Suntory Holdings Limited v Martek Biosciences Corporation
[2012] APO 127
•16 November 2012
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Suntory Holdings Limited v Martek Biosciences Corporation [2012] APO 127
Patent Application: 759623
Title:Process for Producing Unsaturated Fatty Acid-Containing Oils
Patent Applicant: Suntory Holdings Limited
Opponent : Martek Biosciences Corporation
Delegate: Karen Ayers
Decision Date: 16 November 2012
Catchwords: PATENTS –- novelty –- prior use –-implied obligation of confidence –- not all samples available to the public –- subsequent chemical analysis of product not necessarily definitive of levels at the relevant time – prior product not enabled.
Prior disclosure in a document –- claimed product was not inevitable result of an earlier disclosed process
Manner of manufacture – whether lack of manner of manufacture apparent on face of specification – whether new substance, new characteristic of a known substance
Section 40–-failure to accurately measure a particular component did not necessarily lead to section 40 problems if the skilled worker is left with no doubt about the scope of the claims and can produce something within each claim.
Fair basis – certain claims not limited to microbial sourced oil and were inconsistent with what the specification had described as the invention.
Representation: Patent applicant: Griffith Hack, Melbourne
Opponent :Allens Arthur Robinson,Melbourne
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 759623
Title:Process for Producing Unsaturated Fatty Acid-Containing Oils
Patent Applicant: Suntory Holdings Limited
Opponent : Martek Biosciences Corporation
Date of Decision: 16 November 2012
DECISION
Opposition partly successful. Most of the claims (as amended prior to the hearing) were novel and inventive and defined a Manner of Manufacture. They were also fully described, fairly based and did not fail for want of utility. However claims 26-30, 33, 36-38 encompassed any UFA-containing oil with low levels of 24,25-M. The applicant conceded at the hearing that such claims would include common vegetable oils such as olive oil. Such claims therefore prima facie lack novelty. In addition, these claims lack fair basis because they are clearly inconsistent with the invention described as a whole which relate to microbial sourced oils.
There is however clearly patentable subject matter within the specification. The applicant is therefore provided 60 days in which to propose amendments to overcome the deficiencies noted below. This period can be stayed if notice of an appeal is served on the Commissioner within that time frame.
Given that the opponent was partly successful at the hearing and that there were also amendments made prior to the hearing to overcome the prior art raised by the opponent, I award costs against the applicant, Suntory Holdings Ltd.
REASONS FOR DECISION
Background
Patent application 759623 was filed on 4 April 2000 in the name of Suntory Limited (now Suntory Holdings Limited) as a divisional application of 40311/97 (now 719123). The parent application was filed on 27 August 1997 and claimed priority from a Japanese basic document (8-230210) filed on 30 August 1996. This priority flows through to the current application by virtue of its divisional status.
The parent application was sealed on 17 August 2000 having never been opposed. The parent application is still in force with its 20 year term due to expire on 27 August 2017. Its divisional application (the current application) was advertised accepted on 17 April 2003 and a notice of opposition was filed by Martek Biosciences Corporation on 17 July 2003. After evidence was completed, the hearing was scheduled on 15 and 16 February 2012 in Canberra. The applicant was represented by Katrina Howard SC instructed by Stephen Sharp, Janelle Borham and Jacqueline Satchell of Griffith Hack, Melbourne. The opponent was represented by Bruce Caine SC and Jon Gottschall of counsel instructed by Andrew Butler and Louise Brunero of Allens Arthur Robinson, Melbourne (now Allens Patent & Trade Mark Attorneys).
Observers from both the applicant and opponent companies were in attendance at the hearing. Ms Naoko Nanao, Dr Fujikawa and Dr Akimoto attended on behalf of the applicant (with Ms Yukali Katao-Armstrong providing translation services). Dr Tomkins and Dr Apt attended on behalf of the opponent company.
Evidence
The following evidence was filed in this matter:
Evidence in support:
Statutory declarations by
· Jonathon Thomas Gottschall dated 17 December 2004 (Gottschall-1);
· Andrew James Sinclair dated 17 December 2004 with exhibits AJS-1 to AJS-12 (Sinclair-1);
· Ann Campbell Lawrie dated 17 December 2004 with exhibits ACL-1 to ACL-4 (Lawrie).
Evidence in answer:
Statutory declarations by:
· Shigeaki Fujikawa dated 20 December 2006 with exhibits SF-1 to SF-5 (Fujikawa-1);
· Robert Alan Gibson dated 21 December 2006 with exhibits RG-1 to RG-4 (Gibson-1).
Evidence in reply:
Statutory declarations by:
· Sandy Irene Zeller dated 20 December 2007 with exhibits SIZ-1 to SIZ-2 (Zeller-1);
· Andrew James Sinclair dated 21 August 2008 with exhibits AJS-13 to AJS-15 (Sinclair-2);
· Johannes Hendrik Wolf dated 12 August 2008 with exhibits JHW-1 and JHW-2 (Wolf)
· Raymond Michael Gladue dated 12 June 2008 (Gladue-1)
· Cynthia Ann Panker dated 14 February 2008 with exhibits CAP-1 to CAP-14 (Panker-1)
· Cynthia Ann Panker dated 12 June 2008 with exhibits CAP-15 to CAP-16 (Panker-2)
· Angela Lee Tsetsis dated 16 June 2008 (Tsetsis-1)
· Angela Lee Tsetsis dated 14 February 2008 with exhibits ALT-1 to ALT-8 (Tsetsis-2)
· Louise Brunero dated 23 June 2008 with exhibits LB-1 and LB-2 (Brunero-1)
· Jonathon Thomas Gottschall dated 21 February 2008 (Gottschall-2)
· Raymond Michael Gladue dated 21 February 2008 (Gladue-2)
· Adrianna Carvalho de Souza dated 19 February 2008 with exhibits ACS-1 to ACS-7 (de Souza-1)
· Adrianna Carvalho de Souza dated 12 August 2008 (de Souza-2)
· Philippe Thierry François Gaudin dated 19 February 2008 with exhibits PTFG-1 to PTWG-5 (Gaudin-1)
Applicant’s first application for leave to serve further evidence:
Statutory declarations by:
· Robert Alan Gibson dated 3 June 2009 with exhibit RG-5 (Gibson-2)
· Shigeaki Fujikawa dated 4 June 2009 with exhibit SF-6 (Fujikawa-2)
· Kenji Katano dated 4 June 2009 with exhibit KK-1 (Katano)
· Janelle Suzanne Borham dated 5 June 2009 (Borham-1)
Opponent’s response to first round of further evidence:
Statutory declarations by:
· Sandy Irene Zeller dated 17 April 2010 with exhibit SIZ-3 (Zeller-2)
· Louise Brunero dated 14 April 2010 with exhibits LB-4 to LB-9 (Brunero-5)
· Andrew James Sinclair dated 15 April 2010 with exhibits AJS-16 to AJS-19 (Sinclair-3)
· Andrew James Sinclair dated 15 April 2010 with exhibits AJS-20 to AJS-24 (Sinclair-4)
· Raymond Michael Gladue dated 6 April 2010 with exhibit RMG-1 (Gladue-3)
· Philippe Thierry François Gaudin dated 16 February 2010 with exhibits PTFG-6 to PTWG-8 (Gaudin-2)
· Adrianna Carvalho de Souza dated 16 February 2010 with exhibits ACS-8 to ACS-11 (de Souza-3)
· Adrianna Carvalho de Souza dated 16 February 2010 with exhibit ACS-12 (de Souza-4)
· David J Kyle dated 11 February 2010 with exhibits DJK-1 to DJK-5 (Kyle)
· Louise Brunero dated 1 February 2010 with exhibit LB-3 (Brunero-4)
· Michael Alan Davis dated 14 August 2009
· Louise Brunero dated 11 January 2010 (Brunero-2)
· Louise Brunero dated 11 January 2010 (Brunero-3)
Applicant’s second application for leave to serve further evidence:
Statutory declarations by:
· Janelle Suzanne Borham dated 20 October 2010 with exhibits JSB-1 to JSB-6 (Borham-2)
· Shigeaki Fujikawa dated 28 October 2010 with exhibits SF-7 to SF-12 (Fujikawa-3)
· Robert Alan Gibson dated 1 November 2010 (Gibson-3)
Opponent’s response to second round of further evidence:
Statutory declarations by:
· Adrianna Carvalho de Souza dated 9 March 2011 with exhibits ACS-13 and ACS-14 (de Souza-5)
· Louise Brunero dated 10 March 2011 with exhibits LB-10 to LB-18 (Brunero-6)
· Andrew James Sinclair dated 11 May 2011 (Sinclair-5)
· Philippe Thierry François Gaudin dated 26 April 2011 (Gaudin-3)
A third application for leave to serve further evidence was filed by the applicant on 23 December 2011. This third application consists of statutory declarations by:
Statutory declarations by:
· Janelle Suzanne Borham dated 23 December 2011 with exhibit JSB-7 (Borham-3)
· Shigeaki Fujikawa dated 23 December 2011 (Fujikawa-4)
· Shigeaki Fujikawa dated 23 December 2011 with exhibit SF-13 (Fujikawa-5)
Leave to serve the third round of further evidence had not been granted by the Commissioner prior to the hearing. However, the parties agreed that the extra material could be admitted into proceedings before the Commissioner with further submissions or evidence following the hearing should this prove necessary. Leave was therefore formally granted at the hearing for the third round of evidence.
After the hearing, the opponent made a request to file a fourth round of further evidence in response to the applicant’s earlier evidence. This fourth round of evidence consisted of:
Tranche 1:
Statutory declaration by:
· Craig Mallon dated 4 May 2012 with exhibit CM-1 (Mallon-1)
Tranche 2:
Statutory declarations by:
· Denver Joseph Pyle dated 3 July 2012 with exhibit DJP-1 (Pyle); and
· Craig Mallon dated 3 July 2012 with exhit CM-2 (Mallon-2)
For convenience, a summary of when each declarant’s evidence (and when it was filed) is provided in Annex C of the decision.
Specification
Arachidonic acid (ARA) is a polyunsaturated omega-6 fatty acid with a 20 carbon chain backbone containing four cis-double bonds, the first double bond being located at the sixth carbon from the omega end [C:20:4 (n-6)]:
10. ARA is one of the main polyunsaturated fatty acids (UFA) in the brain as well as being an precursor for other important physiological compounds (such as prostaglandins). Although ARA can be synthesised from linoleic acid (an essential fatty acid) using the enzyme ∆6-desaurase, this enzyme is only present at low levels in humans. Hence humans rely on their diet for an adequate supply of ARA[1]. This is particularly true in infancy where there is a higher demand for ARA because of the body and brain’s rapid growth. While human breast milk contains high levels of ARA to satisfy this increased need, infant powdered formula contain almost no ARA. There is therefore a need to supplement infant formula with ARA.
