Rimfrost As v Aker BioMarine Antarctic As - [2019] APO 28

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Rimfrost AS v Aker BioMarine Antarctic AS [2019] APO 28

Patent Application: 2013227998

Title:Bioeffective Krill Oil Compositions

Patent Applicant:                   Aker BioMarine Antarctic AS
Opponent:  Rimfrost AS
Delegate:  K. Wagg
Decision Date:  20 June 2019
Hearing Date:  13 February 2019, further submissions invited from Aker BioMarine Antarctic AS, but were never received.

Catchwords: PATENTS – Opposition to Grant under Section 59 – opposition successful – lack of clear enough and complete enough disclosure not established – lack of clarity not established – lack of support not established – priority date considered – lack of novelty not established – lack of inventive step established – lack of utility not established – lack of manner of manufacture not established – lack of best method of performance not established – inventive concept and technical contribution considered– opportunity to file further amendments – costs awarded against the Applicant.

Representation: Patent attorney for the applicant: Pizzeys
Solicitor for the Opponent: Katrina Crooks of Shelston IP Lawyers Pty Ltd.
Patent attorney for the opponent: Dr Michael Zammit of Shelston IP Pty Ltd.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2013227998

Title:Bioeffective Krill Oil Compositions

Patent Applicant: Aker BioMarine Antarctic AS
Date of Decision: 20 June 2019
DECISION
The Opposition is successful. Claims 1-6 lack support and lack an inventive step.
Costs awarded against the Aker BioMarine Antarctic AS in accordance with Schedule 8.
Subject to appeal, the Aker BioMarine Antarctic AS is given 2 months to file suitable amendments.
REASONS FOR DECISION
Background

Patent application number 2013227998 (the Opposed Application or the Specification) was filed on 11 September 2013. The patent request claims divisional status from patent application number 2011213836 (the parent), now withdrawn. I note that the parent was itself a divisional of the granted patent number 2008231570 (the grandparent). The Opposed Application therefore claims an earliest priority date of 28 March 2007. I note that the grandparent has been re-examined and amended, with the re-examination requestor, Neptune Technologies & Bioresources Inc., reaching an agreement after an interlocutory application had been filed with the Federal Court.
The applicant is Aker BioMarine Antarctic AS (the Applicant). On 29 April 2014 the Applicant filed a request for examination with the Commissioner. Consequently, the substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar Act) apply to the Opposed Application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. Any subsequent references to sections of the Patents Act relate to the Patents Act 1990 as amended by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991.
The Opposed Application was examined and advertised as accepted by the Commissioner on 20 October 2016. Rimfrost AS (the Opponent) filed a notice of opposition to grant on 20 January 2017 under section 59 of the Act. During examination a third party, also represented by Shelston IP Pty Ltd, filed information under Section 27. This decision is in relation to the opposition to grant under section 59 (this opposition) as opposed by Rimfrost AS. I note that Enzymotec Ltd also filed a notice of opposition, however, Enzymotec Ltd withdrew its opposition on 3 March 2017.
After evidence in support was filed, the Applicant sought leave to amend the specification on 20 October 2017 and filed their evidence in answer on the following day. The amendments were to the claims and the Commissioner stayed these proceedings until the outcome of those amendments was known. The amendments were allowed and incorporated into the specification on 8 March 2018.
A hearing was held in Sydney on 13 February 2019 to decide this opposition. The Applicant appeared by written submissions.
The Grounds of Opposition
The Statement of Grounds and Particulars was amended and then further amended to allege the claims were not a manner of manufacture, not novel, did not involve an inventive step, lacked utility, did not comply with subsections 40(2)(aa) and 40(2)(a) and lacked both clarity and support under subsection 40(3). All grounds were pressed.
Onus and Standard of Proof
The onus lies with the Opponent to satisfy me that, on the balance of probabilities, a ground of opposition exists. [1] If I am satisfied then I may refuse the Opposed Application.[2]
[1] Section 60(3A).
[2] Ibid.
Evidence
The parties relied on the following evidence:

Evidence Declarant Date Reference Exhibits

In Support Prof Colin Barrow 19 July 2017 Barrow #1 CB-1 to CB-27

In Answer Mr Finn Myhren 20 October 2017 Myhren FM-1 to FM-5

In Reply Prof Colin Barrow 5 March 2018 Barrow #2 CB-28 to CB-29
The Specification

Before commencing to construe the specification, I note what Middleton J said:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”[3]
[3] Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139].
In order to properly construe the specification it is important to obtain an idea of the technology the invention relates to and from there obtain a picture of the person skilled in the art. A good starting point for this is the field of the invention.
The Field of the Invention
The Opposed Application begins by outlining the field of the invention as:
“This invention relates to extracts from Antarctic krill that comprise bioactive fatty acids.”[4]
[4] Specification page 1 lines 4-5.
The invention clearly relates to extracts from Antarctic Krill in particular. I also note that the fatty acids in the extracts are said to be bioactive, meaning they are not inert in biological systems.
Following the Field of the Invention, the specification provides a section entitled “Background of the Invention” where prior art as well as problems with it is discussed. I will consider that now.
Background of the Invention
The Background begins with a description of Antarctic Krill (Euphausia superba)[5] before discussing a known extraction method of krill oil using solvent extraction.[6] This method uses acetone as the solvent to extract the krill followed by recovery of lipid rich fraction by evaporation of the acetone.[7] The solid krill is then further extracted with ethanol.[8] The specification states that the compositions produced by these methods contain at least 75 μg/g astaxanthin and preferably 90 μg/g astaxanthin.[9]
[5] Ibid lines 8-12.
[6] Ibid line 13.
[7] Ibid lines 15-17.
[8] Ibid lines 17-19.
[9] Ibid lines 20-21.
The specification then goes on to state that krill oils have therapeutic properties and indicates that krill oils have been described as effective for a range of ailments, including cardiovascular conditions.[10]
[10] Ibid lines 23-27.
The specification follows this beneficial activity by describing a prior art krill oil composition comprising a phospholipid and/or a flavonoid and states that the phospholipid content could be as high as 60 % and the content of certain omega-3 fatty acids, namely eicosapentaenoic acid and docosahexaenoic acid (EPA and DHA, respectively), content as high as 35 % (w/w).[11] The specification states that the prior art disclosed uses for the phospholipids including nutraceuticals and pharmaceuticals.[12]
[11] Ibid lines 28-30.
[12] Ibid line 31.
After noting that the compositions containing the phospholipids have these uses, the specification discusses the use of supercritical CO₂ to extract neutral oils such as esterified forms and free astaxanthin.[13]
[13] Ibid lines 32-35.
The specification then notes that extraction of phospholipids has been done on salmon roe by a method involving supercritical CO₂ and a solvent modifier.[14]
[14] Ibid page 2 lines 1-4.
The specification then states that the previous methods of krill oil extraction require transport of the krill to a processing site and there are problems with decomposition.[15] It then states that there is a need to address this issue.[16]
[15] Ibid lines 5-10.
[16] Ibid lines 13-15.
From this background information I am able to consider the characteristics of the person skilled in the art.
The Person Skilled in the Art (PSA)
The person skilled in the art (PSA) has been considered previously with Finkelstein J saying:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.” [17]
[17] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70].
However, the PSA is not a real person, but an artificial construct that is used as a tool of analysis by the Court, and in this case the Commissioner, to make a determination. This concept was established in AstraZeneca v Apotex Pty Ltd:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”[18]
[18] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23].
Lord Diplock stated that those likely to have a practical interest in the subject matter are the PSA:
“My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. ‘skilled in the art’)”[19]
[19] Catnic Industries Inc. v Hill & Smith Limited [1982] RPC 183 at 243.
