Les Laboratoires Servier v Apotex Pty Ltd
[2008] APO 11
•11 April 2008
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 2001276418 in the name of Les Laboratoires Servier
Title: A crystalline form of perindopril tert-butylamine salt
Action: Request under Regulation 5.5(1) by Les Laboratoires Servier for a dismissal of an opposition made under Section 104(4) by Apotex Pty Ltd
Decision: Issued 11 April 2008 .
Abstract
Opposition dismissed.
Some general principles that flow through to the dismissal of patent oppositions from recent changes to Section 31A of the Federal Court Rules and subsequent Federal Court decisions are discussed. Notably, an opposition need not be “clearly untenable” or “manifestly groundless” in order for it to be dismissed. An opposition may be dismissed if it is considered to have no reasonable prospects of success.
The claims as accepted defined a new polymorph of perindopril tert-butylamine salt which was characterised by X-ray crystallography. Uses of the compound in pharmaceutical formulations and methods were also defined. The proposed amendments sought to include claims to the compound and methods with the further characteristic that the polymorph was in the form of “individual needles”. The opponent opposed the amendments under section 104 and addressed all grounds of opposition available under section 102. The applicant requested dismissal of the opposition on the basis that it was manifestly groundless and could not possibly succeed.
A consideration of the case set out by the opponent shows that it has no reasonable prospects of success. The opponent has not established that there is a real issue to be determined, or the issues identified are in respect to matters that do not arise as a result of the amendments and would not be sustainable in an opposition under section 104. On that basis the opposition is dismissed.
Costs awarded against the opponent Apotex.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 2001276418 by Les Laboratoires Servier and a request under Regulation 5.5(1) by Les Laboratoires Servier for a dismissal of an opposition made under Section 104(4) by Apotex Pty Ltd.
BACKGROUND
Patent application 2001276418 in the name of Les Laboratoires Servier (the Applicant) was advertised accepted on 6 July 2005. A notice of opposition to the grant of the patent was filed by Lupin Ltd on 28 October 2005, but the opposition was withdrawn on 5 February 2007 following settlement by the parties. Before the application could proceed to grant a further notice of opposition was filed on 9 March 2007 by GenRx Pty Ltd (who subsequently changed their name to Apotex Pty Ltd). An application under section 223 to extend the time in which to file the notice was required, which the applicant opposed. The opposition was heard on 26 July 2007 and a decision refusing the extension of time was issued on 4 September 2007. This decision was appealed to the Administrative Appeals Tribunal who recently issued a decision affirming the Commissioner’s decision.
An associated divisional Innovation Patent, 2006101079, has also been the subject of action in the Federal Court (NSD 208 of 2007). This innovation patent was revoked pursuant to the grant of leave from the Federal Court on 18 April 2007 for the Commissioner to accept the patentee’s offer to surrender the patent under section 137(1).
The applicant sought to amend the present specification under section 104 on 2 March 2007. Leave to amend was granted by the Commissioner on 27 July 2007, and details of the amendments were advertised for opposition purposes on 16 August 2007. A notice of opposition to the amendments was filed by Apotex Pty Ltd (the Opponent) on 9 November 2007, and this was followed by a Statement of Grounds and Particulars on 8 February 2008. On 14 February 2008 the applicant filed a request under Regulation 5.5(1) for a dismissal of the section 104 opposition.
The request for dismissal was set for hearing on 13 March 2008 in Canberra. Ms Sophie Goddard SC, instructed by Mr Paul Jones and Dr Karen Bentley patent attorneys from Freehills Melbourne represented the opponent. Mr Bruce Caine SC, instructed by Dr Trevor Davies and Dr John Landells from Allens Arthur Robinson represented the applicant.
Relevant Law
The present opposition relates to an amendment under section 104. Therefore the only available grounds for opposition to an amendment under section 104 are given in section 102 which states:
(1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
(2) An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a)a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b)the specification would not comply with subsection 40(2) or (3).
