CSL Limited v Isconova AB et al
[2016] APO 82
•18 November 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
CSL Limited v Isconova AB et al [2016] APO 82
Patent Application: 2011280259
Title:Influenza vaccine
Patent Applicant: Isconova AB and Erasmus University Rotterdam Medical Center
Opponent: CSL Limited
Hearing Officer: P M Spann Deputy Commissioner of Patents
Decision Date: 18 November 2016
Hearing Date: 20 October 2016 by written submissions.
Catchwords: PATENTS – request under regulation 5.16 to amend the statement of grounds and particulars – whether amendment should be made – discretionary considerations – amendment allowed in part – costs awarded against the opponent.
Representation: Patent applicant: Spruson & Ferguson
Requestor:Davies Collison Cave
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011280259
Title:Influenza vaccine
Patent Applicant: Isconova AB and Erasmus University Rotterdam Medical Center
Date of Decision: 18 November 2015
DECISION
I allow the amendments to the statement of grounds and particulars identified in the request filed on 24 August 2016. The request for amendment filed on 17 August 2016 is refused.
I direct the Opponent to file within 14 days of the date of this decision a revised statement excluding the amendment identified in the request filed 17 August.
I award costs in accordance with Schedule 8 against the Opponent.
REASONS FOR DECISION
Background
Patent Application 2011280259 was filed under the provisions of the Patent Cooperation Treaty on 25 July 2011. It was examined and advertised accepted on 22 May 2014. On 22 August 2014 a notice of opposition was filed followed by a statement of grounds and particulars on 21 November 2014. Following the filing of evidence in support of the opposition, the applicant sought amendment of the complete specification and these amendments were allowed on 17 December 2015 without opposition. Relevantly, one aspect of these amendments was the addition of the limitations that ectodomains within the claimed vaccine composition were recombinant and do not contain a streptaviding tag.
The evidentiary stages of the substantive opposition were completed on 21 March 2016 and the opposition set for hearing on 31 August 2016. However, an amendment of the statement of grounds and particulars was filed on 30 June 2016 (subsequently allowed) followed by further requests on 17 and 24 August 2016. The applicant objected to these further requests and the substantive hearing was deferred to allow them to be determined, as well as a request by the applicant for the Commissioner to consider further information under regulation 5.23.
The present matter concerns only whether the amendments of the statement of grounds and particulars filed on 17 and 24 August 2016 should be allowed. I will refer to the submissions of the parties where relevant in my reasons below.
The requests
The substance of the amendment requested on 17 August 2016 is the addition of a further particular under the ground of non-compliance with section 40, that is:
“(viii)The best method known to the applicant for performing the invention of claims 1, 7-12 and 14-28 is not described in the specification because the specification does not provide the best method for producing HA and NA ectodomains that do not contain a streptavidin tag.”
The opponent indicates that this amendment arises from the amendments to the patent specification and was raised at a relatively late stage “because the effect and application of the best method requirement has only recently been made clear in the Full Federal Court decision in Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27”.
In the case of the 24 August request, the proposed amendment is to move particulars of a document from under the ground of lack of inventive step to the ground of lack of novelty. The particulars are:
“D45. Bosch et al. (2010) J Virol. 84:10366-10374
D45 is a paper that is co-authored by one of the inventors and describes the same studies described in the Application. D45 therefore describes compositions comprising an ISCOM matrix and influenza virus NA and HA ectodomains.”
The need for this amendment is said to arise from an error in the amended statement filed 30 June 2016.
Relevant law
The statement of grounds and particulars became a feature of opposition proceedings with the enactment of the regulations associated with the introduction of the Patents Act 1990. It was among a number of measures intended to expedite the determination of oppositions and in Kent-Moore Corporation v Environmental Products Amalgamated Pty Ltd [1992] APO 47 it was stated that:
“The opponent is required to file a statement of grounds and particulars within 1 month of filing their notice of opposition. That statement, in setting out the grounds and particulars, sets out the basis of the opposition. It thus sets the environment for the future actions in the opposition of both the opponent and applicant. Having filed that statement of grounds and particulars, ‘all’ that remains to be done by the opponent is to prove their opposition [such as by establishing publication dates, putting the material into evidentiary form, and (where needed) obtain declarations by appropriate experts in respect of material referred to in the statement]. There is no need, and certainly no expectation, for an opponent to be actively seeking further particulars subsequent to the filing of the statement of grounds and particulars. Statements in the statement of grounds and particulars to the effect that the opponent is still conducting searches, and will let the parties know about the results at some later time, do not in my view provide the opponent with any per se right to either amend the statement, or seek an extension of time to serve evidence in support.”
At that time amendments of the statement were not permitted if the Commissioner reasonably believed that a person would be unduly prejudiced by the amendment. In Diamond Scientific Company v CSL Limited [1992] APO 55 the same delegate stated:
“In my view the applicant has the right to know, at the time the statement of grounds and particulars is filed, the complete case that it has to answer in the opposition.