In Australia the Full Federal Court approved this approach with Heerey, Emmett and Dowsett JJ stating:
“The uninventive but skilled worker is likely to have a practical interest in the subject matter of the claimed invention.”[20]
[20] Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315; 56 IPR 248 at [39], 257.
The Opponent submitted that the PSA should have practical experience in that specific art, not broader or related arts citing Fina Research SA v Halliburton Energy Services Inc.[21] In that case the technology involved formulated drilling mud used in the petroleum industry and the expert was described as being a “general chemist” with knowledge of the petroleum industry but did not give evidence that he had formulated drilling mud and his testimony was not accepted as representative of the PSA.
[21] [2003] FCA 55, [8]-[9].
It is clear from the background I set out above the Opposed Application is concerned with the pharmacological or nutraceutical benefits of the phospholipid portion of krill oil extracts, the extraction techniques of the prior art, including the use of supercritical CO₂ with a solvent modifier and the problems with transport to processing sites. Therefore, the PSA would have knowledge of marine lipid extraction processes as well as pharmaceutical or nutraceutical knowledge. I consider that this must be a team of people in order to bring these disciplines together to produce the product.
In the current case the experts that have provided declarations are Prof Barrow for the Opponent and Mr Myhren for the Applicant. The Opponent submitted that Mr Myhren is not in a position to comment on the PSA as he does not describe any expertise in processing crustaceans, krill oil, or production of astaxanthin. I note that Mr Myhren started working for the Applicant in 2013 but has experience in a pharmaceutical development company from 2001 and before that he worked at Norsk Hydro.[22] I note Norsk Hydro appears to be a very big industrial company involved in different industrial chemistry areas. Mr Myhren states that Norsk Hydro was a world leader in salmon farming and fish feed in the 1980s and as the market became interested in omega-3 fatty acids he worked on a project, but not as project leader, which sought to isolate and purify EPA and DHA from marine sources.[23] This project was spun off into a different company.[24] In my view, although he was not the project leader, and the project appears to have moved to a different company, it is “a practical interest” and some practical experience in the field. I also do not completely discount the fact that he worked at Clavis Pharma before the priority date, given that krill oil has purported pharmaceutical benefits. His experience in the pharmaceutical industry and in the extraction and isolation of long chain polyunsaturated fatty acids (PUFAs) from marine sources is of relevance.
[22] FM-1; Myhren at [4].
[23] Myhren at [6].
[24] Ibid.
Prof Barrow has an academic background in bioorganic chemistry and studied marine natural products in his PhD. He started working with omega-3 and carotenoid fermentation as well as their formulations at Ocean Nutrition Canada in late 2000 and has worked in omega-3 research since.[25]
[25] Barrow #1 at [6-16].
Both experts were provided with the Federal Court of Australia ―Practice Note CM7―Expert witnesses in proceedings in the Federal Court of Australia.[26] I note that in the setting of a patent opposition hearing, the Federal Court rules on evidence do not apply and instead the weighting and evaluating of evidence to decide the characteristics of the PSA and the common general knowledge is the normal work of a delegate of the Commissioner of Patents. However, use of the practice note is common and I appreciate that it affords a high standard of evidence. Given the experience of both experts I have outlined above I consider that they are both in a position to comment on the PSA because they both have a practical interest in the field at the priority date.
[26] Barrow #1 at [32]; Barrow #2 at [10].
The Invention Described in the Specification
The specification provides several embodiments and aspects of the invention under the Summary of the Invention beginning on page 2. Of relevance to the current claims, the following embodiment indicates that the compositions comprise:
“about 3 % to 10 % ether phospholipids on a w/w basis; from about 35 % to 50 % non-ether phospholipids on w/w basis, so that the total amount of ether phospholipids and non-ether phospholipids in the composition is from about 48 % to 60 % on a w/w basis; from about 20 % to 45 % triglycerides on a w/w basis; and from about 400 to about 2500 mg/kg astaxanthin.”[27]
[27] Specification page 3 lines 4-9.
The composition is obtained by extraction of the krill oil from a krill meal. The components are all defined in the specification and it is useful to add these definitions here.
Phospholipid
Phospholipids are defined as being fatty acids with a diacylglycerophosphate backbone with a generic structure shown below.[28] R1 and R2 are fatty acid residues, such as EPA or DHA, and R3 is H or a nitrogen containing compound, for example, choline (HOCH₂CH₂N⁺(CH₃)₃OH^-).[29] Where R3 is choline the molecule is a phosphatidylcholine.
Ether Phospholipid
[28] Ibid page 10 line 29 – page 11 line 8.
[29] Ibid page 11 lines 1-7.
An ether phospholipid is defined as being a phospholipid with an ether bond at position 1 of the glycerol backbone with examples including alkylacylphosphatidylcholine (AAPC), lyso-alkylacylphosphatidylcholine (LAAPC) and alkylacylphosphatidylethanolamine (AAPE).[30]
Astaxanthin
[30] Ibid lines 9-12.
Astaxanthin refers to the molecule shown below.[31]
Astaxanthin esters
[31] Ibid line 20.
Astaxanthin esters refer to the fatty acids esterified at the OH group in the above astaxanthin molecule.[32]
[32] Ibid page 12 lines 1-2.
The method of extracting the krill oil is provided for in some embodiments and is described as follows:
“the extracting step comprises extraction by supercritical fluid extraction. In some embodiments, the supercritical fluid extraction is a two step process comprising a first extraction step with carbon dioxide and a low concentration of a co-solvent (e.g. from about 1-10 % co-solvent) and a second extraction step with carbon dioxide and a high concentration of a co-solvent (e.g., from about 10-30 % co-solvent).”[33]
[33] Ibid page 5 lines 18-24.
The co-solvent used is said to be “preferably ethanol”[34].
[34] Ibid line 24.
The krill oil is also said to be encapsulated in some embodiments[35] with the effective amount of a krill oil composition said to be from about 0.2 to 10 grams.[36]
[35] Ibid page 9 lines 1-2.
[36] Ibid lines 2-3.
The detailed description of the invention follows before the examples start on page 23. Example 1 relates to a krill meal, an oil which is referred to as asta oil, and stickwater. Example 2 is concerned with a Japanese patented ethanol extraction of the krill meal in example 1. Examples 3-4 use a two-step process to extract the krill oil from the krill meal using supercritical CO₂ followed by supercritical CO₂and 20% ethanol to remove the polar compounds. In Example 5 the asta oil from example 1 was blended with the polar extracts from Example 4 and the ethanol removed. This product was encapsulated. It was noted that the any further increase in phospholipids increased viscosity and made encapsulation difficult.[37] Example 6 takes fresh krill from a harvesting trawl and cooks it and denatures it followed by drying. After 19 months of storage the krill meal is extracted with supercritical CO₂ followed by a second step with supercritical CO₂ and 20% ethanol. Example 7 also extracts krill lipids from a dried food grade powder of krill using supercritical CO₂ and 5 % ethanol and then the ethanol content was increased to 23% and extraction maintained for 3 hours and 40 minutes before filtering and evaporation. Example 8 is an analysis of the krill oil obtained in Example 7 compared to a commercially available krill oil (Neptune Krill Oil; NKO). Examples 9, 11 and 12 are biological studies on the effects of the Example 7 in rats for various biological health markers for certain diseases. There is no Example 10.
[37] Ibid page 40 lines 11-12.
The specification ends with 6 claims. Claims 1 and 6 are independent with claim 1 being the broadest claim. A full list of the claims is provided for in Appendix A.
The Claims and Clarity
The approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification” [38]
[38] [2009] FCAFC 70, 81 IPR 228 at [118] – [120].
It is also a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim".[39] Therefore following construction of the claims, if the monopoly defined cannot be determined, then the claims must fail for want of clarity. Claim 1 as accepted is repeated below:
“Encapsulated Euphausia superba krill oil comprising a capsule containing greater than 40% phosphatidylcholine w/w, from 6.0% to 10% ether phospholipids w/w and greater than 100 mg/kg astaxanthin esters.”
[39] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59.

