FEDERAL COURT OF AUSTRALIA
Orion Corporation v Actavis Pty Ltd
[2015] FCA 909
Citation: Orion Corporation v Actavis Pty Ltd [2015] FCA 909 Parties: ORION CORPORATION AND OTHERS AS NAMED IN THE SCHEDULE v ACTAVIS PTY LTD ACN 003 854 626 AND ANOTHER AS NAMED IN THE SCHEDULE; ACTAVIS PTY LTD ACN 003 854 626 AND ANOTHER AS NAMED IN THE SCHEDULE; ORION CORPORATION AND OTHERS AS NAMED IN THE SCHEDULE File number: NSD 2456 of 2013 Judge: RARES J Date of judgment: 21 August 2015 Catchwords: PATENTS – whether patent invalid for failure to define invention – construction of patent – whether characteristics described in complete specification defined invention or constituted preferred embodiments – infringement – addition of integers to invention did not create a new working combination of integers to take claim beyond infringement – whether claims sufficiently clear – construction of phrase “substantial portion” – elucidation of a workable standard for skilled addressee must form part of construction of claim – whether claims fairly based on matter described in specification – description of certain embodiments in specification did not exclude those embodiments from invention merely because other embodiments described as preferable – whether claims lacked utility – whether assertion of monopoly in claims limited to useful results – determination of relevant priority date – whether claims lacked novelty compared with prior art base – skilled addressee’s “background knowledge” of extrinsic matters not relevant to consideration of novelty – whether invention involved inventive step – consideration of difficulties and complications inventors faced, in determining obviousness of invention Legislation: Patents Act 1990 (Cth) Cases cited: Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171
Apotex Pty Ltd v Les Laboratoires Servier [2013] FCA 1426
AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324
Austal Ship Sales Pty Ltd v Stena Rederi Aktiebolag (2008) 77 IPR 229
Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420
Bitech Engineering Pty Ltd v Garth Living Pty Ltd (2010) 86 IPR 468
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260
Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1987) 15 FCR 382
Firebelt Pty Ltd v Brambles Australia Ltd (t/as Cleanaway) (2002) 188 ALR 28
General Tire& Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457
GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Ltd (2013) 305 ALR 363
ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc (2000) 106 FCR 214
Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1
Lewis v Daily Telegraph Ltd [1964] AC 234
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) 235 CLR 173
Martin v Scribal Pty Ltd (1954) 92 CLR 17
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253
Monsanto Co v Commissioner of Patents (1974)…
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- Case
- [2015] FCA 909
- Decision Date
CaseChat Overview and Summary
The primary legal issues before the court were whether the patent was valid, specifically whether it had failed to define the invention, whether it had sufficient clarity, and whether it had utility. Additionally, the court had to determine whether the claims were clearly based on the matter disclosed in the specification, and whether they lacked novelty and inventive step compared to the prior art. The court also had to consider whether the claims were infringed by Actavis' products.
In reaching its decision, the court found that the patent and the claims were valid. The court held that the claims were clear and that the specification sufficiently described the invention. The court also found that the claims were not obvious to a skilled person at the relevant priority date and that they had novelty and inventive step over the prior art. Furthermore, the court determined that Actavis' products infringed the patent claims.
The court dismissed all of Actavis' challenges to the validity of the patent and claims, affirming that the patent was valid and enforceable. The court found that the claims were clearly based on the matter described in the specification and that the skilled addressee would have understood the claims. The court also held that the claims were not lacking in utility and that they were limited to useful results.
The court ordered the parties to prepare draft orders to give effect to these reasons and to address the issue of costs. The parties were instructed to confer and prepare the draft orders by a specified date. If the parties could not agree on the form of the orders, they were required to provide written submissions to the court. The proceedings were then stood over for a mention on a specified date.
Orders
Orders of the court
1. On or before 28 August 2015 the parties confer and prepare draft orders to give effect to these reasons and:
(a) if the form of those orders is:
(i) agreed provide them to the associate to Rares J;
(ii) not agreed provide the respective forms of orders for which each contends together with written submissions limited to one page in support;
(b) deal with the question of costs, if agreed.
2. If on or before 2 September 2015 the parties cannot agree on what order for costs is appropriate, they confer as to a timetable to file and serve any evidence and written submissions limited to five pages in chief and reply so that the question of costs be ready to be heard on a date to be fixed.
3. The proceedings stand over to 28 August 2015 at 2.15 pm for mention.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Background
Background to the litigation
Full text does not contain this section.
Evidence
Evidence Before The Court
Full text does not contain this section.
Decision
Reasons for decision
Ratio Decidendi
Legal Principle Established
Next, the patentee stated that one embodiment of “the said composition of the invention” was “pharmacokinetically comparable” to the known reference formulations, and another embodiment was “substantially bioequivalent with” those reference formulations (page 13 par 3 – page 14):e.g. the bioavailability achieved with the composition of the invention is at levels comparable to that achieved with the concomitant administration of the same doses of the known separate formulations of entacapone, levodopa and carbidopa, e.g. the entacapone and levodopa-carbidopa formulations used herein as a reference. (See also Examples). (emphasis added) Importantly, the specification then set out five preferred embodiments using the same dosage combinations as in [40] above, the first of which was (page 14 par ):In preferred embodiments,a}the therapeutic effect, such as pharmacokinetics, e.g. bioavailability, achieved with a combination composition of the invention of the dose of 200 mg entacapone/100 mg levodopa/25 mg carbidopa is comparable to that of the known formulation of entacapone and the known formulation of levodopa-carbidopa administered concomitantly at the same doses of active agents as the present combination composition; The specification stated that COMTESS and COMTAN were made using compaction granulation for which “large amounts of excipients are needed to obtain compressible granules and tablets having the desired, fast, dissolution behaviour of an immediate release formulation”. The patentee said that the compactability of entacapone was sufficient to allow a tablet with a 200 mg dose that was relatively easy to swallow. The patentee then explained that the compactability of the fixed dose combination tablets was “surprisingly worse than that of entacapone alone”. It said that using polyethylene glycol improved compactability but produced tablets “indicated to be unstable in storage”. The specification stated that the size of a 3-in-one composition prepared by compaction granulation could become too large “especially for parkinsonism patients who have difficulties in swallowing” (page 16). Relevantly, the specification then set out consistory clauses for claims 16 and 17, the latter dealing with a four step process for preparing an oral solid composition “according to the invention”. That process consisted of, first, mixing pharmacologically effective amounts of entacapone and levodopa with at least one pharmaceutically acceptable excipient and, optionally, a disintegrant to obtain a first mixture, secondly, granulation of that mixture to obtain a plurality of granules, thirdly, adding a pharmacologically effective amount of carbidopa and optionally both a lubricant and one or more pharmaceutically acceptable excipients to the granules to obtain a second mixture and, last, formulating the second mixture into a plurality of dosage forms (page 17 par 1). The specification discussed different mixing techniques, including wet granulation and coating for the tablets (page 17 par 2) and then stated (page 17 par 3 – page 18):By using the process of the invention tablet compositions of the invention may be made which are particularly small for the dosages contained therein and are convenient to administer. These may be any of a wide variety of shapes, although an oval form is preferred. The small size is particularly surprising in view of the size of the presently commercialized COMTAN®/COMTESS® entacapone tablet and in view of the fact that entacapone is difficult to compress and still give an acceptable release especially in the presence of levodopa and carbidopa. Furthermore, we have found that the composition of the invention surprisingly have [sic] especially good flowability properties. (emphasis added)