(2A) For the purposes of subsection (2), relevant time means:
(a) in relation to an amendment proposed to a complete specification relating to a standard patent—after the specification has been accepted…
The law in relation is section 102 is well established. A useful summary of some general principles was provided by the Delegate in Moduline Pty Ltd v Electric Cable Duct Systems Pty Ltd [2006] APO 19. As noted in that decision a two-stage process must be followed when determining whether a proposed amendment satisfies the various requirements of section 102 (per RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd 42 IPR 353). In the first stage the matter resulting from the amendment is identified by comparing the specification as it stands immediately before amendment and the specification as it would stand after amendment. For section 102(1), the second stage involves a comparison of the matter resulting from the amendment with the specification as filed in order to determine whether the amended specification would claim matter not in substance disclosed in the specification as filed. For section 102(2)(a), the second stage involves a consideration of whether the amended claims would result in something infringing the amended claims that would not infringe the accepted claims (AMP Incorporated v Commissioner of Patents (1974) 3 ALR 283 at 289, otherwise known as the Distillers test). For section 102(2)(b) the second stage involves a consideration whether as a result of the amendment the complete specification would not comply with section 40(2) or (3).
It is clear from this approach that a consideration under section 102 is confined to matters that arise “as a result of the amendment.” As a consequence, any pre-existing deficiencies which are unaffected by the amendment cannot be argued in an opposition under section 102.
Dismissal of an opposition is provided for by Regulation 5.5, which sets out that:
(1) An applicant may:
(a) within 1 month of being served with a copy of a statement by an opponent under subregulation 5.4 (1) ("filing of statement"); ….
request the Commissioner in the approved form to dismiss the opposition.
(2) As soon as practicable after a request is made, the Commissioner must inform the opponent of the request having been made.
(3) The Commissioner may dismiss the opposition whether or not the applicant
has requested dismissal of the opposition.
Office practice in relation to dismissal of oppositions has followed the approach of the Federal Court in exercising their powers to summarily determine claims and defences, and is as set out in General Steel Industries Inc v Commissioner for Railways (NSW) (1964) 112 CLR 125 at 129:
"[T]he plaintiff ought not to be denied access to the customary tribunal which deals with actions of the kind he brings, unless his lack of a cause of action - if that be the ground on which the court is invited, as in this case, to exercise its powers of summary dismissal - is clearly demonstrated. The test to be applied has been variously expressed; 'so obviously untenable that it cannot possibly succeed'; 'manifestly groundless'; 'so manifestly faulty that it does not admit of argument'; 'discloses a case which the Court is satisfied cannot succeed'; 'under no possibility can there be a good cause of action'; 'be manifest that to allow them (the pleadings) to stand would involve useless expense'."
This approach found approval with the Federal Court in Stack v Commissioner of Patents [1999] FCA 148, and has been applied in a number of dismissal proceedings before the Commissioner. Thus, oppositions or individual grounds of opposition (L’Aire Liquide, SA pour L’Etude et L’Exploitation des Procede Georges Claude v The Commonwealth Industrial Gases Ltd 24 IPR 77) have been dismissed only where it is clear that the opposition could not possibly succeed. The onus in this regard has fallen to the applicant to show that the opposition is clearly untenable.
Recent decisions have considered the material facts necessary for the particular grounds of opposition in order to determine if the statement of grounds and particulars set out an “arguable ground of opposition” (Frenchporte, L.L.C. v Gliderol International Pty Ltd [2008] APO 4), or have considered whether there was a “real issue of dispute” set out in the particulars (The Carnegie Institution of Washington and The University of Massachusetts v Benitec Australia Ltd [2005] APO 49). The latter case involved dismissal of a section 104 opposition, and the delegate noted that in such a context:
“…a mere allegation that an amendment contravenes section 102 on its own is insufficient to identify a real issue of dispute. An amendment to a specification inevitably involves a textual change but not all such amendments fall foul of section 102. To demonstrate a real issue of dispute (as required by the statement of particulars), there has to be a substantive reason for how the particular change in text might cause a problem under section 102. That problem might be self-evident or ascertainable by a detailed analysis of the allegation or the specification. However, if a potential problem cannot be found by any of these means, then the onus resides on the opponent to explain the basis of their argument. If they fail to provide a substantive explanation, then their "argument" is merely an unsupported allegation and has no possibility of success. In such an event, their opposition is subject to dismissal.”