The claim is to the krill oil from Euphausia superba in a capsule with concentrations of phosphatidylcholine and astaxanthin greater than the amounts defined. The concentrations of the ether phospholipids are defined in a range. The specification defines these compounds and their definitions were not in dispute. I have outlined their definitions above.
The Opponent submitted several reasons why they believed the claims were unclear, the first reason being that there are seasonal variations in the concentrations of phosphatidylcholine, ether phospholipids and astaxanthin esters. Mr Myhren mentions that the examples are only representative and that natural variations in concentrations would occur. Mr Myhren said:
“those variations would fall within the scope of the claims.”[40]
[40] Myhren at [22].
In the context of the full paragraph I believe Mr Myhren was saying that based on the examples it would be easy to produce something within the scope of the claims, despite variations. The Opponent submitted that Example 8 did not have the characteristics of claim 1. Indeed, according to Mr Myhren, Example 8 yielded 36.07 % phosphatidylcholine.[41] However, Mr Myhren also stated that Example 6 yielded a krill oil with 42.22% phosphatidylcholine.[42] The Opponent submitted that because of this “practically speaking” it would be difficult to know if they infringed the claims. I do not see this as a lack of clarity. There is a clear understanding by the expert as to what the krill oil comprises, and he is able to apply that to the examples. The scope of the monopoly can be determined. Furthermore, Prof Barrow commented on the scope of the claims and this did not appear to be an issue for him either.[43]
[41] Myhren at [21].
[42] Ibid.
[43] Barrow #1 at [178].
The Opponent submitted other aspects of lack of clarity. These start by commenting on whether or not the claim may include krill oil only sourced from that species mentioned in the claim or if it can be a blend of components. In the context of the specification, krill oil is blended in some examples, however, it is all sourced from the one species of krill. There does not appear to be any evidence of this creating any ambiguity for the declarants.
The Opponent’s remaining aspects of lack of clarity appear to have been reflected in Prof Barrow’s first declaration when he made some comments on his interpretation of the claims.[44] He states that claim 2 defines “said polar krill oil” and there is no antecedent to the term “polar”. Although this is the case, the species of krill is a polar species and because of that it appears that this can be resolved by using common sense and reading the claim in context; the scope can be determined. Furthermore, it did not appear to create further problems in the evidence.
[44] Barrow #1 at [178]; Opponent’s submissions at 220.
The Opponent then states that the use of the term “about” in claim 3 when referring to 25% triglycerides is unclear. However, Prof Barrow states that he understands it to mean +/- 10%.[45] Which I consider means 10% of the 25% since Prof Barrow then goes on to state that anything less than 27-28% would be at the upper end of the range of less than about 25%.[46] Given Prof Barrow’s ability to construe this term I do not consider it to be unclear.
[45] Ibid.
[46] Ibid.
The Opponent submitted that both claim 4 and claim 6 are unclear as they define at least 36 % w/w omega-3 fatty acids and the claim does not state if these are attached to the phosphatidylcholine, the ether phospholipids, the astaxanthin or a combination of these or some other undefined ingredient. Prof Barrow states that this means “there is at least 36% wt% of the total weight of the oil of omega-3 fatty acids” and it is clear from the specification these can be attached to those different compounds. Based on the evidence this appears to be clear.
The Opponent also submitted that claim 5 defines the krill oil as being “suitable for oral administration” and the claim does not define how the krill oil is caused to be suitable for oral administration and that this is unclear. In my view, encapsulated krill oil would be suitable for oral administration, or even the oil itself. Although a transdermal patch or and injectable form might not be, I could envisage oil in a syringe being administered orally. Once again Prof Barrow states that “any relatively pure krill or fish oil could be produced in a food grade form” and he clearly understands what is meant by this. Therefore, this submission is not supported by the evidence.
The Opponent then submits that claim 1 defines no upper limit for phosphatidylcholine and this renders the claim unclear. Indeed, the upper limit would be that which makes the total up to 100%. Prof Barrow states that it could be significantly greater than the 40% limit and is able to construe the claim. The evidence does not establish that this is a lack of clarity.
Claims 2-5 define “the Euphausia superba krill oil of claim 1” and as claim 1 refers to the “encapsulated Euphausia superba krill oil” the Opponent submitted that this is unclear as it is not clear if these claims are directed to the encapsulated krill oil or the neat oil. There is no evidence to support this being a lack of clarity. The “encapsulated” feature of claim 1 was introduced in the amendments and neither Mr Myhren nor Prof Barrow in reply discussed the effect of this change on the dependent claims and instead focused primarily on claim 1, its support and the prior art. In my view, the intention appears to be that all claims refer to the encapsulated krill oil and I consider this to the be the correct construction. I therefore do not have the evidence to establish that this is a lack of clarity.
Conclusion on Clarity
The evidence has not established a lack of clarity.
Subsection 40(2)(a)
The amendments brought about by Raising the Bar amended subsection 40 (2) to read as follows:
“A complete specification must:
(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art”.
This provision was added with the passing of the Raising the Bar Bill and reflects a fundamental principle of international patent law where the patentee must disclose the information to work the invention to the public in exchange for the exclusive rights of the patent.[47] There is limited judicial interpretation of this provision in Australia with Perram J merely stating that:
“the only requirement now in s 40(2)(a) relates to enablement.”[48]
[47] Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011.
[48] Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2018] FCA 421 at [167].
In that case the Respondent did not advance a case that the specification did not enable the PSA to perform the invention and so the ground was addressed without the need to determine a test for enablement.[49]
[49] Ibid.
With that in mind I will follow the approach which has been adopted by the Commissioner utilising the jurisprudence in foreign jurisdictions which have use the same wording. The Deputy Commissioner in CSR Building Products Limited v United States Gypsum Company[50] considered that the test involves the following three steps:
(1) Construe the claims to determine the scope of the invention as claimed,
(2) construe the description to determine what it discloses to the person skilled in the art, and
[50] [2015] APO 72.
[51] Ibid at [89].
(3) decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.[51]
This was expanded by another Deputy Commissioner in Evolva[52] to include the following two questions as sub-questions to question (3) above:
(a)Is it plausible that the invention can be worked across the full scope of the invention?
[52] Evolva SA [2017] APO 57.
(b)Can the invention be performed across the full scope of the claims without undue experimentation?
This approach has subsequently been adopted by delegates of the Commissioner,[53] and is also summarised in those decisions. Furthermore, in Gary B Cox v MacroGenics, Inc. the delegate provided a good summation of the UK law as it stands.[54] The following are extracts from that decision which I agree with an apply to the current case.
[53] See, e.g. Rimfrost AS v Aker BioMarine Antarctic AS [2018] APO 34; Cytec Industries Inc. v Nalco Company [2018] APO 4; Grant Fisher v ToolGen Incorporated [2018] APO 65; Gary B Cox v MacroGenics, Inc.[2019] APO 13.
[54] Gary B Cox v MacroGenics, Inc.[2019] APO 13 at [56] et seq.
The Supreme Court in the UK recently provided further guidance with regard to the plausibility consideration in Warner-Lambert Company LLC v Generics (UK) Limited (t/a Mylan) and ors (Warner Lambert).[55] Warner-Lambert considered the plausibility element of clear enough and complete enough disclosure with respect to a second medical use (Swiss style) claim. In a majority decision, the conclusions of the lower courts with regard to the plausibility threshold were overturned, with Lord Sumption (with whom Lords Reed and Briggs agreed) stating:
“They [the Court of Appeal] considered that the threshold was not only low, but that the test could be satisfied by a ‘prediction … based on the slimmest of evidence’ or one based on material that was ‘manifestly incomplete’. Consistently with that approach, they considered (paras 40, 130) that the Board’s observations in SALK laid down no general principle. I respectfully disagree. The principle is that the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. … The test is relatively undemanding. But it cannot be deprived of all meaning or reduced, as Floyd LJ’s statement does, to little more than a test of good faith. Indeed, if the threshold were as low as he suggests, it would be unlikely to serve even the limited purpose that he assigns to it of barring speculative or armchair claims.”[56]
[55] [2018] UKSC 56.
[56] Warner-Lambert at [36].
He then commented that “[p]lausibility is not a term of art, and its context is inevitably influenced by the legal context” and identified a number of considerations relevant to the context of second medical use claims:
“First, the proposition that a product is efficacious for the treatment of a given condition must be plausible. Second, it is not made plausible by a bare assertion to that effect, and the disclosure of a mere possibility that it will work is no better than a bare assertion. As Lord Hoffman observed in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] RPC 28, para 28, ‘it is hard to see how the notion that something is worth trying or might have some effect can be described as an invention in respect of which anyone would be entitled to a monopoly’. But, third, the claimed therapeutic effect may well be rendered plausible by a specification showing that something was worth trying for a reason, i.e. not just because there was an abstract possibility that it would work but because reasonable scientific grounds were disclosed for expecting that it might well work. The disclosure of those grounds marks the difference between a speculation and a contribution to the art. … Fourth, although the disclosure need not definitively prove the assertion that the product works for the designated purpose, there must be something that would cause the skilled person to think that there was a reasonable prospect that the assertion would prove to be true. … Sixth, … the effect on the disease process need not necessarily be demonstrated by experimental data. It can be demonstrated by a priori reasoning. … Seventh, sufficiency is a characteristic of the disclosure, and these matters must appear from the patent. The disclosure may be supplemented or explained by the common general knowledge of the skilled person. But it is not enough that the patentee can provide that the product can reasonably be expected to work in the designated use, if the skilled person would not derive this from the teaching of the patent.”[57]
[57] Warner-Lambert at [37].
To my mind, these considerations are all directed in a broad sense to the notion that plausibility is a technical consideration and assertions must be based on a reasonably credible technical or scientific basis derivable from the specification as understood by the skilled person. While Sumption LJ’s comments were made in the context of second medical use claims, this notion is generally applicable.
I note in particular that, consistent with the observation of the Court of Appeal in Regeneron Pharmaceuticals, Inc v Kymab Limited that “the skilled person may use his or her common general knowledge to supplement the information contained in the specification”[58] (applied in Grant Fisher v ToolGen Incorporated[59]), the requirement that sufficiency is a characteristic of the disclosure is tempered to the extent that the common general knowledge may be used to supplement or explain the disclosure.
[58] [2018] EWCA Civ 671 at [209].
[59] [2018] APO 65.
The Explanatory Memorandum directs to the corresponding provisions of UK legislation and the European Patent Convention in relation to the application of subsection 40(2)(a) as amended by the Raising the Bar Act.[60] Sumption LJ in Warner-Lambert has drawn from the body of UK and European cases in arriving at his conclusion, and accordingly I consider this judgment highly persuasive with regard to the application of the approach set out in Evolva. Further, while it is clear that the Supreme Court has adopted a higher threshold with respect to plausibility than that adopted by the lower courts in the UK, I do not view the reasoning as inconsistent with the Deputy Commissioner’s statements in Evolva.[61] It remains the case that, as set out in Evolva, the consideration is one of technical credibility or believability. Plausibility may be a low threshold, but it is a threshold nonetheless, and is not satisfied by mere speculation or assertion.
[60] The Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, item 8.
[61] Evolva at [43].
The second limb of the enablement test is whether performing the invention across its full scope would constitute an undue burden. The concept of an undue burden was discussed in Evolva. Having considered UK and European authorities the Deputy Commissioner concluded:
“My understanding of these authorities is that the emphasis in relation to undue burden has been on the nature of the work that is required by the skilled person in view of the guidance in the specification. To this end, one approach has been to ask whether the skilled person would be required to undertake a ‘research programme’ in order to perform the invention.”[62]
[62] Evolva at [33].
Put another way (as approved by Kitchin J in Eli Lilly & Co v Human Genome Sciences, Inc[63]):
“… patent specifications need not set out every detail necessary for performance, but can leave the skilled man to use his skill to perform the invention. In so doing he must seek success. He should not be required to carry out any prolonged research, enquiry or experiment. He may need to carry out the ordinary methods of trial and error, which involve no inventive step and generally are necessary in applying the particular discovery to produce a practical result. In each case, it is a question of fact, depending on the nature of the invention, as to whether the steps needed to perform the invention are ordinary steps of trial and error which a skilled man would realise would be necessary and normal to produce a practical result.”
[63] [2008] EWHC 1903; [2008] RPC 29 at [241].
The consideration of what constitutes an undue burden is necessarily dependent upon the nature of the technology, and factors relevant to the consideration include the level of predictability in the art and the level of guidance in the specification.[64]
[64] Evolva at [34]-[35].
A feature which is defined in broad terms will be allowable if it can be understood to be a principle of general application – which was described by Lord Hoffmann in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd as:
“an element of the claim which is stated in general terms. Such a claim is sufficiently enabled if one can reasonably expect the invention to work with anything that falls within the general term”. [65]
[65] [2005] RPC 169 at [112].
It is still necessary that the invention can be performed across the scope of the claims without an undue burden.[66] In American Home Products Corporation v Novartis Pharmaceuticals UK Ltd[67] (American Home Products) Aldous LJ made the following observations in relation to enablement in the context of functional limitations to a claim:
“There is a difference between on the one hand a specification which requires the skilled person to use his skill and application to perform the invention and, on the other, a specification which requires the skilled person to go to the expense and labour of trying to ascertain whether some product has the required properties. When carrying out the former the skilled person is trying to perform the invention, whereas the latter requires him to go further and to carry out research to ascertain how the invention is to be performed. If the latter is required, the specification would appear to be insufficient.”[68]
[66] See, e.g., Novartis AG v Johnson & Johnson Medical Limited [2009] EWHC 1671 at [244].
[67] [2001] RPC 159.
[68] American Home Products at [40].
The Opponent submitted that the specification does not provide an example of an oil having 6-10% w/w ether phospholipids, greater than 100 mg/kg of astaxanthin and greater than 40% phosphatidylcholine. These are features of claim 1. In addition, the Opponent submitted that there is no example having the features of the additional claims, i.e. an oil with greater than 45% phosphatidylcholine, a triglyceride concentration less than about 25% w/w and an omega-3 fatty acid content of at least 36% w/w. The Opponent’s submission alleged that it is not plausible or credible that any 2-step supercritical fluid extraction (SFE) method will result in an oil falling within the scope of the claims and it is an undue burden to determine what specific extraction conditions will produce the claimed oil.[69]
Construction of the claim
[69] Opponent’s submissions at 106.
I have set out claim 1 above. The claim relates to encapsulated krill oil with specific lower limits for phosphatidylcholine (greater than 40% w/w), astaxanthin (greater than 100 mg/kg) and a set limit of 6.0-10% w/w ether phospholipids. Claim 3 defines an upper limit of the amount of triglycerides (less than about 25% w/w) and claim 4 has a lower limit of 36% w/w of omega-3 fatty acids.
Construction of the description
The focus of the Opponent’s submissions is on Examples 7 and 8. In Example 7 a two-stage extraction of dried krill meal is carried out with supercritical CO₂ and 5% ethanol and then the ethanol content is increased to 23%. The extract was then analysed in Example 8. I have summarised the results in the table below. In Example 6 a two-step extraction using supercritical CO₂ followed by supercritical CO₂ and 20% ethanol is conducted on frozen krill meal. I have included Example 6 in the table below.

