Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft
[2001] APO 13
•16 March 2001
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 679428 in the name of Sonus Pharmaceuticals, Inc.
Title: Gaseous ultrasound contrast media and method for selecting gases for use as ultrasound contrast media
Action: Requests to serve further evidence in two oppositions to the grant of a patent by Alliance Pharmaceutical Corp and Schering Aktiengesellschaft
Decision: Issued
Abstract
The further evidence was based on an assertion that the evidence served in reply was not properly reply evidence, and raised new issues.
Found:
The applicant had provided a reasonable explanation of the delay.
The evidence was not significant as it was either prima facie evidence in reply, or was of a nature that did not require a response. This determination required a consideration of the material served as evidence in reply, and the material served as evidence in answer.
The interests of the applicant were low because of the low significance of the evidence.
The interests of the opponents and the Patent Office were against allowing the further evidence.
The request was refused.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 679428 by Sonus Pharmaceuticals, Inc. and requests to serve further evidence in two oppositions to the grant of a patent by Alliance Pharmaceutical Corp and Schering Aktiengesellschaft
BACKGROUND
Patent application number 25503/92 was filed as an international application designating Australia (number PCT/US92/07250) on 2 September 1992 by Steven C. Quay. The applicant was changed to Sonus Pharmaceuticals, Inc (hereafter referred to as Sonus) during the international phase. The application claims priority from US 761311 (which was filed on 17 September 1991) and US 893657 (which was filed on 5 June 1992). The application was examined by the Commissioner, and advertised accepted under the serial number 679428 on 3 July 1997.
Alliance Pharmaceutical Corp (hereafter referred to as Alliance) filed a notice of opposition on 3 October 1997. A statement of grounds and particulars was served on 5 January 1998. The evidence stages (up to and including evidence in reply) were completed on 16 August 2000.
Schering Aktiengesellschaft (hereafter referred to Schering) filed a notice of opposition on 3 October 1997. A statement of grounds and particulars was served on 2 January 1998. The evidence stages (up to and including evidence in reply) were completed on 28 September 2000.
Molecular Biosystems, Inc filed a notice of opposition on 3 October 1997. This opposition was withdrawn following the service of evidence in reply.
The matter was set for hearing in Canberra on 1 and 2 March 2001. On 31 January 2001 Sonus applied to serve further evidence in both of the oppositions. The reasons provided are identical in each case. Both Alliance and Schering objected to the further evidence.
It was the intention of the Commissioner to hear the further evidence matter in conjunction with the substantive opposition. Unfortunately Sonus were not able to proceed with the substantive opposition on the agreed date, and the hearing proceeded on 1 March 2001 only with respect to the further evidence. Sonus appeared by telephone, and was represented by Mr B.Hess of counsel assisted by Dr S.Boyer of Griffith Hack. Alliance was represented by Dr A.Bennett of counsel assisted by Mr I.Rajkovic of Baldwin Shelston Waters, who appeared in person. Schering appeared by telephone and was represented by Dr P.Stearne and Dr R.Heisey of Davies Collision Cave.
DECISION
The requests to serve further evidence
The request to serve further evidence in both oppositions were identical, except for the name of the opponent appearing at the top of the requests. The request is quoted extensively below. The essence of the requests is that it has taken time to review the evidence served in all of the oppositions, and Sonus has determined that some of the evidence in reply is not properly in reply, and needs to be countered by serving further evidence.
At the hearing Mr Hess realised that the request in respect of the Schering opposition was in error in that it referred (only) to paragraphs of the Klein, Howe and Kabalnov declarations. The significance of this is that the Klein, Howe and Kabalnov declarations are not part of the evidence in the Schering opposition (they are part of the Alliance evidence). The request in respect of the Schering opposition contains no detail of deficiencies in the Schering evidence in reply. On the face of the request there is no case to answer. Dr Heisey stated that this was his interpretation of the request.
Mr Hess submitted that the request was clearly in error, in that it should have referred to deficiencies in the evidence served by Schering, and that Schering should have questioned the request. It is not appropriate to place on Schering the responsibility for ensuring that Sonus has made a proper request. It is the responsibility of Sonus to make their request correctly, and in this case they have manifestly failed to do so. I consider that this first request must fail.
Mr Hess faxed a copy of the request (as it should have been filed) to both Schering and myself during the course of the hearing. This second request seems to be identical to the first version except that it identifies paragraphs of the Uhlendorf declaration rather than the Klein, Howe and Kabalnov declarations.