However, whilst a “detailed analysis of the allegation or specification” may be required to determine whether or not there is a real issue of dispute and the opposition can be dismissed, an in-depth consideration of the substantive issues of the opposition has been avoided. As noted by the Deputy Commissioner in L’Aire Liquide [supra]:
‘[A]n action for dismissal of an opposition is not intended to be a de facto hearing of the substantive opposition. Rather, it is intended to provide a mechanism to dispose, at an early stage of the proceedings, those oppositions that are "obviously" or "manifestly" "groundless" or "untenable". It may be appropriate to dismiss an opposition if one could readily conclude from the technical divergence of the citation and the opposed specification that an opposition could not possibly succeed (for example, a safety-pin cited against an airplane). A dismissal might also be appropriate if the publication date of the citation is later than the latest priority date that could be accorded the opposed specification (that is, the application date of the opposed specification or any later alleged priority date that may be determined under section 114 of the 1990 Act, or section 159A of the 1952 Act). In my view, an argument for summary dismissal that relies an interpretational analysis of the claims, pointing out that this or that feature is not present in the citation, is an argument which pre-empts the substantive opposition. (I also note here that any such analysis is properly open to expert evidence, which can only arise as part of the evidence in support of the opposition [or subsequent evidentiary stages] or at the substantive hearing. If expert evidence is required to support a particularised ground of opposition, I do not consider the absence of that expert evidence to be a justification for dismissal of the opposition.)’
As noted above, practice in relation to dismissals of oppositions has been guided by the approach of the Federal Court, and particularly on the standard set by Barwick CJ in General Steel [supra]. However changes to section 31A of the Federal Court Rules, which deals with summary judgement, came into effect on 1 December 2005. In particular, section 31A now provides that:
“(1) The Court may give judgment for one party against another in relation to the whole or any part of a proceeding if:
(a) the first party is prosecuting the proceeding or that part of the proceeding; and
(b) the Court is satisfied that the other party has no reasonable prospect of successfully defending the proceeding or that part of the proceeding.
(2) The Court may give judgment for one party against another in relation to the whole or any part of a proceeding if:
(a) the first party is defending the proceeding or that part of the proceeding; and
(b) the Court is satisfied that the other party has no reasonable prospect of successfully prosecuting the proceeding or that part of the proceeding.
(3) For the purposes of this section, a defence or a proceeding or part of a proceeding need not be:
(a) hopeless; or
(b) bound to fail;
for it to have no reasonable prospect of success.”
Pursuant to this change, the principles set out in General Steel (supra) are not given “canonical force” in summary dismissal proceedings (Batistatos v Roads and Traffic Authority of New South Wales (2006) 227 ALR 425 at 427). Rather, a proceeding may be dismissed where a party has “no reasonable prospect of successfully prosecuting the proceeding” (see for example Garrett v Macks [2006] FCA 601, White Industries Aust Ltd v Commissioner of Taxation [2007] FCA 511, Boston Commercial Services Pty Ltd v GE Capital Finance Australasia Pty Ltd [2006] FCA 1352, Rogers v Asset Loan Co Pty Ltd & Ors [2007] FCA 195, Vans, Inc. v Offprice.Com.Au Pty Ltd [2006] FCA 137, E. & J. Gallo Winery v Lion Nathan Australia Pty Limited [2008] FCA 136, and Alphapharm Pty Ltd v Merck & Co Inc [2006] FCA 1227).
The “no reasonable prospects of success” formula applied by the Federal Court is based on Part 24 of the Civil Procedures Rules (Eng) and rr 292(2) and 293(2) of Queensland’s Uniform Civil Procedure Rules 1999 (see White Industries (supra) at [53] and Boston Commercial Services (supra) at [33] to [38]). In this regard, Greenwood J in Rogers v Asset Loan (supra) suggested that:
“[P]erhaps the test in determining a reasonable prospect of successful prosecution of a proceeding is whether there is a demonstrated ‘real (as opposed to fanciful) issue of fact to be decided’…However, the ‘real issue of fact’ must be framed within a comprehensible cause of action (in respect of which the applicant has standing) so that findings of fact in favour of the applicant give rise to a recognised remedy.”
