Euroceltique S.a. v Universal Marketing Corporation
[1997] APO 18
•13 May 1997
official notice
decision of a delegate of the commissioner of patents
Application : No. 636721 in the name of EUROCELTIQUE S.A.
Title: Pharmaceutical iodine compositions
Action: Opposition under section 59 of the Patents Act 1952 by UNIVERSAL MARKETING CORP
Decision: Issued .
Abstract
Opposition successful on the grounds of novelty and section 40.
One citation disclosed a similar composition. Evidence established that the composition would change in constitution over time, producing a composition having the claimed constitution. The claim is not anticipated on this basis as neither the citation nor other evidence teaches how long, and under what conditions, to allow the composition to stand.
The citation also disclosed compositions that bordered on the claimed compositions at both ends of the range of iodate concentrations. It seems highly probable that an instructed reader would consider that the citation also makes public compositions with intermediate iodate concentrations, so the claims are not novel. Selection is not appropriate as the evidence does not support the existence of an advantage, only a choice amongst alternatives.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 636721 by EUROCELTIQUE S.A. and opposition by UNIVERSAL MARKETING CORP under section 59 of the Patents Act 1952
background
Patent application 72741/91 was lodged on 7 March 1991 by Euroceltique S.A. (hereafter referred to as Euroceltique). The application claimed priority from UK application number 9006346 which was filed on 21 March 1990. Application number 72741/91 was advertised accepted on 6 May 1993 and assigned the serial number 636721. On 6 August 1993 a notice of opposition to the grant of a patent was lodged by Universal Marketing Corp (hereafter referred to as Universal). A statement of grounds and particulars was filed on 8 November 1993. The service of evidence was completed on 12 December 1995.
The matter was heard in Sydney on 25 October 1996. Euroceltique was represented by Ms A.Kurtz, patent attorney of Griffith Hack & Co, Sydney. Universal was represented by Mr P.Whenman, patent attorney of F B Rice & Co, Sydney.
grounds of opposition
The statement of grounds and particulars lists as the grounds of opposition the grounds in section 59(1)(e), (g), (h), (i) of the Patents Act 1952.
evidence
The evidence in support by Universal consists of a declaration by Philip A Marshall (referred to as the first Marshall declaration) and a copy of a certificate by the Commissioner of Patents relating to the date that certain documents were laid open to public inspection.
The evidence in answer by Euroceltique consists of declarations by Stewart Thomas Leslie and Richard I Christopherson.
The evidence in reply by Universal consists of a declaration by Philip A Marshall (referred to as the second Marshall declaration), and a further declaration by Marshall which merely corrects some errors in his second declaration.
The evidence is quoted where relevant in this decision.
submissions
Mr Whenman made submissions on the following matters:
·the invention as claimed in all claims is not novel in the light of AU 519505, AU 532821, and AU 564632;
·the invention as claimed in all claims is obvious;
·the specification does not comply with section 40 in that claims 1 and 7 are not clear and not fairly based; and
·the award of costs.
Ms Kurtz made submissions on all of these matters.
decision
The relevant law
Patent application 636721 was lodged on 7 March 1991 (i.e. before the commencing date of the Patents Act 1990), advertised accepted on 6 May 1993 and the notice of opposition was lodged on 6 August 1993. By virtue of subsections 234(2) and 234(3) and regulation 23.3 of the Patents Act 1990, the opposition is determined under the provisions of Part V of the 1952 Act and Chapter 5 of the Patents Regulations 1991.
In patent oppositions the onus of justifying their case lies upon the opponent, who must establish that it is clear that a valid patent cannot be granted (Stamp v W.J.Powell Pty Ltd (1918) 24 CLR 339, Henry Berry & Co. Pty Ltd v Potter (1924) 35 CLR 132).
Matters to be decided
The matters that have to be decided in this opposition are:
i) novelty;
ii) obviousness;
iii) section 40; and
iv) costs.
