Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368
Citation:
Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368
Parties:
RANBAXY LABORATORIES LIMITED and RANBAXY AUSTRALIA PTY LTD v ASTRAZENECA AB and ASTRAZENECA PTY LIMITED; ASTRAZENECA AB and ASTRAZENECA PTY LIMITED; RANBAXY LABORATORIES LIMITED and RANBAXY AUSTRALIA PTY LTD
File number:
VID 1008 of 2011
Judge:
MIDDLETON J
Date of judgment:
23 April 2013
Catchwords:
INTELLECTUAL PROPERTY – Patents – Construction of claims – Infringement of claims – Applicable principles – Section 116 Patents Act 1990 (Cth) – Amended patent – Whether reference to specification without amendment and other Patent Office documents permissible in construction – Skilled addressee and skilled team
INTELLECTUAL PROPERTY – Patents – Validity – Novelty – Prior art and common general knowledge
INTELLECTUAL PROPERTY – Patents – Validity – Inventive step – Common general knowledge and s 7(3) documents – Cripps question – Inventive journey of patentee – Secondary indicators – Commercial success – Conduct of competitors
INTELLECTUAL PROPERTY – Patents – Manner of new manufacture
[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.
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AGLC
Ranbaxy Laboratories Ltd v AstraZeneca AB [2013] FCA 368
Case
[2013] FCA 368
Decision Date
CaseChat Overview and Summary
Ranbaxy Laboratories Ltd initiated legal proceedings against AstraZeneca AB, challenging the validity of certain patents related to pharmaceutical compounds. The primary dispute centred on the validity of two patents, specifically those concerning the chemical purity and formulation of a proton pump inhibitor (PPI). The case was heard and decided by the Federal Court of Australia. The court was tasked with determining the validity of the patents under the Patents Act, considering whether the inventions were novel, involved an inventive step, and were susceptible to industrial application. Additionally, the court had to address the proper construction of the patents, particularly in relation to the identification and role of the skilled addressee, and whether the claims were clear and supported by the specification.
The court first examined the identity and role of the skilled addressee, concluding that the appropriate team for interpreting the patents would be a group of scientists in the field of gastrointestinal disorders, specifically those interested in treating gastric acid-related diseases. The court then delved into the specific claims of the patents, assessing whether they met the statutory requirements for patentability. The court found that the patents did not sufficiently disclose the necessary information to enable a person skilled in the art to replicate the inventions, leading to a conclusion that the claims were not adequately supported by the specification. This lack of clarity and support rendered the patents invalid.
Ultimately, the court ruled in favour of Ranbaxy Laboratories Ltd, declaring the contested patents invalid. This decision effectively resolved the dispute, allowing Ranbaxy to proceed without the burden of the invalid patents.
Orders
Orders of the court
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Background
Background to the litigation
Accordingly, the issues of validity in relation to each of the Patents is to be determined under the Act in the form in which it existed prior to the Amendment Act.BACKGROUND It is useful to commence with a summary of some of the key scientific concepts relevant to the Patents and the issues raised in this proceeding. Stereochemistry As will shortly become apparent, the Purity Patent invokes certain stereochemical concepts, such as the concept of enantiomers, which may require explanation. I understand that these basic principles are uncontroversial as between the parties. At 28 May 1993 (being the priority date of the Purity Patent, which was the earliest priority date in issue in this proceeding), it was known that enantiomers are isomers (being compounds that have the same molecular formula, but which differ in the way in which their atoms are arranged) with identical structural connectivity and physical properties, except the direction in which they rotate a plane of polarised light. But another key aspect of the definition of enantiomers is that they are, at the molecular level, non-superimposable mirror images of each other. This property is known as ‘chirality’. In a molecule, a carbon atom with four different functional groups attached to it is known as the ‘stereogenic’ or ‘chiral’ centre. However, any atom that can form four or more bonds to other atoms can demonstrate chirality. Accordingly, other atoms (such as sulphur) can also behave as chiral centres. Diastereomers (also known as diastereoisomers) are molecules that contain two or more chiral centres (and can also exist as pairs of enantiomers). Enantiomers rotate the plane of polarised light in either a clockwise or counter-clockwise direction. Compounds that rotate the plane of polarised light in a clockwise direction are described as dextro-rotatory and are represented with a “(+)” symbol. Compounds that rotate the plane of polarised light in a counter-clockwise direction are described as levo-rotatory and are represented with a “(-)” symbol. Omeprazole has two enantiomers: (-)-omeprazole and (+)-omeprazole. The absolute configuration of an enantiomer is characterised as “(S)” or “(R)” depending on the spatial arrangement of atoms around the chiral atom. It is now known that the (-)-enantiomer of omeprazole is the (S)-enantiomer of omeprazole. When both enantiomers are present in a mixture in equal proportions (ie 1:1), this is known as a ‘racemic mixture’, or a ‘racemate’. A racemate does not rotate the plane of polarised light (and is therefore not optically active) because, the rotation caused by the (-)-enantiomer is cancelled out by the equal and opposite rotation of the (+)-enantiomer. ‘Racemisation’ is a process whereby enantiomers interconvert to create a racemate (ie a 1:1 mixture of the two enantiomers just discussed), resulting in a complete loss of optical activity.Omeprazole and acid secretion Humans produce hydrochloric acid in the stomach, secreted by specialised cells known as ‘parietal cells’. These are generally located in the proximal two-thirds of the stomach lining, namely, in the part of the stomach lining that is closer to the mouth.
