Bayer New Zealand Limited v Merial Limited
[2017] NZHC 2946
•1 November 2017
IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY
I TE KŌTI MATUA O AOTEAROA
TE WHANGANUI-Ā-TARA ROHE
CIV-2017-485-480 [2017] NZHC 2946
UNDER the Patents Act 1953 IN THE MATTER
of an appeal of the decision [2017] NZIPOPAT 8 of the Assistant Commissioner of Patents dated 12 May
2017
BETWEEN
BAYER NEW ZEALAND LIMITED Appellant
AND
MERIAL LIMITED Respondent
Hearing: 11 October 2017 Counsel:
I Finch for Appellant
C Dimitriadis and C I Cunliffe for RespondentJudgment:
1 November 2017
Reissued:
29 November 2017
JUDGMENT OF THOMAS J
Table of contents
Introduction ............................................................................................................. [1] Patent Application ................................................................................................... [4] Procedure .............................................................................................................. [8] Background............................................................................................................ [10] PART I: Reply evidence ........................................................................................ [23] The law ................................................................................................................... [28] Is the Disputed Evidence reply evidence? ........................................................... [39] Opposition ........................................................................................................... [40]
BAYER NEW ZEALAND LIMITED v MERIAL LIMITED [2017] NZHC 2946 [1 November 2017]
Bayer’s counterstatement .................................................................................... [41] Merial’s supplementary notice ............................................................................ [45] Bayer’s evidence.................................................................................................. [48] Disputed Evidence............................................................................................... [52] D30 ...................................................................................................................... [53] Declaration of Dr Page....................................................................................... [59] Evidence of Professor Trott ................................................................................. [61] Declarations of Mr Meaney ................................................................................ [63] Analysis .................................................................................................................. [68] Submissions ......................................................................................................... [68] Consideration ...................................................................................................... [79] Australian Decision............................................................................................. [87] Other Disputed Evidence .................................................................................... [95] Insufficiency ...................................................................................................... [102] PART II: The Amended Pleadings..................................................................... [104] The law ................................................................................................................. [104] Analysis ................................................................................................................ [108] Diligence ........................................................................................................... [108] Relevance .......................................................................................................... [122] Time elapsed since the filing of the original documents ................................... [127] Public interest and prejudice ............................................................................ [129] Conclusion ........................................................................................................ [138] Result .................................................................................................................... [139]
Introduction
[1] In September 2008, the appellant, Bayer New Zealand Limited (Bayer), filed application 571347 (the Patent Application) with the Intellectual Property Office of New Zealand (IPONZ). In August 2010, the respondent, Merial Limited (Merial) filed a notice of opposition. Some nine years after its filing, the Patent Application has yet to be determined.
[2] The matter is before the High Court because Bayer has filed an appeal against the decision of the Assistant Commissioner of Patents (the Commissioner) permitting Merial to admit certain evidence in reply and to amend its notice of opposition and statement of case (the Decision).
[3] The appeal is on the grounds the Commissioner erred in his application of fact and law.1
1 The appeal is pursuant to s 97 of the Patents Act 1953 which continues to apply to the Patent
Application.
Patent Application
[4] The claimed invention relates to an anti-infective formulation and method of use to prevent or ameliorate mammary gland infections, including mastitis.2
[5] A major problem associated with dairy cows is the high occurrence of bovine mastitis. Treatments previously developed include external teat seals and internal teat seals. It is common ground that antiseptics have been used on external teat seals. The invention claimed by Bayer is an internal teat seal product with the claimed inventive step of including an antiseptic in the internal teat seal.
[6] Merial opposed the Patent Application on the basis the invention had been published in documents D1–D14 in New Zealand before the priority date of the claim. Four of those documents (D1–D3 and D5) all mention acriflavine in a context of internal teat seals. Merial’s position is that acriflavine is present for its antiseptic qualities. The Patent Application makes no reference to acriflavine.
[7] The Patent Application is therefore opposed on the grounds the alleged invention is not novel.
Procedure
[8] The Patents Regulations 1954 (the Regulations) prescribe the procedure for opposing an application for a patent. The steps are:3
(a) a notice of opposition;
(b) a counterstatement from the applicant; (c) the opponent’s evidence;
(d) the applicant’s evidence; and
2 Patent Application 571347 at 2.
3 Patents Regulations, pt 9.
(e) the opponent’s evidence “confined to matters strictly in reply”.4
[9] A party opposing a patent application must file its evidence first, followed by the applicant. In contrast to most commercial litigation, it is the opponent who has the right to file reply evidence and the applicant does not have a right to file evidence by way of rejoinder after such reply evidence.
Background
[10] The Patent Application was published on 30 April 2010.
[11] On 30 August 2010, Merial filed a notice of opposition identifying inter alia documents D1, D3 and D5. On 29 October 2010, Merial filed its statement of case.
[12] On 24 March 2011, Bayer filed a counterstatement, together with an amended set of claims. Claim 1 was amended as follows (as shown by underlining and deletion):
A single formulation, when used for administration to the teat canal or/and lower portion of teat cistern of a mammary gland of an animal, wherein the formulation is in the form of a paste
prior to delivery, the formulation including:
an oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern, and at least one antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic.
[13] On 4 October 2011, Merial requested the matter be put in abeyance pending a resolution of related High Court proceedings. After further correspondence, IPONZ agreed in February 2013. The proceedings came out of abeyance when the related High Court proceedings were resolved on 24 September 2013.
[14] On 25 November 2013, Merial filed a supplementary notice of opposition and a supplementary statement of case. The last of its evidence in support was filed
on 25 June 2014.
4 Regulation 51.
[15] On 24 August 2015, Bayer filed the last of its evidence in support of its counterstatement. This suggested that acriflavine does not have an antiseptic effect in concentrations of 0.1 per cent weight/weight (w/w).
[16] Merial maintains settlement discussions were entered into in October 2015. The proceedings were halted by consent in light of settlement discussions from
1 March 2016 to 25 April 2016.
[17] On 27 May 2016, Merial filed evidence in reply and sought leave to file a second supplementary notice of opposition and third supplementary statement of case (the Amended Pleadings) to add:5
(a) D1a (NZ 258,199) as a separate document (D1a had originally been cited with D1); and
·D30 comprising a 2007 report by Dr Andrew Bradley entitled A Study of the Anti-infective Properties of TeatSealTM Formulations in the Presence and Absence of Acriflavine
[18] On 10 June 2016, IPONZ asked Bayer to provide comments on the Amended Pleadings, saying that Bayer would be given an opportunity to file an amended counterstatement if the amendments were allowed. IPONZ noted its concern that the amendment was introduced “at a very late stage in the proceeding”.