In Boston Commercial Services (supra) at 43, Rares J further observed that the process envisaged by s 31A is summary, and likened the test to that under common law as to whether a jury properly instructed could reach a verdict for the plaintiff (citing Hocking v Bell (1947) 75 CLR 125 at 130-131). He further noted at 45 that:
“in assessing what reasonable prospects of success are for the purposes of s 31 A, the Court must be very cautious not to do a party an injustice by summarily dismissing the proceedings where, in accordance with the principles in Hocking v Bell… contested evidence might reasonably be believed one way or the other so as to enable one side or the other to succeed. As soon as the evidence may have such an ambivalent character prior to a final determination, I am of opinion that then, as a matter of law, at that point there are reasonable prospects of success within the meaning of s 31A. Unless only one conclusion can be said to be reasonable, the moving party will not have discharged its onus to enliven the discretion to authorize a summary termination of the proceedings which s 31A envisages.”
In Alphapharm Pty Ltd v Merck & Co Inc (supra), Moore J considered a request for summary disposal under s 31A of pleadings in relation to inutility. He determined that these could not be rejected as “unarguable or having no reasonable prospects for success” without the benefit of expert evidence to explain which steps could readily have been undertaken by a chemist without any guidance.
I consider that several key principles flow through to patent oppositions from the changes to s 31A of the Federal Court Rules and the guidance provided by the above decisions:
·An opposition need not be “clearly untenable” or “manifestly groundless” in order for it to be dismissed. An opposition may be dismissed if it is considered to have no reasonable prospects of success.
·In determining whether or not there is a real prospect of success, consideration is given as to whether there is a real rather than fanciful issue to be decided. The onus will initially be on the applicant to show that the opposition has no reasonable prospects of success, but the onus may shift to the opponent to explain its case if a real issue is not self-evident. This will not involve an in-depth consideration of the substantive opposition, but may involve sufficient analysis to determine if a prima facie case has been established.
·A dismissal will generally be inappropriate where expert evidence is required to determine an issue. However, this does not preclude dismissal of an opposition where there is a clear deficiency in the case to be argued, such as a technical divergence of a citation and the application or where an opposition involves issues of construction and expert evidence is not necessary to clarify technical terms or other matters that are in doubt.
·Evidence of an “ambivalent character” will generally be sufficient to establish a reasonable prospect of success. However, if the evidence is only one-way, or can clearly lead only to a single conclusion, then a proceeding may be dismissed. If no particulars have been provided in relation to a ground of opposition then it may be considered to have no reasonable prospects of success.
·Care must be taken not to cause an injustice to a party by dismissing an opposition.
These are the principles that I will apply in the present case.
The specification
The invention relates to a new crystal form of the drug perindopril tert-butylamine salt. This compound is known to inhibit angiotensin I converting enzyme, and is useful in the treatment of cardiovascular diseases such as arterial hypertension and heart failure. The application purports to have found that a particular crystalline form (hereinafter referred to as the “a crystalline form”), may be obtained in a “well defined, perfectly reproducible crystalline form that especially exhibits valuable characteristics of filtration, drying and ease of formulation.”
The claims as accepted define the a crystalline form as characterised by its powder X-ray diffraction (Claim 1). The claims further define processes for preparing the a crystalline form (Claims 2 to 7), pharmaceutical compositions comprising the a crystalline form (Claim 8), the use of compositions comprising the a crystalline form in the preparation of medicaments for use as inhibitors of angiotensin I converting enzyme (Claim 9) and for use in the treatment of cardiovascular diseases (Claim 10), the use of the a crystalline form in the preparation of medicaments for use in the treatment of cardiovascular diseases (Claim 14) and methods of treating cardiovascular diseases using the a crystalline form (Claim 13). The pharmaceutical compositions are defined to optionally include a diuretic (Claim 11) such as indapamide (Claim 12). Several omnibus claims define uses, methods and a compound of the above claims with reference to the examples or specification.