This second request cannot be ignored. In my opinion a second request has been made, and it must be considered on its merits. Schering are clearly disadvantaged by receiving the request during the hearing, but they still made submissions on the request. I will consider the merits of the second request and the Alliance request together.
It must be understood that the argument of Sonus is that further evidence is required because the evidence in reply includes new evidence that is not properly in reply. The request identifies paragraphs of the evidence in reply that it is alleged are not properly in reply, but does so by way of examples only. At the hearing Mr Hess further elaborated on the paragraphs that were not in reply, and provided me with his complete list of disputed paragraphs of the evidence.
The relevant law
Further evidence is governed by regulation 5.10. The relevant subregulations state:
(4) The Commissioner may:
(a) on the application of a party; and
(b) on such reasonable terms (if any) as the Commissioner specifies;
permit the party to serve further evidence on the other party.(5) The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:
(a)if he or she proposes to grant an application by a party - is reasonably satisfied that the other party has been notified of the application; and
(b)if he or she proposes to act on his or her own motion - ensures that the parties are notified of the proposed action; and
(c)in either case:
(i)gives the parties a reasonable opportunity to make representations concerning the application or proposed action; and
(ii)is reasonably satisfied that a direction, an extension of time or the serving of further evidence is appropriate in all the circumstances.
In the circumstances, I am satisfied that Alliance and Schering have been notified, and the parties have had an opportunity to make representations. Due to the short period of time in respect of the second Schering request, it is open to me to consider whether Schering have had a reasonable opportunity. In addition, the contentious paragraphs of the Alliance evidence were only fully identified at the hearing, which raises the same question in relation to Alliance. I will consider this issue more fully if I find that the further evidence should otherwise be allowed.
The question that must now be considered is whether I am satisfied that it is appropriate to allow the serving of the further evidence. In exercising this discretion I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) AIPC 91-057; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents (1997) AIPC 91-330; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33 on the operation of regulation 5.10(5) in relation to extensions of time. The general principles that flow from these decisions are:
a)The power is discretionary: Regulation 5.10 confers a broad discretion, which cannot be reduced to imperative compliance with particular requirements. It is necessary to give genuine and proper consideration to all relevant considerations. (Ferocem at AIPC 38,208; IPR 247-8, Goninan at AIPC 39,434; IPR 220)
b)Explanation of delay: The reasons why the evidence was not served earlier are a relevant consideration, but a satisfactory explanation is not a mandatory requirement. (Ferocem at AIPC 38,207-8; IPR 247)
c)The public interest: The public interest in determining a serious opposition on its merits is a relevant consideration. (Goninan at AIPC 39,435-6; IPR 222)
* 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. (Goninan at AIPC 39,438; IPR 225-6)
* The significance of the evidence is assessed having regard to any relevant material available, not just the evidence itself. (National Starch at [33])
* The public interest is not protected merely because some evidence has already been served. (Goninan at AIPC 39,438; IPR 225)
d)The interests of the party seeking the exercise of discretion: The interests of the party seeking the exercise of discretion are a relevant consideration. (Ferocem at AIPC 38,208; IPR 247)
e)The interests of other parties: 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. (Ferocem at AIPC 38,208; IPR 247, Goninan at AIPC 39,436; IPR 222)
These considerations seem equally relevant to the determination of the present request for further evidence. Previous decisions of the Commissioner on further evidence illustrate different aspects of these considerations, but do not represent binding rules. It also follows from the words of regulation 5.10(5) that, before allowing a party to serve further evidence, I must be satisfied that allowance is appropriate in all the circumstances.
The facts
The applications for further evidence (as originally filed) state:
"In preparation for the hearings our Australian attorneys retained and briefed counsel. Our Australian- and United States-based experts began reviewing the Evidence-in-Reply served by all three opponents in the light of our Evidence-in-Answer. This obviously necessitated the re-reading of all three opponents Evidence-in-Support together with our Evidence-in-Answer. The Evidence-in-Reply served by the three opponents was: [a list of the evidence in reply follows]
Even though MBI withdrew their opposition, our experts and we had already undertaken the process of reviewing their Evidence-in-Reply before they withdrew. Furthemore, it was considered that, even though not directly relevant any more, it was important to complete the review as there may have been material encompassed in MBI's Evidence-in-Reply which could be relevant to the remaining oppositions.