[19] At Bayer’s request, IPONZ granted it an extension to 12 August 2016 to
respond. Bayer opposed the admission of the Amended Pleadings.
[20] On 31 August 2016, IPONZ allowed the Amended Pleadings. Bayer requested a hearing, which was held on 21 February 2017.
[21] On 12 May 2017, the Decision was released allowing the Amended Pleadings
and Merial’s disputed reply evidence.
[22] On 7 June 2017, the Australian Patent Office published its decision (the
Australian Decision) on Bayer’s counterpart Australian patent (the Australian
5 There was in fact no second supplementary statement of case.
Proceedings). Merial’s opposition was successful in Australia on the grounds of
novelty and inventive step.6 The Australian Decision found that each of claims 1 and
7–13 lacked novelty in light of D1 and D1a and that each of claims 1–4 and 7–13 lacked an inventive step in light of cited prior art and common general knowledge. The deficiencies were considered capable of being overcome by amendment and Bayer has been given the opportunity to do so.
PART I: Reply evidence
[23] The first part of the appeal relates to Bayer’s challenge to the Commissioner’s decision to permit Merial to rely on the following evidence filed purportedly in reply (Disputed Evidence):
(a) the prior art document D30, including the experiment carried out in it; (b) a statutory declaration of Professor Darren Trott;
(c) two statutory declarations of Mr William Meaney filed in the
European Patent Office;
(d) the analysis of the above documents in a statutory declaration of
Dr Stephen Page;
(e) parts of a statutory declaration of Dr Marcus Caulfield annexing materials filed in the Australian Proceedings, including a statutory declaration of Professor Ted Whittem and comprising 681 pages of material;
(f) evidence as to accession dates in Dr Caulfield’s statutory declaration
and a statutory declaration of Dr Marianne Seter.
[24] Bayer appeals on the grounds that the Commissioner was wrong because he considered only whether the disputed evidence responded to a matter at issue in the
proceeding and failed to take into account authority which compelled him also to
6 Merial Inc v Bayer New Zealand Limited [2017] APO 27 [Australian Decision].
consider whether the evidence could have been filed in support of the notice of opposition and whether the dominant purpose was genuinely to reply to a matter first raised in Bayer’s evidence or was to support the original notice of opposition.
[25] There are two categories of evidence in dispute:
(a) That concerning D30, which is also the basis of Merial’s application to allow the Amended Pleadings. It is accepted that a natural consequence of any amendment of the pleadings would be that evidence in support of it would then be admissible.
(b) All other evidence, including that of experiments.
[26] In its letter dated 12 August 2016 to IPONZ, Bayer objected to the Disputed Evidence on the grounds it should have been raised in Merial’s evidence in chief. It claimed the late introduction of the documents would severely prejudice Bayer, particularly in the absence of evidence from its own expert witnesses as to the significance of the documents and evidence. By letter dated 31 August 2016 to both parties, IPONZ said the following:
The applicant’s letter of 12 August 2016 has expressed concern with the very late introduction of the amended pleadings and cited document D30 and opposes admission of D30 and the Meaney, Trott [declarations] and the field trial to the proceeding. The evidentiary stages of this proceeding have been protracted and both parties have contributed to delays in completing these steps. In particular, the applicant was allowed a period of eleven months and the opponent was allowed a period of nine months to complete their reply evidence. These time frames are well outside our published guidelines on timeliness in proceedings, but at each stage the parties provided consent to extensions of time. In light of this, we do not consider the issue of timeliness outweighs the public interest in having the case ultimately determined on the best cases and evidence of the parties.
[27] IPONZ concluded the disputed evidence was filed following Merial’s discernment from Bayer’s evidence of a matter Merial sought to answer and that it was in the public interest to have the matter determined on the best pleadings and evidence. The Commissioner was satisfied that conclusion was correct in the circumstances.
The law
[28] There are two different issues in the case: the appeal regarding the Disputed Evidence and the appeal against the Commissioner’s discretion to allow the Amended Pleadings.
[29] The appeal in respect of evidential matters is a general appeal whereby the Court must reach its own view. As the Supreme Court said in a trademark appeal, Austin Nicholls and Co v Stichting Lodestar:7
Those exercising general rights of appeal are entitled to judgment in accordance with the opinion of the appellate court, even where that opinion is an assessment of fact and degree and entails a value judgment.
[30] The key provision regarding reply evidence is reg 51, which provides:
51 Filing of evidence by applicant
Within 2 months from the receipt of the copy of the opponent’s evidence or, if the opponent does not file any evidence, within 2 months from the expiration of the time within which the opponent’s evidence might have been filed, the applicant may file evidence in support of his case and shall deliver to the opponent a copy of the evidence; and within 2 months from the receipt of the copy of the applicant’s evidence the opponent may file evidence confined to matters strictly in reply and shall deliver to the applicant a copy of the evidence.
[31] Mr Finch, who appeared for Bayer, relied on the decision of the High Court in The Scotch Whisky Assoc v The Mill Liquor Save Ltd,8 which upheld a decision by the Assistant Commissioner of Trademarks excluding as inadmissible five statutory declarations in reply.9 The Court referred to the fact that reply evidence is not an opportunity for evidence which could have been adduced at the outset in support of opposition because that would place the applicant in an invidious position which it could not fairly be expected to occupy.10
[32] The test was described as whether:11
7 Austin Nicholls and Co v Stichting Lodestar [2007] NZSC 103, [2008] 2 NZLR 141 at [16].
8 The Scotch Whisky Assoc v The Mill Liquor Save Ltd [2012] NZHC 3205.
9 The procedure for opposing a trademark application is essentially the same as relates to patent applications.
10 At [43].
11 At [45] (emphasis in original).
(a) the “reply evidence” could have been filed in support of the notice of
opposition … ; and
(b) the dominant purpose for its being adduced in reply is to support the original notice of opposition, as opposed to responding directly to something said in evidence from the applicant.
[33] Because the Court held the dominant purpose for the evidence at issue was to support the original notice of opposition, as opposed to responding directly to evidence from the applicant, it was held to be unreasonable to allow the evidence to be adduced.
