Chiron Corporation v SmithKline Beecham Biologicals (S.A.)
[2005] APO 57
•16 December 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 16 December 2005.
Abstract
The further evidence in question consists of two statutory declarations.
The first declaration is made by Jean Petre, one of the inventors of 709406. The declaration addresses the issue of enablement of the Korean thesis, a document filed as part of a previous round of further evidence and assessed in a previous decision on 709406 as prima facie highly relevant to the novelty of the invention as claimed. Although the declaration provides experimental data that is of some relevance to enablement of the Korean thesis the experimental data is not conclusive and it adds little to evidence that is currently on file
The second declaration is made by Cameron John Marshall, an attorney engaged by the opponent. The declaration provides details of various pending oppositions on family equivalents of 709406 in a number of other countries and regions. This information is not directly relevant to the grounds of the opposition, nor is it likely to have any impact on the outcome of the substantive opposition.
The serving of further evidence was not considered appropriate in all of the circumstances, and was not allowed.
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 and the matter was heard on 14 April 2005. Leave to file the further evidence was granted on 27 April 2005 and the applicant was given two months from the date of the decision to file a response to this evidence. The applicant’s evidence in response was filed on 27 June 2005.
On 14 October 2005 the opponent filed a fourth request to file further evidence, together with that evidence. The applicant objected to the filing of this further evidence.
The applicant's opposition to the fourth request to file further evidence was heard in Canberra on 8 December 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
10. The further evidence consists of two statutory declarations made by Dr Jean Petre and Cameron John Marshall respectively. Dr Petre’s declaration addresses enablement of the Korean thesis, a document filed as part of the opponent’s second round of further evidence. As noted in the earlier decision relating to further evidence, the Korean thesis appears to be prima facie highly relevant to the novelty of the claimed invention.
11. Mr Marshall’s declaration provides details of a number of pending oppositions on family equivalents of 709406 in other countries and regions.
THE RELEVANT LAW
12. 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
(ii)Is reasonably satisfied that a direction, an extension of time or the service of further evidence is appropriate in all the circumstances.
13. This issue of extension of time for filing evidence 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, as noted by the delegate in Nalco Chemical Company v W.R. Grace and Co.-Conn. [1998] APO 65. As also noted in by the delegate this decision the 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. His declaration focuses on two issues relating to enablement of the Korean thesis. These issues were raised by the applicant’s expert witness, Dr Nathalie Garçon in her first and second declarations in response to the Korean thesis and the opponent’s following round of further evidence.
15. In her first declaration Dr Garçon described experiments that challenged enablement of the Korean thesis. These experiments purported to repeat the vaccine formulation protocol disclosed in the Korean thesis and in contrast to the Korean thesis failed to produce an acceptable vaccine.
16. These experiments have already been dealt with by Dr Petre in his previous declaration, filed on 16 February 2005. In this previous declaration Dr Petre suggested that it was Dr Garçon’s choice of strain that led to her failure to produce an acceptable vaccine rather than an inherent problem with the Korean protocol. Dr Petre explained that particular strains of B. pertussis produce unacceptable aggregation in vaccine formulations. He described this aggregate as a “jellyfish” aggregate and stated that he had seen this aggregate a number of times previously when inappropriate B. pertussis strains were used.
17. Dr Petre’s current declaration also deals with the issue of aggregation in vaccine formulations. In his declaration he discloses experiments in which a specific B. pertussis strain produced aggregation in an otherwise acceptable vaccine formulation prepared according to the protocol described in the Korean thesis. However, the sources of B. pertussis and hepatitis B surface antigen (HBsAg) in these experiments are not the same as those used by Dr Garçon in her experiments. As such Dr Petre’s experiments do little more than provide a further example to support Dr Petre’s previous assertion that “an inappropriate source of cells can cause failure of an otherwise successful formulation protocol”. Although this information is relevant to the issue of enablement of the Korean thesis, it is unlikely to play a critical part in the substantive opposition proceedings because it is not new information and it still falls short of conclusive or convincing evidence that Dr Garçon’s problems were not caused by deficiencies in the Korean thesis protocol. Proof that Dr Garçon’s problems were not caused by the deficiencies in the Korean protocol could only come from experiments that faithfully duplicate Dr Garçon’s experiments using the same B. pertussis and HBsAg source and that also show that use of a different, more appropriate B. pertussis strain in the Korean protocol will produce an acceptable vaccine.
18. In her second declaration Dr Garçon criticised experiments described in Dr Petre’s previous declaration of 16 February 2005. The experiments in Dr Petre’s previous declaration purported to repeat the Korean protocol to produce an acceptable vaccine. However, as Dr Garçon explained, Dr Petre’s experiments did not mix antigens and adjuvant in the order described in the Korean thesis. In his latest declaration Dr Petre’s describes a new set of experiments in which the antigens and adjuvant are mixed in the manner described in the Korean thesis to produce an acceptable vaccine. However, these experiments are still not a faithful reproduction of the Korean protocol. As acknowledged by Mr Fitzpatrick at the hearing, Dr Petre’s experiments use a recombinant HBsAg rather than plasma derived HBsAg, and a B. pertussis source that appears to differ from the source used in the Korean protocol. As such Dr Petre’s latest round of experiments still does not provide conclusive evidence that the Korean protocol works. Evidence of this would require a faithful reproduction of the experiments disclosed in the Korean thesis including use of the antigens derived from the same sources as the antigens in the Korean protocol.