Claimed feature Example 7/table 21 Example 8/table 22 Example 6

> 40 % phosphatidylcholine w/w/; 45% w/w in claim 2 and 6 Not given 36.07 % w/w 42.22% w/w

6.0 to 10 % ether phospholipids w/w Not given 7.38 % w/w Not given

> 100 mg/kg astaxanthin esters 2091 mg/kg Not given Not given

< about 25 % triglycerides w/w in claim 3 25.9% Not given Not given

At least about 36 % omega-3 fatty acids 35.7 % Not given Not given

The Opponent noted that the specification states that the krill oil analysed in Example 8 is the same as the extract made in Example 7, however, the total polar lipids in Example 8 is given as 47.9 % and the total polar lipids given in Example 7 is 50.55%.

Examples 7 and 8 have different starting materials to Example 6 and the protocols of the extractions are different, with different temperatures, pressures and amounts of ethanol. Prof Barrow states that because of the differences in the experimental conditions between Examples 6 and 7 the analysis results cannot be combined.[70] I accept this, particularly given that the one feature that is provided for in Example 6 is different to Example 7 so I am unwilling to assume that all the other features of Example 7 are the same as Example 6.
[70] Barrow #2 at [27].
Mr Myhren states that the differences can be accounted for by variations which could be expected. He states that:
“Based on the examples, it is my opinion that a person of skill in the art could easily produce krill oil from the identified starting materials in the examples that meets the limitations of the claims. It would be apparent to a person of skill in the art that krill oils with the compositions described in the Examples are representative and that variations in the composition could be expected. It can be expected by a person of skill in the art that those variations would fall within the scope of the claims.”[71]
[71] Myhren at [22].
I accept that there might be variations in wild krill populations, and this might account for the differences between Example 7 and Example 8 which are said to be the same extract. However, Example 7 is said to be the method used to make the “Superba” product[72] and the amount of phosphatidylcholine is lower than that claimed and if it is expected that the variations would fall within the scope of the claims then it does not account for why this example is not within the scope of the claims.
[72] The Opposed Application page 45 line 13.
Example 6 provides a krill oil with a phosphatidylcholine concentration within the scope of claim 1, however, the other features of the claim are not given in the specification. The next questions then follow.
Is it plausible that the PSA could make a krill oil within the scope of the claims based on the disclosure?
When Prof Barrow responded to Mr Myhren’s comment, which I have quoted above, he did not appear to disagree entirely. He stated that he did not think Mr Myhren was competent to comment on the PSA at the priority date and he stated:
“because the ether phospholipid concentration scales with the total phospholipid concentration [to have 6-10% as claimed] means that the total phospholipid concentration is likely to be around 60% or greater [and no example has this]”.[73]
[73] Barrow #2 at [38].
I find this comment hard to understand given that Example 8 has an ether phospholipid concentration of 7.38 % and a total phospholipid concentration of 50.55%. I do not accept that this means it would not be plausible for the PSA to make a krill oil with 6-10 % ether phospholipids.
Prof Barrow states that if a krill oil could be easily produced from the examples which falls within the scope of the claims then:
“it must equally apply to the oils which are documented before the priority date, too.”…“and based on Mr Myhren’s comments it seems that on his view a skilled person would easily be able to produce a krill oil within the claims based on [the prior art] too.”[74]
[74] Barrow #2 at [39].
Mr Myhren is arguing that from the examples in the specification it would be easy to produce something within the scope of the claims. Now it appears the Opponent is arguing that it would be difficult to do something within the scope of the claims based on the examples in the specification but easy to do something within the scope of the claims based on the prior art and the Applicant’s arguing the reverse.
The krill oil produced in Example 7 is 4% w/w below the limit of phosphatidylcholine in claim 1 but has all the other features and I am unsure if Example 6 has other features within the scope of the claims. However, the difference between the phosphtidylcholine level in Example 7 and the claims is only small and therefore I do think that it is indeed plausible for the PSA to make a krill oil within the scope of the claims. The variations mentioned by Mr Myhren are not addressed by the specification but if this is the reason why Examples 7 and 8 differ from the claims then adjustments would need to be made. This leads to the next question.
Can the PSA, based on the specification, make a krill oil within the scope of the claims without undue experimentation?
The question of undue experimentation does allow for some trial and error and supplementing the disclosure with the common general knowledge. However, this supplementation cannot be in a way that could be considered inventive.[75] I accept that natural variations in krill oil extracts would exist and a PSA would understand this as stated by Mr Myhren. The argument of Prof Barrow is simply that if it is easy then it is also easy to do based on the prior art. It follows that both declarants found that small adjustments to the examples would be “easy” and it is clear from Prof Barrow’s other comments on the prior art that these adjustments can be done without undue burden. Therefore, on the balance of probabilities I do not consider it to be an undue burden for the PSA to produce a krill oil within the scope of the claims based on the disclosure of the specification and therefore there is a clear enough and complete enough disclosure.
[75] Grant Fisher v ToolGen Incorporated [2018] APO 65 at [63].
Subsection 40(3)
The amendments brought about by Raising the Bar introduced the following requirement under subsection 40(3):
“The claim or claims must be … supported by matter disclosed in the specification.”
Perram J discussed support in Encompass Corporation Pty Ltd v InfoTrack Pty Ltd[76] where he cited the Explanatory Memorandum and concluded that it did not allow for any continuity of the law of fair basis. Perram J did not elaborate on the approach to be taken in assessing support.
[76] [2018] FCA 421 at [168]-[172].
In CSR Building Products Limited v United States Gypsum Company (CSR) the delegate provided a three-step approach:
(1) construe the claims to determine the scope of the invention as claimed,
(2) construe the description to determine the technical contribution to the art, and
[77] [2015] APO 72 at [110].
(3) decide whether the claims are supported by the technical contribution to the art.[77]
The Deputy Commissioner in CSR relied on UK and European law in order to formulate these questions. The technical contribution the patent makes to the art “supports” or “justifies” the extent of the monopoly which can be claimed.[78]
[78] Generics (UK) LTD v H Lundbeck A/S [2009] RPC 13 at 14, citing with approval the Technical Board of Appeal in para 3.3 of its decision in Fuel Oils/EXXON (T 409/91) [1994] O.J. E.P.O. 653.
The Opponent made further arguments that there was no technical contribution made. It is useful to quote Lord Walker here:
“‘Inventive concept’ is concerned with the identification of the core (or kernel, or essence) of the invention—the idea or principle, of more or less general application (see Kirin-Amgen [2005] R.P.C. 9 paras.112–113) which entitles the inventor’s achievement to be called inventive. The invention’s technical contribution to the art is concerned with the evaluation of its inventive concept—how far forward has it carried the state of the art? The inventive concept and the technical contribution may command equal respect but that will not always be the case.”[79]
[79] Ibid at 30.
An important question will often be whether the technical contribution to the art is a general principle or if the specific example in the specification is limited to that product. Lord Hoffmann gave some examples in Biogen:
“Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them.”[80] [citations omitted]
[80] Biogen at 49.
In order to answer the question of support, the general approach is as stated by Aldous J:
“to decide whether the claims are supported by the description it is necessary to ascertain what is the invention which is specified in the claims and then compare that with the invention which has been described in the specification. Thereafter the court's task is to decide whether the invention in the claims is supported by the description. I do not believe that the mere mention in the specification of features appearing in the claim will necessarily be a sufficient support. The word ‘support’ means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed.”[81]
[81] Schering Biotech Corp.'s Application [1993] RPC 249 at 252.
In the current case, I consider the claims to be to the encapsulated krill oil product with the specific limitations on the amount of phosphatidylcholine, ether phospholipids and astaxanthin esters. It is clear from the description that the product with these characteristics is to be made by a particular process, i.e. the two-step process using supercritical CO₂ and ethanol. The Opponent argued that the process was a known process and cannot form part of the technical contribution.
In Example 6 a krill oil is extracted which has an amount of phosphatidylcholine within the scope of the claims. In Example 7 the amount of phosphatidylcholine is below the 40% w/w limit of claim 1 and 45% in the further claims. It is Example 7 that is used in the biological assays which are said to show the purported health benefits. I consider these purported health benefits of a krill oil with high levels of phosphatidylcholine and 6-10 % ether phospholipids to be part of the technical contribution. I note that the Opponent submitted that the Figures used to demonstrate the purported health benefits did not show error bars and because of this Prof Barrow was of the opinion that the activity of all three oils evaluated could be the same.[82] This would include the prior art krill oil and fish oil which were also assessed. Prof Barrow did note that in Figure 7 there was a trend whereby “Superba” has lower lipid accumulation in the liver.[83] Furthermore Example 6 might have the features of the claims and might have the purported health benefits, but this has not been demonstrated. In my view, the experimental error could be improved with further research, however, the examples do show an overall trend that demonstrates that higher levels of phosphatidylcholine and between 6-10% ether phospholipids have improved health benefits over the prior art and this is a technical contribution. Furthermore, it is clear that this technical contribution would extend even higher levels of phospholipids and therefore the claims are supported.
[82] Barrow #1 at [174]-[176].
[83] Barrow #1 at [175].
Subsection 40(2)(aa)
Even if a manner of performing an invention is self-evident, applicants are nevertheless required to set out the best method of performing the invention known to them. This requirement was confirmed by the Full Court of the Federal Court in Les Laboratoires Servier v Apotex Pty Ltd.[84]
[84] [2016] FCAFC 27.
The best method requirement is assessed on the basis of the applicant’s knowledge at the time of filing the complete specification (Rescare Ltd. v Anaesthetic Supplies Pty. Ltd.)[85]. If the applicant identifies a better method at a time subsequent to filing, there is no obligation to amend the specification to include that method.
[85] 25 IPR 119.
The Opponent’s submission stated that:
“If the claims are found to be properly disclosed and supported, it is submitted that the best method has not been disclosed.”[86]
[86] Opponent’s submissions at 188.
The Opponent also submitted that no examples fall within the scope of the claims. Indeed, the example which appears to the “best” example of the invention as it is compared to commercially available krill oils, Example 7, has a phosphatidylcholine concentration of 36% w/w and this is lower than the claimed amount of at least 40%.[87] In Example 6, the amount of phosphatidylcholine is within the scope of the claims, however, no amount of ether-phospholipid is given. As I have noted above, I am unwilling to assume the amount of phosphatidylcholine and ether phospholipids are the same as that for example 7.
[87] The Opposed Specification, table 22.
The Opponent did not make any submission on the Applicant’s knowledge of a better method at the time of filing. This question of whether or not the Applicant acted in good faith, and disclosed the best method they knew of at filing, or if they withheld the information is part of the established test.[88] As there is no evidence on this point I cannot be satisfied that the Applicant knew of a better method and consequently this ground of opposition must fail.
[88] Servier at [108].
Priority Date
The grounds of novelty and inventive step involve a comparison between the claims and the prior art base.[89] I will therefore decide the priority date here. The patent request claims divisional status from patent application number 2011213836, now withdrawn. The grandparent claims priority from four priority documents. The Opposed Application therefore claims an earliest priority date of 28 March 2007 from US 60/920,483 (US ‘483).[90] The Opponent alleged that the accepted claims are not entitled to the priority date claimed and instead are only entitled to the date of the fourth priority document US 61/024,072 (US ‘072).[91] This is relevant to the current opposition because it affects both the grounds of novelty and inventive step. It is generally accepted that the prior base is defined by publication or action before the priority date.[92] Therefore, I will form a conclusion on the priority date in order to decide the grounds of novelty and inventive step.
[89] Subsections 7(1)(a) and 7(3)(a).
[90] Exhibit CB-20.
[91] Exhibit CB-23.
[92] With the exception of “whole of contents” novelty, which will be discussed later.
The Opponent submitted that the Opposed Application is not entitled to the claimed priority date because the first three priority documents do not provide a clear enough and complete enough disclosure of the alleged invention. This is because US ‘072, dated 28 January 2008, is the first document that mentions the ether phospholipid content feature of the current claims. The Applicant submitted that the test for priority for the grandparent and parent should be the pre-Raising the Bar provision.