It can be seen that the amount of Evidence-in-Reply served by the opponents was considerable. Moreover the evidence brought forward by the declarants was complex and required exhaustive examination. Consequently, given that both the Evidence-in-Reply and Evidence-in-Answer for all three oppositions needed to be read or re-read by all of our experts and counsel, the process of reviewing the opponents Evidence-in-Reply has taken longer than anticipated. The intervening Christmas/New Year holidays further complicated this process. More importantly, our principal instructing attorneys in the USA, who have coordinated the activities of all concerned in these oppositions for a number of years, ceased operation as a patent attorney firm on 31 December 2000.
Accordingly, we have found the task of coordinating the various activities in the United States and Australia to be severely impeded. Despite this the review of all of the opponents Evidence-in-Reply has now been completed. Having done so, it is our opinion, and that of our patent attorney and counsel, that much of the purported Evidence-in-Reply served by the opponents, travels well beyond strict Evidence-in-Reply and, in fact, constitutes new evidence introduced into the opposition for the first time at the Reply stage.
For instance, a number of the statutory declarations served by the opponents are by experts not previously used in that opponents Evidence-in-Support. It is our opinion that these 'new' declarants have sought to introduce matter not previously raised in the Evidence-in-Support. In particular, a number of the declarants have attempted to overcome our experts' opinions by raising scientific argument and opinion which needs to be properly addressed by way of answering evidence and opinion, and which, if left unchallenged, could not be effectively addressed merely by submission during the hearing. If the hearings were to proceed as scheduled on the present state of the evidence, without the ability to advance further answering evidence, we should be severely disadvantaged.
Without pre-empting the nature of the further evidence, which might be advanced in answer, we note by way of example that the Evidence-in-Reply by the opponents constitutes new material. For instance, as follows:
1). Paragraphs 9, 13 & 14 of Klein;
2). Paragraphs 6 to 9, 11 to 14, 16, 17 & 19 of Howe; and
3). Paragraphs 10, 12, 13 & 15 of Kabalnov.
Accordingly, we request the opportunity to have further answering evidence to be brought into the opposition, and placed on the record in a proper form so that rebuttal submission points can be made if required. We anticipate that the process of preparing and finalising the answering evidence should take three to four weeks."
Prior to the hearing, Alliance requested that Sonus provide more information about the disputed paragraphs of the evidence in reply. Sonus replied in a "Without prejudice" letter dated 22 February 2001. A copy of this letter was given to me with the agreement of the parties. This letter identifies the same paragraphs as in the original request.
The second request in relation to the Schering opposition identifies the following paragraphs:
Paragraphs 10-13, 20, 24, 29, 30a/30b, 31 to 35 of Uhlendorf.
At the hearing Mr Hess provided further information about the events leading up to the further evidence. At my request, these facts were included in a statutory declaration filed on the day following the hearing. These additional facts can be summarised as:
19 May 2000 Part evidence in reply received. 31 May 2000 Part evidence forwarded to Professor MacFarlane for comment 20 June 200 Further part evidence in reply received 3 July 2000 Evidence forwarded to Professor MacFarlane for comment 21 July 2000 Professor MacFarlane confirmed receipt of evidence 26 July 2000 Further part evidence in reply received 3 August 2000 Evidence forwarded to Limbach & Limbach and Professor MacFarlane 20 September 2000 Further part evidence in reply received 28 September 2000 Evidence forwarded to Limbach & Limbach and Professor MacFarlane 6 October 2000 Professor MacFarlane confirmed he had started reading the evidence 11 October 2000 Section 104 amendments proposed 17 October 2000 Limbach & Limbach advised that Professor MacFarlane should cease his evaluations of the evidence 19 December 2000 Limbach & Limbach advised that Professor MacFarlane should resume evaluating the evidence 19 December 2000 Limbach & Limbach advised that they would cease operation 19 January 2001 Professor MacFarlane sent his comments to Griffith Hack 22 January 2001 Professor MacFarlane sent further comments 29 January 2001 Dr Boyer met with Mr Hess to discuss Professor MacFarlane's comments 31 January 2001 Request to file further evidence
Mr Hess also expanded on the paragraphs of the evidence in reply that he considers go beyond evidence in reply. The ultimate list of paragraphs is:
A. In relation to the Alliance opposition
Paragraphs 10, 11, 12, 13, 15 and 16 of Kabalnov
Paragraphs 6, 7, 8, 9, 11, 12, 13, 14, 16, 17 and 19 of Howe
Paragraphs 9, 13, 14 of Klein
Paragraph 4 of Trevino
Paragraphs 4, 5, 6, 7, 8, 11, 12 and 13 of GrieserB. In relation to the Schering opposition
Paragraphs 8, 9, 10, 11, 12, 13, 20, 24, 29, 30, 31, 33 and 35 of Uhlendorf
Paragraphs 4, 5, 6, 7, 8, 9, 10, 11, 13, 15, 16, 17 and 18 of Grieser
Application of the facts to the law
Explanation of delay
Sonus has argued that the evidence is in response to new matters raised in the evidence in reply. If this is correct, then this further evidence could not have been served with the evidence in answer. The delay between the filing of the evidence in reply and the request for further evidence is four months (in the case of the Schering opposition) and five months (in the case of the Alliance opposition). The reason for this delay was essentially the amount of material that needed to be reviewed, the complexity of the material and the intervention of the Christmas period. It appears that Griffith Hack passed on the evidence in reply promptly. There was a period of 2 months during which Professor MacFarlane was advised not to consider the evidence in reply. However, overall there has been a reasonable explanation of the delay.
