Inexa, Industria Extractora C. A v OmniActive Health Technologies Limited
[2012] APO 128
•23 November 2012
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Inexa, Industria Extractora C. A v OmniActive Health Technologies Limited 2012 APO 128
Patent Application: 2002348718
Title:Novel trans-lutein enriched xanthophyll ester concentrate and a process for its preparation
Patent Applicant: OmniActive Health Technologies Limited
Opponent: Inexa, Industria Extractora C. A
Delegate: L. F. McCaffery
Decision Date: 23 November 2012
Hearing Dates: 8 November 2011 and 1 August 2012
Catchwords: PATENTS – request for further evidence – whether foreign opposition matters justify the delay of the Australian hearing – nature and significance of evidence uncertain – advantages to hearing the application for further evidence in conjunction with the substantive matter – reasons for delay unsatisfactory – request granted on reasonable terms
novelty – inherent disclosure – whether shipping documents were publicly available – prior use – whether parties were free in law and equity to make use of information
inventive step – whether an “arbitrary” figure is inventive
clarity – whether the skilled person would be able to determine the scope of the claim
fair basis – whether the specification provides support for a precise value which is not specifically disclosed in the specification
Representation: Patent applicant: Ben Fitzpatrick, Counsel instructed by John Landells of Griffith Hack, Melbourne
Opponent: Barry Hess, Senior Counsel instructed by Bernadette Hawkins of Cullens, Brisbane
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2002348718
Title:Novel trans-lutein enriched xanthophyll ester concentrate and a process for its preparation
Patent Applicant: OmniActive Health Technologies Limited
Date of Decision: 23 November 2012
DECISION
The opposition succeeds on the grounds of novelty and inventive step. Claims 1, 2, 4 and 14 lack novelty and Claims 1 to 4, 14 and 15 lack inventive step. OmniActive Health Technologies Limited is given 2 months from the date of this decision to propose amendments to address these deficiencies. I allow the parties 1 month from the date of this decision to make submissions in relation to costs.
REASONS FOR DECISION
OmniActive Health Technologies Limited (hereinafter, the Applicant) is the applicant for patent application 2002348718, which claims an earliest priority date of 5 June 2002. The application was advertised accepted on 3 January 2008.
A notice of opposition was served on the Applicant by Inexa, Industria Extractora C. A. (hereinafter, the Opponent) on 3 April 2008. A Statement of Grounds and Particulars was subsequently served by the Opponent on 3 July 2008. This statement was later amended after applications under Regulation 5.9 were made on 3 February 2010, 1 November 2011 and 27 July 2012.
Evidence in Support was completed on 31 October 2008 and comprises the following:
· Declarations by Clarissa Wynne dated 3 October 2008 and 31 October 2008 and exhibits CW-1 to CW-4
· A declaration by Luis W. Levy dated 24 October 2008 and exhibits LWL- to LWL-3
· A declaration by John P. Bartley dated 29 October 2008 and exhibits JPB-1 to JBP-3
Evidence in Answer was completed on 24 November 2010 and comprises the following:
· A declaration by Sunil Kumar T. K. dated 15 November 2010 and exhibits SK-1 to SK-4
· A declaration by Julia Humphries dated 16 November 2010 and exhibits JH-1 to JH-4
Prior to the completion of the Applicant’s Evidence in Answer, the Opponent filed further evidence. This consisted of:
· A declaration by Luis W. Levy dated 1 February 2010
· A declaration by Kenneth G. Finney dated 3 February 2010 and exhibits KGF-1 to KGF‑11
Evidence in Reply was completed on 24 February 2011 and comprised:
· A declaration by Luis W. Levy dated 14 February 2011
· A declaration by Kenneth G. Finney dated 23 February 2011 and exhibits KGF-12 to KGF-20
This completed the original evidentiary stages of the opposition and the matter was set for hearing for 8 November 2011. However, on 1 November 2011, the Opponent filed a request to serve further evidence and sought a deferral of the hearing pending consideration of their request. Despite submissions by the Opponent the Commissioner was not satisfied that a deferral of the hearing was justified and determined that the request for further evidence would be considered at the hearing. Details of the further evidence and subsequent considerations are provided below.
The hearing was held in Canberra on 8 November 2011 and was reconvened on 1 August 2012. The Applicant was represented on both occasions by Ben Fitzpatrick of Counsel, instructed by John Landells of Griffith Hack Melbourne. The Opponent did not appear at the hearing of 8 November 2011 but was represented at the reconvened hearing by Barry Hess Senior Counsel, instructed by Bernadette Hawkins of Cullens Brisbane.
The Specification and Claims
10. Carotenoids are terpenoid plant pigments that include xanthophyll esters. Lutein and zeaxanthin are two xanthophyll esters that have widespread use as poultry feed colourants and as nutritional supplements. Xanthophyll esters are generally found in nature as the trans-isomer, but the cis-isomer may be formed under adverse conditions of heat and light. Trans-isomers are generally preferred because of their better stability and bioavailability.
11. Xanthophyll esters form the major colouring component in marigold flowers, and indeed this is one of the richest sources of trans-lutein in nature. Marigold flowers and marigold extracts have therefore been widely used commercially for several decades as pigmenting agents in foodstuffs.
12. The present invention relates to a novel trans-lutein enriched xanthophyll esters concentrate and a process for its preparation. The specification states that “the main objective of the present invention is to provide a novel xanthophyll esters concentrate having higher amounts of trans- isomer and negligible or trace amounts of cis- isomer which is useful for human consumption, either as nutraceutical, nutritional supplements, food additives and also for colouring foods and feeds which has better stability and bio availability” (page 6, lines 25 to 30). Specifically the invention relates to a xanthophyll esters concentrate containing 90-95% trans-lutein esters, 0-5% cis-lutein esters and 3.5-6% zeaxanthin esters.
13. The process by which the invention is obtained involves admixture of a marigold oleoresin with a ketonic solvent such as 2-propanone (acetone), 2-butanone or their mixtures under stirring at a controlled temperature of 15 to 30°C so as to remove impurities and precipitate the xanthophyll esters, followed by filtration and washing with the same solvent. Aliphatic ketonic solvents have been found to preferentially dissolve cis-isomeric lutein esters as well as impurities such as triglycerides and waxes, and provide a xanthophyll esters concentrate enriched with trans-lutein esters.
14. The specification ends with 15 claims. Claims 1 and 5 are independent claims that define the xanthophyll esters concentrate and a process for its preparation respectively:
(1) A xanthophyll esters concentrate, which is useful for human consumption, either as a nutraceutical or as food additives and also for coloring food and animal feeds comprising predominantly of a composition containing lutein and zeaxanthin fatty acid esters wherein the composition contains 90-95% of trans-lutein esters, 0-5% of cis-lutein and 3.5 to 6% of zeaxanthin esters.
