Chiron Corporation v SmithKline Beecham Biologicals (S.A.)
[2005] APO 21
•27 April 2005
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 709406 in the name of SmithKline Beecham Biologicals (S.A.)
Title: Combined Vaccines Comprising Hepatitis B Surface Antigen and Other Antigens
Action: Opposition under s.59 of the Patents Act 1990: objection to a request for leave to serve further evidence by Chiron Corporation
Decision: Issued 27 April 2005.
Abstract
The evidence consists of two statutory declarations. Both declarations address the issue of enablement of a document that appears to be prima facie highly relevant to the novelty of the invention as claimed. The document was filed in a previous round of further evidence and the issue of enablement was first raised in the applicant’s response to this further evidence. Both declarations were found to be relevant to enablement of the document and their admission was likely to contribute to a more correct or just result at the substantive hearing.
Leave was granted to admit both declarations and the applicant was given a period of two months within which to file a response to the declarations.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 709406 by SmithKline Beecham Biologicals (S.A.); opposition under s.59 of the Patents Act 1990, by Chiron Corporation; objection to a request for leave to serve further evidence.
BACKGROUND
SmithKline Beecham Biologicals (S.A.) (the applicant) filed patent application 709406 (16480/97) on 4 March 1997. Following examination 709406 was advertised as accepted on 26 August 1999.
Chiron Corporation (the opponent) opposed the application on 25 November 1999 and served its statement under regulation 5.4 of the Patent Regulations on 28 February 2000. Service of evidence in support was concluded on 2 October 2000. The applicant completed service of evidence in answer on 27 June 2001. Evidence in reply was completed 29 October 2001.
On 1 March 2001, prior to completion of evidence in answer, the applicant filed a request to amend the specification under section 104. The opponent filed a notice of opposition to the amendments on 17 October 2002. The opposition was withdrawn on 13 February 2004 and the amendments included in the specification on 1 March 2004.
On 29 October 2001 the opponent filed a first request to amend the statement of grounds and particulars to add six extra documents. Filing of this further evidence was completed on 6 November 2002. A second request to file further evidence was filed on 24 February 2004. The applicant objected to filing of this further evidence and the matter was heard on 12 May 2004. Leave to file only part of the further evidence was granted on 6 July 2004 and the applicant was given two months from the date of the decision to file a response to this evidence. The applicant’s response to the evidence was filed on 6 December 2004.
On 16 February 2005 the opponent filed a third request to file further evidence together with that evidence. The applicant objected to the filing of this further evidence on 10 March 2005.
The opponent's opposition to the third request to file further evidence was heard in Canberra on 14 April 2005. Mr John Slattery, patent attorney of Davies Collison Cave represented the applicant. Mr Ben Fitzpatrick of Counsel and Dr Ian Rourke, patent attorney of FB Rice & Co represented the opponent.
SPECIFICATION
The specification is entitled "Combined Vaccines Comprising Hepatitis B Surface Antigen and Other Antigens". The described invention relates to a multivalent vaccine composition comprising a hepatitis B surface antigen adsorbed to aluminium phosphate and two or more other antigens selected from diptheria, tetanus, pertussis, polio, Haemophilus influenzae b and hepatitis A adsorbed to aluminium hydroxide or aluminium phosphate.
The specification ends with 34 claims, with the following 2 independent claims.
1. "A vaccine composition comprising a hepatitis B surface antigen (HBsAg) adsorbed to aluminium phosphate (AP) and two or more other antigens adsorbed to aluminium hydroxide (AH) or aluminium phosphate and selected from diptheria (D), tetanus (T), pertussis (P), polio, Haemophilus influenzae b, and hepatitis A."
28. "Use of aluminium phosphate (AP) as an adjuvant for dbsorbing HBsAg, characterised in that the use is for the purpose of formulating a stable and effective combined vaccine comprising a HBsAg component adsorbed to aluminium phosphate and tow or more other antigens adsorbed on aluminium hydroxide or aluminium phosphate and selected from antigens that provide immunity against diptheria, tetanus, pertussis, polio, Haemophilus influenzae b, and hepatitis A, whereby the stability and/or immunogenicity of the HBsAg component is greater than in a corresponding combined vaccine in which the HBsAg component is adsorbed on AH."
FURTHER EVIDENCE
The further evidence consists of two statutory declarations made by Dr Jean Petre and Dr Mario Contorni. Both declarations address the issue of enablement of the Korean thesis. Dr Contorni’s declaration also includes the results of experiments purporting to repeat the experiments described in the Korean thesis.
THE RELEVANT LAW
10. Further evidence is governed by regulation 5.10. In particular, 5.10(5)(c)(i) and (ii) provide inter alia that the Commissioner must not grant an application under sub-regulation (2) or (4) unless the Commissioner:
Gives the parties a reasonable opportunity to make representations concerning the application or proposed direction; and
Is reasonably satisfied that a direction, an extension of time or the service of further evidence is appropriate in all the circumstances.