[1] See Martek-2, page 1, lines 7 et seq
11. There are few known sources of ARA that could provide ARA in commercial quantities[2] but one such source was the fungus microorganism genus Mortierella[3]. The specification however noted that oil from such sources may contain by-products such as the sterol 24,25-methlenecholest-5-en-3ß-ol (24,25-M). This compound is not known in humans but has been reported in the cell membranes of Mortierella alpina 1S-4[4].
[2] See Fujikawa-1 exhibit SF-3, slide 4
[3] See Fujikawa-1 at 3.17 where he notes that Mortierella accumulates ARA in oil droplets forming approximately 50% of the dry cell
[4] LIPIDS vol 27, no 6, 481-483 (1992)
12. 24,25-M is produced in a enzymatic reaction which adds a particular substituent to the C1 position of a more widely known sterol, desmosterol (a precursor for cholesterol) – a process known as “C1 addition”. There are other sterols produced by addition of different substituents at that position – namely ergosta-5,25-dien-3β-ol (Ergosta) and ergosta-5,24(25)-dien-3β-ol. Breast milk contains desmosterol but none of its C1 addition products.
13. The current specification surprisingly found that the levels of 24,25-M in the ARA-containing oil were significantly reduced if the microorganism was cultured with a nitrogen (N) source derived from physically or chemically processed soybean compared to the more commonly used yeast extract.
14. The specification expressed the reduced levels of 24,25-M in terms of a “compositional ratio” based on the ratios of the peak area for 24,25-M compared with the total peak area for all sterols in a gas chromatogram using an ULBON HR-1 column. In mathematical terms, this measurement can be expressed as follows:
Peak area of specific sterol = Compositional ratio for specific sterol
Sum of total peak area for all sterols
15. Some of the claims were defined in terms of the compositional ratio for 24,25-M and others were defined in terms of a proportional ratio of the respective compositional ratios for 24,25-M and desmosterol. The specific parameters are set out as follows:
a)the peak area for 24,25-M was 35% or lower compared with the total peak area of all sterols measured by a gas chromatogram using an ULBON HR-1 column (compositional ratio); and
b)the compositional ratio for 24,25-M was 1.2 or lower in comparison to the compositional ratio of desmosterol measured by a gas chromatogram using an ULBON HR-1 column (proportional compositional ratio relative to desmosterol).
16. There were 3 examples in the specification which compared the levels of 24,25-M obtained using a range of culture conditions with and without soybean as N source. A summary of these conditions and the results obtained is provided in the following table.
Table 1:
Example Microbial Strain Nitrogen source 24,25-M comp ratio
(a)24,25-M: desmosterol proportional comp ratio
(b)ARA content* Test 1 Mortierella elongata IFO8570 Soybean protein 30% 0.46 8% Comparative 1 As above Yeast extract 65% 2.41 9% Test 2 Mortierella alpina CBS754.68 Roasted soybean flour (and 0.2% yeast extract) 25% 0.47 48% Comparative 2 As above Yeast extract 68% 4.25 46% Test 3(i) Mortierella alpina ATCC32221 Defatted soy powder 5% 0.07 25% Comparative 3(a) As above Yeast 37% 1.32 20% Test 3(b) Mortierella alpina ATCC42430 Defatted soy powder 5% 0.14 18% Comparative 3(b) As above Yeast 40% 1.60 18% Claims <35% <1.2 30-50% *ARA content with respect to total fatty acids in oil
17. In each example, the 24,25-M compositional ratios in the test samples (using soy bean as an N source) were significantly lower than those comparative examples (using yeast as the N source) thus demonstrating that levels of 24,25-M could be lowered using soy bean as an N source.
18. The specification (as amended prior to the hearing) ended with 42 claims. Claims 1-13 are directed to a process for the production of an ARA-containing oil by culturing Mortierella in a fermenter using an N source derived from soybean wherein the resulting ARA-containing oil contains specified levels of 24,25-M. Claims 14-25 relate an ARA-containing oil per se with specified levels of 24,25-M (the ARA claims). Claims 26-39 relate to an unsaturated fatty acid-containing oil per se with specified levels of 24,25-M (the UFA claims).
19. The independent claims were claims 1, 14 -16, 26-28, 36 and the omnibus claims 40-42. The main independent claims are as follows:
Claim 1: “A process for production of an arachidonic acid-containing oil, characterised by submerged culturing a micro-organism belonging to the genus Mortierella subgenus Mortierella in a fermenter with aeration in a medium containing a nitrogen source derived from physically or chemically processed soy bean, and collecting the arachidonic acid-containing oil from the cultured product, wherein said arachidonic acid-containing oil has a 24,25-methylenecholest-5-en-3β-ol compositional ratio of 35% or lower and wherein the compositional ratio is the ratio of the peak area representing the specified component 24,25-methylenecholest-5-en-3β-ol to the sum of the total peak areas of all sterol components in a gas chromatogram or the components using an ULBON HR-1 column.”
Claim 14: “An arachidonic acid-containing oil characterised by having a 24,25-methylenecholest-5-en-3β-ol compositional ratio of 35% or lower, an arachidonic acid content of 30-50% and a triglyceride content of 90% or greater wherein the compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all sterol components in a gas chromatogram of the components using an ULBON HR-1 column and the arachidonic acid content is measured as a weight percent with respect to the total weight of all fatty acids in the oil.”
Claim 15: “An arachidonic acid-containing oil characterised by having a 24,25-methylenecholest-5-en-3β-ol compositional ratio in a proportion of 1.2 or less with respect to the desmosterol compositional ratio, an arachidonic acid content of 30-50% and a triglyceride content of 90% or greater wherein each compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all sterol components in a gas chromatogram of the components using an ULBON HR-1 column and the arachidonic acid content is measured as a weight percent with respect to the total weight of all fatty acids in the oil.”
Claim 16: “An arachidonic acid-containing oil characterised by having a 24,25-methylenecholest-5-en-3β-ol compositional ratio of 35% or lower, a 24,25-methylenecholest-5-en-3β-ol compositional ratio in a proportion of 1.2 or less with respect to the desmosterol compositional ratio, an arachidonic acid content of 30-50% and a triglyceride content of 90% or greater wherein each compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all sterol components in a gas chromatogram or the components using an ULBON HR-1 column and the arachidonic acid content is measured as a weight percent with respect to the total weight of all fatty acids in the oil.”
Claim 26: “An unsaturated fatty acid-containing oil characterised by having a 24,25-methylenecholest-5-en-3β-ol compositional ratio of 35% or lower and a triglyceride content of 90% or greater wherein the compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all sterol components in a gas chromatogram of the components using an ULBON HR-1 column”
Claim 27: “An unsaturated fatty acid-containing oil characterised by having a 24,25-methylenecholest-5-en-3β-ol compositional ratio in a proportion of 1.2 or less with respect to the desmosterol composition ratio and a triglyceride content of 90% or greater wherein each compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all sterol components in a gas chromatogram of the components using an ULBON HR-1 column.”
Claim 28: “An unsaturated fatty acid-containing oil characterised by having a 24,25-methylenecholest-5-en-3β-ol composition ratio of 35% or lower and a 24,25-methylenecholest-5-en-3β-ol composition ratio in a proportion of 1.2 or less with respect to the desmosterol compositional ratio and a triglyceride content of 90% or greater wherein each compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all sterol components in a gas chromatogram of the components using an ULBON HR-1 column.”
Claim 36: “A nutritive dietary supplement comprising an unsaturated fatty acid-containing oil characterised by having a triglyceride content of 90% or greater and having:
1.a 24,25-methylenecholest-5-en-3β-ol compositional ratio of 35% or lower; or
2.a 24,25-methylenecholest-5-en-3β-ol compositional ratio in a proportion of 1.2 or less with respect to the desmosterol compositional ratio; or
3.a 24,25-methylenecholest-5-en-3β-ol composition ratio of 35% or lower and a 24,25-methylenecholest-5-en-3β-ol composition ratio in a proportion of 1.2 or less with respect to the desmosterol compositional ratio,
wherein each compositional ratio is the ratio of the peak area representing the specified component to the sum of the total peak areas of all components in a gas chromatogram of the components using an ULBON HR-1 column.
20. A table outlining the structure of the main independent claim set is provided in Annex A. Significantly, all the claims are limited by some reference to the 24,25-M compositional ratio of the oil. To fall within the scope of the claims, the oils must have a 24,25-M compositional ratio of 35% or lower, or have a 24,25-M compositional ratio in a proportion of 1.2 or less with respect to the desmosterol compositional ratio.
21. Both the ARA and the UFA claims (claims 14-39) are also expressly limited in terms of their triglyceride content with the claimed ARA oils having a triglyceride content of 90% of greater. In nature ARA, exists in both the triglyceride and phospholipid forms[5]. A triglyceride (TAG) forms when three fatty acid moieties (either the same or different) are attached to each of the three hydroxyl groups in glycerol via an ester bond. Phospholipids are similar structure to triglycerides except they have a phosphate group in place of one of the fatty acid groups. In human breast milk, ARA exists primarily in the form of a triglyceride. Therefore, claims that are limited to an oil with a triglyceride content of greater than 90% more closely resemble natural breast milk.
[5] See Annex B below
22. Claims 40-42 do not explicitly define a particular triglyceride content but nonetheless on is implicitly included. Each of the examples extracts the UFA-containing oil using n-hexane as a solvent. The evidence establishes that hexane preferentially isolates the triglyceride form of a UFA. This suggests that the examples would inherently produce a UFA-containing oil with a high triglyceride content. In contrast, claims 1-14 are not limited to a particular extraction process and encompass processes which result in an oil with a lower amount of triglycerides.
Preliminary issue of validity
23. Claims 26-29, 33, 36-38 relates to any UFA-containing oil with low levels of 24,25-M. At the hearing, the applicant conceded that such claims would include common vegetable oils such as olive oil because these types of oils are also polyunsaturated, naturally contain high levels of triglycerides and would not contain a fungal contaminant such as 24,25-M. Such claims therefore prima facie lack novelty. In addition, the claims are clearly inconsistent with the invention described as a whole which relate to microbial sourced oils and hence these claims also lack fair basis.
24. The applicant indicated at the hearing that they were intending to limit these claims to a ‘microbial sourced oil’. Although I am not aware of any proposed amendments having been filed to this effect to date, I’ll proceed to base my decision as if the claims were amended in the way suggested by the applicant at the hearing.
Abbreviations
25. There are a number of technical abbreviations used in this decision which are explained in the text. However for ease of access, I have also summarised the abbreviations used in the following table:
Table 2
| Abbreviation | Explanation |
| 24,25-M | 24,25-methylenecholest-5-en-3β-ol |
| ARA | Arachidonic Acid, C20:4(n-6) |
| ARASCO | ARA-containing oil from Mortierella – abbreviation stands for ARachindonic Acid Single cell Oil. |
| C source | Carbon Source in culture media |
| Ergosta | ergosta-5,25-dien-3β-ol |
| GY culture media | Culture media using glucose (G) as a C source and yeast extract (Y) as a N source |
| N source | Nitrogen source in culture media |
| UFA | (Poly)unsaturated fatty-acid |
| TAG | Triglyceride (triacyl glyceride) |
Is the term “compositional ratio of 24,25-M” clear?
