SmithKline Beecham Biologicals (S.A.) v Chiron Corporation
[2004] APO 15
•6 July 2004
OFFICIAL NOTICE
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 .
Abstract
The evidence consisted of two principal documents, a partial translation of a Korean thesis and a declaration made by one of the inventors. The partial translation of the Korean thesis was found to be highly relevant and its admission was likely to lead to a more correct or just result at the substantive hearing. In contrast, the inventor's declaration was unlikely to be determinative in the hearing. Furthermore, if admitted the document would likely lead to substantial further delays and disadvantage to the applicant.
Leave was granted to admit the Korean thesis but not the inventor's declaration.
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 The opposition was withdrawn on 13 February 2004 and the amendments included in the specification on 1 March 2004.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. The applicant objected to filing of this further evidence on 22 March 2004.
The opponent's opposition to the request to file further evidence was heard in Canberra on 12 May 2004. Mr John Slattery, patent attorney of Davies Collison Cave represented the applicant. Dr Ian Rourke and Dr Jenny Petering, patent attorneys 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 absorbed 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) absorbed 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."
2. "Use of aluminium phosphate (AP) as an adjuvant for absorbing 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 parts, the first part being a partial translation of a Korean masters thesis submitted in 1988 by Chang Baek Choi and documents related to the Korean thesis, filed on 24 February 2004 and 7 May 2004.
The second part consists of a document comprising a declaration made by Jean Petre (Petre), one of the inventors of 709406, filed on 7 May 2004. Petre was filed in relation to the corresponding European opposition proceedings on EP 642355, the European equivalent of 709406.
PRELIMINARY MATTERS
10. At the hearing Mr Slattery raised the point that the Korean thesis did not comply with regulation 22.15(2), which states:
Any other document that is filed, other than a document that has been translated into English and has with it a related certificate of verification, must be in English.
11. Following discussions at the hearing Mr Slattery agreed to waive the issue if the opponent promptly provided a certificate of verification for the translation.
12. Mr Slattery also pointed out that the translation was only a partial translation and that it was not clear, either from the translation or from the opponent's submissions, whether the translation represented the majority of the thesis or whether it was simply a translation of selected parts of the thesis. Dr Rourke admitted that he too had been unclear as to the extent of the translation but had been subsequently appraised that it was a translation of the entire thesis, with the exception of the figures whose text was already in English. In light of this information both parties agreed that there was no need for a full translation and that the existing partial translation would suffice.
13. Mr Slattery also submitted that it was not appropriate to consider Petre at the hearing because the document was not part of the original request to file further evidence or the proposed amendment to the statement of grounds and particulars. Both parties agreed at the hearing that this problem could be overcome if the applicant was given one month from the date of the hearing to provide submissions on Petre.
14. There was also discussion about further amendment of the statement of grounds and particulars to include Petre. There was general agreement between both parties that this issue need only be addressed if Petre was admitted as further evidence.
15. In their later submission on Petre the applicant argued that Petre was evidentiary in nature and as it was not drafted in the form of a statutory declaration for the Australian proceedings, it did not satisfy the technical requirements of regulation 22.12.
16. I note that the Commissioner is a tribunal and as such the court "rules of evidence" do not apply in proceedings before the Commissioner. This means that the Commissioner is able to accept "hearsay" evidence that would not be admissible in court. In my view the O'Rourke declaration with the Petre document exhibited is "evidence" of what Petre stated in a declaration on related proceedings in Europe. In that sense it is "hearsay" evidence which does meet the requirements of regulation 22.12. The issue then is not whether it is admissible but how much weight "hearsay" evidence would be given in the proceedings.
THE RELEVANT LAW
17. 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.
18. 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.
(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.
19. 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.
20. 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 Korean thesis
19. The Korean thesis exemplifies a multivalent vaccine comprising HBsAg, diphtheria, pertusis and tetanus antigens with AP as the adjuvant. As such it is prima facie highly relevant to the novelty of the claims of the opposed application.
20. A general review of the evidence on file suggests that none of the evidence exemplifies multivalent HBsAg vaccines comprising at least two of the further antigens listed above with AP as the HBsAg adjuvant. Although numerous documents disclose some of the features of the claims, for example HBsAg vaccines using AP as adjuvant and multivalent HBsAg vaccines using AH as adjuvant, it is not apparent that any document exemplifies multivalent HBsAg vaccines with AP as adjuvant. As such, the Korean thesis is not only highly relevant to the novelty of the claims it is also likely to be highly significant to the substantive proceedings.
The Petre document
21. Jean Petre is one of the inventors of 709406 and Petre represents a concession by one of the inventors that there were flaws in the data presented in 709406. Petre explains that the HBsAg-AH control formulation disclosed in the 709406 was prepared in the absence of phosphate buffer, unlike standard commercial HBsAg-AH formulations at the time, and that subsequent experiments have shown that phosphate buffer is essential for the immunogenicity of HBsAg vaccines. Petre also provides examples of further documents, published after the priority date of 709406 that disclose the formulation of multivalent HBsAg vaccines using AH as adjuvant where the vaccines show good immunogenicity in clinical trials.