(5) A process for the preparation of the xanthophyll esters concentrate as defined in any one of claims 1 to 4 which comprises:
admixing a xanthophyll esters source selected from an extract or oleoresin containing lutein and zeaxanthin fatty acid esters with an aliphatic ketonic solvent selected from 2‑propanone, 2-butanone, 2-pentanone or their mixtures at a temperature in the range of 10.degree.C to 30.degree.C under stirring to selectively solubilize non-xanthophyll ester impurities, cis-lutein esters and lipids present therein and simultaneously enrich the trans‑lutein esters content in the resulting mixture;
filtering the resulting mixture to obtain the xanthophyll esters concentrate in solid form;
drying the concentrate under vacuum at room temperature; and
preserving the concentrate at a temperature below 20.degree.C in an inert atmosphere and in airtight opaque containers to prevent the degradation of the concentrate.
15. Claims appended to Claim 1 further define the composition by the trans:cis ratio of the lutein esters (18:1 to 475:1), the xanthophyll ester content of the concentrate (60-80% by weight) and the form of the concentrate (beadlets, capsules, liquid preparations and other typical pharmaceutical formulations). Claims appended to Claim 5 further characterise the process by features such as the type of xanthophyll ester source, the temperature employed for the admixture step, the time of stirring, and the weight to volume ratio of xanthophyll ester source to ketonic solvent.
The Application for Further Evidence
16. The Opponent’s request of 1 November 2011 for further evidence was based on matters arising from the prosecution of an opposition on the corresponding European patent. The request noted that the Opposition Division of the European Patent Office had issued a preliminary opinion on the opposition and intended to hold a hearing and summon witnesses in January 2012. The Opponent had identified further evidence from that opinion that they considered may be relevant to the Australian opposition.
17. The relevant documents included:
(a) Purchase of Inexa lutein ester products distributed by Henkel Corporation (including product sold under "Eyegold" label) by Dr Luis Levy from GNC store in Florida USA in 2000
(b) Supply of Inexa lutein ester product by Cognis Corporation to various customers in USA in 2000 and 2001
The opponent considered that documents (a) and (b) would address issues identified in relation to the evidence of prior use on file.
(c) Documents associated with supply of Inexa lutein ester product by Inexa to Henkel Corporation in USA in 1999
The opponent noted that Dr Levy had referred to documents (c) in his declaration of 24 October 2008, but only two pages had been provided in evidence. The opponent considered that all relevant material should be provided.
(d) Documents associated with exhibition and offer for sale of Xantopina plus lutein ester product by Bioquimex Nutrition at trade show (SupplySide East) in New Jersey USA in May 2001.
(e) Documents associated with exhibition and offer for sale of lutein ester product by Nutriscience at trade show (SupplySide West) in Las Vegas, USA in November 2001
(f) Exhibition and offer for sale of Xantopina plus lutein ester product by Bioquimex Nutrition at trade show (SupplySide East) in New Jersey USA in May 2001
(g) Exhibition and offer for sale of lutein ester product by Nutriscience at trade show (SupplySide West) in Las Vegas, USA in November 2001
Items (d), (e), (f) and (g) relate to evidence that is already on file. The preliminary opinion of the EPO suggested that the existing evidence did not establish the publication date of the documents, and the opponent has sought to address that issue in Europe by providing evidence from Mr Peter Levy as to his attendance at those trade shows and the availability of the documents.
18. The Opponent requested that the hearing be deferred on the basis that the evidence would be subject to cross-examination in Europe. A deferral would enable appropriate consideration to be given to incorporation of any evidence arising from such cross-examination into the Australian opposition and ensure consistency of evidence in the two jurisdictions.
19. The Supervising Examiner, Patent Oppositions, Hearings and Legislation did not consider that a deferral of the hearing was justified on the reasons provided. The parties were advised that the hearing of the request for further evidence would be considered as part of the substantive hearing and if necessary the hearing could be re-opened if further evidence was granted.
20. The attorney for the Opponent also advised that a proposal for settlement had been put by the opponent to the applicant in the EP opposition, but could not confirm whether it included the Australian application. A settlement proposal specific to the Australian application was subsequently made to the Applicant’s attorneys on 7 November 2011, but the Opponent acknowledged that this provided little time for the Applicant to consider it prior to the scheduled hearing. In any case, while it may be a consideration I do not consider the prospect of settlement to be determinative in whether or not a hearing should be delayed. Mere speculation of a possible settlement is not sufficient reason to delay a matter unless both parties agree that negotiations are at a stage where the balance of interests lies with such a delay. In this case the applicant did not agree to defer the hearing and the Commissioner advised the parties accordingly.
21. In view of the Commissioner’s intention to proceed with the hearing on 8 November 2011, the Opponent advised that they would not appear at hearing. Moreover, they advised that they would not be withdrawing the opposition. As there were no submissions made in relation to the existing evidence on file, I could only speculate on the nature of any potential further evidence that might arise from the case the Opponent may have presented at hearing.
22. A request to serve further evidence requires a proper, genuine and realistic consideration to all relevant aspects of the case. Such aspects include: the reasons for the delay; the nature and significance of the evidence; and the interests of the parties. I will consider each of these in turn.
Reasons for the delay
23. The onus lies with the party seeking to serve further evidence to justify the need for the extension with sufficient details of the circumstances and reasons why the evidence was not available sooner, but a satisfactory explanation is not a mandatory requirement. There is also an underlying principle that matters before the Patent Office should be dealt with in an efficient, orderly manner and not be unduly prolonged.
24. The potential further evidence resulted from a preliminary opinion by the European Patent Office on the case put forward in the corresponding opposition in Europe. This opinion was dated 10 June 2011 and indicated that Dr Luis Levy, Mr Peter Levy, Mr Pedro Steiner and Mr Holger Becker would provide evidence addressing the particular evidentiary issues.
25. It appeared that the issues to be addressed by evidence and the witnesses who would provide such evidence were identified in the European Opposition proceedings by, at the latest, 10 June 2011. Prima facie the opponent had ample time to consider the evidence and prepare and serve relevant further evidence well before 1 November 2011. The failure to do so indicates a lack of diligence that was not consistent with a serious opposition.
Nature and significance of the evidence
26. The public interest calls for a balance between the requirements that the Commissioner deal with opposition matters expeditiously and economically and that a serious opposition is dealt with on its merits. In order to make such an assessment, the Commissioner must form a view as to the nature of the evidence that is sought to be adduced and the significance of that evidence for the opposition proceedings. In forming this view, the significance of the evidence to be adduced is assessed in the context of the opposition and a prima facie view of its relevance, rather than being an assessment of its merits.
27. The opponent submitted that it was necessary to delay the present proceedings until after an opposition hearing has been held in the EPO since oral evidence (which may be subject to cross-examination) will be provided in the EP hearing. Delaying the present proceeding would enable ‘appropriate consideration’ to be given to the incorporation of such evidence in the present proceedings and would provide consistency in the evidence available in each opposition.
28. Prima facie there was information of a nature and significance that would justify the grant of leave to serve further evidence. However, the extent to which these documents were to be relied upon was unclear – indeed the submissions suggested that further evidence may or may not have been required depending on the issues that were identified during the European action.
29. In any case, while the European hearing and the outcome of cross-examination as part of that process may be relevant to the Australian proceeding, it is not determinative of whether the request for further evidence should be allowed. As noted by the Supervising Examiner (OH&L) on 3 November 2011, it is often advantageous to hear a request for further evidence as part of a substantive opposition in order to make such a determination. An underlying reason for this approach is that the process for further evidence can add significantly to the time taken to determine a matter, but the further evidence provided may ultimately be of little or no relevance. Considering the evidence as part of the substantive hearing increases the efficiency of the process and reduces the potential for unnecessary delay.