26. The evidence establishes (and both parties accept) that the ULBON HR-1 column is actually incapable of separating 24,25-M from another C1 addition sterol, ergosta-5,25-dien-3ß-ol (Ergosta). Hence the peak representing 24, 25-M (ie: the ‘defined’ level of 24, 25-M) necessarily includes both 24,25-M and Ergosta and is not a true measure of the ‘actual’ level of 24,25-M. The opponent even noted that there were examples where the actual 24,25-M level was zero (as measured by the HR-17 column) but there was still a measurable peak because of the presence of Ergosta[6]. In such cases, the opponent argued that it was meaningless to refer to the peak area as representing 24,25-M. As a consequence, according to the opponent, there was a fatal clarity problem with the claims under section 40(3) of the Patents Act [1990] Cth.
[6] See Exhibit SF11 to Fujikawa 3
27. I accept that the PSA cannot know the actual 24,25-M content from the test provided in the claims. However, a claim does not lack clarity because it uses inexact expressions or is difficult to construe, as long as it provides a “workable standard” suitable to the intended use (as per Henriksonv Tallon Ltd [1965] RPC 434; Minnesota Mining& Manufacturing Co & 3M Australia Pty Ltd v Beiersdorf (Aust) Ltd [1980] HCA 9; (1980) 144 CLR 253 at 274. The term ‘represents’ means ‘stands for’ or ‘denotes’. Therefore, the peak area ‘standing for’ the specified component 24,25-M on a plain reading of the words means the peak area which corresponds to elution of 24,25-M irrespective of whether other components also elute at the same point. This is a construction which gives functionality to the claim in the sense that it allows the claim to be worked.
28. The experts were clearly able to work the formula defined in the claims. Exhibits AJS 16 and AJS 18 to Sinclair-3 compare the ‘defined’ 24,25-M ratio with the ‘actual’ 24,25-M ratio (using methods that effectively separate the Ergosta and 24,25-M results) for various products. While the aim of this evidence was to establish that the ULBON HR-1 column does not show the actual composition of 24,25-M, it also shows that it is possible to clearly construe and work the definition which is found in the claims. Even when no 24,25-M was detected at all, the compositional ratio was still calculable (as evidenced by AJS 19).
29. In my view, the definition of “compositional ratio of 24,25-M” is clear even if it is not a true measure of the actual amount of 24,25-M in the oil. Unless otherwise indicated by context in this decision, I will be using the term “24,25-M” as meaning the combined Ergosta/24,25-M peak measurement (ie: the ‘defined’ 24,25-M ratio).
Novelty
Relevant Legislation
30. As both parties acknowledged in their submissions, the opposed application (being filed on 4 August 2000) predates the Patents Amendment Act 2001 (Cth). Section 13 of that Act states that the amendments only apply to applications made on or after the date of commencement. As a consequence, novelty in the current case has to be considered in light of section 7(1) of the Patents Act as the section existed prior to the Patents Amendment Act 2001. The relevant sections are provided below:
7 Novelty and inventive step
(1)For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;
(b)prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;
(c)prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base in Schedule 1.
Prior art base was in turn defined in Schedule 1 as follows:
i.information in a document, being a document publicly available anywhere in the patent area; and
ii.information made publicly available through doing an act anywhere in the patent area; and
iii.where the invention is the subject of a standard patent or an application for a standard patent—information in a document publicly available outside the patent area; and
31. The effect of this legislation (as it then was) is that documents published anywhere in the world are relevant for assessing novelty. However only information made publicly available through doing an act in the patent area are relevant for determining novelty by prior use because of the transitional provisions which apply to the current case.
32. The patent area is defined in Schedule 1 as being within Australia.
Relevant Law
33. A claimed invention is deprived of novelty if it has been given to the public before the priority date, either by prior use of a product or process, or by publication of information that equates to the claimed invention (Justice Bennett in Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282 at [248]; (2011) IPR 209 at [248]. It is well established that the general test for anticipation 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 [1977] HCA 19 at [20]; [1977] HCA 19; (1977) 137 CLR 228 at 235:
“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.”
34. This test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40 at [19]; (1990) 16 IPR 545 at 549). To meet this requirement, the prior art must contain “clear and unmistakable directions” to the claimed invention (Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [314]; [2005] FCAFC 224; (2006) 68 IPR 1 at 67 [314]). This means that if the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in such a way that would not do so, the patentee’s claim will not be anticipated (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1971) 1A IPR 121 at 138).
35. Where a prior publication does not explicitly disclose all of the integers of the claimed invention, it would still deprive the claimed invention of novelty if (i) the skilled reader understands the disclosures of the prior publication to include a missing integer, and (ii) if the document contains a direction to use a process that inevitably or inexorably results in something within the claim (Justice Bennett in Danisco v Novozymes (No 2) supra at [248]).
36. The onus of proof in opposition proceedings lies with the opponent who must establish that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; [2000] FCA 283; (2001) 50 IPR 305 at 311 [29], 319 [67]; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; [2008] FCAFC 182; (2009) 79 IPR 426 at 430 [18], 432 [22]).
37. The primary facts are to be established on the balance of probabilities, but the ultimate facts - the facts leading directly to a conclusion of a lack of novelty or a conclusion of obviousness - must be proved to the level of “practical certainty” (Besanko J in Aspirating IP Ltd v Vision Systems Ltd [2010] FCA 1061 at [35]; [2010] FCA 1061; (2010) 88 IPR 52 at 63 [35]) Besanko J at that reference quotes Bennett J in Austal Ships v Stena Rederi Aktiebolag [2005] FCA 805; (2005) 66 IPR 420. The relevant quote in full is as follows (at paragraph [12]):
“I can accept that a lower standard may apply to proof of evidence such as whether a document has been published or, indeed, whether a prior art vessel was well-known. I do not accept that it properly applies to the factual question that itself is the test for obviousness or lack of inventive step. Where the factual question is itself the legal test, as set out in s 7(3) of the Act, it seems to me that it should be determined at the higher standard. That means that where there are two opposing expert views that are conclusive on obviousness, both presented bona fide by witnesses of accepted expertise, unless one set of views can be rejected on proper grounds, the legal burden to establish a ground of opposition is not discharged; the court cannot be practically certain that obviousness or lack of inventive step is established.”
Prior Use
38. There are few Australian decisions where the novelty consideration was based on a publication by prior use and both parties referred to me to a relatively recent Full Court decision in Jupiters v Neurizon Pty Ltd [2005] FCAFC 90. That decision related to a jackpot system for an electronic gaming device (EGD) which had been operating in a casino prior to earliest priority date of the relevant patent.
39. The Full Court noted that what is required to satisfy the provision is an "enabling disclosure" of the invention by the prior conduct (PLG Research Ltd v Ardon International Ltd [1993] FSR 197 at 225, unaffected by the subsequent appeal [1995] RPC 287); Asahi Kasei Kogyo KK’s Application [1991] RPC 485 at 539; Quantel Ltd v Spaceward Microsystems Ltd [1990] RPC 83 at 108; Pall Corporation v Commercial Hydraulics (Bedford) Ltd [1990] FSR 329).
40. Referring to PLG Research, the Full Court observed that a skilled worker might have been able to use available investigation techniques and “glean” the information to reproduce the gaming device. However there was no evidence of unrestricted access to the gaming devices that would enable the skilled worker to analyse the inner workings of the gaming devices. As the skilled worker could not “glean” the relevant information by mere observation, there was not an enabling disclosure and hence there was no anticipation.
41. Both PLG Research and Neurizon considered whether the information disclosed by the prior use was publicly available and this is also a key issue in the current case. The principles for determining whether information has been made “publicly available” are summarised by the Full Court in Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd [2008] FCAFC 139 at [124]
· The information must have been made available to at least one member of the public who, in that capacity, was free, in law and equity, to make use of it (PLG Research Ltd v Ardon International Ltd [1993] FSR 197 at 226 per Aldous J cited in Jupiters at [141]). (This test of communication to a member of the public who is free in law or equity to use the information as he or she pleases had been enunciated by the English Court of Appeal as early as 1887 in Humpherson v Syer(1887) 4 RPC 407 at 413 per Bowen LJ.)
· It is immaterial whether or not the invention has become known to many people or a few people (Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd [1961] HCA 39; (1961) 180 CLR 98 at 111 per Windeyer J). As long as it was made available to persons as members of the public, the number of those persons is not relevant. Availability to one or two people as members of the public is sufficient in the absence of any associated obligation of confidentiality (Fomento Industrial S.A. v Mentmore Manufacturing Co Ltd [1956] RPC 87 at 99–100; Re Bristol-Myers Co’s Application[1969] RPC 146 at 155 per Parker LJ).
· The question is not whether access to an invented product was actually availed of but whether the product was made available to the public without restraint at law or in equity (Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91; (2006) 154 FCR 31 (Merck) at [98]–[103]).
· In order to be "available", information said to destroy novelty must be of a kind that would disclose to a person skilled in the relevant art all of the essential features or integers of the invention (cf RD Werner & Co Inc v Bailey Aluminium Products Pty Ltd(1989) 25 FCR 565 at 593–594).
· In order to be "available", information said to destroy novelty must "enable" the notional person skilled in the art at once to perceive, to understand, and to be able practically to apply the discovery, without the need to carry out further experiments in order to arrive at that point (Stanway OysterCylinders Pty Ltd v Marks (1996) 66 FCR 577 at 581–582).
42. In Insta Image v Kanopy [supra], the Full Court considered whether the display of the patentee’s prototype collapsible canopy structure (the ‘Original’) at public events such as motocross races and jet-ski races allowed the public to understand the nature of the invention such that the claims would be deprived of their novelty (at [125]). The Full Court found that a lack of novelty based on prior use concluding (at [151]):
“The public was not denied access, and there was a means for the public to inspect the Original. There was nothing to prevent a member of the public from going to its location at the back of the pits, and examining it sufficiently to understand its construction and its component features. There is nothing in the evidence to suggest that examination would not have revealed all the integers of the claimed invention including the mounts and pins as described in the Patent specification. The information gleaned from such an inspection would, for the purposes of practical utility, be equal to that given in the Patent (Hill v Evans (1962) 31 LJ CL 456 at [7]; Merck at [111]–[112]). An inspection would enable a person skilled in the art to put the claimed invention into practice (cf Bodkin at [3790] and the cases there cited).”
43. The Full Court contrasted this with the circumstances in Jupiters, where the key features had been internal to the gaming device which could not have been observed by members of the public.