Before considering the substance of the opposition I will discuss the specification.
The specification
The specification relates to germicidal compositions containing iodine. The problem addressed by the specification is as follows:
"It is recognised in the art that in aqueous iodine compositions wherein the iodine is formulated with organic substances with which it reacts, such as water soluble organic solvents, iodine complexing polymers or surface agents, the elemental iodine concentration decreases on storage leading to decreased germicidal effectiveness and lack of reproducibility of results."
[page 1A]
The solution to this problem is to add iodate ions to the composition:
"We have now found that by adding iodate ions in the range of 0.01% to 0.04% by weight to aqueous iodine compositions stable compositions with unexpectedly reduced irritancy are obtained."
[page 1A]
The thrust of the invention is thus an iodine composition in which iodate ions in a specific concentration have been added in order to stabilise the solution, and this produces the added result of reducing the irritancy of the solution.
The specification ends with twelve claims, which read as follows:
1. A pharmaceutical composition comprising an aqueous solution of elemental iodine and at least one organic substance which reacts with iodine, whereby iodine loss is controlled by providing a source of iodate ions sufficient to provide from 0.01% to 0.04% by weight of iodate ions.
2. A composition according to claim 1 wherein the amount of iodate ions is within the range of 0.02% to 0.03% by weight.
3. A composition according to claim 1 or 2 wherein the amount of elemental iodine is within the range of 0.75% to 0.25% by weight.
4. A composition according to any of claims 1 to 3 wherein the organic substance comprises a water soluble solvent, an iodine solubiliser, an iodine complexing polymer or a surface active agent.
5. A composition according to claim 4 wherein the organic substance comprises polyvinylpyrrolidone.
6. A composition according to claim 5 wherein the amount of polyvinylpyrrolidone is within the range of 1% to 12% by weight.
7. A process for preparing a composition according to claim 1 which comprises forming a solution of iodine and at least one organic substance with which iodine reacts and adding iodate ions in the range of from 0.01% to 0.04% by weight.
8. A composition substantially as hereinbefore described with reference to the Example, excluding comparative examples and compositions described in the prior art.
9. A process for preparing a composition substantially as hereinbefore described with reference to the Example, excluding comparative examples and compositions described in the prior art.
10. A composition substantially as hereinbefore described when administered topically or mucosally.
11. A composition substantially as hereinbefore described in solution, soap, ointment, gel or paint form.
12. A composition substantially as hereinbefore described, excluding comparative examples and compositions described in the prior art when used in the germicidal treatment or prophylaxis of a mammal.
Novelty
Mr Whenman submitted that the invention defined by all claims is not novel in the light of the following documents:
· AU 519505 (referred to as document D1)
· AU 532821 (referred to as document D2)
· AU 564632 (referred to as document D3)
Copies of each of these documents were served in evidence as exhibits attached to the first Marshall declaration. These documents were open to public inspection in the Australian Patent Office on the following dates: 10 December 1981, 13 October 1983, 20 August 1987 (these dates appear on the abridgment forming part of the copies of the documents). Consequently, all of the documents were published before the earliest priority date of the present claims.
a) The relevant law
The 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) 137 CLR 228, at page 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"
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at page 517; 16 IPR 545 at page 549).
b) The essential features
The features of the invention defined by claim 1 are as follows:
a pharmaceutical composition (i.e. one that is suitable for a pharmaceutical use) comprising a solution of:
water
elemental iodine
at least one organic substance that is capable of reacting with iodine
an iodate source sufficient to provide from 0.01 to 0.04 % by weight of iodate ions in solution
[It is necessary to say a few words about the iodate concentration. I note that Professor Christopherson declared that "Compositions are defined at the time of manufacture as in the opposed specification, not over an undefined storage period" [para 11]. It is important to my decision on novelty to decide whether the claims should be regarded as defining a composition containing 0.01 to 0.04% iodate when made up, or a composition containing 0.01 to 0.04% iodate at any time.