Interests of the parties
30. Clearly the interests of the parties lie in having the opposition finalised in a timely manner. The public interest lies in having a serious opposition dealt with on its merits.
The proposed direction and reasonable terms
31. Without the benefit of the Opponent’s submissions it was difficult to fully assess the nature and relevance of the evidence the Opponent sought to adduce, or whether indeed at that stage the Opponent intended to adduce any evidence at all. It is questionable whether some of the material actually constitutes evidence (such as the preliminary opinion of the EPO and the submissions to the EPO by the applicant’s attorney). However, I considered that there may have been material adduced that is of a nature that justified the grant of leave to serve further evidence. On balance I considered that the interests of all parties lay in providing the Opponent with the opportunity to serve further evidence.
32. Furthermore, regulation 5.10(4)(b) allows for the Commissioner to specify reasonable terms on which the application for further evidence may be allowed. A further consideration in the present case was therefore whether leave to serve further evidence should be subject to reasonable terms.
33. Following the hearing and in view of my determination that there may be grounds for further evidence, the Opponent proposed a timetable for the service of evidence that would further delay re-convening the hearing until at least July 2012. I did not consider such a delay was justified under all of the circumstances. However I considered the interests of the parties would be better balanced by granting leave to serve the further evidence but allowing only a limited time for filing such evidence. I noted in this regard that many of the issues identified in the request related to matters of fact, such as the availability of a document at a particular trade show or the supply of particular material commercially, rather than expert opinion. As such, my expectation was that the evidence would be quite specific to certain issues and obtained in a relatively short time. I also noted that the particular declarants had apparently already agreed to provide the evidence in the European matter, so there should have been little delay in that regard. However, if extensions of time were required these could be dealt with in the usual manner.
34. On that basis I made the following direction on 23 November 2011:
· That leave to serve further evidence in relation to the issues set out under sections (a) to (g) in the opponent’s request of 1 November 2011 be granted on appropriate terms, the appropriate terms being that the evidence was filed within 4 weeks of the date of the direction.
· Once the further evidence was filed, that the applicant had 4 weeks to file evidence in response to the further evidence.
· That the hearing be re-convened at a date to be determined in February 2012. That the re‑convened hearing be in relation to the issues not yet covered in the hearing: namely ‘prior user’ and documents in relation to this issue, and costs. This was not to be an opportunity to re-visit the issues already discussed at the hearing of 8 November 2011.
· In the event that no evidence was filed, the hearing could be re-adjourned at an earlier time. This would be negotiated with the parties if required.
35. The Opponent sought, and received, extensions of time under Regulation 5.9 up to 22 March 2012. The further evidence was completed on 22 March 2012 and comprised:
· A declaration by Luis W. Levy dated 15 February 2012 (Levy 4) and exhibits LWL-4 and LWL-5.
· A declaration by Wagner Lombeida dated 15 February 2012 and attached exhibit KGF-20.
· A declaration by Luis W. Levy dated 23 March 2012 (Levy 5) and exhibits LWL-6 to LWL-11.
· A declaration by Pedro E. Levy dated 23 February 2012 and exhibits PEL-1 to PEL-4.
· A declaration by Luis W. Levy dated 19 March 2012 (Levy 6) and exhibits LWL-12 to LWL-15.
· A declaration by Holger F. Becker dated 16 March 2012 and exhibits HFB-1 to HFB-8.
36. The Applicant did not file evidence in response to the further evidence.
Grounds of opposition
37. The Opponent opposed the application on the grounds of manner of manufacture, novelty, inventive step, clarity and fair basis. Submissions were made in relation to each of these at the re-adjourned hearing of 1 August 2012.
Onus of Proof
38. 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]; (2001) 50 IPR 305 at 311 [29], 319 [67]; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; (2009) 79 IPR 426 at 430 [18], 432 [22]).
Novelty
39. The Opponent relied on the following documents:
(D1) International Application WO 1999/054408 (CW-1);
(D2) documents associated with supply of Inexa lutein ester product by Inexa to Henkel Corporation in U.S.A. in 1999 (LWL-6);
(D3) documents associated with supply of Inexa lutein ester product by Inexa to Betatene Limited in Australia in October 1998 (LWL-8);
(D4) documents associated with exhibition and offer for sale of Xantopina plus lutein ester product by Bioquimex Nutrition at trade show (SupplySide East) in New Jersey U.S.A. in May 2001 (PEL-1 and PEL-2);
(D5) documents associated with exhibition and offer for sale of lutein ester product by Nutriscience at trade show (SupplySide West) in Las Vegas, U.S.A. in November 2001 (PEL-3 and PEL-4).
(D6) Purchase of Inexa lutein ester products distributed by Henkel Corporation (including product sold under "NOW" label) by Dr Luis Levy from GNC store in Florida U.S.A. in 2000.
40. The opponent made submissions in relation to novelty with respect to both disclosure of the invention by a document, as well as prior public use.
41. The law on novelty is well established. 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]). 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) 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.”
42. 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]; (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).
43. Furthermore, there may be circumstances where a document can deprive a claimed invention of novelty even though it does not explicitly disclose all of the integers of the claimed invention. One example is where the skilled reader understands the disclosures of the prior publication to include a missing integer. Another is 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]).
44. The definition of the prior art base for determining novelty also includes “information made publicly available through doing an act, whether in or out of the patent area”. Furthermore, Section 7(1) requires that the prior art information must be publicly available. 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 Ltd v Neurizon Pty Ltd (2005) FCAFC 90 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 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).
45. In Insta Image v Kanopy the Full Court considered whether the display of the invention, a collapsible canopy structure, at public events allowed the public to understand the nature of the invention sufficiently to deprive the claims of novelty (at [125]). The Full Court concluded (at [151]) that there was nothing to prevent a member of the public from going to its location and examining it sufficiently to understand its construction and component features. This contrasts with the Full Court decision in Jupiters v Neurizon where the invention involved a system for electronic gaming. In this case the Full Court found that there was no evidence that the skilled person would have unrestricted access to the gaming devices that would enable them to analyse the working of the invention. As the skilled person was unable to glean such information by mere observation there was no anticipation by prior use.
46. Notably, Insta Image v Kanopy (at [153]) also considered the issue of confidentiality where the inventor arranged for a manufacturer to assist with the fabrication of the invention. The full bench agreed with the primary judge in concluding that the circumstances of the collaboration strongly suggested that the information was confidential and could not be imparted to others.
47. The claims in question here relate to chemical compositions, the nature of which cannot generally be gleaned by mere observation. The Opponent submitted that in the case of a chemical or pharmaceutical product it is not necessary that the public be given notice of the chemical composition of the product. If it is shown that a product has been used in public or made available to the public, and that use was in a manner that allowed its nature to be ascertained, then it is sufficient to destroy the novelty of the claimed invention. They argued that it is availability that is important and it is immaterial that the product does not, in itself, disclose its composition. In this regard they referred to Re European Community and Aleis International Pty Ltd (2002) 58 IPR at [55] wherein the Delegate noted that:
“the law has established that prior use includes a sale where the effect of that sale is to give the purchaser an opportunity to obtain knowledge of the invention. I think this applies in the present circumstances; anybody purchasing Aleis’s boluses would then have an opportunity to analyse the material of the body of the bolus and discover the components of the ceramic material; so the evidence does not have to prove that the parties involved in using the opponent’s products had full knowledge of the materials used.”