Evidence of Prior Use
44. In the early 1990s, the opponent (Martek) developed an industrial scale process for the production of a high ARA containing oil from Mortierella alpina.[7] The oil was marketed under the trade name ARASCO which stands for ARachindonic Acid Single cell Oil.
[7] See outline of opponent’s submissions, part K (lack of novelty) at [8]
45. By 1993, Martek had begun making commercial scale lots of ARASCO oil and were marketing the use of the product as a nutritive supplement particularly for use in making infant formula.[8] The product was never actually sold to the public in Australia but there was nonetheless evidence of at least three supplies of the product to organisations within Australia which were received in Australia prior to the earliest priority date of the current specification which were relied on by the opponent at the hearing[9]:
(a)Oil taken from Lot A013-DS and shipped to CSIRO Division of Oceanography on 22 May 1995 respectively[10];
(b)Oil taken from Lot A015-40-DS and shipped to CSIRO Division of Fisheries on 17 October 1995[11]; and
(c)Oil taken from Lot A015-40-DS and shipped to Professor Gibson at Flinders Medical Centre on 21 November 1995.[12]
[8] See outline of opponent’s submissions, part K (lack of novelty) at [12]
[9] See Panker-1 at [3.10] and [3.28]
[10]Zeller 1 at [3], Panker- 1, at [3.10] , Tsetsis 1 at ALT-8 and Brunero-6 at LB-10
[11] Panker-1 at [3.28], Tsetsis 1 at [4.5] and [4.6] and to Brunero-6, Exhibit LB-11
[12]Tsetsis-1 at [4.1]-[4.7] and exhibits ALT-4 to ALT-7
46. Patents were also filed in Australia encompassing the technology - in particular:
(a)AU 12355/92 A (MARTEK BIOSCIENCES CORPORATION) filed on 24 January 1992, published on 6 August 1992 (Martek-1)[13]; and
(b)AU 48542/96 A (MARTEK BIOSCIENCES CORPORATION) filed on 3 January 1996 and published 11 July 1996 (Martek-2)[14].
[13] Exhibit AJS-3 to Sinclair-1
[14] Exhibit AJS-8 to Sinclair-1
47. Unlike Martek-2, Martek-1 was not relied on as a document by the opponent for the purposes of novelty and inventive step. However at the hearing, the opponent acknowledged that the specific ARASCO oil provided to CSIRO was manufactured using the culture conditions outlined in Martek-1. These culture conditions included yeast extract (rather than soy bean) as the preferred N source[15] with hexane being the preferred solvent of extraction[16]. The predominant form of ARA produced by Mortierella alpina is trigyceride.[17]
Was the information made available to at least one member of the public who was free in law and equity to make use of it?
[15] See Martek-1, page 9, lines 8-10
[16] See Martek-1, page 11, lines 22-25
[17] See Martek-1, page 15, lines 22-23
48. The applicant noted that the onus was on the opponent to establish that each of these supplies of the ARASCO oil was provided to a person who was “free in law and equity” to make use the information gained from the prior use. The opponent argued that they (as the supplier) had not provided the information in confidence nor would there be any need to do so. The oil was already available overseas and they were seeking to market in Australia.
49. The opponent referred to the case of Ansell Rubber Co Pty Ltd v Allied Rubber Industries Pty Ltd [1967] VicRep 7; [1967] VR 37 (29 April 1966) to support their contention that the way the supplier treats the information is highly significant in determining whether a fetter of confidentiality was placed on the receiver of the information. That case concerned whether it was unlawful for an employee to disclose information about machines in a factory when the employer had communicated in various ways that the information was private. In such a case, clearly the way the employer treated the information (as confidential) was highly significant.
50. However the converse is not necessarily true. Even if a supplier does not explicitly mention that the information was confidential, this could nonetheless still be implied because of the nature of the transaction or the relationship between the two parties. In such cases, evidence about the perception of the receiver of the information (as to whether they considered themselves free to use the information) would be highly relevant in determining whether the information was publicly available regardless of how the supplier viewed the transaction.
51. In this regard, the supplies to the three organisations were made in three very different circumstances. As each require individual considerations concerning their public availability, I’ll discuss them separately.
CSIRO Division of Oceanography
52. In the first Australian supply of ARASCO, the opponent paid CSIRO Division of Oceanography to conduct a “sponsored analysis” of their ARASCO oil (Lot A013-DS). Although the opponent did not impose any explicit conditions of restriction or confidentiality in that transaction[18], the nature of the transaction was such that CSIRO’s role was provide paid independent information about a product for a client (ie: a “fee for service”). Because of this commercial arrangement, the information therefore necessarily belonged to the client rather than CSIRO and CSIRO has an implied obligation not to pass this information onto anyone else.
[18] Tsetsis-1 at [4.8]
53. In this type of transaction, CSIRO had been provided the sample for the limited purpose of obtaining information for a customer. CSIRO holds the sample “in trust” so that they can perform the analysis for (and on behalf of) the requestor but is not free to use the sample for themselves or for any other purpose. Further, the information gathered was paid for (and therefore was owned by) the customer meaning that CSIRO would not be free in law and equity to disseminate it.
54. CSIRO had clearly understood that there was an implied term in their sponsored analyses contract because they saw the need to include a specific clause (clause 9) to preserve a restricted right to use or publish their results[19]. This clause allowed CSIRO to publish their results but only in a form which did not directly identify the sample or the sponsor (unless the sponsor requested otherwise in writing). The opponent did not provide any of the results obtained in relation to Lot A013-DS which might have been publishable and instead relied on CSIRO’s analysis on a different sample (Lot number A011-DS) which had been supplied earlier[20]. The problem with this is that I have no details of the analysis of A013-DS and no evidence on the conditions of supply of lot number A011-DS. As a result, I am unable to conclude that CSIRO had produced publishable results under the contractual sponsored analysis arrangement referred to above which they were free in law and equity to use.
Supply to CSIRO Division of Fisheries
[19] Exhibit LB-10 to Brunero-6
[20] Exhibit SIZ-1 to Zeller-1 and exhibit SIZ-3 to Zeller-2
55. In contrast, CSIRO Division of Fisheries initiated the purchase of the ARASCO oil (Lot A015-40-DS) for their own analysis around 5 October 1995 (and this was not disputed by the applicant). Where a product is purchased, there is an implied term of contract such that the purchaser is entitled (ie: free in law and equity) to use it as they see fit. There was no term in the sales contract to suggest otherwise and given that the supplier (the current opponent) has clearly indicated that they did not consider the material confidential, I consider this supply as being “publicly available” without fetter.
56. The applicant points out that the specific oil is not identified in this request. However, the request is clearly consistent with the evidence of Panker-1 that ARASCO oil lot A015-40-DS was supplied to CSIRO Division of Fisheries on 17 November 2005. There is no evidence that oils from any other lots were supplied to CSIRO Division of Fisheries. I am therefore satisfied that the oil provided in response to the supply request was ARASCO oil lot A015-40-DS.
Professor Gibson
57. The third supply of ARASCO oil (Lot A015-40-DS) was made to Professor Gibson at the Flinders Medical Centre on 21 November 1995. Professor Gibson originally did not recall the circumstances of this supply but accepted Dr Kyle’s explanation in evidence in response that they had been provided to him as early as 1992 on request on an informal basis[21]. Dr Kyle did not remember how the oil was used but Professor Gibson believed that he would have used it for “rat experiments.”[22]
[21] Kyle at [4.5]-[4.7]
[22] Gibson-3 at 3.3
58. While Dr Kyle did not believe the transaction was confidential, Professor Gibson had understood that the sample was not commercially available and had considered the sample as provided by a scientific colleague in confidence. Thus, although Professor Gibson had initiated the request, it was provided as a “favour” and he had understood and respected that the material was not generally available. The nature of the transaction was therefore in the form of a “shared secret”. This confers an implied obligation on the receiver to seek permission from the original source to pass on the material or publish data related to it. Without evidence of an explicit agreement that Professor Gibson could use the sample freely from Dr Kyle, Professor Gibson was not free in law and equity to use the information. As a consequence, this supply was not publicly available.
59. I note, as an aside, that there was a later email from Professor Gibson to Dr Kyle where Professor Gibson clearly indicates his knowledge and interest in ARASCO and his willingness to pass on supplies to clinicians[23]. If the supply had been made as a result of this email, this may have provided an explicit agreement that Professor Gibson could use it freely. However, the email post-dated the supply relied on by the opponent and there was no supply of the oil as a consequence of that email[24].
What was disclosed by the supply of oil from lot A015-40-DS to CSIRO Division of Fisheries?
[23] Exhibit DJK-1
[24] Kyle at [4.6] and Gibson-3 at [3.2]
60. Given the analysis above, my view is that the only publicly available supply of ARASCO in Australia was Lot A015-40-DS shipped to CSIRO Division of Fisheries on 17 October 1995. This sample was a “blended oil” meaning that vegetable oil was blended with the microbial sourced oil to ensure a standardised (commercial) concentration of ARA (40%).
61. As noted above, the ARASCO oil sample provided to CSIRO had been generated using the culture conditions of Martek-1 (with yeast as the N source). Based on the teaching of the current specification, the ARASCO oil would not be expected to have low levels of 24, 25-M because the claimed (lower) levels of 24,25-M were only achieved using soybean meal as the N source.
62. However, the opponent argued that there was no need to use soy bean meal as the N source to achieve the claimed result[25] and argued that the their oil samples also had low levels of 24,25-M which fell within the scope of the claims. Although these levels were not measured at the time of production, samples of the same batch had been stored at Martek’s facilities protected from light at -20°C under nitrogen. The opponent was therefore able to analyse a sample for 24, 25-M levels from the same batch lot 10 years later (in 2007).
[25] See opponent’s submissions on utility at M-7
63. These experiments were described in Zeller-1. Based on Zeller’s data, Professor Sinclair concluded that the levels of both 24,25-M and ARA in ARASCO oil batch A015-40-DS as measured in 2007 fall within the limits defined in the current claims as outlined in the table below[26].
[26] See Sinclair-2 at [3.12]
Table 3:
| Component | Levels in ARASCO (Lot A015-40-DS) | Limits in the current claims[27] |
| ARA (weight percentage) | 40.3% | 30-50% |
| 24,25-M compositional ratio | 5.3% (HP-5 column) | ≤ 35% (HR-1 column) |
| 24,25-M compositional ratio/desmosterol compositional ratio | 0.07 (HP-5 column) | ≤ 1.2 (HR-1 column) |
[27] See annex A of this decision for analysis of the claims.
64. The applicant criticised Zeller’s work because she measured the 24,25-M content using an HP-5 column (rather than an ULBON HR-1 column as specified in the claims). The applicant’s expert (Dr Fujikawa) noted that there are differences in polarities between the two types of columns and that he would expect the percentage figures in the Zeller tables to be different if the oils had been analysed using the HR-1 column [28].