Mr Hess indicated that the further evidence should be available within about 2 weeks of the hearing.
The public interest
The public interest requires a consideration of the nature and significance of the evidence. The nature of the evidence is said to be an answer to new issues raised in the evidence in reply. Mr Hess stated that the evidence would consist of declarations by Professor MacFarlane and an unidentified expert based in the United States. The evidence will include exhibits, such as extracts from text books.
The reason why the evidence is needed is said to be to address matters in the evidence in reply which is not properly reply evidence. The significance of this evidence is that it will provide a counter to this "new" evidence. In order to assess the significance of this evidence I believe that there are three questions that I need to consider:
(i)is there material in the evidence in reply that is not properly reply evidence
(ii)does the evidence address any matters that are not properly in reply
(iii)is any material that is not properly in reply likely to be significant in the opposition
Before looking at the disputed paragraphs, it is essential to have a clear understanding of the definition of evidence in reply. Evidence in reply is a part of the three stage evidence process set up under the Patents Regulations: the opponent presents the evidence to support the case that they have spelt out in the statement of grounds and particulars (the evidence in support stage); the applicant presents evidence to rebut that case (the evidence in answer stage); and the opponent can respond to the evidence of the applicant (the evidence in reply stage).
Evidence in reply is clearly distinguished from evidence in support. Phipson on the Law of Evidence states that evidence in reply must be confined to rebutting the applicant’s case, and should not merely confirm the case in chief. Additionally, evidence in reply cannot raise matters that should have been raised in the evidence in support. This was emphasised by Graham J in Ernest Scragg & Sons Ltd’s Application [1972] FSR 219 at 223:
“To my mind it is quite wrong in these cases that there should be any sort of skirmishing in regard to evidence, and if an opponent has a case he should straight away state what his case is and should put in declarations dealing with any evidence which he thinks may be relevant to that case. The applicant can then deal with the matter in the normal way, and a lot of time is saved, and the Office can get on with deciding the case. If the opponent does not do that and waits until he sees what the applicant says, then obvious difficulties will result and oppositions will inevitably be drawn out and never finished.”
While this case was referring to the Patents Act in the United Kingdom, the principles are equally relevant to the present Australian Patents Act.
I note that there have been several decisions of the Commissioner that illustrate other principles of further evidence:
Optech International Ltd v Buxton Hicarium Ltd (1993) 28 IPR 649: evidence provided in an attempt to rectify deficiencies in the evidence in support is not evidence in reply.
Inax Corp v Caroma Industries Ltd [1994] APO 48: evidence that had no link to statements or opinions in the evidence in answer was not evidence in reply.
Emory University v Biochem Pharma Inc (1997) 39 IPR 603: matter that should have been raised as evidence in support (because it was an essential part of a ground of opposition) was not properly evidence in reply.
I conclude that in general evidence in reply:
(i)is not evidence that should have been served as evidence in support
(ii)responds to some matter raised by the evidence in answer
(iii)does not merely confirm the evidence in support
I am also conscious of the fact that material that is filed as evidence may also include material which is not strictly evidence, for instance quotes from the specification, and submissions on matters of law. Such material cannot be characterised as evidence in reply, because it is not even evidence. However, it follows that such material would not require responding evidence (since there is no evidence in such reply material).