I consider that it is standard practice to define a composition at the time it is made up. However, knowing that the iodate concentration will decrease over time (presumably to zero), it would be an absurd construction to construe claim 1 as including the composition when the iodate concentration had decreased to a level where it was no longer capable of carrying out the function for which it was included. As claim 1 makes it clear that it is essential to have a minimum of 0.01% iodate in order to control iodine loss, I consider that the only sensible construction of claim 1 is that the composition as made up contains 0.01 to 0.04% iodate, and that the iodate concentration has not reduced to less than 0.01%.]
I can see no reason for regarding any of these features as inessential, so I shall treat them all as essential.
c) Disclosure of the citations
AU 519505 (document D1)
The citation relates to organic iodophor containing germicidal compositions substantially free of iodide. Example 4 is particularly relevant:
"Polyvinylpyrrolidone-iodine compounds containing from 1 percent to 30 percent by weight of available or titratable iodine may be prepared in the manner described above by suitable adjustment of the ratio of reagents to be used. The preferred ratio of iodate ion to iodide ion is 1 gm. molecular weight fraction of iodate ion for each 5 gm. molecular weight fractions of iodide ion used and 0.04 percent by weight of iodate ion for each percent by weight of elemental iodine used. The remainder of the steps are the same."
[page 26]
The "manner described above" refers to the previous three examples, which can be summarised by the following reactions (these formulae are not meant to be stoichiometrically correct):
Example 1, 2:
PVP + I- + IO3- + H+ ® PVP-I2
Example 3:
PVP + I2 + IO3- ® PVP-I2
Dr Marshall interprets this disclosure as follows:
"D1 discloses in Example 4 an aqueous solution of elemental iodine and an organic substance which reacts with iodine (polyvinylpyrrolidone). The solution also has 0.04% iodate per 1.0% iodine. Since the example teaches that a solution may have 1.0% iodine, such a solution would have 0.04% iodate."
[para 7 of the first Marshall declaration]
Professor Christopherson places a different interpretation on this disclosure:
[With respect to example 1] "given that only 0.1 g of potassium iodate is added, in an acidic environment, there would almost certainly be no iodate ions left in the solution once the reaction reached equilibrium. Example 1 does not therefore disclose the formation of a composition containing complexed iodine, together with iodate ions."
[para 5 of the Christopherson declaration][With respect to example 3] "discloses a procedure where povidone is added to 10 g of elemental iodine and 0.4 g of potassium iodate. As the procedure teaches the formation of a powder, and there is no indication as to the amount of water this powder is to be dissolved in, it is not possible to say what concentration of iodate ions would be in the final solution. ... Example 3 also discloses a process involving the addition of 10 g of elemental iodine to povidone in solution. Potassium iodate is then added in 0.1 g increments. The example does not state how many increments are added. It is therefore impossible to say how much potassium iodate in total is added. This part of Example 3 appears to be a titration, whereby iodate ions are added incrementally until there is an absence of iodide ions. As the amount of potassium iodate added is not specified, I presume that a sufficient amount is added incrementally so as to reach a titration end point where there are no iodide or iodate ions in solution."
[para 11 of the Christopherson declaration]
Mr Leslie noted in relation to example 3:
"The second part of this Example involves preparing the PVP-I compound in solution by adding potassium iodate to a stirred suspension of PVP and iodine. I note this part of the Example states quite clearly, that upon completion of the reaction, i.e. upon formation of the PVP-I compound, an additional 0.1 gm of potassium iodate is added. I take this to be one of the essential 'remainder steps' required by Example 4. This being the case, and thus following the instructions of Example 3, if one made a PVP-I compound containing 1% iodine (according to Example 4) one would certainly arrive at an aqueous solution according to Example 3 containing considerably more iodate than the 0.04% w/w by weight upper limit of the claim in question, namely about 0.08% w/w iodate.