[28] See Fujikawa-2 paragraph 7.7
65. The opponent did not believe that a small difference in the column would underestimate the level of 24,25-M by a factor of more than 6.6[29]. Nevertheless they were prepared to do provide additional evidence after the hearing to address the applicant’s criticisms. This evidence consisted of a statutory declaration from Mr Mallon[30]. Mr Mallon repeated the Martek-1 protocol (which had been used to generate batch A015-40-DS) and compared the 24,25-M content in 6 samples of ARA-rich crude oil taken from the fermentation of Mortierella alpina at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours and 144 hours using both an HP-5 and HR-1 column.
[29] There is a 6.6 fold difference between the measured level of 24, 25-M in ARASCO (5.3%) and the claimed level (35%). There is also a 17 fold difference between the measured ratio of 24,25-M :desmosterol (0.07) and the claimed ration (1.2).
[30] See Mallon statutory declaration of 4 May 2012
66. I have extracted the key pieces of his data in the table below.
Table 4:
| Sample | 24, 25-M compositional ratio | 24,25-M:desmosterol proportional compositional ratios | ||
| HP-5 | Ulbon HR-1 | HP-5 | Ulbon HR-1 | |
| 1-24 | 6.78 | 6.28 | 0.095 | 0.087 |
| 2-48 | 10.67 | 9.52 | 0.165 | 0.147 |
| 3-72 | 14.12 | 14.54 | 0.266 | 0.270 |
| 4-96 | 14.22 | 14.97 | 0.292 | 0.305 |
| 5-120 | 16.71 | 16.14 | 0.386 | 0.351 |
| 6-144 | 17.22 | 16.43 | 0.410 | 0.380 |
| Claims | ≤ 35 | ≤ 1.2 | ||
67. In each case, the levels of 24,25-M measured by either the HP-5 or HR-1 columns were very similar[31] confirming Zeller’s conclusions about the 24,25-M content in ARASCO lot number A015-40-DS. Mr Mallon’s evidence also demonstrated that the levels of 24,25-M in the ARA-oil were low even though a GY medium was used (rather than soy bean). The opponent argued that this was further support for the batch lot containing a low level of 24,25-M.
[31] See Mallon at page 12
68. The applicant generally criticised the opponent’s repeat experiments suggesting (with regard to Martek-2) that the possible “permutations and combinations” in the culture conditions “created such a broad array of possible results that it cannot be said that all results lead to a product within the scope of the claim”.[32] I agree with the applicant. Microbial fermentation is a complex process with a large number of possible variations which could be made in the culture conditions and no understanding of how any of these might affect the levels of 24,25-M. Although the opponent’s experimental evidence repeating the Martek-1 protocol (GY medium) shows that it was possible to produce an ARA oil with a low level of 24,25-M with the specific conditions used by the opponent, this does not necessarily mean that a skilled worker would achieve the same result using slightly different conditions (at least to ‘the level of practical certainty’ required in an opposition[33]).
[32] See applicant’s further submissions dated 6 August 2012 at [40]
[33] As per Besanko J in Aspirating IP Ltd v Vision Systems Ltd [2010] FCA 1061 at [35]; [2010] FCA 1061 – see discussion above at [33]
69. With regard to the levels of 24,25-M in lot number A015-40-DS itself, Zeller’s measurements were still based on a sample that has been stored (albeit very carefully) for more than 10 years. The opponent provided some evidence that 24,25-M levels are stable over time based on data for another batch lot (A017-40-DS). Professor Sinclair compared NMR spectrums of A017-40-DS at different times – the first dated 19 August 1996 and the second dated more than 10 years later (in 2007). In both cases the 24,25-M compositional ratio was the same (4%). Based on this data, Professor Sinclair concluded that the 24,25-M compositional ratio of ARASCO oil does not change (or change in any substantial way) during storage[34].
[34] Sinclair-2 at [3.14]-[3.18].
70. However (as the applicant noted), the opponent’s stability evidence is based on one test of one oil lot which is different to the oil lot in question. The applicant’s expert (Dr Fujikawa) also argued that the stability and rate of degradation of samples of oil can vary significantly even when stored under the same conditions. His view was that no general conclusion concerning the stability of sterol content could be made based on the results of one experiment involving a single sample of ARASCO oil[35]. The applicant also tested two samples of an ARA-containing Suntory oil at different points in time to demonstrate that the 24,25-M compositional ratio can change over time[36].
[35] See Fujikawa-2, 3.4-3.9
[36] See Katano declaration
71. The applicant’s experimental evidence is not particularly convincing because the samples being analysed were not stored under the same temperature conditions as the ARASCO oils. Nonetheless they have shown that 24,25-M levels can change over time in storage and their criticism of the opponent’s conclusions based on “one test of one sample” is valid. I therefore can’t be “practically certain” that the ARASCO oil had low levels of 24,25-M at the priority date as the opponent has argued. As a consequence, I am unable to conclude that the claims fail for want of novelty based on prior use.
Novelty based on Information published in a document
72. The opponent alleges lack of novelty based on three publications:
a)AU 48542/96 A (MARTEK BIOSCIENCES CORPORATION) 11 July 1996 (Martek-2) originally published as PCT application WO 96/21037[37]
b)Zu-Yo Li, Yingyin Lu, V.B. Yadwad and O.Ward “ Process for the Production of Arachidonic Acid Concentrate by a Strain of Mortierella alpina” Can. J. Chem. Eng. 73: 135-139 (February 1995) (hereafter Li-Lu)[38]
c)Yamada H., Shimizu S., Shinmen Y., Akimoto K., Kawashima H. and Jareonkitmongkol S. “ Production of Dihomo-γ-linolenic Acid, Arachidonic Acid and Eicosapentaenoic Acid by Filamentous fungi” Chapter 7 in D Kyle and C Ratledge (eds) Industrial Applications of Single Cell Oils (1992) 118-138[39] (hereafter Yamada) when read together with Shinmen Y.,Shimizu S., Akimoto K., Kawashma H. and Yamada H. “Production of arachidonic acid by Mortierella fungi” Appl. Microbiol. Biotechnol. (1989) 31: 11-16 (hereafter Shinmen-Shimizu)[40]
[37] Exhibit AJS-8 to Sinclair-1
[38] Exhibit AJS-7 to Sinclair-1
[39] Exhibit AJS-20 to Sinclair-4
[40] Exhibit AJS-5 to Sinclair-1
73. I’ll discuss each of these citations separately.
Martek-2[41]
[41] Exhibit AJS-8 to Sinclair-1
74. Martek-2 was the second ARASCO patent application filed by the opponent and their primary novelty citation. Filed 4 years after Martek-1[42], Martek-2 also related to the production of an enriched fungal oil which contained ARA in a triglyceride form. Martek-2 was a further development of the original work having higher yield and purity compared with the first application. The later claims defined these advantages in terms of the levels of ARA (at least 40%) and the lack of detectable eicosapentaneoic acid (EPA) in the oil.
[42] See discussion above under prior use
75. In a particularly preferred embodiment, Martek-2 teaches that Mortierella alpina can produce high levels of ARA if cultured in a fermenter using very high nutrient levels.[43] Although Martek-2 notes that nitrogen is typically supplied to the microorganism in the form of a yeast extract[44], it explicitly recommends the use of soy flour as a nitrogen source to be added at a level of about 16 grams/litre of medium (see page 9 line 21). Based on the results in example 7 (see tables 5 and 6), this modification produces both a high oil content and a high ARA content (generally above 30%).
[43] See Martek-2, page 9, lines 10-15
[44] See Matek-2, page 7, line 27
76. Martek-2 also discloses the following features of claim 1:
submerged culturing – page 7 line 9;
use of a fermenter – page 8 line 8;
aeration – page 8 line 21; and
Mortierella fungus – page 9, line 10
77. Martek-2 notes that by optimizing the fermentation of M.alpina, it was possible to obtain very high yields of biomass containing 20-60% oil in the biomass, where 25-75% by weight of the oil is ARA residues in triglyceride form”[45]. While the specific levels of ARA were not relevant to claim 1, they were certainly significant to a number of the later claims (including claims 14-25).
[45] See Martek-2, page 13, lines 6-8
78. The percentage of TAG is also a significant feature in many of later claims (claims 14-42). Martek-2 doesn’t mention the exact % TAG. However, the exemplified oil extraction method uses n-hexane (see page 13, line 22) which (as noted above) preferentially extracts the TAG form of ARA. In addition, Martek-2 suggests that the aim of fermentation is to produce extractable triglyceride (TAG) oil having a high proportion of ARA residues (see page 5, lines 2-5). This teaching infers that there is a high proportion of TAG in Martek-2 (ie: ≥ 90%) as defined in most of the claims (claims 14-42).
79. This means that the key difference between all the current claims and Martek-2 is the compositional ratios of 24,25-M. Martek-2 had not recognised that 24,25-M is a potential contaminant of the ARA oil and had not measured the levels of this component. The document also failed to understand that a soybean medium might reduce the levels of 24,25-M in the final product.
80. Despite this, the opponent argued that the citation discloses the claimed levels of 24,25-M nonetheless as an inherent result of the culture and extraction process used in Martek-2 which used soybean as the nitrogen source. The opponent’s argument is based on the proposition outlined by Lord Hoffman in the UK decision of SmithKline Beecham Plc’s (Paroxetine Methanesulfonate) Patent [2006] RPC 10 [24] (see 177 FCR at 193):
“…..the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. ... [W]henever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so” (my emphasis)
81. Based on this reasoning, it is possible for Martek-2 to have anticipated the claimed invention even though there is nothing in the disclosure about the levels of 24,25-M. However where the original authors were not aware of the disclosure, the test for whether a process is anticipatory is necessarily a high one. Lord Hoffman explained this in the following terms in SmithKline Beecham[46]:
“anticipation requires prior disclosure of subject-matter which, when performed, must necessarily infringe the patented invention” (my emphasis).
[46] SmithKline Beecham Plc’s (Paroxetine Methanesulfonate) Patent [2006] RPC 10 (see 177 FCR at 193)
82. He expanded his comments further at [23]:
But the infringement must be not merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. If there is more than one possible consequence, one cannot say that performing the disclosed invention will infringe. The flag has not been planted on the patented invention, although a person performing the invention disclosed by the prior art may carry it there by accident or (if he is aware of the patented invention) by design. (my emphasis)
83. Bennett J in the Full Court decision of H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; (2009) 177 FCR 151 agreed with Lord Hoffman’s approach noting at [182] that:
It may be that the prior disclosure is of a method that produces the claimed product. If that method leads inexorably to the product, there is anticipation .... If it may or may not result in the claimed product, there is no anticipation. (my emphasis)
84. In the current case, the opponent provided a large amount of experimental evidence which repeated Example 7 of Martek-2 where soy flour had been used as a N source[47]. The key experiments were reported in table 1 of Mallon-2 which I have reproduced below.
