Chiron Corporation v SmithKline Beecham Biologicals (S.A)
[2006] APO 4
•24 February 2006
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 24 February 2006.
Abstract
The further evidence consists of a statutory declaration made by Dr Mario Contorni, together with exhibits MC-4 to MC-6. The evidence addresses the issue of enablement of the Korean thesis, a document filed as part of an earlier 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. This latest round of further evidence represents the third round of evidence directed at establishing enablement of the Korean thesis.
Although this latest evidence is relevant to enablement of the Korean thesis it does not significantly add to the evidence already on file. As such it is unlikely to resolve the issue of enablement of the Korean thesis or to play a key role in the substantive proceedings.
The serving of further evidence was not considered appropriate in all of the circumstances, and was not allowed.
Costs were awarded against the opponent.
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 on 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 allowed 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. Service of this further evidence was completed on 6 November 2002. A second request to serve further evidence was filed on 24 February 2004. The applicant objected to service of this further evidence and the matter was heard on 12 May 2004. Leave to serve only part of the further evidence, the Korean thesis, 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 served on 6 December 2004.
On 16 February 2005 the opponent filed a third request to serve further evidence together with that evidence. The evidence consisted of two statutory declarations addressing enablement of the Korean thesis. The applicant objected to the service of this further evidence and the matter was heard on 14 April 2005. Leave to serve both declarations was granted on 27 April 2005 and the applicant was given two months from the date of the decision to serve a response to this evidence. The applicant’s evidence in response was served on 27 June 2005.
On 14 October 2005 the opponent filed a fourth request to serve further evidence, together with that evidence. The evidence consisted of a further declaration addressing enablement of the Korean thesis and a declaration providing details of various pending oppositions on family equivalents of 709406 in a number of other countries and regions. The applicant objected to the service of this further evidence and the matter was heard on 10 December 2005. Leave to serve this further evidence was not granted.
Four days prior to the 10 December hearing the opponent served a fifth request to file further evidence. Although the applicant had indicated that they intended to oppose this request and the opponent had asked for the matter to also be heard on 10 December, Reg 22.23(1) of the Patent Act 1990 stipulates that the Commissioner must give at least 10 days notice of the time, date and place of a hearing. As such the matter was deferred to be heard at a later date.
The applicant formally objected to the fifth request to serve further evidence on 10 January 2006 and the matter was heard in Canberra on 10 February 2006. Mr John Slattery, patent attorney of Davies Collison Cave represented the applicant. The opponent chose not to appear but provided written submissions to support their latest request to serve further evidence.
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 a statutory declaration made by Dr Mario Contorni together with exhibits MC-4 to MC-6. Dr Contorni’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.
THE RELEVANT LAW
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:
(i)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.
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)The broad discretion conferred by Reg 5.10 should not be reduced to an imperative 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.
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 by the delegate in this decision the application of the principles of Goninan requires a balancing exercise in which all competing considerations must be taken into account.
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 nature of the evidence is clear. The evidence relates to experiments that generally follow the protocol described in the Korean thesis. In particular the experiments repeat the adjuvant preparation procedure described in the thesis, and use the same plasma-derived source of hepatitis antigen.
This corrects shortfalls in previous experiments conducted by Dr Contorni where he produced an effective vaccine but failed to use the same adjuvant preparation protocol as the Korean thesis and used a recombinant rather than plasma-derived source of hepatitis antigen. Dr Contorni’s latest experiments also attempt to demonstrate that the applicant’s expert Dr Garcon’s failure to reproduce the Korean thesis protocol was unrelated to her use of plasma-derived hepatitis antigen. Although the latest experiments are a closer reproduction of the Korean thesis protocol, as acknowledged by the applicant in their written submission, the experiments are still not an exact repeat of the experiments outlined in the Korean thesis. This is because Dr Contorni’s experiments use a different source of pertussis toxin to that used in the Korean thesis protocol.