Whilst I do not dispute that this reference discloses the addition of potassium iodate, within very broad ranges, to povidone iodine, I do not see that it has either recognized the problem identified by the Patentees of irritation and erythema due to certain concentrations of iodate ion, nor the Patentee's selected, beneficial narrow range of iodate content; it is noteworthy that there is no specific example of iodate concentration falling with the Patentee's defined range."
[para 5.2.5 of the Leslie declaration]
Mr Whenman asserted that Example 4 anticipates claims 1 and 7 as it discloses a composition containing 0.04% iodate (and in addition anticipates claims 2-6). Mr Whenman considered that the normal stoichiometry of iodate addition to iodide may not occur when PVP is present, and thus Professor Christopherson's calculations may not be correct in this case. Ms Kurtz noted that there are no examples specifying that they contain 0.01 to 0.04% iodate.
Mr Whenman speculated that if the neutralisation of iodide in Example 1 is exceeded by a small amount (Mr Whenman suggested that 0.3 ml of a 0.1M solution of potassium iodate might be a reasonable excess) then a solution containing 0.01% iodate ion would result. An excess of iodate would be necessary to ensure the complete neutralisation of iodide. It is highly likely in practice that the product would be of the invention. These "calculations" were not part of the evidence, and were advanced by Mr Whenman at the hearing (I gave Ms Kurtz 2 weeks to respond to this matter). Ms Kurtz submitted that D1 is a "rough and ready" procedure, and that a large excess of iodate was more likely than a small excess.
AU 532821 (document D2)
This citation is the equivalent of a prior art document acknowledged in the application under opposition.
The citation relates to germicidal iodine compositions. The invention lies in counterbalancing the slow loss of iodine from such solutions by the slow release of iodine by reaction between iodate and iodide. The specification describes the compositions as follows:
"The compositions of this invention contain elemental iodine in an amount that usually does not exceed 1%, but is more generally in the range of 0.01% to 0.25% iodine; iodide ion (from any source) preferably 0.025% to 0.5%, more preferably in the range of 0.05% to 0.5%; iodate ion (from any source), at least 0.005%, preferably in the range of 0.05% to 0.1%, an organic substance or substances (detergent or solvent, for example) which contains C, H, and O atoms in an amount from 1 to 50%, and pH control, usually accomplished by the inclusion of a buffering agent (citrate, phosphate, etc.) capable of maintaining a pH in the range of 5 to 7."
[page 5]
Mr Whenman pointed out that an iodate concentration in the range of 0.005 to 0.2% is clearly disclosed, and specifically claimed. The specific examples (in Table II, at page 12) demonstrate compositions containing the specific iodate concentrations of 0.0088 and 0.044% (other concentrations less relevant to the present case are also disclosed). The specific examples are as follows:
C F G H I
Lauryl sulfate, NH4 salt 5.0 5.0 5.0 5.0 5.0
Lauric diethanolamide 2.0 2.0 2.0 2.0 2.0
Iodine 0.05 0.05 0.05 0.05 0.05
Sodium iodide 0.25 0.25 0.25 0.25 0.25
Sodium iodate 0.01 0.05 0.05 0.05 0.05
Citric acid 1.0 1.0 1.0 1.0 None
Sodium hydroxide pH 6.5 pH 6.5 pH 7.0 pH 7.5 pH 6.5
Water to 100% to 100% to 100% to 100% to 100%
[0.01% sodium iodate equates to 0.0088% iodate; 0.05% sodium iodate equates to 0.044% iodate]
Mr Whenman submitted that 0.0088% is essentially the same as 0.01%, and 0.044% is essentially the same as 0.04%. Mr Whenman further noted that the iodate in such a composition would continue to react over time:
"it is well known that these particular components continue to react over time"
[para 8 of the first Marshall declaration]
Consequently, a composition containing 0.044% iodate would eventually form a composition containing 0.01 to 0.04% iodate.