22. It is clear that Petre throws doubt on the selective advantage of AP demonstrated in 709406 and that this is relevant to the hearing. If there is no selective advantage to AP, then there may be no inventive step in selecting a known adjuvant for the formulation of a multivalent HBsAg vaccine. None of the documents already on file raise this issue or provide a direct comparison of multivalent HBsAg vaccines formulated with AP and AH. However, relevance alone is not sufficient, further evidence must also add to the existing evidence or assist in resolving unanswered questions.
23. Petre does not resolve the question of selective advantage or provide evidence that AP and AH are equally effective adjuvants, it simply provides one reason why AH may have performed poorly in the comparative examples in 709406. The question of selective advantage can only be resolved by a direct comparison of multivalent HBsAg-AP and HBsAg-AH and Petre does not provide this information.
24. As such, although Petre is clearly relevant to the hearing, it does not provide evidence that is likely to have any real impact on the hearing or that is likely to contribute to a more correct decision.
Reasons for the delay
25. At this late stage of proceedings the onus is on the opponent to provide a reasonable explanation for the delay in filing further evidence.
26. Dr Rourke explained that he first became aware of Petre in May 2003 and the Korean thesis in December 2003, during discussions with the attorney managing the opponent's European and Korean proceedings respectively. At this stage the s104 opposition was ongoing and both parties had agreed to put the s59 proceedings on hold until the s104 matter was resolved. This is a common approach. Until a s104 matter is resolved it is not clear which specification will be the subject of a substantive opposition. It also follows that a s104 decision may affect the relevance of further evidence.
27. As a consequence the opponent elected to await the outcome of the s104 matter before deciding whether or not to file a request to serve Petre and the Korean thesis as further evidence.
28. The s104 opposition was withdrawn on 13 February 2004 and the amendments were subsequently incorporated into the specification. Both parties were informed of the restart of s59 proceedings in a letter sent on 18 February 2004. Following receipt of this letter, on 24 February 2004 the opponent filed their second request to serve further evidence and to amend the statement of particulars. A copy and a partial translation of the Korean thesis accompanied the request.
29. Although I agree with the applicant that it is unfortunate that the further evidence was only revealed at this late stage in the opposition proceedings, I believe that the opponent's decision to await resolution of the s104 matter before proceeding with further evidence provides sufficient reason for the delay.
Interests of the parties
30. 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 response to the evidence. The Patent Office is also disadvantaged by disruption of orderly and efficient proceedings within the office. However, if the evidence is relevant to the hearing and it is not allowed, the public and the opponent will be disadvantaged because the case will not be heard on its merits.
31. In the case of the Korean thesis, the thesis is prima facie highly relevant to the opposition and it is likely that both the opponent and the public would be significantly disadvantaged if it was not admitted as evidence and the case not determined on its merits.
32. In contrast, Petre is unlikely to determinative and thus unlikely to advance the opponent's case or lead to a more just outcome. Furthermore, if Petre were to be included its inclusion would significantly disadvantage the applicant in terms of costs and delays in the opposition proceedings.
DECISION
33. I find that the opponent has provided a satisfactory reason for the delay in filing the further evidence.
34. Furthermore, it is clear that the Korean thesis is highly relevant to the substantive opposition proceedings and is likely to be a key determinant in the hearing. The relevance and significance of the thesis and the likelihood that its 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 the Korean thesis 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 Korean thesis.
35. In contrast, the evidence in Petre is inconclusive and it is not clear that it will add to the opposition proceedings. Although it raises a question about the selective advantage of AP, it does not answer this question nor provide any evidence that there is no selective advantage to AP.
36. Furthermore, if it were to be admitted as further evidence it is likely that the applicant would need a substantial period of time, and would incur substantial costs, to prepare a response. The questions raised by Petre are best addressed by experimental data that either directly compares AP and AH or that disputes the conclusions drawn by it. Collecting this data or conducting these experiments is likely to take considerable time and to be associated with significant costs. Thus, the inclusion of Petre would significantly disadvantage the applicant and lead to substantial further delays at what is already a very late stage in the opposition proceedings.
37. Given that Petre's inclusion is unlikely to contribute to a more just determination in the substantive proceedings the disadvantages arising from its inclusion outweigh any advantages that may arise from including a document that although relevant does not add to any existing evidence or answer any outstanding questions. As such, I do not grant leave to serve Petre as further evidence with the result that there is also no need for further amendment of the statement of grounds and particulars to include a reference to Petre.
COSTS
38. The normal practice is that costs follow the event. However, it appears that there are good reasons why the applicant chose to object to admission of both pieces of evidence.
39. It was not clear that the partial translation of the Korean was not simply a selection of only those parts of the thesis that related a multivalent HBsAg-AP vaccine, or that the translation did not exclude contradictions and non-AP examples that might reduce the impact of the AP example. Although Dr Rourke's submissions at the hearing established that this was not the case, this information was not available at the time that the applicant objected. With respect to Petre, any response to Petre at this late stage in the proceedings would lead to further delays and costs that would significantly disadvantage the applicant.
40. Given these reasons, I believe that the applicant's objections were reasonable and justified and that it is appropriate that costs be awarded against the opponent.
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Davies Collison Cave, Melbourne
Patent attorneys for the opponent : FB Rice & Co, Melbourne
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