100. The current provision was brought in with Item 10 of part 1, Schedule 1 of the Raising the Bar Act. It applies to complete applications made on or after the day the Schedule commences and for complete applications made before that day if they had not already requested examination.[93] The Schedule commenced on 15 April 2013. The Opposed Application was filed, and examination requested, after this date, so this provision applies. However, the request for examination of the parent application was filed on 13 October 2011 and the request for examination of the grandparent was also before the commencement of this Schedule. Accordingly, these applications are governed by the pre-Raising the Bar provision. The Opponent filed submissions on this point, stating that, although it is a divisional application, subsection 43(2A) applies because the application was filed after the commencement of the Schedule. I provided the Applicant with a copy of these submissions after the hearing and gave them a week to respond. They chose not to.
[93] Item 55(1)(a)(d) and (e).
101. The priority date of a claim is determined by subsection 43(2A) which states that:
(a) prescribed circumstances apply in relation to the invention defined in the claims; and
(b) a prescribed document discloses the invention in the claim in a manner that is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.

102. However, for divisional applications the priority date is determined by regulations 3.12 and 3.13D and 3.13E. The regulations were also amended with Raising the Bar and, in particular regulation 3.13Dstates that for divisional applications filed prior to grant of the patent (which applies to the current case) the earlier application must clearly disclose the invention. I note that “clearly discloses” means a clear enough and complete enough disclosure of the invention.[94] The earlier application is the parent application. Then under regulation 3.13D(3):
[94] Regulation 3.13D(1)(b); note that this regulation refers to “clearly discloses” which is defined to mean a clear enough and complete enough disclosure in this division in Reg 3.12(4).
“…the priority date is the priority date that the claim would have had if the claim was in the earlier specification”.

103. Provided there is a clear enough and complete enough disclosure of the invention in the claim in the parent then the priority date is the date the claim “would have had” if the claim was in the parent application. If the claim was in the parent application, its priority date is determined by regulation 3.12 before Raising the Bar and therefore the claim must be fairly based on the disclosure of its parent, i.e. the grandparent.[95] Then the priority date of the grandparent requires that the claim be fairly based on the priority document and if there are 1 or more priority documents, the date of filing the priority document in which the matter was first disclosed is the priority date.[96] This test applies to all of the claims.
[95] Regulation 3.12(1)(c) before raising the bar.
[96] Regulation 3.12(1)(b) before Raising the Bar.

Is the invention clearly disclosed in the parent?
104. The parent application discloses the same Examples 6-8 as the Opposed Application which I have discussed above for subsection 40(2)(a) and I found that these provide a clear enough and complete enough disclosure of the invention and by definition clearly discloses the invention.[97] I note that although the Opponent argued that the current specification lacked a clear enough and complete enough disclosure, they did not argue that a clear enough and complete enough disclosure did not exist in either the parent, the grandparent or the fourth priority document.
[97] Ibid.
Is the parent application entitled to the priority date of the grandparent? I.e. Is the invention defined in the parent fairly based on the grandparent?
105. The grandparent also discloses the same Examples 6-8 of the Opposed Application. I have found above that these provide a clear enough and complete enough disclosure of the invention. I note that the test for fair basis is different to that of a clear enough and complete enough disclosure and instead requires there be a real and reasonably clear disclosure of the invention.[98] The requirement of a real and reasonably clear disclosure is a lower bar than that of clear enough and complete enough disclosure. The grandparent also discusses the invention under the summary of invention and provides several embodiments which all relate to a krill oil composition.[99] This includes amounts ether phospholipids and non-ether phospholipids and astaxathin as well as amounts of triglycerides.[100] In view of this, the grandparent provides a real and reasonably clear disclosure of the invention and thus the priority date can therefore be determined from the priority documents.
[98] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58; 217 CLR 274 at 300.

[99] The grandparent page 2 line 16-page 2a lines 30.
[100] The grandparent page 3 lines 4-29.
Is there a real and reasonably clear disclosure of the invention in the priority documents?
106. Jagot J provided a good summary of the law on priority in the priority document before Raising the Bar in Gilead Sciences Pty Ltd v Indenis Pharmaceuticals LLC.[101] The test for priority is the same test as fair basis, that is, there must be a real and reasonably clear disclosure of the invention claimed. There are some subtle differences and because of this, priority is often referred to as external fair basis.
[101] (2016) 117 IPR 252 at 256 et seq.
107. In F. Hoffman-La Roche & Co. Aktiengesellschaft v Commissioner of Patents, Gibbs J noted that compounds selected from a general disclosure in the priority document which have a special utility in the complete specification would not be fairly based.[102]
[102] 123 CLR 529 at 542.
108. The Full Federal Court also dealt with this issue in Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd and Others (Coopers).[103] In the Coopers case the patent in suit was a petty patent which claimed a pour-on formulation for sheep. The specification stated that the solvent DGBE[104] “has been found to be particularly useful. It has minimal adverse effect on the skin in terms of mild epidermal shedding seen with other solvents in some sheep. It also exhibits good spreading over the skin and fleece of the sheep.” This advantage of DGBE was not stated in the provisional specification and Fox J noted at 29:
[103] 11 IPR 20.
[104] Diethylene Glycol Butyl Ether
“The patent claim concerning DGBE is not simply a more specific application of what is claimed in the provisional specification. It is the result of further experimentation and can properly be regarded as involving an inventive step. Indeed, the whole product is different from any which could be regarded as part of an invention disclosed in the provisional specification, but what has since been arrived at, although in a sense derived from various ingredients mentioned in the provisional specification, is itself a special product. A reading, or study, of the provisional specification would not lead readily, or by a process of selection, to what is set forth in the patent claim.”

109. The Full Court noted in Multigate Medical Devices Pty Ltd v B Braun Melsungen AG[105] (Multigate) that the use of “disclosed” rather than “described” connotes greater flexibility in the test for external fair basis. They continued with the following:
[105] [2016] FCAFC 21 at 189.
“In the context of external fair basis, the test of real and reasonably clear disclosure requires attention not on whether a subsequent claim had previously been made, but whether in the earlier specification there had been a real and reasonably clear disclosure of the invention that is claimed. Further, a real and reasonably clear disclosure in the prior specification need not be made only in the verbal description, but can appear from the accompanying drawings (CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 (CCOM) at 280 per Spender, Gummow and Heerey JJ; Leonardis at 137 per Burchett, Hill and Tamberlin JJ referring also to the fact that expert assistance may be necessary to interpret the drawings). Further, the relevant passage(s) from the prior specification need not be disclosed as part of the invention claimed therein. Further, the task of determining whether there has been a real and reasonably clear disclosure is not to be undertaken with an over-meticulous verbal analysis: Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240 per Barwick CJ; approved in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [15] per Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ and in Lockwood No 1 at [57], [68] and [69]. Further, the relevant disclosure is not limited to the description of preferred embodiments.”[106]
[106] Ibid at 190.

110. In Multigate the Full Court found that the aid of experts may be an aid in construction but the incorporation of externally made statements into a patent specification was not of assistance in that case and the consideration is to be made by the text alone of each specification.[107]
[107] Multigate at 229-330.
111. The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd[108] approved the words of Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd:
[108] [2004] HCA 58; 217 CLR 274 at 300.
"the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification".[109]
[109] (1988) 81 ALR 79 at 95.

112. Indeed, the test of a real and reasonably clear disclosure was applied by the High Court to divisional applications in Societe Des Usines Chimques Rhone-Poulenc v Commissioner of Patents.[110]
[110] (1958) 100 CLR 5 at 11.
113. The Opponent did not submit that the invention is not fairly based in the priority document as they are of the opinion that the test for clear enough and complete enough disclosure applies. However, their submissions and evidence on the priority documents can still be used if the test of fair basis is applied.

114. I note that when Prof Barrow reviewed the priority documents 2-4, he was asked whether ether phospholipids or non-ether phospholipids were discussed.[111] When he was asked to review the first priority document, he said he was asked:
[111] Barrow #1 at 134 and 135.
“I was asked to explain the information presented in this document in relation to NKO.”[112]
[112] Ibid at 130.

115. Prof Barrow reviewed the priority documents and noted that in priority documents 2 and 3, there is no discussion of either ether phospholipids or non-ether phospholipids.[113] When he reviewed the fourth priority document he noted that both ether phospholipids and non-ether phospholipids were discussed.[114] He also looked at Example 14 which provides an analysis of the ether phospholipids of the krill oil compositions and is similar to Example 8 in the Opposed specification.[115] The Opponent argued that this was the first disclosure of ether phospholipids and that the filing date of this document should be the priority date.
[113] Barrow #1 at 134.
[114] Ibid at 135.
[115] Ibid.
116. Indeed, on my review of the priority documents 1-3, they do not define ether and non-ether phospholipids and instead discuss phospholipids more generally. The Opposed application and the fourth priority document analyse alkylacylphosphatidylcholine (AAPC), lyso-alkylacylphosphatidylcholine (LAAPC) and alkylacylphosphatidylethanolamine (AAPE) as the main classes of ether phospholipids. There is no disclosure of these in the priority documents 1-3. The priority documents 1-3 discuss the phospholipids such as phosphatidylethanolamine, phosphatidylcholine, phosphatidylinositol and phosphatidylserine. The importance of the ether phospholipids, which are now an aspect of the claimed invention, did not form part of the invention until the fourth priority document. Thus, there is no real and reasonably clear disclosure of invention as claimed in priority documents 1-3 and therefore the priority date is the filing date of the fourth priority document, that is 28 January 2008.
Novelty
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, be novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel when compared to prior art information considered separately. The Act states that prior art information can be contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base.[116] The Act defines the prior art base in the determination of novelty as follows:
[116] Subsection 7(1)(c).
prior art base means:
...
(b) in relation to deciding whether an invention is or is not novel:
…(ii) information contained in a published specification filed in respect of a complete application where:
           (A) if the information is, or were to be, the subject of a claim of the specification, the claim has, or would have, a priority date earlier than that of the claim under consideration; and
           (B) the specification was published on or after the priority date of the claim under consideration;
and
           (C) the information was contained in the specification on its filing date.[117]
[117] Patents Act 1990 Schedule 1 Dictionary.