On this point, Professor Christopherson noted:
"Compositions are defined at the time of manufacture as in the opposed specification, not over an undefined storage period."
[para 11 of the Christopherson declaration]
Mr Whenman noted that Professor Christopherson did not disagree that the iodate concentration would decrease.
AU 564632 (document D3)
The document relates to pharmaceutical iodophor compositions. The invention lies in producing compositions with improved storage stability by means of compositions of iodophor, iodide and an oxidising agent such as iodate.
Dr Marshall's declaration refers to Example 1 as relevant:
"Example 1 (preparation, iodine to iodide ratio)
Eight different PVP iodine preparations with differing iodine to iodide ratios were manufactured as follows:
Batch 1 - 4: 10 g of PVP iodine containing 10% iodine were dissolved in 100 ml water at room temperature while stirring. Dependent upon the objective the desired iodine to iodide ratio was set up by the addition of potassium iodate as oxidizing agent or by potassium iodide. Then the pH value was adjusted by the addition of citric acid or soda lye. The individual batches had the following parameters:
Batch titratable PVP iodide I2: iodide
iodine content content1 1.00% 8.5% 0.25% 3.6:1
2 1.00% 8.5% 0.33% 3.0:1
3 1.00% 8.5% 0.50% 2.0:1
4 1.00% 8.5% 1.00% 1.0:1
Batch 5-10: 5g of PVP iodine containing 10% iodine were dissolved in 100 ml water at room temperature while stirring. Dependent upon the objective the desired iodine to iodide ratio was set up by the addition of potassium iodate or by potassium iodide. Then the pH-value was adjusted by the addition of citric acid or soda lye. The individual batches had the following parameters:
Batch titratable PVP iodide I2: iodide
iodine content content5 0.50% 4.25% 0.125% 3.6:1
6 0.50% 4.25% 0.16% 3.0:1
7 0.50% 4.25% 0.25% 2.0:1
8 0.50% 4.25% 0.50% 1.0:1
A microbiological test was then carried out which revealed that preparations with an iodine to iodide ratio from approximately 3.0:1 are rapidly effective for practical use."
The amount of iodate added is specified on page 3 of the specification as: "The preparation of the invention still further requires the presence of an oxidizing agent such as iodate ions in an amount of at least 0.22% in order to stabilize the free iodine levels of the composition."
d) Decision on novelty
AU 519505 (document D1)
Mr Whenman invited me to conclude that a composition falling within the scope of the claims was likely to result in practice by following the instructions of the citation. This conclusion follows from the suggestion that the composition would be produced by titration, which would inevitably lead to the use of a small excess of iodate. However, the citation does not state that the compositions are prepared by titration rather than addition of the calculated amount required to neutralise the iodide. There is no evidence that titration is the way that a skilled worker would inevitably have carried out the preparation, or that a 0.3 ml excess would have been employed. I am not satisfied that the citation provides a clear and unmistakable instruction to produce a composition containing 0.01 to 0.04% iodate.
AU 532821 (document D2)
There is no clear disclosure of a composition having an iodate concentration within the range of the claimed invention. Compositions C, F, G, H and I of Table 2 contain iodate concentrations of 0.0088% and 0.044%. I am not prepared to accept that a concentration of 0.0088% is, in reality, the same as a concentration of 0.01% by rounding up to two decimal places (and similarly for rounding down a figure of 0.044%). I believe that the citation should be construed as meaning what it says, and the claims of the present application should be construed as claiming only what they say.
The suggestion that a composition of the citation containing 0.044% iodate would eventually yield a composition containing less iodate, appears to be true as a matter of fact. However, the citation does not provide sufficient information to enable the public to prepare a composition containing 0.01 to 0.04% iodate. The citation does not teach how long to let the solution stand, and under what conditions to let it stand, in order to produce a solution containing 0.01 to 0.04% iodate. Consequently, there is no specific disclosure of a composition containing 0.01 to 0.04% iodate.