19. Given the shortfalls in Dr Petre’s current experiments, although I accept that the Petre declaration is relevant to the issue of enablement of the Korean thesis, it does little more than repeat an ongoing theme and does not substantially add to the evidence that is currently on file. As such I do not believe that it is likely to play a key role in the substantive proceedings.
The Marshall Declaration
20. Mr Marshall is a British patent attorney who has been engaged by Chiron to co-ordinate opposition proceedings on 709406 and its family equivalents. His declaration includes information about a number of oppositions in respect of equivalents of 709406 and provides details of the proceedings in some of these oppositions. As pointed out by Mr Slattery at the hearing, this information is of no relevance to the grounds of the current opposition and it certainly does not address any of the issues raised by Dr Garçon in her evidence, or raise any further issues that might help resolve the question of enablement of the Korean thesis.
21. When pressed on this point at the hearing Mr Fitzpatrick explained that Mr Marshall’s declaration is provided as evidence of the relevance of the Korean thesis to the substantive proceedings and to stress the importance of resolving the issue of enablement of the thesis. Mr Fitzpatrick submitted that the Marshall declaration highlights the fact that enablement of the Korean thesis is a pivotal issue in a number of opposition proceedings relating to family equivalents of 709406 in various countries and regions. However, it is already well accepted in these current proceedings that enablement of the Korean thesis is likely to be a critical issue in the substantive proceedings and there is no need for this point to be reiterated.
22. As such, I do not believe that the Marshall declaration adds anything significant to the opposition proceedings.
23. Given this I am not convinced that either the Petre or the Marshall declaration makes a significant further contribution to the issue of enablement of the Korean thesis and as such I believe it is unlikely that either will be highly relevant to the opposition proceedings.
Reasons for the delay
24. The applicant submitted that the opponent had had ample opportunity to address the issue of enablement of the Korean thesis and had provided no reasonable explanation as to the delay in providing the current round of further evidence. However, as explained by Mr Fitzpatrick, the experiments disclosed in the Petre declaration are specific to the issue of mixing antigens and adjuvant and this issue was only raised in Dr Garçon’s declaration of 27 June 2005. As such, I believe that the opponent has been reasonably expedient in preparing and filing the experimental evidence presented in the Petre declaration.
25. Furthermore, although some of Dr Petre’s experiments also address the issue of B. pertussis sources, which was raised in Dr Garçon’s previous declaration, it is reasonable that these two sets of experiments were combined as they both hinge on first duplicating the mixing protocol disclosed in the Korean thesis and criticised by Dr Garçon in her most recent declaration. Given this, I believe that the opponent has provided good reason for the filing the Petre declaration at this stage in the opposition proceedings.
26. However, I do not believe that the opponent has provided any reasonable explanation for filing the Marshall declaration at this late stage in the opposition proceedings. Much of the information in the Marshall declaration has been available for a significant period of time and it certainly does not represent highly relevant new data that has only recently come to light.
27. As such, although the opponent has provided a reasonable explanation for the delay in filing the Petre declaration I am not convinced that the opponent has provided any good reason for filing the Marshall declaration at this late stage in the opposition proceedings.
Interests of the parties
28. 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. 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.
29. In the case of both the Petre and Marshall declarations, neither appears likely to play a significant role in the substantive opposition proceedings. The Marshall declaration does not provide any evidence that directly relates to the grounds of the substantive proceedings and the Petre declaration experiments are not faithful reproductions of either the original Korean protocol or the Garçon experiments. Given the limited relevance of this evidence neither the opponent nor the public is likely to be significantly disadvantaged if the evidence is not admitted. In contrast, the applicant is likely to suffer considerable disadvantage in terms of delays and cost if evidence is admitted at this very late stage in what is already a very protracted and delayed opposition proceedings.
DECISION
30. On balance, I do not believe that inclusion of the Petre and Marshall declarations will lead to a more just or correct result. Neither declaration adds substantially to the evidence that is already on file or adequately addresses the issue of enablement of the Korean thesis. As a consequence there is no strong public interest in allowing this application for further evidence. Nor are the interests of the applicant served by introducing evidence that will lead to further delay and costs in what are already protracted and delayed opposition proceedings. In the current circumstances these factors outweigh the interest of the opponent in seeking to introduce the further evidence.
31. As a consequence, I do not believe that it is appropriate to allow the opponent’s application to file this further evidence.
COSTS
32. 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 opponent, Chiron Corporation.
Terry Moore
Delegate of the Commissioner of Patents
16 December 2005
Patent attorneys for the applicant : Davies Collison Cave, Melbourne
Patent attorneys for the opponent : FB Rice & Co, Melbourne
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