[47] Previous repeats were by Dr Lawrie (see his declaration from paragraph 5) [the results of which are summarized in Sinclair-1 at paragraph 7.4] and by Drs Pfeifer and Zeller [documented in exhibit LB-15 to Brunero-6].
Table 5
| Sample (log hour) | 24, 25-M compositional ratio (A) | Desmosterol compositional ratio (B) | 24,25M/desmosterol proportion (A/B) | ARA content | %TAG | |||
| HR-1 | HR-5 | HR-1 | HR-5 | HR-1 | HR-5 | |||
| 0 | ||||||||
| 66 | 9.70 | 9.36 | 54.16 | 52.96 | 0.18 | 0.18 | 29.50 | ≥90% |
| 94 | 10.43 | 10.39 | 58.43 | 57.67 | 0.18 | 0.18 | 38.76 | ≥ 90% |
| 118 | 10.95 | 11.17 | 60.76 | 58.46 | 0.18 | 0.19 | 42.83 | ≥ 90% |
| 142 | 12.17 | 12.51 | 59.36 | 57.08 | 0.21 | 0.22 | 46.14 | ≥ 90% |
| 165 | 13.21 | 13.51 | 58.83 | 56.05 | 0.22 | 0.24 | 50.28 | ≥ 90% |
| 188 | 14.85 | 16.27 | 57.90 | 53.43 | 0.26 | 0.30 | 53.52 | ≥ 90% |
| 215 | 16.51 | 17.42 | 57.39 | 54.22 | 0.29 | 0.32 | 57.11 | ≥ 90% |
| 237 | 17.81 | 19.12 | 55.05 | 50.73 | 0.32 | 0.38 | 59.13 | ≥ 90% |
| Claims | ≤ 35 | ≤ 1.2 | 30-50% | ≥ 90% | ||||
85. At each time point, the level of 24,25-M was always well below (by at least 50%) the claimed compositional ratios of 35% and 1.2 regardless of the time of sampling. The previous repeats had shown similar results. In addition to these experimental results, the opponent argued that the current specification had taught that using soybean as a nitrogen source will reduce 24,25-M levels. Given that Martek-2 also directed the skilled worker to use soybean as an N source (albeit for a different reason), the opponent argued that Martek-2 would inevitably produce an oil with the claimed (low) levels of 24,25-M.
86. The opponent suggested that legal principles outlined in Danisco v Novozymes [supra] related to the ‘sufficiency’ or ‘quality’ of disclosure. They relied on Bennett J’s comments at [257] of that decision which states:
“As discussed in Lundbeck at [180]-[190] per Bennet (Middleton J agreeing), it is necessary for anticipation that the skilled addressee would add missing information as a matter of course, or that the prior art disclosure of a process would lead inexorably to the product or that a skilled worker may observe on inspection sufficient to enable him or her to comprehend the invention.” (my emphasis)
87. The opponent argued that because example 7 of Martek-2 used the same starting material and followed the same general process as the current invention, it would inevitably produce the same product as the current specification[48]. However, without any direction to measure and control the levels of 24,25-M, I would not be inevitable that the use of soy in the fermentation medium would produce the low levels of 24,25-M defined in the claims.
[48] See first tranche of Evidence in response filed 21 August 2012 at [9]
88. Fermentation is not a simple process with a single and predictable outcome. There are a multiple number of minor variations in the culture conditions used in fermentation which might affect the final levels of 24,25-M. The opponent even suggested that the high levels of 24,25-M observed in the applicant’s comparative examples must have been an (unknown) aberration of the culture conditions. Thus, I accept that it is possible for high levels of 24,25-M to be produced even when soy bean was used as a N source as the applicant argued[49] noting that it was (and still is) unknown why soy would affect such levels[50].
[49]See for example applicant’s further submissions of 6 August 2012, pages 10 et seq
[50] However, the applicant speculated that there is a minor (but unknown) contaminant in the soy flour that decreases the levels of 24,25-M.
89. While the opponent’s experimental results (and the opposed specification itself) suggest that low levels of 24,25-M are likely to result from the method of Martek-2 which uses soy bean as a Nitrogen source, this falls short of the test which requires this to be an inevitable (inexorable) result of the prior art process. This could only be assured if the skilled worker tested the final oil and confirmed that 24,25-M levels were low as the opposed specification teaches. Without the same teaching in Martek-2, this document does not deprive any of the claims of their novelty or inventive step.
Li-Lu[51]
[51] Exhibit AJS-7 to Sinclair-1
90. In Li-Lu, various strains of Mortierella alpina fungi were screened for their capacity to produce ARA. The produced ARA (around 40%) was isolated using hexane extraction and therefore inherently has a triglyceride (TAG) concentration of ≥ 90%. The citation reported that ARA content of biomass and overall yield per litre of culture was highest in a soya flour supplemented GY medium as demonstrated in table 2 of that citation (the relevant parts of which are extracted below).
Table 6
ARA content M.alpina strain supplement Biomass
g/LIn biomass (%w/w) In lipids
(% w/w)Yield
(g/L)UW-1 control 11.0 11.5 39.5 1.27 Soya flour (1% w/w) 23.0 11.0 43.2 2.53 ATCC 32222 control 11.0 14.3 34.2 1.57 Soya flour (1% w/w) 21.0 16.2 40.1 2.31
91. The applicant argued that the N source was provided by GY rather than soya flour and that the latter was only added to produce dispersed mycelium in culture. However while the soya flour may not have been intentionally added as an N source, it is nonetheless present in a form and at a level that would inherently provide a supplementary N source. The opposed specification notes that additional N sources can be present as long as the sterol composition is not affected[52]. As a consequence, I accept that there is a clear teaching in Li-Lu for the skilled worker to use soya flour in their culture medium.
[52] See opposed specification page 5, lines 30-32
92. However, Li-Lu does not recognise 24,25-M as a potential contaminant of the ARA oil. Li-Lu has not measured the levels of this component and does not contain any teaching to reduce the levels of this component. As discussed above for Martek-2, although the use of soya flour might mitigate the risk of having high levels of 24,25-M in the final product, it is not an inevitable result of using soya flour in the culture medium and hence Li-Lu does not deprive any of the claims of their novelty.
Yamada/Shinmen-Shimizu[53]
[53] Exhibits AJS-20 to Sinclair-4 and AJS-5 to Sinclair-1
93. Yamada is a review paper which discusses the production of various UFAs (including ARA) from filamentous fungi, in particular from the genus Mortierella. The paper noted that ARA contents of most of these strains accounted for more than 15% of the total extractable fatty acids and more than 50% of the total UFAs. The method of extraction used n-hexane which (as noted above) preferentially extracts triglycerides and inherently results in greater than 90% triglycerides. This is confirmed in table 7-4 of the disclosure.
94. Table 7-3 entitled “Production of Arachidonic Acid by selected Mortierella strains under Optimal Culture conditions” shows an ARA content between 30-50% for several strains of Mortierella. Yamada does not mention the specific culture conditions which produced these results but does contains a cross reference to citations “6” and “14” which were intended to provide these details.
95. Citation “14” is the Shinmen-Shimizu citation. Table 2 of Shinmen-Shimizu is very similar to table 7-3 of Yamada but includes details of culture conditions missing from Yamada, viz:
“Each strain was cultivated in a 5.1 bench-scale fermentor (Mitsuwa Rika, Osaka, Japan) with 2.5 l medium GY. Glucose periodically added to maintain a 1.5%-2.5% concentration except for the case of M.alpina 20-17. All cultivations were carried out with aeration of 1vvm[54] and agitation at 400rpm under the conditions given in the table” (my emphasis)
[54] ‘vvm’ is volume of air per volume of fermenter per minute
96. Under section 7(1)(b) of the Patents Act [1990], prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, can be considered for novelty if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information.
97. Table 7-3 of Yamada specifically directs the reader to Shinmen-Shimizu for more specific detail on the culture conditions used in obtaining the data reported in table. I accept that this explicit reference in Yamada is sufficient for the skilled worker to consider the 2 documents as a single source of information with regard to the data in the table and the culture conditions in which it was obtained. However, this means that there is a clear teaching in Yamada to use GY medium rather than the soybean based media which is defined in claims 1-13 of the current specification.
98. The opponent argued that an expanded disclosure in Shinmen-Shimizu can also be read into Yamada (including other examples where different culture conditions had been used including soybean meal). These additional culture conditions are not explicitly referenced in Yamada and without such I do not believe that a skilled worker would treat the disclosure as a single source of information. However, even if this were to be the case I do not believe the combined disclosure would deprive the claims of their novelty (or even inventive step).
99. Shinmen-Shimizu looked at the effect of N source on the production of ARA and found that three different N sources were all suitable for ARA production – yeast extract, soybean meal and corn steep liquor[55]. There was no “clear and unmistakeable direction” in the document to use soybean meal in preference to the other N sources nor would the skilled worker have recognised any advantage of this N source from their CGK. As a consequence, this citation (either alone or in combination with Yamada) does not teach (or directly lead) the skilled worker to using a soybean based media. This does not deprive claims 1-13 of either their novelty or inventive step.
[55] Page 14, column 1, para 2
Claims 14-42 of the current specification do not specify that the media used for culturing should contain soybean. Instead, each of these claims is limited to specific 24,25-M levels which are defined in terms of their compositional ratios (either as a whole or in proportion to desmosterol). Neither Shinmen-Shimizu nor Yamada recognised the possibility of a sterol contaminant such as 24, 25-M and took no steps to minimise the levels of this contaminant. The skilled reader therefore would not have understood the disclosures of the prior publication to include this missing integer.
As discussed above, the documents could still deprive the claims of their novelty if they contained a direction to use a process that inevitably or inexorably results in something within the claim.[56] The teaching in Yamada was to use a GY medium which the current specification showed could result in higher 24,25-M levels[57]. While Shinmen-Shimizu had mentioned soybean media as an alternative medium, it did not recognise that it had a potential advantage of being able to lower the levels of 24,25-M. Given this, a skilled person following the directions in either Yamada or Shinmen-Shimizu would not necessarily use a soybean as a medium and could potentially produce a product with fell outside the scope of claims 14-42 with regard to the levels of 24,25-M. This means that neither Yamada nor Shinmen-Shimizu deprive any of the claims of their novelty and inventive step.
[56] As per Justice Bennett in Danisco v Novozymes (No 2) supra at [248],
[57] see the comparative examples in tables 1-3
Inventive Step
The opponent relied on the following document for the purposes of inventive step:
P. Bajpai, P.K. Bajpai and O.P. Ward “Effects of Aging Mortierella Mycelium on Production of Arachidonic Acid and Eicosapentaenoic Acids” JAOCS 68:775-781 (October 1991[58]) (hereafter Bajpai or D5).[59]
[58] first published in Australia on 29 May 1992 – see Gottschall-2 2.1(d)
[59] Gaudin-1 (EIR) exhibit PTFG-2
The document describes the production of oils having a high content of ARA from Mortierella and the opponent argued would have inevitably been found in a search using those terms.[60] As a consequence (and this was not seriously disputed by the applicant), this document was part of the prior art base for inventive step because it was one which a skilled worker would have ascertained, understood and regarded as relevant at the priority date.