Where, for whatever reason, the statement is deficient and requires amendment to correct those deficiencies by adding particulars not specifically referred to in the original statement, the applicant will necessarily be prejudiced to some degree - in that the case they have to answer will be changed. Such prejudice is not necessarily undue. However, if there is any unnecessary delay in seeking a relevant amendment of the statement of grounds and particulars, the applicant will not timely know the case it has to answer - indeed they will not know until the opponent chooses to so inform them by seeking an appropriate amendment. Such delays are inconsistent with the function of the statement of grounds and particulars. Any delays in seeking a relevant amendment will unjustifiably hamper the preparation of the applicant's case in answer. It follows, generally speaking, that if there is any unnecessary delay in seeking amendment of the statement to include extra particulars, the applicant (at least) will be unduly prejudiced if the amendment is allowed.
Furthermore, as I said in the Kent-Moore decision supra:
‘There is no need, and certainly no expectation, for an opponent to be actively seeking further particulars subsequent to the filing of the statement of grounds and particulars’
That is, the opponent should know the full basis of its case when it files the statement of grounds and particulars. It should not thereafter be actively endeavouring to find any further basis for its opposition. Furthermore, as I said above, the applicant has the right to know, at the time the statement of grounds and particulars is filed, the complete case that it has to answer in the opposition. In my view, where an opponent actively pursues further particulars in the opposition after having filed its statement, the applicant will be unduly prejudiced by any resultant change to the case it has to answer if the statement is amended.
This is not to say, however, that all amendments to particulars will give rise to undue prejudice. Amendments to particulars may properly arise incidental to the preparation of the case - as distinct from efforts by the opponent to find a ´better' basis for its opposition. In my view, extra particulars that arise incidental to the preparation of the case which:
i. do not result in any protraction of the preparation of the case, and
ii. are included by way of amendment of the statement of grounds and particulars at the earliest reasonable opportunity, and
iii. do not substantially change the case the applicant has to answer in the opposition
will not prima facie give rise to the applicant being unduly prejudiced by the relevant amendments.”
However the Patents Amendment Regulations 2000 (No. 1) removed the consideration of undue prejudice and amendments of particulars were generally permitted at any time. This was the case until the commencement of the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 which resulted in a redrafting of Chapter 5 including the remaking of regulations governing the amendment of opposition documents. Hence currently regulation 5.16 provides:
“5.16 Statement of grounds and particulars
(1)An opponent may request the Commissioner in writing to amend the opponent's statement of grounds and particulars:
(a) to correct an error or omission in the grounds of opposition; or
(b) to update the grounds of opposition to reflect an amendment to the patent request or complete specification to which the statement relates; or
(c) to amend the facts and circumstances forming the basis for the grounds.
(2)The Commissioner must:
(a) notify the applicant of the opponent's request; and
(b) give the parties an opportunity to make representations about the amendment.
(3)The Commissioner must not make the amendment if:
(a) the Commissioner is considering an application for dismissal of the opposition under Part 5.4; or
(b) for an opposition begun under subregulation 5.4(1):
(i)the applicant's complete specification is being re-examined; and
(ii)the re-examination is not completed as required by regulation 9.5.
(4)The Commissioner must make the amendment if:
(a) subregulation (3) does not apply; and
(b) the Commissioner is satisfied that the amendment should be made.
(5)The Commissioner must, as soon as practicable:
(a) notify the parties of the Commissioner's decision; and
(b) if the Commissioner decides to make the amendment--give the applicant a copy of the amended statement
It can be seen that amendment of the statement is subject to the Commissioner being satisfied that the amendment should be made. The Explanatory Statement does not explicitly address this change but in general states:
“A second purpose of the Regulation is to amend the Patents Regulations and the Trade Marks Regulations 1995 (the Trade Marks Regulations) to reduce delays in the resolution of patent and trade marks applications. Currently, delays in the resolution of opposition proceedings (administrative proceedings where a person can challenge the grant of a patent or registration of a trade mark) and patent divisional applications (where the subject matter of an earlier application is divided out into a later divisional application which proceeds separately) cause unnecessary expense for other parties, and prolong the period of uncertainty for competitors. Schedule 3 to the Raising the Bar Act amended provisions of the Patents Act and Trade Marks Act to address issues regarding delays. However, many of the provisions that may lead to delays in resolution of IP matters are procedural issues dealt with by the Patents Regulations and Trade Marks Regulations. Schedule 3 to the Regulation amends both the Patent Regulations and Trade Marks Regulations to streamline the opposition process by reducing time frames and introducing a more rigorous test for granting extensions of time to file evidence.”
It appears that the Commissioner in considering whether to allow an amendment should consider this context and must take into account a range of relevant factors including the prospect of undue prejudice as discussed in Diamond, supra. As the delegate stated in K-Tec, Inc v Healthy Foods, LLC [2016] ATMO 4 when considering similar provisions in the Trade Marks Act:
“The factors that will generally need to be taken into account in the exercise of the Registrar’s discretion to amend an SGP are the likely prejudice to the parties, the public interest, whether the ground proposed to be added is sufficiently particularised and the nature and importance of the requested amendment. In the present matter the timing of the amendment request and the reasonableness of the explanation offered for the delay in requesting the amendment are also relevant.”