It follows that there is no requirement for the person giving evidence in reply to have given evidence in support. It is the nature of the evidence that must be considered, not the identity of the person giving the evidence.
The only time that a final determination of whether the evidence is actually in reply is made is during the substantive hearing of the opposition. However, that does not mean that I cannot form a view of the question, and indeed it is essential for me to do so in order to decide the matter before me. However, it is only possible to form a preliminary view. If there is a reasonable basis for believing that evidence fits the definition of evidence in reply, then I believe that I should treat that evidence as reply evidence at this time unless Sonus can satisfy me that that conclusion is not appropriate. It may be that a different conclusion would be reached after detailed analysis of the declarations, such as during the substantive opposition. It clearly would have been easier to determine these issues as a part of the substantive opposition, but that option is not available. I am required to make a preliminary assessment, and to base my decision on that assessement. I will go through the disputed paragraphs of the evidence in reply in turn.
Kabalnov declaration
Paragraph 10: This paragraph does not refer to any parts of the evidence in answer. It is stated that the Q coefficient alone does not explain the lifetime of bubbles. The usefulness of the Q coefficient was discussed by MacFarlane at paragraph 8 at least. Thus Kabalnov is responding to an issue raised in the evidence in answer.
Paragraph 11: This paragraph does not refer to any parts of the evidence in answer. However, this paragraph seems to follow on from paragraph 10. It is stated that the Q coefficient is incorrectly calculated in the specification. It appears on the face of this paragraph, read in conjunction with paragraph 18 (to which it refers), that Kabalnov agrees that the Q coefficient is a valid approach to estimating bubble lifetime (as stated by him in paragraph 10), but that the Q values in the specification are not useful. To this extent, Kabalnov is responding to an issue raised by MacFarlane in paragraphs 8 and 23, at least, of his declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 12: This paragraph does not refer to any parts of the evidence in answer. It is stated that there are more errors in the specification. Dr Kabalnov goes on to explain that Table IV of the specification contains some non-gases. This is an observation on the specification, rather than a matter of evidence needing a reply.
Paragraph 13: This paragraph does not refer to any parts of the evidence in answer. It is stated that the method of evaluating microbubble stability in the specification is not entirely sound, and leads to an overestimate of bubble stability. However, Dr Kabalnov does not seem to indicate anything that flows from this alleged overestimation. This seems to be analogous to the matter raised in relation to paragraph 11, and again is responding to the usefulness of the Q values, which was discussed by MacFarlane. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 15: This paragraph refers to the MacFarlane declaration, and disagrees with some of his views. The disputed part of the paragraph is where Dr Kabalnov appears to give reasons why he disagrees with Professor MacFarlane. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Howe declaration
Paragraph 6: This paragraph refers to paragraph 12 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 7: This paragraph refers to the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 8: This paragraph does not refer to any parts of the evidence in answer. The paragraph appears to summarise Example 6 of the opposed specification. This is an observation on the specification, rather than a matter of evidence needing a reply.
Paragraph 9: This paragraph does not refer to any parts of the evidence in answer. The paragraph gives a view of the construction of the specification with regard to Example 6. Example 6 is discussed by MacFarlane in paragraph 12 (at least). On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 11: This paragraph refers to Exhibit DRM-9. This is an Exhibit to the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 12: This paragraph compares Example 6 with Exhibit DRM-9. On the face of it this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 13: This paragraph again refers to Exhibit DRM-9. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 14: This paragraph refers to paragraph 12 of the MacFarlane declaration, and Exhibit DRM-9. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 16: This paragraph refers to paragraphs 15-21 of the MacFarlane declaration and Exhibit DRM-6. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 17: This paragraph refers to Exhibit DRM-5 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 19: This paragraph refers to paragraphs of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Klein declaration
Paragraph 9: This paragraph does not refer to any parts of the evidence in answer. The paragraph places a construction on Example 6 of the specification. Example 6 is discussed by MacFarlane in paragraph 12 (at least). On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 13: This paragraph refers to paragraph 12 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 14: This paragraph refers to paragraph 12 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Trevino declaration
Paragraph 4: This paragraph refers to the Lai declaration, stating “Lai gives no details on the preparation of the perfluorohexane or hexane microbubbles”. Thus rather than responding to an issue raised by Lai, this paragraph is responding to a perceived deficiency in the evidence of Lai. On the face of it, this paragraph is responding to a deficiency in the evidence in answer.
