primary judge in the Federal Court of Australia (Jagot J)[88] noted that according to the MIMS Annual 1998, recommended starting doses of statins were typically 10, 20 or 40 milligrams. Medical practitioners usually prescribed the lowest dose of statins to begin with, to minimise the risk of adverse side-effects associated with statins[89]. If the target level of LDL cholesterol was not met and the dose had been well tolerated, it would be increased ("dose titration") over months. Dose titration aimed to increase the dose until the patient reached his or her target safely, but the practice was costly, because it necessitated a number of visits to the doctor and blood tests. It therefore risked patient non-compliance. As a result, titration often did not take place and the patient remained on the starting dose even though his or her target level was not reached.[88]Apotex Pty Ltd v AstraZeneca AB (No 4) (2013) 100 IPR 285 at 318 [104].[89]Apotex Pty Ltd v AstraZeneca AB (No 4) (2013) 100 IPR 285 at 319 [109]. AstraZeneca AB and AstraZeneca Pty Limited (together "AstraZeneca") are respectively the registered proprietor and exclusive licensee of Australian Patent No 200023051 (which has been referred in the proceedings in the Federal Court as the "051 patent" and the "low dose patent", but is here referred to as "the Patent"). The specification for the Patent identifies the problem which the claimed invention seeks to overcome as finding dosages of alternative statins which have a similar or improved safety profile and are more efficacious in altering lipid levels than dosages of statins then being marketed. It discloses a method of treatment by the administration of what is called "the Agent" in a particular dose or dosage range. The Agent is rosuvastatin and pharmaceutically acceptable salts thereof. The method involved a starting dosage of rosuvastatin of 5-10 milligrams per day. The Patent's specification claimed that at these dosages LDL cholesterol is lowered "by an unexpected degree, and without any significant adverse side effects."
Ratio Decidendi
Legal Principle Established
Established by:
FRENCH CJ,
KIEFEL J,
GAGELER AND KEANE JJ,
NETTLE J