[34] Following Scotch Whisky, Ellis J in Merial v Virbac refused to allow evidence in reply which was in reality evidence in support of the notice of opposition.12 Her Honour described such evidence as gaming the system, with the opponent “keeping their forensic powder dry until after an applicant has fired its best (and only) evidential shot”.13
[35] Two cases were discussed at the appeal hearing to demonstrate the difference between evidence in reply and evidence which could have been filed with evidence in chief. The first, Vital Food Processors Ltd v Anagenix Ltd, concerned an application for revocation.14 The patent holder argued the applicant for revocation had filed evidence in reply which should have been filed with its evidence in chief. The evidence related to the contribution of simple sugars to prebiotic effect. The patent holder had filed evidence in support of its patent, placing significant weight on this concept to which the applicant for revocation sought to respond in reply. The
patent holder argued that, because the concept was mentioned in the patent, the applicant for revocation could and should have dealt with the issue in its evidence in chief. The Assistant Commissioner allowed the evidence to be admitted, holding the situation was simply a result of the way the evidential dialogue had played out in the circumstances. Furthermore, that it could not have been clear from the outset that the patent holder was going to place so much emphasis on the role of simple
sugars.15
12 Merial v Virbac SA [2012] NZHC 3392.
13 At [26].
14 Vital Food Processors Ltd v Anagenix Ltd [2014] NZIPOPAT 21.
15 At [38] and [41]–[42].
[36] In Vital, the patent holder’s evidence suggested its own understanding of the science may have evolved during the period between filing of the complete patent specification and the date on which its evidence was prepared.16
[37] Ernest Scragg & Sons Ltd’s Application involved two types of evidence.17 In respect of the first, the Judge considered it could not have been clear from the outset that the applicants were going to adopt a particular line of defence to the opposition and therefore his Honour considered it only proper the opponents in reply should have been able to adduce evidence to the contrary. The second type of evidence related to reply evidence of experiments carried out by the opponents and was ruled inadmissible. The applicants submitted, if the experiments were admissible, they would need an opportunity to carry out their own and this would cause considerable delay. The Judge identified the point at issue as whether the general opinion in the art at the priority date of the application was that decreasing the diameter of a bore in a spindle device would have an adverse effect on yarn tenacity. In the Judge’s view, no amount of subsequent experimentation could assist in determining what the opinion was at the time. He therefore concluded the evidence was not strictly in reply, and indicated the evidence was not decisive or evidentially relevant. The
Judge said:18
… it seems to me that if the opponent’s case is … that the whole patent is obvious, it is up to them, at the first stage at which they can put in their evidence to make it quite clear what they are saying and to back their statements at that stage by evidence of any experiments which they think may be necessary in order to enable them to prove their case.
…
… it should have been obvious to the opponents from the start that if they were going to succeed not only on claim 1 but also on the later claims they must in the first instance put in the evidence which they are now seeking to put in in reply.
[38] The rules of evidence apply to patent applications.19
16 At [39].
17 Ernest Scragg & Sons Ltd Application [1972] RPC 679 (Appeal Tribunal).
18 At 683.
19 Rainbow Technologies Inc v Logical Networks Ltd [2003] 3 NZLR 553 (HC) at [51].
Is the Disputed Evidence reply evidence?
[39] In Mr Finch’s submission, this case was closer to the circumstances of Ernest Scragg. Bayer’s primary objection is to the third declaration of Dr Page and the declaration of Professor Trott related to the experiments Dr Page commissioned Professor Trott to carry out. Before dealing with that evidence, it is necessary first to place it in context by exploring the way in which the pleadings have identified the issue in dispute.
Opposition
[40] On 29 October 2010, Merial filed a statement of case in support of its notice of opposition, characterising D1 as a formulation which:
… is suitable for administration to the teat canal and/or lower portion of the teat cistern of a mammary gland of an animal and includes the following features: an oil based physical barrier which is able to form a cohesive mass in the teat canal (the combination of … a non-toxic heavy metal salt, bismuth subnitrate, mixed with a gel based of aluminium monostearate) and a known antiseptic (acriflavin) which is present inside the seal formulation.
Bayer’s counterstatement
[41] Bayer’s counterstatement and an amended set of claims were filed on
24 March 2011. Bayer’s counterstatement justified the amendments to the Patent Application on the grounds, inter alia, that the amendments distinguished that the formulation claimed “includes an amount of antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic (not used as a dye or pigment)”.
[42] The critical passages of the counterstatement are as follows:20
7.9… although D1 discusses that acriflavin is used within the formulation, D1 does not disclose that the antiseptic compound is in sufficient quantities to act effectively as an antiseptic using the concentration discussed in D1 (0.1% w/w). A person skilled in the art would acknowledge this is true. It is clear that the only active agent in D1 is the antibiotic cloxacillin benzathine.
20 Emphasis in original.
7.10 Indeed, D1 states on page 14 that the acriflavin is used as a pigment.
This is a characteristic and use of acriflavin which is well known
(acriflavin is commonly used for such purposes in many commercial products, including therapeutics). D1 does not teach the use of acriflavin as an antiseptic in the formulation and nor would the person skilled in the art seek to use it for that purpose after reading D1.
[43] Bayer’s position therefore was that reference to acriflavine in the prior publications did not disclose it at sufficient quantities to act as an antiseptic and did not teach the use of acriflavine as an antiseptic, rather it was used as a pigment. In respect of other prior publications, for example D3, the counterstatement said as follows:
7.29Acriflavin (which can be used as an antiseptic) is listed as a component in the Example on page 2 of D3, yet there is no discussion in D3 of the role of acriflavin in the formulation. The amount of acriflavin (0.075% w/w) in the disclosed formulation is so low that it would not act effectively as an antiseptic, nor is it described to do so in D3. It is most likely that the acriflavin is used as a pigment in the disclosed formulation, in line with this well understood use of acriflavin (similar to that disclosed in D1, where the amount of acriflavin used was similarly low and described as a pigment).
[44] In respect of D5, the counterstatement said:
7.42 In addition, the disclosed concentration of acriflavin in D5 is only
0.075% w/w. Similar to the disclosures in D1 and D3, it is clear that this concentration would not provide sufficient quantities to act
effectively as an antiseptic.
Merial’s supplementary notice
[45] Merial’s first supplementary notice of opposition and supplementary statement of case were filed on 25 November 2013, following the proceedings having been being held in abeyance between October 2011 and September 2013.
[46] Merial’s statement of case, under “Considering documents relevant to common general knowledge”, included D26 being a document which “describes the minimum inhibitory concentration/minimum bactericidal concentration of acriflavine against [staphylococcus] aureus, which is a common mastitis-causing pathogen”.
[47] The last of Merial’s evidence in support of its opposition was filed on 25 June
2014. That included evidence from Dr Page to the effect he would understand the acriflavine in D1 to have been included as an antiseptic. No experiments had been carried out and Merial relied on D26 regarding the necessary concentration of acriflavine.
Bayer’s evidence
[48] Bayer’s evidence then included experiments using acriflavine at the highest levels disclosed in Merial’s documents (0.1 per cent w/w), replicating the tests disclosed with the Patent Application which had used the ingredient proposed in the Patent Application. The result of the tests was that “no zone of inhibition” was observed with the use of acriflavine at those levels, leading to Bayer’s submission that acriflavine at the highest levels referred to in Merial’s documents has no effect.