Proposed Claim 19 is identical to original Claim 1, with the additional feature that the a crystalline form is “further characterised by being in the form of individual needles.” Similarly, proposed claims 21 to 24 mirror original Claims 2 and 4 to 6 with the additional characterisation of the a crystalline form as individual needles. Proposed Claim 25 defines pharmaceutical compositions comprising, and Claim 35 methods using, the a crystalline form in the form of individual needles. Claim 38 defines the use of the a crystalline form for the manufacture of a medicament for the treatment of cardiovascular disease, wherein the crystal form is in the form of individual needles. Other claims further characterise the invention in terms of the ability of the individual needles to allow “rapid and efficient filtration and drying,” the form of the pharmaceutical composition (tablets and the like), and the additional inclusion of a diuretic. The proposed claims will be further discussed where necessary in relation to the grounds of opposition and the requested dismissal.
The Request for dismissal
The request for dismissal filed by the applicant stated that:
“[T]he Statement of Grounds and Particulars served by the Opponent on 8 February 2008 would not support a finding that the proposed amendments are not allowable under section 102 of the Patents Act 1990 (Cth). New claims 19 to 39 have been considered by the Commissioner and were found to be patentable and the Opponent has not raised or particularized any grounds that should change this view of patentability. The Applicant submits that as the opposition to the allowance of the amendments is manifestly groundless and cannot possibly succeed, the opposition should be dismissed.”
The opponent addressed all grounds of opposition under section 102. I will deal with each of these in turn below.
Section 102(1): “not in substance disclosed”
Perhaps the most significant issue identified in the particulars related to the inclusion of the term “individual needles” in the amended claims. In particular, the opponent submitted that the a crystalline form having the defined X-ray diffraction characteristics and being in the form of “individual needles” was not disclosed in the specification as filed. They acknowledged that the specification described individual needles, but argued that this disclosure related only to the production of a homogenous distribution of individual needles of about 0.2mm in length (page 3, last paragraph), or to a process of producing the a crystalline form in the form of “readily filterable individual needles” (original Claim 7). Thus, the disclosure in the specification of the formation of needles was qualified by the process steps and the size of needles obtained. These “qualifications” were not present in the proposed claims, which as a result included individual needles of any size and distribution which may or may not be readily filterable.
Similarly, the opponent also submitted that the proposed claims were directed to individual needles produced by any process, while there was a real and reasonable disclosure only of needles prepared by the procedure described at page 3. As a consequence the amendments resulted in the specification claiming matter that was not in substance disclosed in the specification as filed.
The applicant submitted that it was apparent from the application of the first step of the RGC two-stage test that proposed Claim 19 differed from original claim 1 only in the feature of the a crystalline form being in the form of individual needles. They asserted that this feature was disclosed at page 3 and Claim 8 of the specification as filed, and noted that in any case Claim 1 as filed included “a compound by any means” (that is, the crystalline form was not restricted by any method of preparation, properties or form). As a consequence any issues relating to the fair basis of the term “individual needles” were pre-existing and not created as a result of the amendment.
The opponent’s case is predicated on the qualification of the individual needles as “readily filterable” or being the result of the process described at page 3. I do not consider that this argument is sustainable. In RGC v Wimmera (supra) Burchett J accepted that the test for determining whether matter is “in substance disclosed” is the same as for determining fair basis: is there “a real and reasonable clear disclosure” of the proposed amendment in the original disclosure. Consistent with that approach, the key question here is whether a crystalline form being in the form of individual needles was “broadly, that is to say in a general sense, described in the body of the specification.”
Page 2 of the specification states that “[T]he Applicant has now found that a particular salt of perindopril, the tert-butylamine salt, can be obtained in a well defined, perfectly reproducible crystalline form that especially exhibits valuable characteristics of filtration, drying and ease of formulation.” The specification then goes on to state that the invention relates to the a crystalline form having a particular X-ray diffraction pattern. There is nothing in this description of the invention to suggest any limitation by way of form or method of preparation, and an ordinary construction would read this to include all physical forms of the polymorph (as characterised by the X-ray crystallographic data). At page 3 the specification then describes a process for the preparation of the a crystalline form is described in which the salt in ethyl acetate is heated at reflux and cooled gradually until crystallisation is complete. Again there is nothing to suggest that the process is in any way limited to producing a particular size of crystals or indeed to whether the product is “readily filterable” or not. The specification subsequently describes certain “advantageous” conditions that provide the salt in the form of needles of about 0.2mm in length.