117. The well-established general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement".[118]
[118] [1977] HCA 19; 137 CLR 228 at 235.

118. This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed, see Nicaro Holdings Pty Ltd v Martin Engineering Co.[119] In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited (General Tire)).[120] If it is an inevitable consequence of carrying out the directions in the prior art that the PSA would do something that falls within the scope of the claims, then the claims will lack novelty.[121]
[119] (1990) 91 ALR 513 at 517.
[120] [1972] RPC 457 at 486.
[121] Novozymes A/S v Danisco A/S [2013] FCAFC at [145].
119. The Opponent submitted that the claims lacked novelty when compared to the following document:
WO 2008/060163 A1 (PRONOVA BIOPHARMA NORGE AS) 22 May 2008 (BREIVIK)[122]
[122] Exhibit CB-19.

120. Breivik was published after the priority date of the current claims; however, it claims a priority date of 16 November 2006. The priority document for Breivik does not appear to have been filed in evidence therefore I am unable to make an assessment as to whether or not it forms part of the prior art base or whether a notional claim could be drawn from the priority document based on the information it discloses. The priority of Breivik did not appear to be in dispute, either in evidence or the submissions of either party. In this case, I will make an assessment on the disclosure of Breivik on the assumption that the priority is valid.
What does Breivik disclose?
121. Breivik begins by stating that it relates to a process for preparing:
“substantially total lipid fraction from fresh krill, and a process for separating phospholipids from the other lipids.”[123]
[123] Breivik, page 1 lines 9-10.

122. I note that the current claims relate to encapsulated krill oil with specific amounts of phospholipids and from reading the Opposed Application it is clear this is achieved by a process using supercritical CO₂ and ethanol.
123. The process provided for in Breivik first involves reducing the water content. Breivik states that:
“According to the invention it is provided a process for extracting a substantially total lipid fraction from fresh krill, comprising the steps of:
a) Reducing the water content of krill raw material; and
b) Isolating the lipid fraction.”[124]
[124] Breivik, page 4 lines 18-21.

124. The process is then said to have further “optional” steps:
“Optionally, the above-mentioned process comprising a further step of:
a-1) extracting the water reduced krill material from step a) with CO₂ at supercritical pressure containing ethanol, methanol, propanol or iso-propanol. This step, a-1), is performed directly after step a).”[125]
[125] Ibid lines 23-26.

125. A preferred embodiment is given stating that:
“In a preferred embodiment of the invention, step a) comprises washing the krill raw material with ethanol, methanol, propanol, and/or isopropanol in a weight ratio 1:0.5 to 1:5. Preferably, the krill raw material is heated to 60-100°C.”[126]
[126] Ibid lines 35-37.

126. Breivik then states that:
“Extraction of the total lipids with carbon dioxide containing less than 5% ethanol or methanol is another option.”[127]
[127] Ibid lines 17-18.

127. I note that there are some differences in this disclosure to the method used in the current specification, for example it is not a two-step process with CO₂ and then CO₂ and 20% ethanol. The Opponent submitted that Example 7 of Breivik provides a krill oil within the scope of the current claims. Example 7 states:
“Fresh E. superba (12 kg) was heated to 80°C for a few minutes and thereafter extracted with ethanol (26 kg). This gave an ethanol extract of 0.82 kg (7 %). Analysis of lipid classes (HPLC; Column: Alltima HP silica 3~tm; detector: DEDL Sedere; Solvents: Chloroform/methanol) showed a content of 58% phospholipids. Analysis by GC (area %) showed a content of 24.0% EPA and 11.4% DHA, sum EPA+DHA = 35.4 %.
The remaining krill was extracted at 280 bar and 50°C with CO2 (156 kg) containing ethanol (15 kg). This gave an extract of 0.24 kg (2%). The remaining krill was white, except for the dark eyes. Analysis of lipid classes showed a content of 19 % phospholipids. The extract contained 8.9% EPA and 4.8% DHA (sum 13.7 %). Extraction of the remaining krill material (Folch method) showed a content of only 0.08 kg lipids (0. 7 % compared to initial krill weight). This means that substantially all lipids had been extracted.”[128]
[128] Ibid page 9 lines 14-26.

128. In table 2 the phospholipid content is said to be > 30-40% by weight. However, I note that in table 3 the phospholipid content is said to be ≥50 % by weight and this is achieved only by applying extraction according to step a) of the invention. The specific amounts of phosphatidylcholine and ether phospholipids are not given.
129. Prof Barrow in his first declaration states that:
“Example 7 on page 9 describes a krill extract having 58 % phospholipids. Based on data from Catchpole (phosphatidylcholine around 88% of total phospholipids), the phosphatidylcholine concentration is Breivik would be around 51% w/w of the extract, and the ether-phospholipids present at around 5.8 % of the extract (based again on Catchpole, around 10% of total phospholipids).”

130. Catchpole is cited for inventive step. Catchpole uses freeze dried krill powder and extracts it with supercritical CO₂and the residual powder is then extracted with supercritical CO₂ and ethanol.[129] In Catchpole the amount of phosphatidylcholine and ether-phospholipids is provided. It is clearly the Opponent’s opinion that the phospholipids extracted in Catchpole, using a different process, i.e. using supercritical CO₂ followed by supercritical CO₂ and ethanol, will have the same concentrations of phosphatidylcholine and ether-phospholipids as an extraction using only ethanol. A lack of novelty can only exist when a document is missing a feature of the claims if that feature is inherently present and following the teaching of the prior art would inevitably lead to doing something within the scope of the claims. In my view the krill oil extracts of the current claims have phospholipids with different polarities and that affects which solvents can and cannot dissolve them. For example, it appears very little phospholipids can be extracted with supercritical CO₂ alone, but the astaxanthin esters can be extracted.[130] Breivik does not explain why a two-step extraction using supercritical CO₂followed by supercritical CO₂ and ethanol would have the same proportion of polar compounds and non-polar compounds as an extraction using just ethanol, nor is there any evidence to support this. As a consequence, I am not satisfied that the process in Breivik would provide a krill oil within the scope of the current claims.
[129] Catchpole, Example 19 page 24 lines 2-19.
[130] Yamaguchi, K “Supercritical Carbon Dioxide Extraction of Oils from Antarctic Krill” Journal of Agricultural Food Chemistry (1986) 34, 904-907, page 904, second column.
131. The evidence does not establish that the claims lack novelty in view of Breivik. Given I do not need to make an assessment on whether or not Breivik is entitled to its priority date.
Inventive Step
132. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art (subsection 7(3)).
133. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd[131] Aickin J stated:
[131] [1981] HCA 12; 148 CLR 262 at 286.
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."

134. In Alphapharm,[132] the High Court endorsed the use of the reformulated "Cripps question":
[132] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411.

"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts, directly be led as a matter of course to try the invention as claimed in the expectation that it might well produce a solution to the problem."[133]
[133] Alphapharm at [53].

135. This has been elaborated on in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft:
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited (1981) 148 CLR 262, at 280‑281, 286, per Aickin J). We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.“[134]
[134] [2014] FCAFC 73 at [71].

136. In AstraZeneca AB v Apotex Pty Ltd[135] (AstraZeneca), the court held that in formulating the problem it is not permissible to incorporate information that is not available to the PSA either as common general knowledge or information available under subsection 7(3).
[135] [2014] FCAFC 99; 107 IPR 177.
137. The Opponent submitted that the claims lacked an inventive step when the current claims are compared to the following document and combined with the common general knowledge:
WO 2007/123424 A1 (CATCHPOLE ET AL.) 1 November 2007 (Catchpole).

138. I note that Catchpole is published on 1 November 2007, however, as I have determined above the priority date of the current claims is 28 January 2008. This document is therefore considered to be prior art for the purposes of inventive step.

139. The Opponent also submitted that the current claims lacked an inventive step when compared with the following document:

Tanaka, Y. et al. “Extraction of Phospholipids from Salmon Roe with Supercritical Carbon Dioxide and an Entrainer” Journal of Oleo Science Vol. 53, no 9, 417-424 (2004) (Tanaka).

140. In the alternative to combining Tanaka with the common general knowledge, the Opponent submitted that the claims lacked an inventive step when Tanaka is combined with the following prior art document:
Yamaguchi, K “Supercritical Carbon Dioxide Extraction of Oils from Antarctic Krill” Journal of Agricultural Food Chemistry (1986) 34, 904-907 (Yamaguchi).

141. Both Tanaka and Yamaguchi were published well before the priority date I have established, and the priority date claimed. In order to decide this matter, it is necessary for me to determine what information can be viewed as common general knowledge.
Common General Knowledge (CGK)
142. The Opponent submitted that the claims lacked an inventive step when the common general knowledge is combined with either of two documents.[136] The common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc:
[136] Opponent’s submissions at 74.
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·           standard texts and handbooks;
·           standard English dictionaries;
·           technical dictionaries relevant to the field;
·           magazines and other publications specific to the field.” [137]
[137] [1999] FCA 345; 45 IPR 577 at [112].

143. The CGK must be established by evidence as stated by Emmett J in Dynamite v Aruze:
“It is necessary to establish common general knowledge by appropriate evidence. Evidence that consists of generalised and sweeping statements of opinion or recollection, unsupported by secondary materials such as text books, trade journals and technical publications, should be treated with caution and given little weight.” [138]
[138] [2013] FCA 163 at [104].

144. Prof Barrow described a large amount of material in his evidence.[139] I note that when he made these statements, he believed that:
[139] Barrow #1 at [38]-[93].
“…this kind of knowledge was generally held by people working in my field around the world.”[140]
[140] Barrow #1 at [37].

145. Further, he was of the opinion that this is:
“general background knowledge which was taken for granted in discussions about more specific topics of interest”.[141]
[141] Ibid.