48. More recently Bennett J considered a similar question of enablement in relation to chemical compounds (Lundbeck v Alphapharm (2009) 177 FCR 151; (2009) 81 IPR 228; [2009] FCAFC 70 at [187]) and applied the principles outlined by Lord Hoffmann in Smithkline Beecham plc’s (Paroxetine Methanesulfonate) Patent [2006] RPC 32 at [29], noting that they were consistent Nicaro:
“Indeed, when the prior art is a product, the product itself, though dumb, may be enabling if it is “available to the public” and a person skilled in the art can discover its composition or internal structure and reproduce it without undue burden.”
49. In Lundbeck v Alphapharm the invention was a specific enantiomer of a known racemic compound which was found to be novel as the skilled addressee would “have to conduct further experiments, conduct further research and gain further information to hit upon the present invention” (at [209]). In contrast the Full Bench of the Federal Court in Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR at [106] found that a specific enantiomer was disclosed in a prior art document since:
“[I]n this case, there was a disclosure of the enantiomers in the prior art patents. Those enantiomers were not only described, they were also claimed. Thus there was a clear direction to the skilled reader to prepare the enantiomers and in addition, but not necessarily, it was made clear that such enantiomers were, or were likely to be, useful for the desired purpose. The primary judge was not in error in concluding that the prior art patents disclosed the enantiomers as part of the invention and as compounds predicted to have the beneficial qualities of the compounds exemplified. If his Honour were correct in his conclusion that the skilled reader would understand to separate the enantiomers and would know the methods to apply, and that the preparation of the d-enantiomer was routine and involved no inventive step, it is hard to see how his Honour erred in concluding that there had been disclosure of the d-enantiomer to the skilled addressee and that a claim to the d-enantiomer had been anticipated (Ranbaxy).”
50. The Court also dealt with the issue of enablement in the prior art as follows:
“Sanofi’s submissions seem to suggest that unless the claimed compound was actually made and the making of it described in the prior publication, there could be no anticipation. We do not accept that submission. Sanofi appears to submit that it would have been necessary for the prior publication to describe, or for the evidence to establish, a prior resolution of PCR 4099 or, at least, of a compound of the general formula as claimed in each of the prior art patents. That is, Sanofi’s submissions are to the effect that it would be necessary for a prior publication, in every case, to set out the method of preparation, no matter how routine, and presumably the detailed methodology of each step taken in the preparative process. That cannot be correct.”
51. 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) 88 IPR 52 at 63 [35]). These are the principles that I will apply here.
(D1) WO 1999/054408
52. The Opponent relied on D1 inasmuch as it is prior art information made publicly available in a single document.
53. D1 is in the name of the Opponent, and Dr Luis Levy is named as inventor. This document broadly discloses the preparation of trans-xanthophyll ester concentrates wherein an oleoresin is stirred with an alcohol at ambient temperature to provide a purified xanthophyll ester concentrate having xanthophyll ester content of at least 40 wt% and a trans:cis-xanthophyll isomer ratio of at least 4:1, and preferably at least 9:1. The examples describe the preparation from marigold oleoresins of concentrates having a lutein ester content of up to 69% and a trans:cis-lutein isomer ratio of 90:10.
54. The Opponent submitted that D1 described the preparation of concentrates having a trans:cis ratio of at least 9:1, and therefore the composition of Claim 1 is disclosed. In support of the submission Mr Lombeida provided results of a comparative study he carried out in December 2010 (Lombeida and KGF-20). The study compares the purification process of the present invention with that described in D1, and includes the results of a process wherein the process of D1 is carried out with an additional alcohol washing step. As shown in the following Table, the process of D1 results in a concentrate having a trans-lutein content lower than the presently defined range of 90-95%. However an additional wash step gave a product that fell within the scope of the present claims.
| Product of the present application | Product as per D1 | Product as per D1 with an additional wash step | |
| Trans-lutein | 91.73% | 89.30% | 90.44% |
| trans:cis Ratio | 39:1 | 18:1 | 30:1 |
| Xanthophyll ester content | 73.0% | 71.5% | 78% |
55. Dr Levy (Levy 4 at 4) and Mr Lombeida both stated that the decision to include the additional wash step was made in view of the disclosure in D1 of various conditions under which the purification could be performed. These included increasing in the amount of alcohol in order to achieve the desired purity and fractionation:
“A sufficient quantity of alcohol should be used to wash out most of the non-xanthophyll ester components and to fractionate the cis-/trans-xanthophyll isomers. The quantity of alcohol needed depends on the characteristics of the oleoresin, which may be affected by variation in factors such as climate… In general, the quantity of alcohol used for the alcohol mixing step of the present invention may be varied based on laboratory data, i.e., content of ester and cis-isomer, obtained before and after the mixing of the oleoresin with alcohol. The progress of the purification is monitored throughout the alcohol mixing step, such that the volume used, like the length of time taken for mixing, may be adjusted to achieve the highest possible purity at the lowest possible processing cost. Preferably between two and five parts alcohol by volume per each one part by volume oleoresin are employed for the alcohol mixing step. However, a much greater excess of alcohol may be used in accordance with the present invention. Once the desired degree of purity and isomer fractionation has been achieved…” (D1 at page 9, lines 3 to 16).
56. I acknowledge that the passage suggests that the conditions used for the mixing step may be varied, particularly in response to differences in the characteristics of the oleoresin that occur as a result of climate and the like. However I understand this to include varying the length of time used for mixing and increasing the ratio of alcohol to resin. I do not take this as contemplating the use of repetitive washes. I therefore consider that the Opponent’s evidence in relation to the use of a second wash step is not relevant in the determination of novelty in view of D1.
57. Such matters aside, the key issue is that D1 does not specifically disclose the presence of any zeaxanthin in the products prepared from marigold oleoresins let alone the ratios defined by the present claims. The only mention of zeaxanthin in D1 relates to the extraction of berries of genus Lycium and Physalis to provide zeaxanthin ester concentrates. However Dr Levy stated that lutein is always accompanied by zeaxanthin in marigold extracts (Levy 5, and exhibits LWL-9 to 11). The Opponent argued that as a consequence the concentrates disclosed by D1 would inherently comprise zeaxanthin in the quantities defined by the present claims.
58. In this regard the Opponent referred to the House of Lords decision in SmithKline Beecham plc [supra] at [22] wherein it was stated that:
“…..the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent… whether or not a person is working [an]… invention is an objective fact independent of what he knows or thinks about what he is doing… It follows that, whether or not it would be apparent to anyone at the time, whenever 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” [emphasis added].
59. I note that the House of Lords went on to say at [23] – [24]:
“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 anticipation requires prior disclosure of subject-matter which, when performed must necessarily infringe the patented subject matter” [emphasis added].