11. This provision has been considered by the Federal Court in Ferocem Pty Limited v Commissioner of Patents (1994) 38 IPR 243, and A Goninan & Co Ltd v Commissioner of Patents (1997) 38 IPR.. The general principles flowing from Ferocem and Goninan are:
(a)Compliance with particular requirements. It is necessary to give genuine and proper consideration to all relevant considerations.
(b)The reasons why the evidence was not served earlier are a relevant consideration, but a satisfactory explanation is not a mandatory requirement.
(c)The public interest in determining a serious opposition on its merits is a relevant consideration. In order to do this it is necessary for the Commissioner to form a view as to the nature of the evidence that it is sought to adduce, and the significance of that evidence for the opposition proceedings. However, as Sackville J went on to explain in Ferocem this does not mean that the evidence has to be scrutinised in the same way as would occur at a substantive hearing. Rather it is necessary to form a prima facie view of whether that evidence is likely to be important in the substantive opposition proceedings given the nature of the issues addressed by the proposed evidence.
(d)The interests of the party seeking the exercise of the discretion are a relevant consideration.
(e)It is relevant to consider the disadvantage to the other party of delays in determining the opposition, and the effect of delays on the efficient and orderly administration of the Patents Office.
12. While both Ferocem and Goninan deal with extensions of time for filing evidence, the general principles flowing from them are equally applicable to the filing of extra evidence. Also as noted by the delegate in Nalco Chemical Company v W.R. Grace and Co.-Conn. [1998] APO 65 application of the principles of Goninan requires a balancing exercise in which all competing considerations must be taken into account.
13. In my decision I will discuss these principles under the following broad headings:
(a)Nature and significance of the evidence;
(b)Reasons for the delay; and
(c)Interests of the parties.
DISCUSSION
Nature and significance of the evidence
The Petre Declaration
14. Dr Jean Petre is one of the inventors of 709406. Dr Petre’s declaration addresses evidence in the declaration of Dr Nathalie Garçon, which was filed by the applicant in response to the Korean thesis. Dr Garçon’s declaration describes experiments conducted by Dr Garçon that purport to duplicate the protocols described in the Korean thesis. In contrast to the Korean thesis, which described production of an effective multivalent hepatitis B surface antigen (HBsAg) vaccine, Dr Garçon’s experiments did not produce an acceptable or effective vaccine.
15. The Petre declaration submits that Dr Garçon’s experiments were not a faithful reproduction of the experiments described in the Korean thesis and provides reasons why differences between Dr Garçon’s protocol and the protocol described in the Korean thesis led to Dr Garçon’s failure to produce an acceptable vaccine.
The Contorni Declaration
16. Dr Mario Contorni is a scientist working in Chiron Corporation’s Drug Formulation Technical Development Group. Dr Contorni’s declaration also addressed Dr Garçon’s experiments and provided reasons why the differences between Dr Garçon’s experiments and the Korean thesis experiments resulted in Dr Garçon’s failure to produce an ineffective vaccine.
17. As such both Dr Contorni’s and Dr Petre’s declarations deal with the applicant’s assertion that the Korean thesis does not provide an enabling disclosure of multivalent HBsAg vaccines. This issue is likely to play an important role in the substantive proceedings because enablement is a key to the Korean thesis’ potentially determinative role in the substantive opposition.
18. At the hearing Mr Slattery submitted that the Contorni and Petre declarations were not relevant to the opposition proceedings because they were primarily directed at refuting Dr Garçon’s experimental findings rather than directed at establishing that the Korean thesis provided an enabling disclosure. However, I believe that evidence directed at refuting Dr Garçon’s experimental finding, although most probably less relevant than evidence that directly establishes enablement of the Korean thesis, is still prima facie highly relevant to the opposition proceedings. Evidence that highlights where Dr Garçon’s protocols differed from the Korean protocols and explains why these differences led to the failure to produce an efficacious vaccine is likely to play a role in determining the importance of the Korean thesis as a potential novelty citation and as a key determinant in the opposition proceedings.
19. Dr Contorni’s declaration also describes experiments conducted by Dr Contorni which purport to duplicate the experiments described in the Korean thesis. In keeping with the Korean thesis, and in contrast to Dr Garçon’s experiments, Dr Contorni’s experiments produced an effective multivalent HBsAg vaccine. As such Dr Contorni’s declaration purports to confirm the Korean thesis as an enabling disclosure of the invention as claimed.
20. At the hearing Mr Slattery submitted that the Contorni declaration was not relevant to the question of enablement because the experiments conducted by Dr Contorni were not a faithful reproduction of the protocols disclosed in the Korean thesis and that as such Dr Contorni’s success could not be regarded as evidence of enablement in the Korean thesis. Although I agree that there are differences between Dr Contorni’s protocols and those described in the Korean thesis, the impact of these differences can only be assessed by an in-depth analysis of Dr Contorni’s protocol and the Korean thesis and as pointed out by the Mr Fitzpatrick at the hearing this level of scrutiny is inappropriate in the current proceedings. As stated in Goninan, further evidence should not be scrutinised in the same way as would occur at a substantive hearing, rather it should only be scrutinised to the extent that the hearing officer can form a prima facie view of whether the evidence is likely to important in the opposition proceedings.