146. Prof Barrow sets out a very detailed account of this “general knowledge” but in it he refers to several documents, including those cited by the Opponent. It appears to me to be a comprehensive review of krill oil with documents discussed in detail[142] and while I appreciate these documents being summarised, Prof Barrow states that these documents were not known to him at March 2007.[143] Furthermore although Prof Barrow states that the properties of the krill oils that are said to be well known, he is shown a document with the information on phospholipids and ether-phospholipids.
[142] See for example Barrow #1 at [62]-[73].
[143] Barrow #1 at [62].
147. In view of this I accept the following formed part of the CGK:
There was a growing interest and market for essential fatty acids EPA and DHA, which are omega-3 fatty acids, e.g. Fish oil.[144]
Krill oil from Euphausia superba was known to be a source of EPA and DHA (essential fatty acids) and it had been sold as a dietary supplement.[145]
The omega-3 fatty acids (namely EPA and DHA) existed in extracts in different forms such as triglycerides and phospholipids but made up the majority in krill oil.[146]
Astaxanthin is a carotenoid present in krill oil.[147]
There was a growing interest in the omega-3s present as phospholipids in krill oil as they appeared to have better bioavailability.[148]
Solvent extraction was commonly used to extract krill oil.[149]
Encapsulation of oils in soft gel capsules was known.[150]
[144] Barrow #1 at [40]-[51].
[145] Barrow #1 at [57] and CB-2 (Superba GRAS Notice).
[146] Barrow #1 at [51].
[147] Barrow #1 at [61].
[148] Barrow #1 at [54].
[149] Barrow #1 at [81].
[150] Barrow #1 at [50].

148. The Opponent submitted that the use of supercritical CO₂ for extraction was common general knowledge and Prof Barrow did discuss the use of supercritical CO₂. However, it was clear to me that he thought this was a “specialised”[151] method and would only use it if he “had access to it”[152]. From this in my view it was not a very well-known or widely used technique, it was specialised, and not everyone had access to it. I therefore do not accept that its use was part of the CGK.
[151] Barrow #1 at [83].
[152] Barrow #1 at [91].
149. I note that Prof Barrow believes that the amounts of phosphatidylcholine and ether-phospholipids in krill oil was well known, however, these appear to only come from the cited prior art. I do not accept that these various amounts were well known.

Inventive step when compared to Catchpole and the CGK
150. Catchpole is a directed towards a process for separating lipid materials and this process uses supercritical CO₂ and a co-solvent (a monohydric alcohol).[153] It is said that the co-solvent makes up at least 10% by mass of the CO_2.[154] A large number of the examples in Catchpole are directed to extractions from dairy products followed by egg products.[155] The process is used to extract krill lipids in one example and in this example the various amounts of the phospholipids are given. It is worth repeating this example here:
[153] Catchpole abstract.
[154] Ibid.
[155] Ibid examples 1-9,14 and 10-11,16, 19.
“This example shows the fractionation of krill lipids from krill powder and demonstrates concentration of AAPC in the extract, and AAPE in the residue. 5619.9 g of freeze-dried krill powder containing 21.4% lipid and corresponding phospholipids concentrations shown in table 16 was extracted continuously with supercritical CO2 at 300 bar and 313 K until no further extract was obtained. This extract (extract 1) contained no phospholipids, and was substantially all neutral lipids. A total of 650 g of this extract was obtained, and 66.41 kg of CO2 was used. The residual powder was then extracted with CO2 and absolute ethanol, using a mass ratio of ethanol to CO2 of 11 %. The CO2 and ethanol extract phase was passed through two sequential separators in which the pressure was 95 and 60 bar respectively. The bulk of the phospholipids-rich extract (extract 2) was obtained in the first separator, and the bulk of the co-solvent in the second separator (extract 3). The composition of extract 2 and residual powder are shown in table 16. The alkylacylphosphatidylcholine (AAPC), a type of alkylacylphospholipid, is highly enriched in the concentrated phospholipids-rich extract, whilst alkylacylphosphatidylethanolamine (AAPE), another type of alkylacylphospholipid, is not extracted to any great degree.

.”[156]
[156] Catchpole page 24 lines 1-26.

151. In the above example the amount of ethanol used is 11 %. This provides a krill oil which has 39.8 % phosphatidylcholine and the ether-phospholipids, AAPC and AAPE are at 4.8%. These quantities are below the at least 40% phosphatidylcholine and from 6.0% to 10 % ether phospholipids claimed. I note that the amount of astaxanthin is not given in Catchpole, however, I note this is usually extracted in the non-polar (neutral) first step[157] and would be likely to be a similar amount to the current specification.
[157] Yamaguchi, K “Supercritical Carbon Dioxide Extraction of Oils from Antarctic Krill” Journal of Agricultural Food Chemistry (1986) 34, 904-907, page 904, second column.
Would the person skilled in the art be directly led as a matter of course to change the method in Catchpole to arrive at a krill oil as claimed?
152. Prof Barrow states that he was asked by the Opponent what refinements to this experiment he would make, if any.[158] He was asked this question before viewing the Opposed Specification.[159] He answers this with the following statement:
[158] Barrow #1 at [104].
[159] Ibid at [138].
“…at the second extraction step ethanol co-solvent is used at 11%, which is at the low end of the experiments discussed in Catchpole. I consider this to be a ‘threshold’ amount to enable phospholipids to solubilise in the SCE/ethanol solvent mixture. I have also noted that Examples 7 and 8 in Catchpole use a low and high ethanol concentration respectively, which resulted in a significant increase in the amount of phospholipids extracted. I have also noted above at paragraph 54 that as at March 2007, it would have been desirable to obtain a high level of phospholipids in a krill oil due to the perceived health benefits. Presented with Catchpole, I would therefore increase the ethanol concentration in the second extraction step in order to increase the yield of phospholipids in the second extract. By increasing the concentration of ethanol to say, 20% or 30%, based on the information from Examples 7 and 8 of Catchpole, I would expect the yield of phospholipids in Extract 2 to possibly double, i.e. from 4.[3] to 8-9%. A phospholipid-rich oil could then be sold as is, or blended with a triglyceride extract in order to prepare an oil with other target properties (i.e. overall omega-3 concentration, etc.).”[160]
[160] Ibid at [104].

153. It would appear from Prof Barrow’s above statement that the amount of ethanol used in Catchpole was low and, given that phospholipids appeared to have better bioavailability, increasing the amount of ethanol would give more phospholipids and he states that he would do this.
154. I note that it is the ether-phospholipids in Catchpole that fall 1.2% below the current claims. Mr Myhren responds to Prof Barrow’s evidence by stating that a PSA would not be motivated to increase the amount of ether-phospholipids.[161] Mr Myhren states his reason for this:
[161] Myhren at [24].
“The reason for this is that products derived ether phospholipids in Euphausia superba krill were known in the art that ether phospholipids, especially of marine origin, are precursors for compounds with high Platelet Activating (“PAF”) activity.”[162] [SIC]
[162] Ibid at 25.

155. Mr Myhren then goes on to explain that certain ether-phospholipids can be oxidised to compounds which are pro-inflammatory and increase platelet aggregation and he cites references for this.[163] These oxidised compounds basically do the opposite to what the omega-3 fats like EPA (which is said to be beneficial) do. He provides references which support this view and states that:
[163] Ibid.
“Thus, references such as Prescott et al., Zimmerman et al. and Tanaka [1995] would strongly discourage a person in the art from utilizing oils with substantial levels of ether phospholipids as encapsulated dietary supplements and would not choose such oils for encapsulation.”[164]
[164] Ibid.

156. Prof Barrow responds to this and disagrees that this was well known and states that he does not recall ever hearing about this issue.[165] He also states that the amount of ether-phospholipids in krill was “not even a topic of conversation.”[166]
[165] Barrow #2 at [59].
[166] Ibid.
157. The issues that Mr Myhren notes, while being well documented, have not been established as CGK in the current field of krill oil. The documents discuss that these problematic compounds are caused by ether-phospholipid oxidation and none of documents discuss food sources of the oxidised compounds and instead in vivo oxidation is said to be increased by the oxidative stress caused by cigarette smoke.[167] Furthermore, astaxanthin is known to act as an antioxidant and these documents do not show that consumption of a krill oil extract would result in these oxidised species forming in humans or be a potential problem for supplements containing ether-phospholipids generally. Therefore, I do not accept that the CGK would not motivate a PSA to avoid increasing the phospholipid content of a krill oil and I accept Prof Barrow’s evidence on the steps he would take when presented with Catchpole.
[167] Exhibit FM3-FM6 and FM3 at page 432.

158. In view of the evidence of Prof Barrow, a PSA would be motivated to increase the amount of phospholipids in the krill oil by increasing the ethanol used in the extraction method of Catchpole. Prof Barrow stated that he would expect this to result in a krill oil within the scope of the claims.[168] I accept that increasing the ethanol content would increase the amount of phospholipids and this would include the phosphatidylcholine and ether phospholipids and thus the skilled person would arrive at the current claims 1-6. Furthermore, I accept that encapsulating krill oil would have been routine and a step that the PSA would have undertaken. Consequently claims 1-6 do not involve an inventive step when compared to Catchpole and the CGK.
[168] Barrow #1 at [104].

Inventive step when compared to Tanaka and the CGK and/or Yamaguchi
159. Tanaka discloses a method for the efficient extraction of phospholipids from salmon roe.[169] It states that when the extraction is performed with supercritical CO₂ and 20% ethanol mixture more than 80% of phospholipids are extracted.[170] Tanaka makes a specific mention of Yamaguchi which is worth repeating below:
[169] Tanaka abstract.
[170] Ibid.
“Some works refer to the application of SC-CO₂ extraction of marine materials to obtain PUFA. Yamaguchi et al. (15) reported the extraction of lipids from Antarctic Krill. According to their report, only non-polar components such as cholesterol, carotenoid triacylglycerols and their derivative were extracted. Phospholipids did not appear in the extracted fraction.”

160. The Opponent submitted that it would be obvious to the PSA to apply the method in Tanaka, using 20% ethanol and this would provide a krill oil within the scope of the current claims. Indeed, Tanaka shows that if 20% ethanol is used then the extraction of phospholipids is 80% in salmon roe.[171] There was no declaratory evidence from the experts about whether they would, on reading this information in Tanaka, apply the technique to krill. Instead Prof Barrow merely states that:
[171] Tanaka Fig 2.
“I would expect the same principle to apply to other marine-based organisms, as they are generally composed of the same materials.”[172]
[172] Barrow #1 at [109].