60. Bennett J recently followed a similar approach when discussing circumstances where there may still be anticipation of a claim despite the prior art document not disclosing of all of the essential features, and in particular the need for there to be an enabling disclosure of the invention:
“Where the prior publication discloses exactly what is claimed there is anticipation. This can be objectively determined and, apart from an understanding of terms in the art, the evidence of the skilled person is not likely to be of much further assistance. However, this does not always occur and many of the authorities contain discussions of the extent to which a disclosure less than the entirety of the claim constitutes an anticipation of product or a process to deprive the claimed invention of novelty.
If the prior art discloses some but not all integers of a claimed patent to a product, such as a combination, there is anticipation if the skilled addressee would add the missing information as a matter of course and without the application of inventive ingenuity or undue experimentation...
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.
It is the last of these two examples that, in Australia, could be said to be within a shorthand description of “enabling disclosure”. That is, the disclosure is not complete but it is sufficient to enable the skilled addressee, in the ordinary course and without invention, to add what is missing in the prior publication to obtain the claimed invention. The term “enabling disclosure” may also be apposite to disclosure to the skilled addressee of an asserted prior use: whether what the skilled addressee observes on inspection is sufficient to enable him or her to comprehend the complete invention…, that is, whether it is sufficient to amount to a disclosure of the invention.” (Lundbeck v Alphapharm [supra]).
61. I take this to mean that in order for there to be an anticipation of a claim where a feature is not explicitly disclosed the prior art, the teaching of the prior art must inevitably or inexorably lead to the defined product. It is not sufficient that the prior art could (“may or may not”) provide the claimed product. Rather the prior art teaching must always (“inevitably”) provide that product.
62. Thus in order to anticipate the present claims, the Opponent would firstly need to establish that D1 provides clear and unmistakable directions to a method that provides a composition falling within the scope of the present claims and secondly, the evidence would need to establish that such method inevitably or inexorably leads to a product comprising the two lutein isomers and zeaxanthin in the defined quantities. That is to say, the Opponent must establish that the teachings of D1 would lead to the defined invention, not merely that it could.
63. As noted above, D1 broadly discloses concentrates having a trans:cis-xanthophyll isomer ratio of at least 4:1, and preferably at least 9:1, and the examples provide having a 9:1 ratio of these isomers. Dr Levy also provided data indicating that the trans:cis ratio increases as the overall ratio of volume of solvent to weight of oleoresin increases (Levy 4 at 5):
| Overall ratio of volume of solvent (L) to weight of oleoresin (Kg) | Lutein ester content of the obtained product | Average trans/cis lutein ester ratio in the obtained product |
| 1:1 | Not determined | 4:1 |
| 3:1 | Not determined | 6:1 |
| 4:1 | 64.1% | 16:1 |
| 5:1 | 65.9% | 32:1 |
64. Despite the lack of a data for the zeaxanthin content of the products, the ratio of trans:cis lutein of 32:1 appears to be consistent with the products defined by the present claims. Setting aside the absence of zeaxanthin data for the moment, the first consideration is whether D1 provides clear and unmistakable directions to use the ratio of solvent to oleoresin that would provide such an ester ratio. Notably, none of the examples specifically disclose a trans:cis-isomer ratio as defined in the present claims or employ a 5:1 ratio of alcohol to oleoresin. However at page 9 lines 15 to 17, D1 states that:
“[P]referably between two and five parts alcohol by volume per each one part by volume oleoresin are employed for the alcohol mixing step. However a much greater excess of alcohol may be used in accordance with the present invention.”
65. I note that D1 refers to a volume:volume ratio, whereas Dr Levy referred to a volume:weight ratio. However D1 otherwise uses a weight measure in relation to the oleoresin and this appears to be the measure generally used in the art (for example in the present application). I am therefore satisfied that this reference is intended to be a volume:weight ratio, and that D1 does broadly disclose the use of 5:1 ratio of solvent to oleoresin. Furthermore, the indication that these are preferred ranges suggests that the skilled person would be directed to employ such conditions. On balance I am satisfied that there are clear and unmistakable directions to the use of such a ratio.
66. Notwithstanding the conclusion that there may be clear and unmistakable directions to the use of a 5:1 ratio of solvent to oleoresin, the second consideration is whether the method of D1 would provide the compositions of the present claims, and in particular zeaxanthin in the defined levels. The gist of the Opponent’s argument is that it is common general knowledge that marigold oleoresins always contain zeaxanthin and therefore the prior art compositions inherently possess this feature of the present claims.
67. These arguments appear to be consistent with the principle set out in Lundbeck where Bennett J stated that there may be anticipation if “the skilled addressee would add the missing information as a matter of course and without the application of inventive ingenuity or undue experimentation”. However I do not see this as such a situation. Here the skilled person would not merely need to add the information that zeaxanthin is present in marigold extracts in order to anticipate the present claims – they would need to add the information that would result in the concentrates defined by the present claims - in this case the ratio of lutein esters as well as both the presence of zeaxanthin and the defined range in which it is present.
68. To this end, Dr Levy’s provided analytical results for various products (LWL-6 to LWL-8) that indicates that zeaxanthin is generally present in such concentrates. Furthermore, Dr Levy stated that concentrates using a 5:1 ratio had been supplied by Inexa to Henkel Corporation as lutein ester concentrates lot L - 919608. A copy of an analysis report indicates that this product contains 91.3% trans-lutein, 4.5% zeaxanthin and 2.4% cis-lutein (Levy 4, Exhibit LWL-6), which falls within the scope of the present claims. However, no corroborative evidence was provided to clearly link the processes disclosed in D1 with the product represented as L-919608, so the extent to which I can use this evidence in the present determination is limited. Moreover, the Applicant argued that the content of the product will be dependent on a number of factors, including the starting material, extraction time and quantity of alcohol. This argument is supported by D1 in its reference to the characteristics of the oleoresin being affected by variation in factors such as climate (D1 at page 9, lines 3 to 16), and by the evidence of Dr Becker, who stated that “[I]n my experience, I would expect there to be some variation in the composition of lutein esters and zeaxanthin esters as a result of variation in the source of marigolds from which the natural material was extracted” (Becker at [16]). In view of the evidence adduced by the Opponent, I am satisfied that lutein ester concentrates from marigolds will generally contain zeaxanthin. However, I do not consider that the evidence clearly establishes that zeaxanthin would always be present in products produced in D1 in the quantity defined by the present claims.
69. Of course there is an argument that the purification process could be monitored in order to provide desired compositions, and Dr Levy and Mr Lombeida both noted that D1 suggested such monitoring (D1 at page 9, lines 3 to 16 as quoted above). However, it is implicit that in order to monitor a process a target product must be known and specifically sought. Absent such knowledge it would prima facie be a matter of chance that the correct conditions and starting materials would be selected to give a particular product. I consider that this is consistent with the approach taken by Bennett J in Dansico v Novozymes at [257]-[258]:
“…it is necessary for anticipation that the skilled addressee would add missing information as a matter of course, or that the prior disclosure of a process would lead inexorably to the product, or that a skilled addressee may observe on inspection sufficient to enable him or her to comprehend the complete invention. There is no sufficient evidence here that the performance of example 20 would necessarily infringe the claims of the Patent. In view of the limited information about any lipase activity of the phospholipase of the Novo patent, it cannot be said that the disclosure enables the skilled addressee to perceive, understand or apply that disclosure necessarily to obtain the claimed invention.