Grieser declaration (filed in the Alliance oppositon)
Paragraph 4: This paragraph says there are some details missing from Lai’s declaration. These matters are apparently addressed in the later paragraphs of the Grieser declaration. Thus this paragraph does not provided any evidence, but merely foreshadows what is to follow.
Paragraph 5: This paragraph refers to paragraph 17 of the Lai declaration, but states “nowhere in his declaration does Lai acknowledge that …”. Thus rather than responding to an issue raised by Lai, this paragraph is responding to a perceived deficiency in the evidence of Lai. On the face of it, this paragraph is responding to a deficiency in the evidence in answer.
Paragraph 6: This paragraph refers to Table 2 of Lai’s declaration. On the face of it, this paragraph is responding to a matter raised in the evidence in answer.
Paragraph 7: This paragraph refers to paragraphs 22 and 23 of the Lai declaration. On the face of it, this paragraph is responding to a matter raided in the evidence in answer.
Paragraph 8: This paragraph does not refer to any part of the evidence in answer. The paragraph presents an explanation of an observation in Example 6. Example 6 is discussed by MacFarlane in paragraph 12 (at least). On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 11: This paragraph refers to Example 6, and to the Lai declaration. Example 6 is discussed by MacFarlane in paragraph 12 (at least). On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 12: This paragraph does not refer to any parts of the evidence in answer. The praragraph presents some views on Example 6. Example 6 is discussed by MacFarlane in paragraph 12 (at least). On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 13: This paragraph does not refer to any parts of the evidence in answer. The paragraph refers to the Q coefficient and Example 6. As mentioned previously, both of these matters are raised in the evidence in answer.
Uhlendorf declaration
Paragraph 8: This paragraph does not refer to any parts of the evidence in answer. The paragraph consists of quoting various parts of the specification. I would characterise this as observations on the specification, rather than a matter of evidence needing a reply.
Paragraph 9: This paragraph does not refer to any parts of the evidence in answer. The paragraph consists of quoting various parts of the specification. I would characterise this as observations on the specification, rather than a matter of evidence needing a reply.
Paragraph 10: This paragraph does not refer to any parts of the evidence in answer. The paragraph consists of quoting various parts of the specification. I would characterise this as observations on the specification, rather than a matter of evidence needing a reply.
Paragraph 11: This paragraph does not refer to any parts of the evidence in answer. The paragraph consists of quoting various parts of the specification. I would characterise this as observations on the specification, rather than a matter of evidence needing a reply.
Paragraph 12: This paragraph does not refer to any parts of the evidence in answer. The paragraph consists of quoting various parts of the specification. I would characterise this as observations on the specification, rather than a matter of evidence needing a reply.
Paragraph 13: This paragraph does not refer to any parts of the evidence in answer. Rather, it contains conclusions that are said to flow from paragraphs 8 to 12. This paragraph is basically a submission on the (lack of) fair basis of claim 19. A submission on a question of law is not strictly a matter of evidence, and does not require evidence n response.
Paragraph 20: This paragraph refers to paragraphs 11, 13 and 15 of the Lai declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 24: This paragraph refers to paragraph 6 of the Kessler declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 29: This paragraph refers to paragraph 9 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 30: This paragraph refers to paragraphs 16 to 20 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 31: This paragraph refers to paragraph 27 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 33: This paragraph refers to paragraph 31 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 35: This paragraph refers to paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Grieser declaration (filed in the Schering opposition)
Paragraph 4: This paragraph refers to paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 5: This paragraph does not refer to any parts of the evidence in answer. However, this paragraph seems to follow on from paragraph 4 (discussed above). The paragraph addresses the definition of a term used in claim 19 of the specification. This claim was discussed in paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 6: This paragraph does not refer to any parts of the evidence in answer. However, this paragraph also seems to follow on from paragraphs 4 and 5. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 7: This paragraph does not refer to any parts of the evidence in answer. However, this paragraph also seems to follow on from paragraphs 4 to 6. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 8: This paragraph does not refer to any parts of the evidence in answer. However, this paragraph also seems to follow on from paragraphs 4 to 7. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 9: This paragraph does not refer to any parts of the evidence in answer. However this paragraph seems to follow on from paragraphs 4 to 8, and draws the final conclusion. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 10: This paragraph refers to paragraphs 35 and 36 of the Fritzsch declaration. Fritzsch gave evidence in support. Consequently, this paragraph seems to be merely confirmatory of the evidence in support.