[60] See opponent’s submissions on Inventive step at [37] – [39]
Bajpai discussed the need to improve the production levels of ARA to meet market demands. It noted that the concentration of polyunsaturated fatty acids significantly increased as the culture ages and investigated the factors which might affect the production of ARA in M.alpina ATCC 32222. However only GY medium was used in these experiments.
From the reported results, the opponent calculated that the concentration of produced ARA was around 28.9%[61]. While this is slightly lower than the specific range of ARA concentrations defined in claims 14-25 (30-50%), it falls within the scope of most of the remaining claims and was similar to the results reported in table 3 of the current specification for Mortierella alpina 32221 (25%).
[61] See opponent’s submissions on inventive step at [44]
The evidence also suggests that 40% ARA was the standard at the time for the known commercial ARA product (ARASCO). This means even if the specific levels of ARA in the citation are slightly lower than some of the claims, the skilled worker would still be motivated to increase the levels of ARA to be on par with the commercial standard. This is particularly so given the stated goal of the Bajpai project was to improve ARA yields for human consumption.
Bajpai did not measure TAG levels of their oil nor could these be directly inferred from the disclosure. The opponent conceded that the levels of TAG are likely to fall outside the claimed range because Bajpai had used the Bligh and Dyer (chloroform) technique to extract ARA rather than n-hexane. However, while this difference might confer novelty, it is difficult to see that it could also confer an inventive step. The evidence suggests that ARA existed in human breast milk in the TAG form and further that n-hexane was known to preferentially extract the TAG form of ARA. In addition, n-hexane was (and still is) the solvent of choice for food grade oils. In developing a suitable infant formula, the skilled worker would clearly be motivated (directly be led) to use n-hexane extraction to make ARA in the TAG form to better mimic breast milk.
This means that the critical differences between the claims and Bajpai is that Bajpai:
(a) does not measure any levels of 24,25-M; and
(b) uses the GY culture medium rather than having soybean as the source of nitrogen.
Similar to Yamada, Bajpai had not recognised that 24,25-M could be a contaminant in the ARA oil. They had not measured the levels of 24,25-M nor had they taken any steps to reduce the levels of this potential contaminant in their final product. They also failed to understand that soybean media could decrease the potential risk of contamination. There was therefore no motivation to use a soybean medium in Bajpai and hence claims 1-13 of their inventive step are novel and inventive compared to Bajpai.
The remaining claims define an ARA-containing oil with low levels of 24,25-M without specifying the N source used to culture the microbe. Experts for the opponent reproduced the culture and extraction conditions described in Bajpai (including the GY medium) and found the resulting product to contain a low level of 24, 25-M which fell within the scope of the current claims (albeit measured using a different column)[62]. The opponent argued that as that in following the method of Bajpai, a skilled worker would inevitably produce a Mortierella cultured ARA product which contained the (low) levels of 24,25-M defined in claims 14-42.
[62] See opponent’s submissions on inventive step at [44] and Gaudin-1 (PTFG-5) and Carvalho de Souza-1 (ACS-4)
However while I accept that Bajpai teaches the skilled worker to produce an ARA-containing oil from Morterella using a GY medium, they would not be directly led to measure the levels of 24,25-M and ensure that these levels were below the claimed levels. Given this, a skilled person following the directions in Bajpai would not directly be led to make an oil with low levels of 24,25-M and hence Bapai does not deprive any of the claims of their inventive step.
Section 18 and section 40 issues
According to the opponent, there were 3 key problems with the invention as described and claimed in the opposed specification:
(a)the ULBON HR-1 column used in the specification did not separate another C1 addition sterol (Ergosta) from 24,25-M. Hence the “compositional ratio of 24,25-M” was a combined measurement of both sterols not a true measure of the levels of 24,25-M in the oil;
(b)low 24,25-M levels generally exist without soybean being used in the culture medium. Hence there was no problem in the prior art to be solved and further in claiming the product per se, certain claims re-defined the prior art; and
(c)even if 24,25-M was present in the ARA-oil, it was not toxic and had no safety concerns. Hence there was no need to remove this component from the ARA-oil for human use.
As discussed in detail below, the opponent argued that each of these problems gives rise to a number of section 18 and 40 objections. Recognising the potential overlap between some of the issues raised because the underlying issues are the same, I will only address the arguments as they were raised by the opponent in their written submissions.
Section 18(2) – Manner of Manufacture
Much of the opponent’s evidence in respect to novelty related to experimental evidence which tested the levels of 24,25-M in different oils produced under a range of culture conditions (with and without soy bean as an N source). All of their results fell within the low limits of 24,25-M defined in the claims regardless of the source of Nitrogen. In fact, apart from the comparative examples themselves, there was no evidence from either party which demonstrated that high levels of 24,25-M existed in ARA-containing oils from Mortierella, a point explicitly made in the opponent’s evidence by both Professor Sinclair and Dr Kyle[63].
[63] See Sinclair-2 at [12.3] and Kyle-1 at [8.7]
The opponent therefore argued that a microbial ARA-oil (produced using yeast or soy bean as an N source) would normally have a low level of 24,25-M and fall within the scope of claims 14-42. According to the opponent, these claims do not define a new oil product but merely describe further properties of an already known oil. In their view, this was a discovery of a new property and not a Manner of Manufacture.
The opponent argued that the levels of 24,25-M in the comparative examples in the current specification were unusually high. According to the opponent, low 24,25-M levels generally exist without soybean being used in the culture medium. Hence the problem of high levels of 24,25-M did not exist in the real (commercial) world. In their view, this meant that there was no invention (on the face of the specification) in solving a non-existent problem.
The opponent did not suggest that the results obtained for the comparative examples (summarised in table 1 above) were incorrect nor did they dispute that soy bean meal could decrease the levels of 24, 25-M under the same conditions. Instead, they believed that some (unknown) variation in the culture conditions used by the applicant must have produced the unusually high levels of 24,25-M observed. However this merely confirms that culture conditions can affect the levels of 24,25-M in an unknown way as the applicant has argued.
The fact that the applicant found high levels of 24,25-M in their comparative examples (using yeast) suggests that this is a real risk in ARA oils. While using soybean decreased this risk, it was (and is still) unknown why this would be the case. Given this level of unpredictability, I accept that higher 24,25-M levels could also result even if soybean was used. This risk had not been recognised in the prior art and its mitigation is both industrial applicable and non-obvious from the specification itself. Further, given the unpredictability of the art, not all microbial oils would necessarily (inherently) have low levels of 24,25-M. Hence the specification does not merely relate to a discovery of a new property of a known substance. As a result, my view is that the claims define a manner of manufacture.
Section 40 issues
(i)Insufficiency/best method of performance [section 40(2)(a)]
Section 40(2)(a) of the Patents Act requires that the applicant describe the invention fully. The legal test is set out in the High Court decision in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) HCA 8; 207 CLR 1; 177 ALR 460; 75 ALJR 518 at [25]:
“The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions of prolonged study of matters presenting initial difficulty?”
The opponent argued that the method of analysis for the 24,25-M compositional ratio requires the use of an ULBON HR-1 column but this has the deficiency (as discussed above) that it provides a composite measure that included both 24,25-M and Ergosta. According to the opponent, the compositional ratio defined in terms of this column cannot determine the actual levels of 24,25-M in the oil without inventive ingenuity. They suggested that the prescribed method of analysis for 24,25-M exaggerates the levels of 24,25-M present (possibly by many fold)[64] and provides a measure that is “neither an approximation nor proportional to the actual levels of 24,25-M”. As a result, the opponent alleged that the specification is neither fully described nor contains a best method of performance.
[64] See opponent’s submissions in “O” (failure to disclose best method known to applicant) – page 12. Ergosta accounted for 50-89% of the compositional ratio in the opponent’s repeat experiments using the ULBON HR-1 column which means that 24,25-M was overestimated in some cases by a factor of over 9.
However whether or not the term “compositional ratio of 24,25-M” accurately measures the real levels of 24,25-M in the oil does not impact whether the specification is fully description. As discussed above in the section on clarity, the term “compositional ratio” does not mislead the skilled worker in the performance of the invention. It is used consistently throughout the specification and it is clear what it refers to and how it should be measured. The skilled worker is therefore left with no doubt about the scope of the claims and can produce something “within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty”.[65] As the applicant noted, a skilled worker would be able to perform the process of any of claims 1-13 or 40 and produce a product within the scope of claims 14-39, 41 or 42 by following the directions provided in the specification. As a consequence, I find that the specification is fully described despite the technical error in the measurement of 24,25-M.
[65]As per Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1at [25]
(ii)Utility [section 18(1)(c)].
As noted in Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC (No 2) [2006] FCA 1787, the question of lack of utility under s18(1)(c) is whether the invention enables the addressee to attain the result promised by the patentee in the patent specification. The opponent referred to the discussion of utility by Bennett J in Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420. She generally accepted the proposition outlined in Norton and Gregory Ld v Jacobs (1937) 54 RPC 271 (the Norton principle) at 275-6 that a claim will fail for inutility if within its scope there is subject matter claimed which will not achieve the desired or promised result.
However, she did not believe this extended to alternatives within the claim that any sensible person would appreciate would lead to unworkability (at [231]). In her view:
“The claims are not directed to readers in a vacuum, they are directed to and are to be understood by the skilled workers in the field. That is the person who construes them, in a commonsense way (Populin at 476-477). It would be artificial to assess utility in a way that ignores the fact that a design that is theoretically or mathematically within the parameters of the claims would never be contemplated for use by the skilled naval architect wishing to design a hull for a multi hulled vessel capable of speeds greater than 30 knots. A design that no naval architect would adopt would not be the appropriate test on the question of utility”. [at 240]
The particulars raised by the opponent under the ground of utility concern whether or not the promise of the claimed invention is achieved. According to the opponent, the promise of the claimed invention is:
a)to provide a means for the production of UFA oils with low content of 24,25-M; and
b)to enable the oils to be safely used in foods and animal feeds where previously they could not because of high levels of 24,25-M.[66]
[66] See opponents submissions on lack of utility - section M, at [5]
The opponent argued that these promises were based on a false premise[67]. According to the opponent, 24,25-M is not toxic and would not present a safety concern either above or below the limits specified in the opposed specification. In any case, low levels of 24,25-M can (and have been) achieved without soybean. The opposed application therefore does not provide a promised benefit because soy bean is not needed to lower the levels of 24,25-M as the specification suggests.