Put another way, the Novo patent does not contain clear and unmistakable directions to the process of the claims – a process with a specified result. The direction is to use the enzyme in baking. Without further direction, the skilled addressee who used that enzyme would not know that the result was the process. That information would not necessarily be made available to the skilled addressee or to the public” [emphasis added].
70. Thus, in my opinion the variability in the starting materials and extraction conditions and the impact they have on the content of the final concentrate precludes a conclusion that the teaching of D1 would inevitably provide a composition falling within the scope of the present claims. I therefore conclude that the claims are novel in view of D1.
(D2) Documents associated with supply of Inexa lutein ester product by Inexa to Henkel Corporation in U.S.A. in 1999 (LWL-6)
71. D2 comprises documents relating to the sale of 200 Kg of lutein ester concentrate to Henkel Corporation. Dr Levy stated that the product was made according to the method disclosed in Example 1 of the Levy patent, but this is not a relevant consideration in relation to a determination of the novelty of the present claims in view of D2.
72. Dr Levy stated that there were no confidentiality restrictions imposed by Inexa on these documents or the contents of any shipments made in the ordinary course of business. In particular, Dr Levy referred to a Distributors Agreement dated 26 May 1998 between Inexa and Henkel (LWL-12), and noted that if material was confidential it was required to be marked as such. None of the documents were marked confidential (Levy 6 at 13, 17). However, I note that these statements are inconsistent with a statement Dr Levy made elsewhere in evidence, where in response to evidence by Mr Kumar that supply documents would be confidential he acknowledged that Inexa do not make such documents available to the public (Levy 3 at 44). I also note that some sections of D2 are redacted, suggesting that these documents were indeed considered by the parties to be confidential in nature.
73. As a consequence I am not satisfied that these documents 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).
74. However the Opponent also argued on the basis of prior use. The documentation shows that Inexa provided Henkel with concentrates that fell within the scope of the present claims. In particular, the lutein ester concentrate sold to Henkel comprised four lots (Levy 4 at 5): lot L‑919606 (trans:cis ratio 16:1 or 94/6); lot L-919607 (trans:cis ratio 24:1 or 96/4); lot L‑919608 (trans:cis ratio 32:1 or 97/3); lot L-919609 (trans:cis ratio 16:1 or 94/6). These details are provided by a certificate of analysis dated 22 July 1999. For example, lot L‑919608 comprises a xanthophyll ester content of 65.9% made up of 91.28% trans-lutein esters, 2.38% cis-lutein esters and 4.52% zeaxanthin esters. Similarly the certificate of analysis for lot L-919607 is shown to have a ratio of esters falling within the present definition. The opponent argued that this disclosure anticipated each of claims 1 and 2.
75. Dr Becker stated that since 1998 Henkel had a distributor agreement with Inexa whereby Inexa appointed Henkel as the sole distributor for their marigold extract products and blends of such extracts in edible oils (Becker at [4] and HFB-1). Henkel marketed the products under the trademark Xangold to customers for incorporation into unit dosage forms for resale such as capsules, tablets and the like.
76. The Applicant noted the confidentiality clauses in the agreement between Inexa and Henkel (HFB-1) and the reference in Exhibit HFB-3 to Henkel controlling the process of production of Xangold “from crop to customer” through a “proprietary” process. They considered that this indicated the relationship between Inexa and Henkel was not “an arm’s length one”, and that there was no apparent reason why Henkel and Inexa would have disclosed the detailed components of the product to third parties.
77. I do not find these submissions persuasive. The agreement covers the sale of concentrates to Henkel for supply to the human dietary supplement market and notes that Henkel is acting as an independent contractor and not as an agent or representative of Inexa. The agreement sets out restrictions on the markets that Henkel and Inexa may each access, as well as providing confidentiality obligations between the two parties in relation to certain information required for regulatory and marketing purposes. However with the exception of the exclusive markets, I do not consider that there are any other restrictions on Henkel, or indeed to any party that subsequently purchased the product from Henkel, as to how they may use the product once purchased.
78. I therefore consider that the product was available to the public in a manner that would enable its composition to be determined by routine means. The remaining question is whether the skilled person could reproduce it without undue burden (Lundbeck v Alphapharm [supra]). In this regard the evidence before me shows that the skilled person would also be able to reproduce the result without undue burden. In particular, the evidence of Mr Lombeida and Dr Levy (as discussed in relation to D1) suggests that once a particular target composition was known then prior art processes could be adapted by routine means to achieve such a product.
79. I therefore consider Claims 1, 2, 4 and 14 lack novelty in view of the supply of Inexa lutein ester product by Inexa to Henkel Corporation in U.S.A in 1999.
80. There is a question as to whether Claim 3 is anticipated by D2. This claim defines that the xanthophyll content is 70%. The Opponent argued that this would be construed as being exactly 70%. However, I consider that a purposive approach is appropriate to construe the scope of this claim, and that the skilled person would understand that strict compliance with this figure was not required and take it to mean about 70%. Notwithstanding this purposive reading of the Claim, I do not consider the evidence suggests that they would read this as broadly as to include values such as 65.9%. Accordingly I consider that this claim is novel in view of D2.
(D3) Documents associated with supply of Inexa lutein ester product by Inexa to Betatene Limited in Australia in October 1998 (LWL-8).
81. D3 comprises shipment and analysis documents relating to the supply of a sample of 550 grams of lutein ester from Inexa to Betatene in October 1998. The documents include an invoice, HPLC chromatogram, export declarations, and a copy of an entry from a Betatene laboratory workbook together with a letter from Cognis Australia Pty Ltd (formerly Betatene Ltd) dated 9 February 2011 confirming the laboratory entry. The workbook entry relates to an analysis of the sample for its lutein content which was carried out on 19 October 1998. Dr Levy stated that there were no confidentiality restrictions imposed by Inexa on the documents or the shipments to Betatene.
82. The documents provide an analysis of the concentrate which shows the following concentrations: a xanthophyll ester content of 63.5% consisting of 91.2% trans-lutein esters, 3.8% cis-lutein esters, and 4.4% zeaxanthin esters. The Opponent submitted that this anticipated Claims 1 and 2.
83. The nature of the relationship between Betatene and Inexa is unclear and no evidence was adduced on this point. The packaging labels and export declaration state that the material had no commercial value. I can therefore infer that Betatene was not purchasing the product. The Betatene workbook entry suggests that the material was supplied for testing for stability during transportation, while the export declaration indicates that the material was supplied for blending experiments. In the absence of evidence to the contrary such experiments and workbook entries associated with them are prima facie of a commercially sensitive nature and would not have been available to the public. Similarly it is not apparent whether Betatene was a party that was free, in law and equity, to make use of the information provided by access to the sample.
84. Accordingly I do not consider D3 to be relevant for the determination of novelty.
(D4) Documents associated with exhibition and offer for sale of Xantopina Plus lutein ester product by Bioquimex Nutrition at trade show (SupplySide East) in New Jersey U.S.A. in May 2001 (PEL-1 and PEL-2).