[49] Dr Kiro Petrovski’s statutory declaration in support of the Patent Application responds to Dr Page’s evidence in chief and his conclusion about the effectiveness of acriflavine at 0.1 per cent w/w. He discusses the zone of inhibition tests commissioned by Bayer and concludes they prove acriflavine has no antiseptic effect in concentrations of 0.1 per cent w/w in an internal teat sealant.
[50] Mr Francis Grayson’s statutory declaration on behalf of Bayer concerns the zone of inhibition tests he was commissioned to undertake on behalf of Bayer “in order to determine whether the compound acriflavine was effective as an antiseptic when included at a concentration equivalent to 1 g/kg in an internal teat sealant intended for the teat canal of a dry dairy cow”. He understood a key consideration for Bayer was to determine whether or not 0.1 per cent w/w acriflavine was sufficient to act effectively as an antiseptic in an internal teat sealant. Mr Grayson’s conclusion on the basis of the report is that it did not.
[51] Mr Dimitriadis, appearing for Merial, submitted it was Mr Grayson’s evidence which put in issue the question of whether 0.1 per cent w/w acriflavine acts effectively as an antiseptic as required by claim 1 of the Patent Application.
Disputed Evidence
[52] Merial then filed its purported evidence in reply which included the Disputed
Evidence as described in the following paragraphs.
D30
[53] D30 is a research report by Dr Andrew Bradley entitled A Study of the Anti- infective Properties of TeatSeal™ Formulations in the Presence and Absence of Acriflavine. D30 was submitted to the European Patent Office on 13 February 2007 as evidence in support of an opposition to a European patent application and, on the basis of enquiries made by Merial, it became publicly available in New Zealand as from that date.
[54] The Amended Pleadings relevantly refer to D30 as follows:
4.7.1This document compares the antimicrobial ability of TeatsealTM (an oil-based barrier material which does not contain an anti-infective) with the antimicrobial ability of TeatsealTM plus 0.1% w/w.
[55] The abstract of D30 states:
In summary the study demonstrated that the inclusion of acriflavine resulted in TeatSealTM acquiring anti-infective properties which directly inhibited the growth of a number of known mastitis pathogens.
[56] D30 describes the preparation of homogenous teal sealant formulations with acriflavine hydrochloride incorporated at 0.1 per cent w/w and concludes that the inclusion of only 0.1 per cent w/w acriflavine completely inhibited the growth of mastitis-causing bacteria. By comparison, no inhibition was observed for TeatSealTM formulations which did not contain acriflavine. The paper explains that the laboratory testing may be extrapolated to the use of the formulation on cows.
[57] Merial’s third supplementary statement of case included a table comparing the disclosure of D30 against the integers of claim 1 in the Patent Application:
Claim integers Feature present [in D30] 1.1 A single formulation, when used for administration to the teat canal or/and lower portion of teat cistern of a mammary gland of an animal,
Yes, discloses a single formulation when used for administration to the teat canal or/and the lower portion of a teat cistern of a mammary gland of an animal
1.2 wherein the formation is in the form of a past, the formation including:
Yes, discloses a formulation in the form of a paste …
1.3 an oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern, and
Yes, discloses an oil-based physical barrier material …
1.4 at least one antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic.
Yes, discloses the inclusion of an antiseptic compound, acriflavine[e], at
0.1% w/w at a concentration sufficient to act effectively as an antiseptic.
[58] D30 therefore purports to show that acriflavine at 0.1 per cent w/w acts as an anti-infective and is therefore plainly relevant to the issue of an inventive step.
Declaration of Dr Page
[59] Dr Page’s evidence in reply considers D30 and the testing carried out as discussed in it. Dr Page’s evidence also sets out his concerns about the testing methodology employed on behalf of Bayer. This later aspect is not objected to nor are his general observations about conclusions which can be drawn.
[60] Dr Page says:
In light of the information provided in [D30] and the two declarations by Mr Meaney discussed above and in response to the Grayson and Ahmed declarations, I commissioned a microbiological study be performed to once and for all settle the question as to whether 0.1 per cent w/w acriflavine in a teat sealant formulation has any effect on mastitis causing pathogens.
Evidence of Professor Trott
[61] Professor Trott’s statutory declaration exhibits a copy of the statutory declaration filed as part of the Merial’s evidence in chief in the Australian Proceedings. He observes the comments are equally applicable to the Patent Application.
[62] The statutory declaration in the Australian Proceedings attached the report Professor Trott was commissioned by Dr Page to undertake. Professor Trott used a different test from that undertaken by Mr Grayson and presented in his evidence. That test had used a “zone of inhibition”, the same as the type of test undertaken in support of the Patent Application. Professor Trott used test agar plates. The methodology of the experiment was essentially the same as that employed by the author of D30.
Declarations of Mr Meaney
[63] Dr Page’s evidence in reply also exhibits two statutory declarations from
Mr Meaney made by him in respect of a European patent.
[64] Dr Page acknowledges Mr Meaney’s two declarations were filed in different proceedings. He sets out what he understands was a key consideration in the European proceedings, which was whether prior art teat sealant compositions contained an anti-infective and what was the purpose of including acriflavine in teat sealant preparations. Dr Page recognises Mr Meaney as a world-leading authority in the area of mastitis treatment and prevention. Dr Page quotes from two paragraphs of Mr Meaney’s first declaration and says he entirely agrees with that position, which is consistent with identified relevant passages in his first and second declarations.
[65] In respect of Mr Meaney’s second declaration, Dr Page quotes from Mr Meaney’s discussion of the role of acriflavine in antibiotic-free teat seal preparations. He again agrees with Mr Meaney, including in saying acriflavine was included in the prior art teat seal formulations for its antibacterial activity rather than for its ability to act as a dye to identify treated milk.
[66] In Mr Finch’s submission, Merial should have briefed Mr Meaney and obtained a statutory declaration for the purposes of this proceeding. He said the evidence was either hearsay or irrelevant, being of limited probative value given it related to other proceedings.
[67] I am not satisfied the evidence is hearsay or irrelevant. Rather, the evidence is the declaration of Dr Page, which includes his consideration of Mr Meaney’s evidence in other proceedings and his agreement with certain aspects of it, given his own expertise. Dr Page’s evidence will be considered in that light.
Analysis
Submissions
[68] In Mr Finch’s submission, Merial has to prove that acriflavine in the concentrations referred to in the prior art acted as an antiseptic. That, he suggested, was the sole purpose of the experiments carried out on behalf of Merial purportedly filed as reply evidence. The evidence was therefore clearly in support of the opposition and should have been part of the evidence in chief. Instead, the experiments were carried out and included purportedly as evidence in reply, and that was not fair, he said.