This difference is pivotal to the question of the significance of the further evidence. On the one hand, if the source of pertussis toxin does not influence the outcome of the vaccine formulation protocol then Dr Contorni’s latest experiments are likely to be highly significant to the substantive opposition proceedings. Dr Contorni’s experiments will provide a strong inference with respect to the outcome of the Korean protocol and play a critical role in addressing the issue of enablement of the Korean thesis. On the other hand, if the pertussis toxin plays a key role in success or failure of the vaccine formulation protocol, then Dr Contorni’s experiments provide at best a weak inference of the outcome of the Korean protocol and add little to the evidence that is already on file.
There is evidence from both parties that suggests that pertussis toxin source can have a significant impact on success or failure of vaccine formulation. In particular, in a first round of further evidence after the Korean thesis the opponent’s expert Dr Petre stated that Dr Garcon’s failure to produce an effective vaccine using the Korean protocol was not a consequence of problems with the Korean protocol rather it was a consequence of using an innappropriate source of pertussis toxin. Dr Petre explained that certain vaccine formulation protocols and pertussis toxin combinations form ‘jellyfish’ aggregates, which seriously compromise vaccine efficacy. Given this it would seem that any close reproduction of the Korean thesis protocol should use either the same source of pertussis toxin, or a source that is know to perform in a similar fashion in the context of the Korean protocol. In the absence of using a closely related source it would be difficult to predict the outcome of the formulation process.
Both party’s experts also agree that vaccine formulation is a highly unpredictable art, where it is very difficult to predict the outcome of any protocol prior to formulation and testing, and where even minor changes in components and formulation protocols can lead to substantial differences in the efficacy or immunogenicity of the final product.
Given all of this, the opponent has failed to convince me that Dr Contorni’s latest experiments should be regarded as more predictive of the outcome of the Korean protocol than any previous experiments. Although I agree that use of the same adjuvant preparation and hepatitis source as the Korean protocol brings Dr Contorni’s latest experiments further into line with the Korean protocol, failure to use the same pertussis source means that the experiments cannot provide a strong inference of the outcome of the Korean protocol. As such the latest experiments are unlikely to resolve issues relating to enablement of the Korean thesis, or have any critical effect on the outcome of the substantive proceedings.
Reasons for the delay
Mr Slattery submitted that the opponent had not provided sufficient reasons for the delay in filing this latest round of further evidence. He explained that it was evident that the opponent was in possession of the principle components of the further evidence, MC-5 and MC-6, in April and June 2005 respectively but that the evidence was not filed until 6 December 2005. He also submitted that at this very late stage in the opposition proceedings there was a strong onus on the opponent to make every effort to avoid further delays.
Although it is clear that the MC-5 and MC-6 were completed well prior to December 2005, the opponent’s submissions explain that further absorption work directed at demonstrating efficacy of the vaccine was not completed until September 2005. The opponent believed that the absorption work was a further demonstration of the efficacy of Dr Contorni’s vaccine formulation and chose to wait until this work was completed before filing all of the evidence together for the sake of completeness.
Although I agree with the applicant that there is a strong onus on the opponent to both avoid further delays and to provide good reasons for the delay, I can see some merit in the opponents decision to wait until all of the evidence relating to Dr Contorni’s latest round of experiments was finalised.
Interests of the parties
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.
In the case of the latest Contorni declaration, the opponent has not convinced me that this evidence is likely to play a significant role in the substantive opposition proceedings. The evidence still does not resolve the issue of enablement of the Korean thesis. The Contorni experiments differ from the Korean protocol and the opponent has failed to explain why, in the unpredicatable art of vaccine formulation, the Contorni experiments should be regarded as predictive of the outcome of the Korean protocol.
Given the limited significance 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
On balance, I do not believe that inclusion of the Contorni declaration will lead to a more just or correct result. The declaration does not add 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.
As a consequence, I do not believe that it is appropriate to allow the opponent’s application to file this further evidence.
COSTS
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
24 February 2006
Patent attorneys for the applicant : Davies Collison Cave, Melbourne
Patent attorneys for the opponent : FB Rice & Co, Melbourne
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