85. Mr Peter Levy stated that he attended the SupplySide East trade show where he obtained documentation for the product Xantopina Plus (D4). This discloses a lutein ester concentrate which the Opponent submitted contained a xanthophyll ester content of 80% which comprised 94% trans-lutein esters, 4% cis-zeaxanthin esters, 0.4% cryptoxanthin and 1.6% other carotenoids (Peter Levy at 2-10, Exhibits PEL-1 and PEL-2). The product is said to be useful as a nutritional supplement.
86. The Applicant noted that Mr Levy did not purchase any products at the trade show, but instead was provided with documents relating to an allegedly available product. They submitted there was no evidence that any product was supplied to any person before the priority date. I do not consider this a relevant consideration since, as noted in Insta Image v Kanopy [supra], 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.
87. The Applicant submitted that Xantopina Plus is described as having a typical carotenoids profile that includes 94.00% trans-lutein and 4.00% cis-zeaxanthin. As a typical profile this did not represent an actual assay result for a particular batch. Furthermore, the absence of percentage amounts of the cis-lutein and cis-zeaxanthin precluded a determination as to whether or not there was a disclosure of the present invention. I do not consider the latter point relevant since the percentage content provided allows for at most a content of 1.6% of these compounds. Even if either comprised the entire amount given for “other carotenoids”, the resulting product would still fall within the scope of the present claims.
88. In as much as the assay is referred to as a “typical” profile, I acknowledge that this does not represent an actual product. I take this to mean that variability is expected in the content of the products supplied. However, the identification of this as a “typical” profile in my opinion provides the skilled person with clear and unmistakable directions to a product with that content. As noted previously in relation to D2, the evidence before me is that the skilled person would be able to obtain such products by routine methods, and on that basis I consider the citation discloses the invention as claimed in present claims 1, 2, 4 and 14.
89. The Opponent also argued that Claim 3 was anticipated by D4 since a disclosure of a product having 80% xanthophyll ester content would necessarily comprise 70%. I do not agree. The product described in D4 is characterised as a whole by the xanthophyll ester content and I do not consider it appropriate to consider the single entity as comprising a component having 70% xanthophyll ester and a further entity consisting of the balance of material. On that basis I consider Claim 3 is novel in view of D4.
(D5) Documents associated with exhibition and offer for sale of lutein ester product by Nutriscience at trade show (SupplySide West) in Las Vegas, U.S.A. in November 2001 (PEL-3 and PEL-4).
90. Mr Levy also stated that he attended the SupplySide West trade show where he obtained documentation relating to a lutein ester product marketed by Nutriscience (Peter Levy at 11 to 16 and exhibits PEL-3 and PEL-4). This includes a Certificate of Analysis which is entitled “Lutein Esters – 80%” which provides the following information:
| RESULTS | |
| Appearance | Yellow-orange colored free flowing powder |
| Carotenoids | 435.72 g/Kg |
| b-Carotene | 0.00% |
| Criptoxanthin | 0.43% |
| Cis-Lutein | 0.29% |
| Trans-Lutein | 93.65% |
| Trans-Zeaxanthin | 4.70% |
| Epoxides | 0.92% |
91. The Applicant noted that although the product was referred to as “Lutein Esters 80%”, the assay lists “carotenoids” (xanthophylls and carotenes) as 435.72 gram per kilogram (44%). They submitted that without “more” this did not establish that the concentrate comprises predominantly of a composition containing lutein and zeaxanthin fatty acid esters, an essential integer of Claim 1. The Opponent noted that the present specification set out a method of analysis at page 12, line 24 to 28 whereby the esters are hydrolysed and a colorimetric analysis provides the xanthophyll content. The xanthophyll ester content is then obtained by multiplication by a factor of 2. This is said to be the “most widely adopted methodology” for such analyses. Similarly, PEL-2 outlines the use of a factor of 2 to obtain the free acid to ester equivalent.
92. The values provided in the table refer to lutein and zeaxanthin, rather than to esters of such. My understanding is that the analysis is therefore referring to the free acid content of the composition which is then multiplied by 2 to provide the ester content. On that basis I am satisfied that the table discloses compositions wherein the concentrate comprises predominantly of a composition containing the lutein and zeaxanthin esters. As discussed in relation to D2, the skilled person would be able to reproduce the invention without undue burden. On that basis I consider that D5 discloses the invention as defined in Claims 1, 2 and 14.
(D6) Purchase of Inexa lutein ester products distributed by Henkel Corporation (including product sold under “NOW” label) by Dr Luis Levy from GNC store in Florida USA in 2000.
93. Dr Levy stated that in March 2000 he purchased a bottle of NOW lutein esters from a vitamin store in Florida as part of Inexa’s routine activities to purchase examples of commercial products containing lutein esters concentrate manufactured by Inexa (Levy 6 at 18-31, Exhibits LWL-13 to LWL 15). A photograph shows an expiration date of September 2001, from which it can be inferred that the product was manufactured prior to that date (Exhibit LWL 14), and Dr Levy suggested that the manufacturing date would most likely be around September 1999 (Levy 6 at 25-26).
94. Dr Levy stated that an analysis of this product shortly after purchase confirmed that each capsule contained 20 mg of lutein esters as indicated on the bottle. The analysis also indicated that the zeaxanthin ester was 4.29. Neither the original analysis nor the specific lutein ester content was provided in evidence. Instead Dr Levy provided a repeat analysis, carried out in 2011, which showed that it contained 90.05% trans-lutein; 4.29% cis-lutein and 4.24% zeaxanthin (LWL-15).
95. The Applicant noted the absence of corroborative evidence of the original analysis and noted the absence of any evidence as to the conditions in which the samples were maintained, who conducted each of the analyses, how they were conducted and the basis on which it could be assumed that the sample had not altered in the 12 years since purchase. I share the Applicant’s concerns in this regard. As noted by Besanko J.,
“… a prior public use must be strictly proved and evidence which is not corroborated must be scrutinised with care, particularly where it is evidence of events which occurred many years ago” (Aspirating IP Limited v Vision Systems Limited at [200]).
96. The evidence as to the original analysis of the product does not provide sufficient information to determine that the product did fall within the scope of the present claims. Moreover, no evidence has been adduced that enables me to conclude that the sample would retain its original composition over such an extended period. Indeed the expiration date of September 2001 suggests that some degradation of product would be expected beyond that time. On that basis I must conclude that the ground of “prior use” has not been made out in relation to D6.
Conclusion on Novelty
Claims 1, 2, 4 and 14 lack novelty in view of the “prior use” detailed in D2.
Claims 1, 2, 4 and 14 lack novelty in view of D4.
Claims 1, 2 and 14 lack novelty in view of D5.
Inventive step
97. The test for obviousness is whether it would have been a matter of routine to proceed to the claimed invention.
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.” (Aicken J in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; (1981) 148 CLR 262 at 286)
98. More recently, the High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59 at [51] - [53]; [2002] HCA 59; 212 CLR 411 at [51] - [53] approved the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had posed the question:
“Would the notional research group at the relevant date in all the circumstances directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce a useful [desired result]?”