[69] Mr Finch submitted there was no nexus between Bayer’s and Merial’s respective tests other than that each purports to establish the same thing. The test methodology was different and produced different results and there was no suggestion from Merial it could not have conducted its own tests earlier.
[70] That being the case, in Mr Finch’s submission the Commissioner was plainly wrong to have concluded that the tests and related evidence was strictly in reply. The Commissioner fell into error by limiting the inquiry as to whether the evidence was couched as a reply. It was not, Mr Finch said, a case where the role and action of acriflavine in prior art formulations rose to prominence through the evidential dialogue.
[71] If evidence relating to the experiments commissioned by Dr Page and conducted by Professor Trott were admitted, then Bayer would have to lead further evidence by way of rejoinder. This, said Mr Finch, may require it to commission a further round of experiments to determine whether the results reported by Professor Trott can be replicated and are accurate, with the consequent cost, inconvenience and delay. He noted it had taken some 14 months for the planning and carrying out of the original tests.
[72] In response, Mr Dimitriadis submitted Bayer’s counterstatement was relevant to and couched in the context of disclosure. There was nothing to indicate to Merial that Bayer would carry out testing to show that use of acriflavine at 0.1 per cent w/w would not have an antiseptic effect. It was not until Bayer filed its evidence in support of its counterstatement that it became clear that acriflavine’s antiseptic properties per se were in issue. On the basis of Bayer’s counterstatement, it appeared that the essential issue was whether the prior art cited disclosed the use of compound acriflavine as an antiseptic, not whether it was in fact an antiseptic.
[73] Mr Dimitriadis submitted there was no obligation for Merial to bring forward experimental evidence. The counterstatement resulted in Merial’s expert evidence and reference to publications concerning acriflavine and its antiseptic effects. It was not, however, incumbent on Merial to conduct any experiments in the absence of those having been foreshadowed by Bayer.
[74] Mr Dimitriadis contrasted the position with that in Scotch Whisky which related to evidence of confusion. The evidence here was responsive in nature and analogous to development of a dialogue. In these circumstances, Merial should have the opportunity to reply to Bayer’s experiments.
[75] Merial’s position is that D30 is properly characterised as evidence in reply because it discloses the results of an independent study demonstrating the anti- microbial effects of one of the formulations referred to in Mr Grayson’s statutory declaration. D30 concludes that inclusion of acriflavine at 0.1 per cent w/w results in a formulation with inherent anti-infective activity.
[76] Similarly, the statutory declarations of Professor Trott and Dr Page highlight the deficiencies in bio-studies and reported on studies showing that formulations containing 0.1 per cent w/w acriflavine were effective as an antiseptic. So too was the opinion evidence of the experts Mr Meaney and Professor Whittem to the effect that acriflavine was known by them to be an antiseptic.
[77] Mr Dimitriadis pointed out that Mr Grayson’s report disclosed testing against one micro-organism whereas Professor Trott’s tests were on a number. The evidence was therefore important because the fact acriflavine at that concentration might not be effective against one micro-organism did not mean it was ineffective against others. This was shown by Professor Trott’s evidence.
[78] In these circumstances, Mr Dimitriadis said the view taken by IPONZ and the Commissioner was that the disputed evidence had been filed as a consequence of the way the evidential dialogue played out and was therefore analogous to the situation in Vital Food Processors. That is, it was not clear to Merial from the outset that Bayer would emphasise the issue of whether acriflavine was in fact an antiseptic and that issue was then properly addressed by Merial in reply.
Consideration
[79] The sequence of events demonstrates it was Merial and not Bayer who raised acriflavine as an issue. Acriflavine was not mentioned in the Patent Application. Merial cited at least five documents which mentioned acriflavine as being relevant in its original notice of opposition and statement of case. It was clear to both parties from then that the role of acriflavine in the prior art would be a key issue.
[80] In my assessment, it was then crystal clear from Bayer’s March 2011 counterstatement and statement as to the effect of the amendments that the claimed invention involved the use of sufficient quantities of an antiseptic compound mixed with the barrier material to act effectively as an antiseptic. The statement as to the effect of the amendments made it clear that the purpose of inclusion of acriflavine in a teat seal formulation and its ability to act effectively as an antiseptic within teat seal products once administered to the animal was an essential question to be resolved in the proceeding, saying:
4.3In summary the amendments clearly distinguish that the formulation as claimed:
…
4.3.3includes an amount of antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic (not used as a dye or pigment).
[81] Merial revised its opposition to include further documents relating to acriflavine in November 2013. These steps were taken before Merial completed its evidence in chief in June 2014. Merial’s opposition and evidence addressed the issue of whether acriflavine can act as an antiseptic in various concentrations.
[82] Merial’s approach to interpretation of the counterstatement was an exercise in semantics. The purpose of pleadings is not to foreshadow evidence but rather to identify material facts. It was clear Bayer did not believe 0.1 per cent w/w acriflavine was effective as an antiseptic. If Merial wanted to show it was, it should have done so by undertaking experiments and providing them as part of the evidence in chief. It was for Merial to establish acriflavine at this level would be effective as an antiseptic.
[83] Applying the test of Scotch Whisky, the experiments commissioned by Dr Page and conducted by Professor Trott could have been filed in support of the notice of opposition and statement of case.
[84] The same could be said of D30. The case of Synthon BV v Smithkline Beecham Plc provides important guidance on prior art. Lord Hoffmann explained as follows:21
… the matter relied upon as prior art must disclose subject-matter which, if
performed, would necessarily result in an infringement of the patent. …
…
Although it is sometimes said that there are two forms of anticipatory disclosure: a disclosure of the patented invention itself and a disclosure of an invention which, if performed, would necessarily infringe the patented invention they are both aspects of a single principle, namely that anticipation
21 Synthon BV v Smithkline Beecham Plc [2005] UKHL 59, [2006] RPC 10 at [22] and [24] (citations omitted).
requires prior disclosure of subject-matter which, when performed, must necessarily infringe the patented invention.
[85] It was therefore incumbent on Merial to refer to D30 in its own evidence.
[86] In any event, even if not properly admissible as reply evidence, D30 has another potential avenue for admission via Merial’s application to admit the Amended Pleadings, addressed in the next section of this decision.
Australian Decision
[87] The position is further complicated by the Australian Decision which is clearly relevant to the Patent Application. Merial’s evidence of experiments was filed as evidence in chief in the Australian Proceedings.
[88] The Australian Decision considered the Trott and Grayson tests,22 as well as Professor Whittem’s evidence,23 and noted Dr Page’s agreement with Mr Meaney’s opinion.24
[89] Relevantly, the Australian Decision commented on D30 (referred to as D7 in the Australian Proceedings), as follows:25
I note that the configuration test agar plates used in the Trott study are identical to those disclosed in the prior art citation (D7).