161. In my view this evidence does not support a conclusion that a PSA would be directly led to use the extraction process on krill oil. Although krill extracts are mentioned, the motivation to do so has not been established. The routine steps have not been set out. Furthermore, I consider that if the passage mentioning Yamaguchi stood out to Prof Barrow, he would have mentioned it.
162. Prof Barrow’s statement that he would expect it to apply to other marine-based organisms does not establish that he would be directly led as a matter of routine to apply it to krill oil. Consequently, the evidence does not establish a lack of inventive step in view of Tanaka.
Manner of manufacture
163. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
164. The Opponent’s argument focused on the general lack of quality of newness or inventiveness, citing Commissioner of Patent v Microcell Ltd:
“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter for a patent.” [173]
[173] (1959) 102 CLR 232.

165. This concept with the law of manner of manufacture was developed further in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd:
“if it is apparent upon the face of the specification, when properly construed, that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further.”[174]
[174] (1995) 183 CLR 655 at 663-665.

166. Furthermore, in Bristol-Myers Squibb Co v FH Faulding & Co Ltd[175] their Honours, Black CJ and Lehane J stated in the majority decision that:
[175] [2000] FCA 316; (2000) 46 IPR 553.
“if, on the basis of what was known, as revealed on the face of the specification, the invention was obvious or did not involve an inventive step – that is, would be obvious to the hypothetical non-inventive and unimaginative skilled worker in the field – then the threshold requirement of inventiveness is not met.”[176]
[176] Ibid at [30].

167. I note that the majority judgment of the Full Federal Court states that this is based on the face of the specification, however, in Advanced Building v Ramset[177] the High Court found that the lower court had erred in finding that the claims were not an invention within the meaning of the Patents Act 1952[178] because it placed decisive weight on prior art disclosures when it had the grounds of Novelty and Obviousness available but instead put them to one side.[179]
[177] [1998] HCA 19; 194 CLR 171; 152 ALR 604; 72 ALJR 673.
[178] In the Patents Act 1952 “invention” means any manner of new manufacture the subject of letters patent and grant of privilege within section six of the Statute of Monopolies and includes an alleged invention”.
[179] [1998] HCA 19; 194 CLR 171; 152 ALR 604; 72 ALJR 673 at [40].
168. In D'Arcy v Myriad Genetics Inc[180] the case related to isolated nucleic acid sequences and the court noted that the artificiality of a product may be perceived by a number of factors and that it is necessary that the inventive concept be seen to make a contribution to the essential difference between the product and nature.[181] The enquiry is one of substance over form:
[180] [2015] HCA 35.
[181] Ibid at [128].
“Whatever words have been used, the matter must be looked at as one of substance and effect must be given to the true nature of the claim.”[182]
[182] Ibid at [144].

169. The court noted that the step of isolation was not invented in that case and instead was longstanding technology well known to those skilled in the science.[183] This led to the finding that the substance of those claims to isolated nucleic acid sequences is the information embodied in the arrangements of nucleotides; the information was not “made” by human action and therefore was not suitable subject matter for a letters patent.[184]
[183] Ibid at [146].
[184] Ibid at [6].
170. In the current case the substance of the invention lies in the make-up of the krill oil composition with the defined minimum amount of 40% w/w phosphatidylcholine, and between 6 and 10% w/w ether phospholipids and greater than 100 mg/kg of astaxanthin.

171. The Opponent submitted that the methods used in the current specification were known and that other commercially available krill oils were known, and this leads to a lack of patentability.

172. I note that the commercially available krill oil, NKO, is used as a reference in the Opposed specification,[185] however, this does not have phosphatidylcholine and ether-phospholipid concentrations of the claims.[186] Therefore, this does not indicate to me that the specification lacks newness or inventiveness on its face.
[185] Opposed Application see example 9.
[186] Ibid table 22; Barrow #1 at [123]- [124].

173. The specification does cite Tanaka, which I have discussed above.[187] However, the specification notes that in Tanaka, the 2-step extraction technique using supercritical CO₂ is not used on krill oil but instead uses salmon roe and the specification highlights this difference.[188] Furthermore there is no self-admission in the specification that it would be obvious to use the technique used on salmon roe in Tanaka on krill oil. Therefore, I am not satisfied that the specification lacks a manner of manufacture based on the face of the specification.

[187] Ibid page 2 line 4.
[188] Ibid lines 1-5.

174. This ground of opposition fails.
Utility
175. It is a requirement of paragraph 18(1)(c) of the Act that the invention, so far as claimed in any claim, must be useful:
Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim: …
(c) is useful.

176. The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd.[189] Emmett J stated:
[189] [2009] FCAFC 70, 81 IPR 228.
“A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility.”[190]
[190] Ibid at [81]; [247].

177. In Apotex Pty Ltd v AstraZeneca AB (No 4)[191] Jagot J pointed out that lack of utility requires evidence, not just speculation:
[191] [2013] FCA 162; (2013) 100 IPR 285.
“Ultimately, an asserted lack of utility must be established by appropriate evidence, not by mere speculation that the invention will not work or meet the promise set out in the specification.”[192]
[192] Ibid at [352].

178. An overview of utility, including areas for consideration, is provided by Nicholas J in Apotex Pty Ltd v Warner-Lambert Company LLC (No 2)[193]. The Applicant noted his Honour’s statement:
[193] (2016) 122 IPR 17 at [164] et seq.
“…much depends upon the proper construction of the claim. Claims are not to be read through the eyes of a skilled addressee purposefully seeking to perform the claimed invention in a manner that would not provide a useful result: see Washex Machinery Corporation v Roy Burton & Co Pty Ltd (1975) 49 ALJR 12 at 19. Nor should claims be construed in a manner that the skilled addressee would appreciate would lead to unworkability if there is another construction that is equally open that avoids that result: Electric & Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23 at 39; Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 99.”[194]
[194] Ibid at [168].

179. Furthermore, his Honour stated:
“A claim may have utility even if a promised advantage cannot be achieved in all cases or with the same degree of success: Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 142-143 (Gummow J) and Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) (2011) 92 IPR 320 at [245], point 8 (Jagot J). Thus, if a claimed method of treatment for nausea was effective in a substantial proportion of patients experiencing nausea, the claim would not be invalid merely because a small proportion of patients experiencing nausea did not respond to the treatment. This is because the skilled addressee reading the specification would not expect (assuming he or she is not told otherwise) that the claimed treatment will be an effective treatment for every patient suffering nausea resulting from every conceivable condition.”[195]
[195] Ibid at [170].

180. In order to determine whether I am satisfied there is a lack of utility I will first determine the desired result of the specification (promise of the invention) and then look to see if the evidence shows whether there is something within the scope of the claim that does not produce that desired result.
What is the promise of the invention?
181. The promise of the invention can be gleaned from the abstract which is to provide a new krill oil composition from a two-stage supercritical fluid extraction process.[196] The krill oil compositions are characterized by having high amounts of phospholipids, astaxanthin esters and/or omega-3.[197] The abstract states that the krill oils are:
[196] Opposed Application abstract.
[197] Ibid.
“more bioeffective in a number of areas such as anti-inflammation, anti-oxidant effects, improving insulin resistances and improving blood lipid profile.”[198]
[198] Ibid.

182. This statement is repeated in the specification.[199] It was not in dispute that this promise is useful.
[199] Opposed Application page 3 lines 1-3.
183. The specification also states a problem with processing frozen krill in the prior art[200] and states that:
[200] Ibid page 2 lines 5-10.
“What is needed in the art are methods for processing krill that do not require transport of frozen krill materials over long distances and the products produced by those methods.”[201]
[201] Ibid lines 13-15.

184. The Opponent’s did make the submission that this statement is not addressed in the claims. Indeed, there is not a method claim but the specification does disclose processing techniques. I do not consider this aim to be part of the promise.
Does the evidence establish that something within the scope of the claim will not achieve the promise?
185. The Opponent submitted that part of the promise is providing “novel/new” krill oil compositions and given that other krill oils are “reasonably similar” that this promise is not met. Firstly, I have found that the claims are novel, so the claimed krill oils do meet any promise of “newness”, and secondly, novelty is a different ground of opposition and I do not consider utility as the other side of the coin.
186. The Opponent then submitted that the health benefits were not met by the biological Examples 9, 11 and 12. In Example 9 the specification states:
“This example shows that supplementation of the Zucker rat with krill oil prepared as in example 7 results in an improvement of metabolic parameters characteristic of the obesity induced type two diabetic condition. The effect induced by the novel krill oil is often more pronounced than the effect of FO and in several cases greater than the effect induced by NKO. Specifically, the effects of the two types of krill oil differentiated with respect to the reduction of blood LDL cholesterol levels as well as lipid accumulation in the liver and muscle (Figure 2-9). Furthermore, the efficacy of transfer of DHA from the diet to the brain tissue was greatest with the krill oil prepared as in example 7 (Figure 10).”[202]
[202] The Opposed Application page 45 lines 21-29.

187. Prof Barrow reviewed the figures and his main criticism was on the fact that NKO and Superba appeared to show the same health benefits when experimental error was considered.[203] He also noted that no experimental error was given for Figures 3-5.[204] Although this does indicate that the above statement in Example 9 appears to be overstated, it merely shows that more evidence is needed. This evidence does not satisfy me that a krill oil composition with the features of the claims would not meet the promise. Furthermore, I note that Example 7 had phospholipid concentrations below the levels claimed. Consequently, a lack of utility has not been established.
[203] Barrow #1 at [175]-[177].
[204] Barrow #1 at [175].
Conclusion
188. The evidence has satisfied me on the balance of probabilities that claims 1-6 lack an inventive step. All other grounds fail.
Opportunity to Amend
189. Subject to appeal, I allow the Applicant 2 months to file suitable amendments to overcome the successful ground.
Costs
190. The Opposition has been successful. Costs are awarded against the Applicant under Schedule 8.
K. Wagg
Delegate of the Commissioner of Patents
APPENDIX A

Evidence	Declarant	Date	Reference	Exhibits
In Support	Prof Colin Barrow	19 July 2017	Barrow #1	CB-1 to CB-27
In Answer	Mr Finn Myhren	20 October 2017	Myhren	FM-1 to FM-5
In Reply	Prof Colin Barrow	5 March 2018	Barrow #2	CB-28 to CB-29

Claimed feature	Example 7/table 21	Example 8/table 22	Example 6
> 40 % phosphatidylcholine w/w/; 45% w/w in claim 2 and 6	Not given	36.07 % w/w	42.22% w/w
6.0 to 10 % ether phospholipids w/w	Not given	7.38 % w/w	Not given
> 100 mg/kg astaxanthin esters	2091 mg/kg	Not given	Not given
< about 25 % triglycerides w/w in claim 3	25.9%	Not given	Not given
At least about 36 % omega-3 fatty acids	35.7 %	Not given	Not given