99. In Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134 at [152] to [154] the Full Federal Court considered that the invention to be assessed for obviousness is ascertained from the patent. In the present case the main objective is stated as being to provide a novel xanthophyll esters concentrate “having higher amounts of trans-isomer and negligible or trace amount of cis-isomer which is useful for human consumption either as nutraceutical, nutritional supplements, food additives and also for colouring foods and feeds which has better stability and bio availability” (page 6, lines 25 to 30). The specification goes on to describe a method of selective extraction whereby admixture of a marigold resin in a ketonic solvent provides a product according to Claim 1. The specification also states that it is “well recognized that trans-xanthophyll esters containing higher amounts of trans-lutein content possess better stability and bio-availability”. The discussion of the prior art includes a discussion of the Levy patent (D1), with particular mention of the trans:cis ratio of isomers (90:10) and the disadvantages of using isopropanol in the purification process. In view of the discussion of the prior art and the present invention I therefore consider that the problem to be solved is to provide a xanthophyll esters concentrate from marigold extracts having a high level of the trans-isomer. Given the discussion of Levy, I take this to mean a higher level than that disclosed in this acknowledged prior art document.
The gist of the Opponent’s submissions is that there can be no inventive step where the subject claims are merely to a “product described by reference to a set of obviously desirable parameters” (Re Raychem Corp’s Patents [1998] RPC 31 at [41] to [42]). Notwithstanding the Opponent’s arguments, I have already determined that claims 1, 2, 4 and 14 lack novelty in view of D2, D4 and D5. As D2, D4 and D5 already provide a solution to the problem of providing extracts with a high level of trans-isomer, it follows that these claims lack inventive step.
Claim 3 defines a composition having a xanthophyll ester content of 70%. Claim 15 is an omnibus claim that defines concentrates with reference to the examples. I take this to define concentrates having compositions corresponding to the products prepared by each of the examples. These claims differ from the prior art in the specific isomer ratios and xanthophyll ester content of the products. The Opponent argued that the application does not provide any special advantages for the 70% xanthophyll ester content defined in Claim 3, and that as an arbitrary figure there can be no inventive step attached to it.
I agree with these arguments. D2, D4 and D5 each disclose concentrates falling within the scope of the present claims and therefore solve the problem of the present application. In my opinion the person skilled in the art would reasonably have been expected to have ascertained and considered these documents relevant as they are directed towards the same problem. The specific products defined by Claims 3 and 15 appear to be mere further alternatives of such compositions – that is, there is nothing advantageous or special in the choice of trans:cis ratio or xanthophyll ester content - and as a consequence there is no apparent inventive step.
Finally, while the Opponent did not pursue inventive step in relation to the methods defined by Claims 5 to 13 at the re-convened hearing, this was discussed in the first hearing. For completeness I will address it here.
The question is whether the skilled person would be led as a matter of course to try the claimed invention in the expectation that it might well produce a useful result. In this case the invention involves the selective removal of the cis-isomer from a marigold oleoresin to provide a concentrate with the increased amounts of trans-lutein esters and zeaxanthin. The common general knowledge in the art included the use of various solvents to extract and purify carotenoids from natural sources. Even where preferential dissolution was used, it was more common for the trans-isomer to be extracted rather than the cis-isomer (Bartley at 1.17). The general approach was to extract the natural source with a strong solvent such as toluene, benzene, pyridine, dichloromethane, ethyl acetate, petroleum ether, acetone and hexane, and then to purify the product using a technique such as chromatography, partitioning and filtration (Humphries at 2.5.3). Acetone in particular has been used for the general extraction of carotenoids (CW-2 at page 82). There is no conclusive evidence as to why the skilled person would be led to use a solvent that is generally used to extract all carotenoids from a natural source in the expectation that it would selectively extract only the cis-isomer.
On that basis I am satisfied that Claims 5 to 13 are inventive.
Conclusion on Inventive Step
Claims 1 to 4, 14 and 15 lack an inventive step in view of D2, D4 and D5.
Clarity
A claim is lacking in clarity if a third party could not ascertain whether an act would fall within the scope of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60). However, a claim does not lack clarity because it uses inexact language or is difficult to construe, as long as it provides a “workable standard” suitable to the intended use (Minnesota Mining & Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; (1980) 144 CLR 253 at 274).
The Opponent submitted that Claim 1 lacked clarity in reciting a concentrate “comprising predominantly of a composition containing lutein and zeaxanthin fatty acid esters…” They argued that it was not clear what components are said to make up the composition as opposed to the concentrate.
I do not find this argument persuasive. I understand the claim as defining a xanthophyll esters concentrate (the entire material), of which the predominant part (greater than 50%) is made up of the xanthophyll esters lutein and zeaxanthin in the defined amounts (based on the xanthophyll esters portion). On that basis I consider that the person skilled in the art would be able to determine the scope of the claim.
Fair Basis
The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58; (2004) 62 IPR 461 stated that fair basis is concerned “purely with the relationship between the body and claims of the one specification”. Thus the primary test for fair basis is whether the claims are consistent with what the specification as a whole describes as the invention. The High Court accepted that there were two subsidiary tests (sub-tests) for fair basis which were relevant to the consideration of fair basis: is there “a real and reasonably clear disclosure” of the invention in the specification? [from Société Des Usines Chimiques Rhône-Poulenc v Commissioner of Patents [1958] HCA 27; (1958) 100 CLR 5 and cited with approval in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79]; and do the claims travel beyond the subject matter of the invention described in the specification? (Olin v Super Cartridge [1977] HCA 23; (1977) 180 CLR 236).
Lockwood v Doric provides further guidance at [69]:
“Section 40(3) requires, in Fullagar J's words, "a real and reasonably clear disclosure." But those words, when used in connection with s 40(3), do not limit disclosures to preferred embodiments.
"The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification."
Fullagar J's phrase serves the function of compelling attention to the construction of the specification as a whole, putting aside particular parts which, although in isolation they might appear to point against the "real" disclosure, are in truth only loose or stray remarks”.The opponent submitted that Claim 3 is not fairly based as it defined a concentrate “wherein the xanthophyll ester content is 70% by weight”. They argued that the exact content of 70% is not disclosed in the specification, with the specification only providing specific xanthophyll ester contents according to the examples, or the broad range of 60-80%.
Admittedly there is no specific, or indeed even general, disclosure of the preparation of compositions containing exactly 70%. However, the specification provides fair basis for the range of 60-80% which in effect includes 70% (and indeed every quantity between 60 and 80). On that basis I consider there is fair basis for this figure. In any case, even if I am wrong in this regard, as noted above I consider that the skilled person would take a purposive approach to the scope of the claim and understand that strict compliance with the defined value is not intended. In this regard there is a disclosure of a composition which comprises a xanthophyll ester content of 70.58% by weight which could reasonably be taken to mean about 70%. I consider this would provide sufficient fair basis for the content defined by Claim 3.
Conclusion
Claims 1, 2, 4 and 14 lack novelty. Furthermore Claims 1 to 4, 14 and 15 lack inventive step. The opposition is therefore successful on these grounds. The claims are clear and fairly based. The opposition fails on these grounds.
The application contains patentable subject matter. I allow the Applicant 2 months from the date of this decision to propose amendments to overcome the deficiencies.
Costs
The Applicant sought its costs in the matter while the Opponent reserved its position on costs dependent on the outcome of the opposition. I therefore allow the parties 1 month from the date of this decision to provide written submissions in relation to costs.
L. F. McCaffery
Delegate of the Commissioner of Patents
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