[90] The Australian Decision concluded the claimed invention lacked novelty in light of both D1 and D1a.
[91] The Australian Decision said as follows:
124. I have previously found the Trott study to provide the evidence that
0.1% (w/w) acriflavine in a teat seal formulation provides bactericidal effect on three different mastitis-causing bacteria species
as assessed in vitro. Therefore, based on the evidence of the Trott
study alone, I am satisfied that 0.1% (w/w) acriflavine in the teat seal formulations of D1 and D1A is an amount of antiseptic that falls
22 Australian Decision, above n 6, at [88].
23 At [108].
24 At [114].
25 At [94].
within the scope of “sufficient quantity to act effectively as an antiseptic” of claim 1.
125.However, in light of the submissions made by both parties, I have considered the evidence of the Flynn study, Professor Whittem’s evidence and Mr Meaney’s evidence in regard to whether 0.1% (w/w) acriflavine does, in fact, provide a bactericidal or bacteriostatic effect in vivo. I am satisfied on Professor Whittem’s evidence that 0.1% (w/w) acriflavine in a teat seal formulation does provide a bacteriostatic or bactericidal effect in vivo in an animal.
126.I conclude that 0.1% (w/w) acriflavine in the teat seal formulations of D1 and D1A is an amount of antiseptic that falls within the scope of “sufficient quantity to act effectively as an antiseptic” of claim 1
…
[92] It is at this point that arguments about whether the Disputed Evidence is in fact in reply become somewhat academic. It would be in my assessment entirely artificial to exclude the evidence of Dr Page and Professor Trott (and Professor Whittem and Mr Meaney) given the relevance of the Australian Decision which includes reference to and reliance on that material.
[93] Furthermore, the Commissioner has a wide discretion under reg 145 to direct further evidence in any case. There is, therefore, scope for the Disputed Evidence to be admitted even if not strictly in reply, given it is relevant and highly probative. It is inconceivable that, having considered the Australian Decision, the Commissioner will not want also to consider the evidence to which it refers. Furthermore, there will be no prejudice to Bayer given it has been granted leave to file further evidence.
[94] Considered in that context, it is difficult to accept that the evidence should not be admitted.
Other Disputed Evidence
[95] Dr Caulfield’s statutory declaration contains 17 exhibits, 12 of which are
objected to by the defence, including D30.
[96] Two of the exhibits are statutory declarations from Professor Whittem. Professor Whittem’s first declaration dated 13 December 2011 was filed by another opponent of the Patent Application. To this extent it will be before the decision-
maker in any event.26 Professor Whittem’s second statutory declaration was prepared on behalf of the same opponent in respect of the Australian Proceedings and I have already addressed this in paragraphs [92] and [93] above.
[97] Ms Veber’s statutory declaration related to other proceedings. I agree with Mr Finch’s submission that Ms Veber’s statement is hearsay. It was not prepared for the purposes of these proceedings. A statutory declaration filed in connection with a different patent application is not properly evidence in these proceedings, except in circumstances such as those pertaining to Mr Meaney’s statutory declaration as addressed by Dr Page in his evidence. It is irrelevant. It is a nonsense to suggest, because it is a statutory declaration, it complies with the requirement all evidence is
by statutory declaration or affidavit.27 Furthermore, there is nothing to suggest it is
evidence in reply.
[98] Dr Caulfield’s statutory declaration and that of Dr Seter seek to exhibit
documents and give evidence on the date they were publicly available.
[99] In Mr Finch’s submission, Bayer’s evidence contains nothing on public availability of documents or accession dates and therefore this cannot be evidence in reply. He noted it was fundamental to prove the availability of documents before the priority date of claim.28
[100] Mr Dimitriadis tried to deal with this objection by claiming the evidence of accession dates in the Caulfield and Seter declarations was simply incidental, formal in nature, and should be admitted in the circumstances.
[101] This evidence is not properly classified as reply evidence. It could have been filed in support of the notice of opposition and its dominant purpose is to support the
original notice of opposition as opposed to responding directly to Bayer’s evidence.
26 It appears there is a different proceeding and it will be a matter for the decision-maker as to whether the evidence is read across both proceedings, although that would seem logical and inevitable as they are in respect of the same Patent Application.
27 Patents Regulations 1954, reg 41.
28 New Zealand Intellectual Property Office “Patent hearings – New Zealand accession dates for
overseas patent specifications” < evidence as to the accession date of D30 is, however, admissible for the reasons discussed above.
Insufficiency
[102] Finally, Bayer objects to Merial’s third supplementary statement of case, seeking to add further particulars to the grounds of insufficiency. The particulars are based on Dr Page’s reply declaration. Previously, the grounds on insufficiency were by way of a general statement only and no evidence in chief was filed in relation to it. As it relies on Merial’s “reply” evidence, Bayer will not have the opportunity to respond. The proper time to include this was at the stage of evidence in chief.
[103] This amendment is not permitted.
PART II: The Amended Pleadings
The law
[104] The Regulations provide for amendments to pleadings as follows:
167 Amendment of documents
(1) In any proceedings before the Commissioner, if he thinks fit,—
(a) any document filed in the proceedings for the amendment of which no express provision is made in the Act or these regulations may be amended during the course of the proceedings:
(b) any irregularity in procedure may be rectified.
(2) Any approval given by the Commissioner under this section may be on such terms as he may direct, including, if he thinks fit, the payment of a fee not exceeding $50.
[105] In an appeal from the exercise of a judicial discretion an appellant must establish the decision-maker erred in principle, took into account some irrelevant consideration, failed to take into account some relevant consideration or was plainly
wrong.29
29 May v May [1982] 1 NZFLR 165 (CA) at 170. Applied in relation to an appeal in respect of the Commissioner’s discretion in Unilever PLC v Commissioner of Trademarks HC Wellington CIV-2006-485-1208, 20 July 2007 at [10].
[106] It is common ground between the parties that the four key factors to be considered in deciding whether to allow amendments to a notice of opposition or statement of case are:30
(a) the diligence of the Opponent in preparing its case; (b) the relevance of any new documents;
(c) the time elapsed since the filing of the original documents; and
(d) whether the delay is unjust or is against the public interest.
[107] The four factors are not, however, determinative and an overall assessment is required.
Analysis
Diligence
[108] The real issue with the Amended Pleadings is the addition of reference to D30. Although D1a was also specified as an amendment, no issue is taken with that given D1a was originally cited with D1.
[109] Bayer says the Commissioner’s assessment of diligence was plainly wrong because it relied on inadmissible hearsay. In addition, it failed to balance the public interest in having documents before the Commissioner with the public interest in requiring parties to disclose their case in full as early as possible, requiring parties to comply with established procedure for the exchange of evidence, and ensuring oppositions are resolved in a time and cost efficient manner.