Evidence
Evidence Before The Court
It is necessary, before going to these specific grounds, to deal with the issue of the skilled addressee and the proper construction of the Purity Patent.The skilled team and the evidenceRelevant principles and their application to this case The parties accepted that the relevant principles regarding the identity of the skilled addressee in the context of the construction inquiry are as set out in my decision in Britax Childcare Pty Ltd v Infa-Secure Pty Ltd (2012) 96 IPR 1; [2012] FCA 467 at 43 to 45, [238]-[250]; and more generally in Eli Lilly and Company Ltd v Apotex Pty Ltd [2013] FCA 214 at [167] and following. The following recent statement from Jagot J in Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162 usefully summarises the position (at [94]):… [I]t is important to understand that the skilled addressee is not a reference to a specific person but is a legal construct (Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 177 ALR 231; [2000] FCA 980 at [71]). The legal construct may not be a single person but may be a team of persons “whose combined skills would normally be employed in that art in interpreting and carrying into effect instructions such as those which are contained in the document to be construed” (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 485) (General Tire). And as Watson and Ascent also said:A patent specification is addressed to those likely to have a practical interest in the subject matter of the invention, and such persons are those with practical knowledge and experience of the kind of work in which the invention is intended to be used. The addressee comes to a reading of the specification with the common general knowledge of persons skilled in the relevant art, and they read it knowing that its purpose is to describe and demarcate an invention. The person skilled in the art is unimaginative without inventive capacity. It is well-established that the hypothetical skilled addressee may be a team whose combined skills would normally be employed in that art in interpreting and carrying into effect instructions such as those which are contained in the document to be construed. It is accepted that the combined skills of a team would be required for the purposes of this proceeding. The first step in identifying the membership of the skilled team is to identify the field of knowledge to which the invention relates. In this proceeding, the relevant field is pharmaceuticals – specifically, those related to gastric acid-related diseases. The impugned claims of the Purity Patent are directed to certain identified optically pure salts of a single compound, and pharmaceutical preparations and treatment methods relating to those salts. The skilled team for the Purity Patent is therefore a team of scientists working in the field of gastrointestinal disorders with a particular interest in the treatment of gastric acid-related diseases, involved in a research project to find a new pharmaceutical compound as at 28 May 1993, which (it will be recalled) is the priority date for the Purity Patent.
Decision
Reasons for decision
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Ratio Decidendi
Legal Principle Established
However, the problem is that the PPI might also react with some acidic compound in the enteric coating layer itself. At p 7, lines 26 to 31, the specification states (emphasis added):Ordinary enteric coating layers, however, comprise compounds which contain acidic groups. If covered with such an enteric coating layer, the acid labile substance may rapidly decompose by direct or indirect contact with the acidic groups resulting in discoloration of the content and loss in content of the active compound with the passage of time. The discoloration can be avoided by applying some type of separating layer between the core material comprising the susceptible proton pump inhibitor and the enteric coating layer. Three separate items are again addressed here, as emphasised. The specification states that the prior art pharmaceutical dosage forms included a separating layer between “a core material” and an enteric coating layer: p 8, lines 1 to 3 (emphasis added): Thus, there are a lot of patent applications describing such a separating layer between a core material comprising the pharmaceutically active substance and an enteric coating layer. See for instance, US-A 4,786,505, EP 0,277,741 and EP 0,342,522. Again, three separate items are referred to here. “US-A 4,786,505” is a reference to US 505 (being AstraZeneca’s patent dated 22 November 1988, that has already been the subject of discussion in these reasons). The specification further states, at p 8, lines 3 to 7 (emphasis added):The prior art techniques to apply at least two different layers on a pellet core or a tablet comprising an acid labile compound is rather complicated and there is a demand for finding new processes and formulations to simplify the manufacturing of such enteric coated articles comprising acid labile substances. This passage indicates that the terms “pellet core” and “tablet” are interchangeable. The reference here to “pellet core” as a tablet is only in the context of discussing techniques to apply at least two different layers, and the complications involved. This obviously follows on from the earlier reference in the very same paragraph to the prior art patent applications, which I have already noted draws a clear distinction between the separating layer, core material, and enteric coating layer.Aspects of the invention There are said to be two aspects of the invention. Under the heading “Summary of the Invention” at p 8, the first aspect of the invention is said to be (at p 8, lines 9 to 16; emphasis added):…an oral pharmaceutical dosage form comprising a core material that contains a proton pump inhibitor, one or more alkaline reacting compound(s) and optionally pharmaceutically acceptable excipients, said core material having a water soluble separating layer thereon, with an enteric coating layer thereupon, characterized in that the core material is alkaline reacting and that the separating layer comprises a water soluble salt of an enteric coating polymer(s) and is formed in situ during the enteric coating.