I consider it clear from these passages that the invention is not limited to a particular size of needle or to the use of the particular conditions that provide such a size of needle. The product produced using certain advantageous conditions is clearly a particularly preferred embodiment. Indeed, even if I take “readily filterable individual needles” as being distinct from a product comprising “individual needles”, then this would clearly constitute a permissible intermediate generalisation falling between the claim to all forms of the polymorph (as defined in Claim 1) and the “readily filterable” individual needles. On even a cursory consideration such as this, the feature of the product being in individual needles is broadly described in the specification as filed, and therefore this matter can be considered in substance disclosed. In short, I do not consider that there is a real issue to be determined in this regard.
The Statement of Grounds and Particulars also sets out that there is no disclosure of a combination of the a crystalline form with a diuretic “as an invention” other than a “bald assertion” at page 4 line 15 that the pharmaceutical compositions according to the invention could further comprise a diuretic. They further asserted that there was no disclosure at all of the combination with the a crystalline form in the form of individual needles. In response the applicant referred to Claims 12 and 13 and page 4, lines 15 to 16 of the specification as filed which referred to the inclusion of a diuretic such as indapramide. Once again they applied the two-part RGC test in support of their argument that this disclosure provided support for amendment.
I consider that the opponent’s argument has no basis in section 102(1), as their submissions concerning the “in substance disclosure” of the combination of a crystalline form with a diuretic are clearly in relation to the fair basis of a combination of any form of the polymorph, and not only in relation to where the a crystalline form is in the form of individual needles. If there is indeed an issue in relation to a combination of a diuretic with perindopril tert-butylamine salt (including where it is in the form of individual needles), then this issue would have arisen in the specification as it existed prior to amendment. That is a matter for consideration in a substantive opposition under section 59, and I therefore consider that this argument could not be sustained in an opposition under section 104(4).
Accordingly, I consider that the case set out by the opponent under section 102(1) has no reasonable prospects of success, and may therefore be dismissed.
Section 102(2)(a): “not within the scope of the accepted claims”
The particulars under section 102(2)(a) set out that as a result of the amendment proposed Claims 33 and 34 would not in substance fall within the scope of the claims prior to amendment. Proposed Claims 33 and 34 are as follows:
33. Use of the pharmaceutical composition according to any one of claims 25 to 32 as an inhibitor of angiotensin I converting enzyme.
34. The use according to claim 33 for treatment of cardiovascular disease.
The particulars asserted that prior to amendment there were no claims in the specification directed to the use of the pharmaceutical composition “for any purpose.” These claims were therefore broader in scope than the accepted claims. At hearing the opponent submitted that the only use claims in the specification as accepted were claims 13 and 14 (and dependent claim 16). These define:
13. A method of treatment of cardiovascular diseases comprising administering to a patient in need of such treatment an efficacious amount of compound of formula (I) as defined in claim 1 or a pharmaceutical composition as defined in any one of claims 8 to 12.
14. Use of compound of formula (I) as defined in claim 1 for the manufacture of medicaments for treatment of cardiovascular diseases.
The opponent noted that claim 13 included a number of limitations (particularly that the compound be administered to the patient, the patient be in need of such treatment, an efficacious amount be administered, and that it be for the treatment of cardiovascular disease). They argued that none of these limitations were present in proposed claim 33 and 34 (the latter with the exception of the treatment of cardiovascular diseases).
In response the applicant submitted that the proper test in this regard was whether anything would become an infringement that would not have been an infringement before the amendment (AMP Incorporated v Commissioner of Patents [supra]). They noted that the definition of “exploit” defined in Schedule 3 resulted in a claim to a compound including the use of such a compound within the scope of the monopoly granted. The compound and pharmaceutical claims per se therefore provided for the amendment of the claims to include the uses defined in proposed Claim 33 and 34.