[67] See opponents submissions on lack of utility - section M, at [7]
However regardless of whether 24,25-M has any safety or long term health concerns, it is still a fungal by-product which is not present in human breast milk. In order to better mimic human breast milk and to mitigate any potential safety concerns, it would still be desirable to have a microbial sourced oil with less of the microbial C1 addition sterols including 24,25-M. The opposed specification has recognised the potential risk of contamination and provides a method that can lower this risk[68]. There is no evidence before me that the skilled worker would have any difficulty following the directions provided in the specification to achieve lower levels of 24,25-M. This means that the specification achieves the promised benefit as required under s18(1)(c). Whether this benefit could also be achieved by means other than soy bean is not a relevant question under the ground of utility.
[68] Note that the opposed specification does not suggest that 24,25-M is toxic only that the toxicity is not known
The opponent also noted that the method of analysis for the “24,25-M compositional ratio” does not measure the true levels of 24,25-M. According to the opponent, the levels of 24,25-M could be exaggerated using the measurement method used in the specification. Hence any reduction in the actual 24,25-M levels could be substantially less than the reduction claimed in the specification. However the specification does not purport to measure the true levels of 24,25-M. Both the description and claims consistently refer to the “24,25-M compositional ratio” with the comparative data showing a reduction of the compositional ratio rather than the actual level of 24,25-M when soy bean is used as the N source. In the context of the specification as a whole, the promise of the invention is therefore fulfilled by decreasing the compositional ratio of 24,25-M even if this does not reflect the actual concentration of 24,25-M itself. In this regard, I note that the levels of 24,25-M as defined in the claims will always over-estimate the actual levels of 24,25-M in the sample (in some cases by a factor of 1.4-13 times the actual levels[69]). Hence the upper concentration limit of 24,25-M (as defined in the claims) inevitably means that the actual levels of 24,25-M are even lower which is in keeping with the promise of the invention.
[69] See Exhibit LB-12 to Brunero-6 (at page 4/22)
Based on these arguments, I cannot find that any of the claims fail for lack of utility.
(iii) fair basis [section 40(3)]
Section 40(3) of the Patents Act 1990 (Cth) requires that the claim or claims must be clear and succinct and fairly based on the matter described in the specification. The High Court in Lockwood v Doric [2004] HCA 58 noted that fair basis is concerned “purely with the relationship between the body and claims of the one specification”. The primary test for fair basis is therefore simply whether the claims are consistent with what the specification as a whole describes as the invention.
The only argument raised by the opponent under this ground related to the inconsistency between the claim language which refers to a peak area representing 24,25-M which would refer to both Ergosta and 24,25-M and the description which was totally silent as to the presence of Ergosta.[70] However the description also referred to the relevant peak as representing 24,25-M. While this may not have been technically correct, it is consistent with the claim language and does not give rise to a fair basis problem. As the applicant argued in their submissions, the claims define the invention in the same terms as the invention is described and hence the claims generally satisfy the requirements of section 40(3).[71]
[70] See opponent’s submissions on lack of fair basis section Q at [40]
[71] See applicant’s submissions 21 August 2012 at [48]
In contrast (as discussed above), the applicant conceded at the hearing that claims 26-30, 33, 36-38 as currently drafted include within their scope common vegetable oils such as olive oil which are also polyunsaturated, naturally contain high levels of triglycerides and have no 24,25-M. This is clearly inconsistent with the invention described in the specification as a whole which relates to microbial sourced oils. These claims therefore lack fair basis. The applicant indicated at the hearing that they were intending to amend the claims to limit them to a ‘microbial sourced oil’. While this will overcome the problem, I am not aware of any amendments having been proposed to that effect.
Conclusion and summary
I find that none of the claims lack novelty or inventive step in light of any of the prior art provided by the opponent. Similarly the claims define a manner of manufacture, are fully described and are useful. However claims 26-30, 33, 36-38 (as currently drafted) relate to any UFA-containing oil with low levels of 24,25-M. Such claims encompass well-known vegetable oils such as olive oils. These are prima facie not novel and lack fair basis because they are clearly inconsistent with the invention described in the specification as a whole.
Karen Ayers
Delegate of the Commissioner of Patents
Annex A
Analysis of main independent claims
| Claim # | Subject matter of claim | arachidonic acid (ARA) % wt per total Fatty Acid content (TFA) | Triglyceride | 24,25-methylenecholest-5-en- | process limited to source of microbe or Nitrogen |
| 1 | Process for ARA -cont. oil | Present but in any amount | Not specified | ≤ 35% compositional ratio | Mortierella/soy bean |
| 14 | ARA-cont. oil | 30-50% | ≤ 90% | ≤ 35% compositional ratio | Not specified |
| 15 | As above | 30-50% | ≤ 90% | ≤ 1.2 in proportion to desmosterol | Not specified |
| 16 | As above | 30-50% | ≤ 90% | ≤ 1.2 in proportion to desmosterol | Not specified |
| 26 | Unsaturated fatty acid-cont. oil | Not specified | ≤ 90% | ≤ 35% compositional ratio | Not specified |
| 27 | As above | Not specified | ≤ 90% | ≤ 1.2 in proportion to desmosterol | Not specified |
| 28 | As above | Not specified | ≤ 90% | ≤ 1.2 in proportion to desmosterol | Not specified |
| 36 | A nutritive dietary supplement | Not specified | ≤ 90% | ≤ 35% compositional ratio and/or ≤1.2 in proportion to desmosterol | Not specified |
Annex B
Triglycerides and Phospolipids [72]
[72] Information and diagrams sourced from Bennet J’s decision in Danisco A/S v Novozymes (No. 2) [2011] FCA 282
Triglycerides (also referred to as a triacyl glycerol) are the major components of vegetable oils and animal fats. They are a fat comprising a single unit of glycerol, combined with three fatty acid groups. A general schematic is shown below.
Phospholipids are fats with a similar structure to triglycerides, except they comprise a phosphate group in place of one of the fatty acid groups.
Annex C
Summary of Evidence
- Opponent
| Declarant | Statutory Declaration | Date | Exhibits | Stage of evidence |
| Louise Brunero | Brunero-1 | 23 June 2008 | LB-1 and LB-2 | EIR |
| Brunero-2 | 11 January 2010 | none | Response Further evidence- 1 | |
| Brunero-3 | 11 January 2010 | none | Response Further evidence- 1 | |
| Brunero-4 | 1 February 2010 | LB-3 | Response Further evidence- 1 | |
| Brunero-5 | 14 April 2010 | LB-4 to LB-9 | Response Further evidence- 1 | |
| Brunero-6 | 10 March 2011 | LB-10 to LB-18 | Response Further evidence- 2 | |
| Adrianna Carvalho de Souza | de Souza-1 | 19 February 2008 | ACS-1 to ACS-7 | EIR |
| de Souza-2 | 12 August 2008 | none | EIR | |
| de Souza-3 | 16 February 2010 | ACS-8 to ACS-11 | Response Further evidence- 1 | |
| de Souza-4 | 16 February 2010 | ACS-12 | Response Further evidence- 1 | |
| de Souza-5 | 9 March 2011 | ACS-13 and ACS-14 | Response Further evidence- 2 | |
| Michael Alan Davis | Davis | 14 August 2009 | none | Response Further evidence- 1 |
| Philippe Thierry François Gaudin | Gaudin-1 | 19 February 2008 | PTFG-1 to PTWG-5 | EIR |
| Gaudin-2 | 16 February 2010 | PTFG-6 to PTWG-8 | Response Further evidence- 1 | |
| Gaudin-3 | 26 April 2011 | none | Response Further evidence- 2 | |
| Raymond Michael Gladue | Gladue-1 | 12 June 2008 | None | EIR |
| Gladue-2 | 21 February 2008 | None | EIR | |
| Gladue-3 | 6 April 2010 | RMG-1 | Response Further evidence- 1 | |
| Jonathon Thomas Gottschall | Gottschall-1 | 17 December 2004 | none | EIS |
| Gottschall-2 | 21 February 2008 | none | EIR | |
| David J Kyle | Kyle | 11 February 2010 | DJK-1 to DJK-5 | Response Further evidence- 1 |
| Ann Campbell Lawrie | Lawrie | 17 December 2004 | ACL-1 to ACL-4 | EIS |
| Craig Mallon | Mallon-1 | 4 May 2012 | CM-1 | Further evidence-4 (tranche 1) |
| Mallon-2 | 3 July 2012 | CM-2 | Further evidence-4 (tranche 2) | |
| Cynthia Ann Panker | Panker-1 | 14 February 2008 | CAP-1 to CAP-14 | EIR |
| Panker-2 | 12 June 2008 | CAP-15 to CAP-16 | EIR | |
| Denver Joseph Pyle | Pyle | 3 July 2012 | DJP-1 | Further evidence-4 (tranche 2) |
| Andrew James Sinclair | Sinclair-1 | 17 December 2004 | AJS-1 to AJS-12 | EIS |
| Sinclair-2 | 21 August 2008 | AJS-13 to AJS-15 | EIR | |
| Sinclair-3 | 15 April 2010 | AJS-16 to AJS-19 | Response Further evidence- 1 | |
| Sinclair-4 | 15 April 2010 | AJS-20 to AJS-24 | ||
| Sinclair-5 | 11 May 2011 | none | Response Further evidence- 2 | |
| Angela Lee Tsetsis | Tsetsis-1 | 16 June 2008 | None | EIR |
| Tsetsis-2 | 14 February 2008 | ALT-1 to ALT-8 | EIR | |
| Johannes Hendrik Wolf | Wolf | 12 August 2008 | JHW-1 and JHW-2 | EIR |
| Sandy Irene Zeller | Zeller-1 | 20 December 2007 | SIZ-1 to SIZ-2 | EIR |
| Zeller-2 | 17 April 2010 | SIZ-3 | Response Further evidence- 1 |
- Applicant
| Declarant | Statutory Declaration | Date | Exhibits | Stage of evidence |
| Janelle Suzanne Borham | Borham-1 | 5 June 2009 | none | Further evidence -1 |
| Borham-2 | 20 October 2010 | JSB-1 to JSB-6 | Further evidence -2 | |
| Borham-3 | 23 December 2011 | JSB-7 | Further evidence -3 | |
| Shigeaki Fujikawa | Fujikawa-1 | 20 December 2006 | SF-1 to SF-5 | EIA |
| Fujikawa-2 | 4 June 2009 | SF-6 | Further evidence -1 | |
| Fujikawa-3 | 28 October 2010 | SF-7 to SF-12 | Further evidence -2 | |
| Fujikawa-4 | 23 December 2011 | none | Further evidence -3 | |
| Fujikawa-5 | 23 December 2011 | SF-13 | Further evidence -3 | |
| Robert Alan Gibson | Gibson-1 | 21 December 2006 | RG-1 to RG-4 | EIA |
| Gibson-2 | 3 June 2009 | RG-5 | Further evidence -1 | |
| Gibson-3 | 1 November 2010 | none | Further evidence -2 | |
| Kenji Katano | Katano | 4 June 2009 | KK-1 | Further evidence -1 |
0
4
0