Paragraph 11: This paragraph refers to paragraphs 36 of the Fritzsch declaration. Fritzsch gave evidence in support. Consequently, this paragraph seems to be merely confirmatory of the evidence in support.
Paragraph 13: This paragraph refers to paragraph 43 of the MacFarlance declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 15: This paragraph refers to paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 16: This paragraph refers to paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 17: This paragraph refers to paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
Paragraph 18: This paragraph refers to paragraph 43 of the MacFarlane declaration. On the face of it, this paragraph is responding to an issue raised in the evidence in answer.
I conclude that prima facie the evidence is in reply. There are some paragraphs that seem to be observations on the specification, submissions or a foreshadowing of evidence, rather than reply evidence. However, these paragraphs do not require responding evidence. There are also some paragraphs that are merely confirmatory. These paragraphs do not raise any issues that could not have been addressed during the evidence in answer. I have not sought to determine whether the evidence in answer addressed these specific matters.
Sonus argued that the disputed paragraphs of the evidence in reply raised new grounds of opposition, such as sufficiency of description and utility. Utility is not a ground of opposition, so any such evidence is irrelevant. The mere fact that the evidence introduces new information does not mean it is not in reply. In fact, reply evidence must raise new information, otherwise it is merely confirming existing evidence (which is inappropriate). Sonus needs to show the evidence is NOT in reply, rather than that it introduces new information. This they have not done.
I conclude that Sonus have not satisfied me that the evidence in reply is not reply evidence. This analysis has necessarily been carried out at a prima facie level, and it should not be assumed that the same conclusions will be reached upon a fuller examination during the substantive opposition. Indeed, it would have been simpler if the further evidence issue had been heard together with the substantive opposition, but that option was not acceptable to Sonus.
Since the significance of the further evidence is alleged to flow from the nature of the evidence in reply, it follows that the further evidence is of low significance, since prima facie the evidence in reply is properly reply evidence.
The public interest in a correct determination of this opposition does not support the inclusion of the further evidence. The evidence is properly in reply, so does not need to be rebutted. Consequently the matter can properly be decided on the evidence already available.
The interests of Sonus
The interests of Sonus lie in favour of having available evidence to support their case and dispute the case of the opponents. However, the reason for having this evidence included is to counter the reply evidence which is not in reply. Since the reply evidence has not been shown to go beyond the proper bounds, this reason is of low importance.
The interests of Alliance and Schering
The interests of Alliance and Schering lie in favour of not allowing further evidence to be served.
Interests of the Patent Office
The interests of the Patent Office in the orderly processing of matters before the Commissioner are a minor consideration in this matter, and rank behind the interests of the parties.
Other relevant considerations
Mr Hess stated that if Sonus was not able to introduce the further evidence they may be unable to rely on that evidence in any subsequent appeal (based on the views of Emmett J in F Hoffman-La Roche AG v New England Biolabs Inc (2000) 99 FCR 56). I do not believe that this is relevant to my present decision because "it would require the delegate to speculate as to the issues which might arise on an appeal, which was not part of the task committed to him" (National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33 at [35]). The parties did not raise any other relevant matters. Sonus argued their case only on the basis of the evidence in reply, and it is not obvious to me that the facts support a case for further evidence on any other basis. I am not aware of any other relevant considerations.
The balance of considerations
I have found that there has been a reasonable explanation of the delay. However, the evidence is of low significance. The interests of Sonus mirror the low significance of the evidence. Consequently, the significance of the evidence and the interests of Sonus do not support the further evidence. The other interests are against the further evidence, but I consider that individually and collectively they are of low importance to my decision. I consider that the significance of the evidence is an important consideration in this case. On balance I consider that an appropriate case for further evidence has not been made.
I refuse the request for further evidence.
Other matters
The hearing of the substantive opposition has been set down for 25 and 26 March 2001 in Canberra. Given that there is no further evidence, this hearing will deal with all matters in the opposition.
Costs should reflect the fact that Sonus has been entirely unsuccessful. I award costs in relation to the application for further evidence against the applicant, Sonus Pharmaceuticals, Inc.
Dr S.D.Barker
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Griffith Hack, Melbourne
Patent attorneys for Alliance : Baldwin Shelston Waters, Sydney
Patent attorneys for Schering : Davies Collison Cave, Sydney
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