[110] Merial completed its evidence in chief on 25 June 2014 and Bayer completed its evidence in support of its counterstatement over a year later, on 24 August 2015. There was then a hiatus from October 2015 to 21 April 2016, when the parties were engaged in settlement discussions. D30 was published online on 13 February 2007,
on the European Patent Register. Merial identified D30 as relevant in February
30 C-Lock Inc v Pastoral Greenhouse Gas Research Ltd [2016] NZIPOPAT 22 at [12] citing
Permutit Co Ltd’s Application [1964] RPC 22 (Appeal Tribunal).
2016. It was cited in opposition in the Australian Proceedings on 5 May 2016. A
copy of D30 was immediately provided to Bayer.
[111] When Merial completed its evidence in reply on 27 May 2016, at the same time it filed an application to amend its statement of case to add D30.
[112] The Commissioner acknowledged Mr Finch’s reference to Ralta Ltd v Zip Holdings,31 wherein Assistant Commissioner Burton recorded that, as a matter of principle, pleadings should not be amended once filed without good and sufficient reason. The Commissioner was satisfied, in considering the chronology of events, that “there is no doubt” Merial was diligent in preparing its case. He cited from the written submissions of Dr Caulfield, who had appeared as counsel for Merial at the
IPONZ hearing.
[113] This led to a complaint by Bayer that the Commissioner had erred in his assessment of diligence because it relied on evidence from the bar or inadmissible hearsay from Dr Caulfield. Mr Finch referred to reg 41, which provides that evidence under the Act and Regulations “shall be by statutory declaration or affidavit unless otherwise expressly provided in these Regulations”.
[114] In my assessment, Mr Finch has overstated the position. In the Decision, the Commissioner simply referred to the submissions of Dr Caulfield as succinctly encapsulating the position. He did not treat them as evidence of Merial’s diligence. Indeed, much of what was said was already referred to in the Commissioner’s opening and recitation of background. Independent confirmation that settlement discussions were conducted was evidenced by the formal abeyance of proceedings by consent.
[115] Mr Finch conceded that neither the Patents Act 1953 (the Act) nor the Regulations prescribe the practice of filing and amending pleadings. He referred instead to the British Patent Office Manual of Office Practice (Patents), which requires any such amendments to be formulated and submitted as soon as possible.
He observed that only the most compelling reasons would move the Commissioner
31 Ralta Ltd v Zip Holding Ltd PO3/1984, 26 March 1984.
to exercise his power to grant leave if the request were made at a very late stage or after unreasonable delay.
[116] I am not persuaded that the British Patent Office requirements have any application here. Furthermore, although the British Patent Office Manual suggests a statutory declaration “may” be necessary to explain the lateness of any amendment, it is not mandatory.
[117] More to the point, perhaps, are the other issues identified by Mr Finch. In particular, the fact that D30 was freely available on the internet from 13 February
2007. Neither Merial nor Bayer was aware of it.
[118] Mr Finch maintained that, as it was Merial who had made the antiseptic effect of acriflavine a live issue, then it was Merial who should have located relevant publications. There should have been evidence as to why, given the claimed high relevance of D30 and its apparent public availability, Merial had only discovered it in 2016.
[119] In Mr Finch’s submission, the Commissioner erred by considering whether Merial had been diligent overall in its opposition as opposed to diligent in respect of locating prior art. Mr Dimitriadis took the contrary view, saying the Commissioner was correct to consider the issue of diligence in general, and the timing of the location of D30 should be considered in all the circumstances of the case.
[120] The Australian Decision considered the evidence about the ability to ascertain D30 in light of the evidence presented to it, including from Dr Page who said it was located during a routine literature search.32 Bayer was reported as having submitted D30 would not be discovered or found by a skilled addressee. The Australian Decision concluded that D30 could be found only by extending literature searches to include patent opposition files and, measured against the Australian test as to
whether it would be reasonably ascertained by the skilled person, concluded it would
not. I accept the Australian Decision was not released until 2017 and would not have
32 Australian Decision, above n 6, at [224]–[229].
been available to the Commissioner. However, I do consider account can be taken of this information in the context of this decision.
[121] I agree that Merial should have provided the Commissioner with more information as to the reason D30 was located at this late stage and the question of diligence should have been approached on that basis. The Commissioner was not, however, wrong to take Merial’s overall diligence into account.
Relevance
[122] Merial’s position is that D30 is a “novelty destroying prior art document” and in any event highly relevant to the Commissioner’s determination of the Patent Application. Bayer disputes this, Mr Finch submitting D30 was deemed irrelevant in the Australian Decision.
[123] Mr Dimitriadis pointed out D30 was not considered in relation to the question of invention in the Australian Decision. Australian law, as it was at the time, meant it was necessary to prove D30 could reasonably be expected to have been ascertained, understood and regarded as relevant by a skilled addressee in order for it to be taken into account. No such requirement applies in New Zealand.33
[124] The Australian Decision did in fact consider D30 in the context of testing and the antiseptic effect of 0.1 per cent w/w acriflavine in teat seal formulations.34
[125] It is certainly arguable that the four integers of claim 1 have features present in D30 as Merial maintains and as set out above. To that extent, it is difficult to contend that D30 is of no relevance. I accept Mr Dimitriadis’ submission that, if D30 is excluded from consideration of the Patent Application, there is a real risk of significant public detriment if the patent were granted to Bayer when it should not
have been.
33 Cool 123 Ltd v Vodafone New Zealand Ltd (2007) 78 IPR 653.
34 See for example [94] and [96] of the Australian Decision, above n 6.
[126] In my assessment, Mr Finch overstated the position in suggesting the Commissioner viewed D30 as of marginal relevance only. In all the circumstances, the Commissioner’s conclusion on this aspect was fairly put:
21.There is clearly some difference in opinion as to the effect of Document 030 in the determination of patentability. Thus, it seems to me that, although I have no doubt that Document 030 should be admitted to the proceedings, there may still be some argument at the substantive hearing as to its relevance in this respect.
Time elapsed since the filing of the original documents
[127] Bayer emphasises that Merial’s first statement of case was filed on 30 August
2010, some six years before its attempt to add D30 to the pleading. Merial knew since at least 24 March 2011 of Bayer’s amended claim requiring the antiseptic to be in sufficient quantities in the teat seal to have an antiseptic effect, and therefore knew that Merial would need to establish that acriflavine was such a compound.