Submissions
Both parties made detailed submissions on the relevance of the amended particulars. I summarise the other main points made as follows:
For the opponent:
a) The relevance of the best method requirement to the amended claims (the subject of the 17 August amendments) only became apparent during the preparation of submissions for the substantive hearing and in the light of recent case law (Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27).
b) The issue should be considered by the delegate if the opposition is to serve the purpose of ensuring that defective patents do not proceed to grant.
c) In this case the issue of best method can be decided as a matter of law and no further evidence is required.
d) The applicant has already made submissions on best method in its substantive submissions filed 24 August 2016.
e) The amendment proposed on 24 August serves to correct a clerical error.
f) The applicant has already addressed the particularised citation (D45) for both novelty and inventive step in its substantive submissions.
g) A correct determination of the opposition is best served by a full ventilation of these issues at the substantive hearing and accordingly it is reasonable for the Commissioner to enter the amendments.
And for the applicant:
a) The 17 August amendments were filed 16 months after the applicant’s amendments to the claims were filed and the opponent has provided no credible reasoning to justify the inordinate delay taken to file the proposed amendment.
b) the Servier decision was handed down on 8 March and it seems unlikely that the relevance to that decision could have been overlooked for the intervening period given the publicity the decision has received.
c) In any event the best method requirement is not new and the Servier decision does not assist the opponent any more than pre-existing case law.
d) The ability of the opponent to pursue this challenge late in the opposition without providing the applicant the opportunity to file evidence would be extremely prejudicial.
e) In relation to the amendment filed on 24 August there was no indication previously the opponent intended to rely on D45 for the purpose of novelty.
f) There is no evidence of an alleged clerical error.
g) There was no indication that D45 would be relied on for novelty until the opponent’s substantive submission were filed 10 days before the date set for the substantive hearing.
Consideration
It appears to be an unfortunate feature of oppositions that a clear distilling of the issues and the case to be pursed at hearing often only occurs at the point when substantive submissions are being drafted. This is particularly so if counsel are briefed and become fully engaged at that time. However, while this is to some extent understandable, it is clearly at odds with the purpose of the statement of grounds and particulars to give early notice of the opponent’s case.
As an exception, it is generally recognised that amendments made to the patent specification may require the case made by the opponent to be amended and consequential changes are often permitted. However the expectation still must be that amendments to the statement are made at the earliest reasonable opportunity. Here, while the inclusion of a particular as to best method is said to arise from the amended specification, an amendment to the statement was not pursued promptly but rather approximately 8 months after the amendments were formally allowed. The amendment therefore can be considered to be highly prejudicial particularly when one further notes that the amendments were only sought shortly before the substantive hearing was due to take place and have resulted in a significant protraction of the case.
I do not consider the fact that the applicant addressed the amended particulars in its submissions to mitigate in favour of the opponent. Neither is the Full court decision in Servier a reasonable excuse for the delay in raising the best method particulars.
It was suggested also that “A correct determination of the opposition is best served by a full ventilation of these issues at the substantive hearing”. Such statements are often used to justify delays by the opponent but fail to take into the account the interests of the applicant and the importance of prompt and efficient opposition proceedings, particularly post the Raising the Bar reforms. A correct determination of the opposition is the correct determination of the issues properly raised in the framework of the proceedings. It is also to be noted that the opponent is not shut out entirely from having the issue considered by the Commissioner in that, if a patent is ultimately granted, it may request re-examination on the ground of lack of compliance with section 40(2). The issue while prima facie arguable does not appear to demand immediate consideration in the public interest.
In my view the raising of new particulars only late in proceedings and at the time of filing submissions for the substantive hearing without sufficient justification weighs heavily against allowing the amendment of the statement and is not justified on any other basis. I consider allowing the amendment would amount to a serious abuse of process and it is regrettable that the opponent by its request has caused the substantive determination to be deferred. Consequently I refuse the request dated 17 August.
Concerning the 24 August request, similar criticisms can be made in relation to the timing of the request however the amendments made to the statement after the request on 30 June were not contested and as D45 will in any event be considered in the opposition there appears to be significantly less prejudice to the applicant than would otherwise be the case. I am therefore inclined to allow this amendment of the statement.
Conclusion
I refuse the amendment of the statement of grounds and particulars filed 17 August 2016 but allow the amendments identified in the request filed 24 August. The opponent will be directed to file a revised statement excluding the amendment sought on 17 August.
Costs
The opponent’s actions in seeking amendment of the statement of grounds and particulars so late in the proceedings has been extremely disruptive and cannot be justified by the applicant’s amendment of the complete specification. I have refused the principle amendment sought and consequently I will award costs in accordance with Schedule 8 against the Opponent.
P M Spann
Deputy Commissioner of Patents
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