The citation clearly teaches a composition having an iodate concentration on either side of that of the present application. It is relevant to ask whether the citation teaches a range of iodate concentrations, and consequently discloses the concentrations of the present application. The passage of the specification quoted above refers to iodate concentrations of "at least 0.005%, preferably in the range of 0.05% to 0.1%". I consider that the specification is discussing a range of equally effective iodate concentrations. Given the specific disclosures of 0.0088% and 0.044% iodate (two values that are comparatively close together), it seems highly probable that an instructed reader would consider that the citation also makes public compositions with intermediate iodate concentrations, i.e. 0.0088 to 0.044%. [This is analogous to the approach to generic disclosures used in Application by American Home Products Corporation, Patent Office decision, 28 September 1994, patent application number 16397/92, unreported] It follows that document D2 contains clear and unmistakable instructions to produce compositions containing 0.01 to 0.04% iodate.
Document D2 also clearly discloses an iodate content of 0.02 to 0.03%, an organic substance being a surface active agent and a method of preparing the composition by adding iodate ions. Thus D2 prima facie anticipates claims 1, 2, 4, 7.
AU 564632 (document D3)
Mr Whenman submitted that claim 1, 2, 6, 11 are not novel in the light of this citation. While the document clearly teaches the use of iodate in PVP-iodine compositions (note Example 1), it appears that the iodate concentration taught is greater than 0.2%. I cannot see that the document contains a clear and unmistakable instruction to produce a composition having the lesser iodate concentration of 0.01 to 0.04%.
Selection considerations
Submissions were also made on the question of whether the claimed invention is a selection. This is relevant to document D2. If the present application is a selection patent, then it is not anticipated as there is no specific disclosure (see discussion of principles in Application by American Home Products Corporation, supra).
Ms Kurtz stated that the application is a selection, based on the property of unexpectedly low irritancy of the compositions. The evidence of this advantage is found in three figures in the specification which record the mean visual erythema (Figure 1), mean erythema meter reading (Figure 2) and blood flow measurement (Figure 3) of a composition of the invention and two comparative examples, plotted against time. The comparative examples differ from the example of the invention in the amount of potassium iodate that they contain: one contains no potassium iodate, and the other contains 0.225% potassium iodate. Figure 1 shows that the invention is marginally better than the comparative examples at all times greater than 2 hours. Figure 2 shows that the invention is marginally better than the comparative examples at all times. Figure 3 shows that the invention is marginally better than the comparative examples at 3, 4 and 5 hours only. The inconsistent nature of the advantage does not accord with the substantial advantage required in a selection. Rather, it has the character of a mere choice amongst alternatives, resembling optimisation rather than selection. I consider that the present application cannot be regarded as a selection.
Consequently, the invention claimed by claims 1, 2, 4, 7 is not novel.
Obviousness
Mr Whenman submitted that the invention defined by all claims is obvious.
a) The relevant law
The approach to considering obviousness under the Patents Act 1952 was set out in Minnesota Mining and Manufacturing Co. v Beiersdorf (Aust.) Ltd (1980) 144 CLR 253 and summed up by Aickin J in The Wellcome Foundation Limited v V.R. Laboratories (Aust.) Pty Ltd (1981) 148 CLR 262 at 270 in the following terms:
"It is as well to bear in mind that the question of obviousness involves asking the question whether the invention would have been obvious to a non-inventive worker in the field, equipped with the common general knowledge in that particular field as at the priority date, without regard to documents in existence but not part of such common general knowledge."
The normal approach is to consider the problem solved by the claimed invention, and to ask whether that is an obvious solution in the light of the relevant common general knowledge. This analysis can be considered as a problem-solution approach. The problem used in this analysis is one that can reasonably be inferred on the basis of the specification as a whole and surrounding facts (see my discussion of the principles in Application by Rhone-Poulenc Rorer S.A., Patent Office decision, 25 August 1995, patent application number 12264/92, unreported).