[128] As the Commissioner noted in the Decision, the opposition was in abeyance for significant periods by reason of High Court proceedings and settlement discussions. Mr Dimitriadis emphasised that Merial became aware of D30 in February 2016 at a time settlement discussions were in progress and the amendment and evidence was filed on 27 May 2016. Furthermore, that Bayer filed evidence responding to D30 in the Australian Proceeding and, had it filed the same evidence in New Zealand, the matter could have proceeded to a hearing by now.
Public interest and prejudice
[129] In Mr Finch’s submission, while the Commissioner correctly held there was public interest in ensuring relevant documents were put before him, he did not consider in the balance the public interest in requiring parties to disclose their cases in full as early as possible, requiring parties to comply with established procedure for the exchange of evidence and ensuring oppositions are resolved in a time and cost effective manner. That was plainly wrong in Mr Finch’s submission.
[130] Furthermore, the Commissioner was plainly wrong to allow amendment to include D30, having decided it was of debateable relevance when other criteria were
considered. The Commissioner erred, in Mr Finch’s submission, by failing to balance the relevance of D30 against the prejudice to Bayer and the effect of the delay on Bayer and the public. As damages can run from the date of publication of the Patent Application, there was also prejudice to third parties by delay. In contrast, he suggested Merial could deal with any prejudice by applying for post-grant
revocation or as the basis for a re-examination under the 2013 Patents Act.35
[131] Mr Finch relied on the dicta from Permutit that the closer to the hearing, the higher the need to be satisfied that the document would be conclusive in opposition. All circumstances of the progress of the case should have been considered and the Commissioner should only have allowed the amendment for the most compelling reason. In Mr Finch's submission, the situation described in Permutit is exactly the case here. D30 is of debateable relevance and certainly does not meet the test of being conclusive or compelling.
[132] The Appeal Tribunal in Permutit said as follows:36
It has, however, long been held that it is the duty of the Comptroller, in the public interest, to take into account any document placed before him at any stage up to the issue of a decision. This applies, of course, equally to a document produced either by an applicant or an opponent. But before admitting it or permitting a change of ground of opposition, he must be satisfied that the new matter is highly relevant, that its introduction is necessary in the public interest and that no injustice would be done. In determining the weight to be given to public interest, all the circumstances of the progress of the case must be considered, including any further consequential delay likely to occur. No hard and fast rule can be set, and each case must be decided on its merits, but in my view, if the opposition has been running for a sufficient time to enable it normally to be brought to hearing and decided, new matter should be admitted only in face of the most compelling reasons. That is to say it must, as a first consideration, be substantially conclusive in determining a ground of opposition. The addition of evidence which is of itself inconclusive and only introduces a supplementary argument to bolster up a ground first pleaded should not, I think, be allowed at this stage. In an extreme case of delay in prosecution, the Comptroller may well decide that justice and the public interest are best served by refusal to permit further delay in any circumstances.
[133] As against those submissions, Mr Dimitriadis emphasised that Bayer was aware from when it received the original statement of case on 29 October 2010 that
35 Patents Act 2013, s 95. The grounds for revoking a patent are set out in s 114.
36 Permutit, above n 30, at 24.
Merial relied upon the use of acriflavine in the prior art teat sealant formulations. The proposed amendment strengthened Merial’s case and added support to it by D30, but did not change the nature of its case.
[134] Mr Dimitriadis said the Commissioner was correct to emphasise the need for the best evidence, emphasising that the success of the Patent Application will result in a 20-year monopoly. The purpose of the patent regime, in his submission, is to enable third parties to oppose a patent before it comes into force, reflecting the significant public interest in the fact that only properly justified patents should be granted. Procedural law must reflect and be decided in that context, he said.
[135] In his decision, the Commissioner referred to the public interest in having the opposition determined on the best evidence and most relevant prior art documents, citing Amadeus Global Travel:37
[25] The confirmation of an application for a patent creates a powerful monopoly. There is significant public interest in ensuring that only those patent applications that can be justified are granted. Part of the process of verification or otherwise is a form of adversarial process which allows those who say a patent should not be granted to, by evidence, justify their opposition. This is one, perhaps the most effective, way in which the integrity of the patents system is ensured. And it is vital to keep in mind that procedural law has as its ultimate justification the doing of justice between the parties. That will include expeditious hearing and proper exchange of information in a timely way. Most importantly, it will involve ensuring the parties put their best case forward. In this way the judicial officer will be in the best position to give his/her best decision. This principle seems to have been lost sight of in this case. Nor has there been any consideration by the Assistant Commissioner of any potential prejudice to the Respondent in the Appellant's delay. This will be a relevant factor. If none, this will be in favour of granting an extension. Nor has the Assistant Commissioner considered what effect there will be if the application for extension is refused. How will this affect the application and opposition? How will this affect the public interest?
[136] There is no doubt that early disclosure of an opponent’s full case is important.38 In cases of extreme delay it may well be that justice and the public interest are best served by a refusal to permit any further delay.39 However, in all the
circumstances, the Commissioner’s assessment of public interest was clearly correct.
37 Amadeus Global Travel Distribution SA v Sabre Inc HC Wellington AP126/02, 14 March 2003.
38 Ernest Scragg, above n 17, at 682.
39 Permutit, above n 30.
The nature of the case has not changed and any prejudice to Bayer is met by allowing it to file further evidence as the Commissioner already identified. Given such evidence was filed in the Australian Proceedings,40 this should not cause significant delay, although I note Mr Finch’s observation that Bayer’s approach in New Zealand will not necessarily be the same as its approach in Australia.
[137] Bayer’s frustration at the length of time taken to conclude the Patent Application is entirely understandable. However, in this instance and in unusual circumstances given the Australian Decision, I am satisfied that on balance the public interest in having the opposition determined on the best evidence and most relevant prior art documents outweighs the delay and other matters raised by Bayer. I agree with the approach in Amadeus that the fact there is a right to bring revocation proceedings is of little value and is not the correct way conceptually to consider the
matter.41
Conclusion
[138] The Commissioner was correct in allowing the Amended Pleadings.
Result
[139] For the reasons given, the appeal is dismissed save that in respect of the
Disputed Evidence:
(a) the statutory declaration of Dr Seter is inadmissible;
(b)those parts of Dr Caulfield’s reply evidence relating to accession dates is inadmissible, as is the exhibit of a statutory declaration by Ms Veber in other proceedings; and
(c) the further particulars in Merial’s third supplementary statement of
case are not permitted.
40 As Bayer also has in relation to the experiments carried out by Professor Trott.
41 Amadeus, above n 37, at [27].
[140] Costs are reserved. Any submissions are to be filed and served within
28 days of the date of this decision and any reply 14 days thereafter. Costs will be determined on the papers.
Thomas J
Solicitors:
James & Wells, Hamilton for Appellant
Martelli McKegg, Auckland for Respondent
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