21. With this in mind, I have restricted by consideration of the evidence to an assessment of the evidence’s prima facie relevance to the issue of an enablement of the Korean thesis. Based on this level of scrutiny I am satisfied that Contorni declaration is prima facie relevant to enablement of the Korean thesis and thus likely to play a significant role in the substantive hearing.
22. Given all of this, I believe that both the Petre and Contorni declarations are highly relevant to the issue of enablement of the Korean thesis and thus both likely to play an important role in the substantive opposition proceedings.
Reasons for the delay
23. Although the evidence has been introduced at what is a very late stage in a protracted and delayed opposition proceeding, the evidence addresses a new issue in the proceedings that was only raised in the applicant’s response to the Korean thesis filed on 6 December 2005. As such I believe that the opponent has actually made good speed in preparing their evidence to address this new issue over the Christmas and New Year period and filing it on 16 February 2004.
24. At the hearing Mr Slattery suggested that the opponent had not been duly diligent in preparing evidence relating to enablement of the Korean thesis because they had known of Dr Contorni’s experiments at least as early as 24 September 2004, when a copy of Dr Contorni’s experimental results was attached to a letter sent by the opponent to IP Australia. However, at this stage there had been no suggestion in the opposition proceedings that there were any problems with enablement of the Korean thesis or that the applicant intended to address this issue in their responding submissions. Given this it is reasonable to accept the opponent’s assertion that prior to the applicant filing their submissions in response to the Korean thesis there was no reason for the opponent to regard Dr Contorni’s experiments as relevant to the opposition proceedings or to commence preparation of any further evidence to address the issue of enablement of the Korean thesis.
25. As also pointed out by Mr Fitzpatrick at the hearing, it is not reasonable to penalise a party in an opposition simply because they have been unable to predict what issues the other party might raise in their responding evidence. In particular, with respect to enablement, even if an opponent suspects that enablement may be an issue, they are still not necessarily in a position to predict what aspect of enablement may be challenged. The current case provides an excellent example of this, where although Dr Contorni’s results in the 24 September 2004 letter broadly address the issue of enablement they do not address the specific issue of aggregation, which is the issue raised by Dr Garçon in her declaration.
26. Given this and based on the evidence I have before me, I believe that it was quite reasonable for the opponent to wait for the applicant to file their responding evidence before commencing preparation of the further evidence and as such I am satisfied that the opponent has provided sound reasons for the delay in filing this latest round of further evidence.
Interests of the parties
27. The interests of the relevant parties are a consideration that must be taken into account in exercising the discretion to allow further evidence. If the further evidence is allowed the applicant is disadvantaged by delaying the hearing and by introducing further costs associated with preparation of the applicant’s evidence in response. In the current case I am particularly mindful of this given that the applicant has already been subjected to delays and costs associated with admission of the Korean thesis as further evidence. The Patent Office is also disadvantaged as by disruption of orderly and efficient proceedings within the Office. However, if the evidence is relevant to the hearing and is not allowed, the public and the opponent will be disadvantaged because the case will not be heard on its merits.
28. In the case of both the Contorni and Petre declarations, both are prima facie relevant to the opposition because both are critical to establishing whether or not a key document, the Korean thesis, meets one of the critical requirements for a novelty citation. Given the importance of this issue in the opposition proceedings it is highly likely that both the opponent and the public would be significantly disadvantaged if the further evidence was not admitted and the case was not heard on its merits.
DECISION
29. I find that the opponent has provided a satisfactory reason for the delay in filing the Contorni and Petre declarations.
30. It is also clear that the Contorni and Petre declarations are directly relevant to the issue of enablement of the Korean thesis and are thus likely to be critical in establishing whether or not the Korean thesis plays a determinative role in the substantive hearing. The relevance and significance of the declarations and the likelihood that their inclusion will lead to a more just outcome outweigh any disadvantages arising from delays in the hearing and increased costs for the applicant. As such, I grant the opponent leave to serve both the Contorni and Petre declarations as further evidence. As negotiated at the hearing, the applicant has two months from the date of this decision to serve responding evidence to the declarations.
COSTS
31. The normal practice is that costs follow the event and in the current circumstances I see no reason to deviate from this practice. As such I believe that it is appropriate that costs be awarded against the applicant, SmithKline Beecham Biologicals.
Terry Moore
Delegate of the Commissioner of Patents
27 April 2005
Patent attorneys for the applicant : Davies Collison Cave, Melbourne
Patent attorneys for the opponent : FB Rice & Co, Melbourne
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