The question of what is obvious in the light of the common general knowledge is assessed using the following approach:
"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."
(Wellcome Foundation Limited v V.R. Laboratories (Aust.) Pty Ltd, supra, at page 286)
b) The problem
The problem addressed by the claimed invention is the production of a stable pharmaceutical iodine composition with reduced irritancy.
c) The common general knowledge
Mr Whenman argued that D2 is part of the common general knowledge because Dr Marshall stated that it is "a well known document in this art in Australia" [para 12 of the first Marshall declaration]. Dr Marshall's work experience states that he has over ten years experience in research and management in chemical and pharmaceutical companies. I consider that Dr Marshall is in a position to comment on what is well known in the pharmaceutical industry in Australia.
Professor Christopherson stated that in this area research scientists gain their information almost exclusively from scientific journals rather than from patent applications [para 18 of the Christopherson declaration]. However, he did not comment on whether D2 is part of the common general knowledge. On balance, I consider that there is reason to accept that D2 is common general knowledge.
Mr Whenman argued that D3 is also common general knowledge based on the following passage by Dr Marshall:
"In my view, it is not unreasonable to combine the teachings and disclosure of D2 and D3 given that D2 is a well known document and D3 on page 1A last paragraph refers to the United States equivalent to D2."
[para 18 of the first Marshall declaration]
I can see no reason, from this statement or otherwise, for regarding D3 as a part of the common general knowledge.
d) The obviousness question
The obviousness argument advanced by Mr Whenman depended on combining information in documents D2 and D3. As D3 is not part of the common general knowledge, it cannot be used for assessing obviousness.
An alternative view is that the invention is obvious in the light of the common general knowledge of D2 alone. However, D2 is not relevant to the problem addressed by the present application, i.e. reduced irritancy. The compositions described in D2 possess increased elemental iodine stability, and there is no reference to irritancy. Consequently, D2 is not relevant to the problem addressed by the present application, and the application is not obvious in the light of D2 alone.
Section 40
The only section 40 issue pursued in the opposition relates to the phrase "organic substance which reacts with iodine" in claims 1 and 7. Mr Whenman stated that this term is too broad, and that many compounds would satisfy this criterion, and it is not clear which of those compounds would be suitable for the invention (i.e. a pharmaceutical composition). This is a question of clarity. However, I believe that there is also a question relating to the fair basis of this terminology.
Dr Marshall stated at para 7 of his first declaration that he considered the term indefinite. Professor Christopherson disagreed:
"The phrase does define a very broad class of compounds, which are subsequently defined more specifically in the patent specification. Although it defines a broad class, a skilled chemist could readily ascertain whether any particular substance or compound fell within this class of compounds."
[para 3 of the Christopherson declaration]
Mr Leslie stated in his declaration:
"The Patent Application in question concerns PVP-I complex which has been designed to avoid problems of irritancy and erythema ..."
[para 3 of the Leslie declaration]
I consider that the phrase is entirely clear, and means what it says. However, the phrase defines too broad a class of compounds. The specification only provides a real and reasonably clear disclosure of compounds that react with iodine to produce iodophors.
Conclusion
Universal is successful in its opposition on the grounds of novelty and fair basis.
I allow Euroceltique 60 days in order to propose amendments to overcome these deficiencies.
Costs
The power of the Commissioner to award costs is based on section 210 and regulation 22.8. The power to award costs is discretionary, so I must take into account all relevant considerations (see American National Can Co. v W.R. Grace & Co.-Conn (1994) AIPC 91-063; 29 IPR 292).
Universal have succeeded on the grounds of novelty and section 40. I consider that the novelty issue is an important issue, and it is appropriate for Universal to be awarded costs. I award costs in accordance with Schedule 8 against Euroceltique.
Dr S.D.Barker
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Griffith Hack & Co, Sydney
Patent attorneys for the opponent : F B Rice & Co, Sydney
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