I agree with the applicant’s submissions in this regard. The operation of section 13 and the definition of “exploit” as set out in Schedule 3 will provide support for proposed Claims 33 and 34 (some guidance in this regard is given by Prosidian Limited v Novo Nordisk [2006] APO 6). Moreover, the particular uses defined in the proposed claims were specifically set out in the claims as accepted as Claims 9 and 10 as accepted are Swiss-style claims to methods of preparing compositions for the treatment of cardiovascular diseases and as inhibitors of angiotensin I converting enzyme. The opponent’s submissions as to the absence of the other limitations are rendered moot as a consequence of this analysis. However, even if this was not the case, a purposive construction of the proposed use claims would not support the opponent’s submissions with regards to the absence of method steps and the like.
Accordingly, I consider that the case set out by the opponent under section 102(2)(a) has no reasonable prospects of success, and may therefore be dismissed.
Section 102(2)(b): section 40(2) and (3)
The Statement of Grounds and Particulars set out particulars in each of full description, best method of performance, claims not defining the invention, fair basis and clarity. Most of the issues identified in this regard related to the inclusion of the term “individual needles.” As this issue has been dealt with above I intend to only briefly deal with such issues.
The opponent submitted that as a result of the amendments the specification failed to describe the invention fully, including the best method of performance, as there was no disclosure in the specification as filed of a method to produce the compound of Claim 19 let alone a best method. I consider that the specification clearly sets out a method of preparing individual needles of the a crystalline form (see the discussion above under section 102(1)). Moreover, the use of particular conditions, as acknowledged by the opponent, can further result in individual needles that have the additional advantage of being readily filtered. Prima facie this represents a best method. As a consequence, I do not consider the opponent’s argument sustainable in this regard.
The opponent submitted that the claims did not define the invention as the XRPD spectrum data was unclear, imprecise and inadequate. This data was used as a characterising feature of the invention prior to acceptance. Accordingly, this is an issue that does not arise as a result of the amendments and therefore cannot be sustained under section 102(2)(b).
The opponent submitted that proposed claims 19, 21, 25, 35 and 38 lacked fair basis for similar reasons to those provided under the ground of section 102(1). As noted above, I consider that the individual needles and their method of preparation are in substance disclosed as there is a real and reasonably clear disclosure of such matter. It follows that the above claims would be fairly based for similar reasons. The opponent further argued that Claims 20, 26, 36 and 39 lacked fair basis as these claims specify that the individual needles “allow rapid and efficient filtration and drying of the compound.” They considered that these features derived from the particular salt being in an homogeneous distribution of individual needles about 0.2mm long. I do not find the opponent’s submissions persuasive. The properties defined in Claims 20, 26, 36 and 39 are simply a further characterisation of a subset of a crystalline forms, including the “readily filterable individual needles” and needles of 0.2mm in length which were described in the specification as filed. Accordingly I do not consider that this argument could be sustained in an opposition under section 102(2)(b).
The opponent also raised a number of clarity issues in relation to the terms “rapid”, “efficient”, “needle” and “individual needles.” I note that these terms were used throughout the specification as filed, so that any issue would not have arisen as a result of the amendments. A clarity issue relating to the phrase “comprising as active ingredient a crystalline form” was conceded at hearing. A further clarity issue in relation to the phrase “has been isolated” was also raised by the opponent, who argued that it was unclear when the needles must be isolated and whether they remain in that form. I do not consider this a real issue as it is quite clear that the only requirement is that at some point the individual needles of the invention must be isolated. There is no requirement that they remain in that form in any subsequent formulations and the like. Accordingly, I do not consider that the arguments raised by the opponent under section 102(2)(b) could be sustained.
As a consequence, I consider that the case set out by the opponent under section 102(2)(b) has no reasonable prospects of success, and may therefore be dismissed.
Conclusion
As a consequence of the analysis above, I consider that the grounds of opposition raised by the opponent in their Statement of Grounds and Particulars have no reasonable prospects of success. I therefore dismiss the section 104 opposition in its entirety.
Costs
Costs generally follow the event in matters before the Commissioner, and both parties provided submissions to that extent at hearing. I therefore award costs according to Schedule 8 against the opponent Apotex Pty Ltd.
L. F. McCaffery
Delegate of the Commissioner of Patents
11 April 2008
Patent attorneys for the applicant : Allens Arthur Robinson
Patent attorneys for the opponent : Freehills Melbourne
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