Allergan Pharmaceuticals Inc v Alcon Laboratories (Australia) Pty Ltd

[1991] APO 36

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No 588049 by ALLERGAN PHARMACEUTICALS INC, Opposition by ALCON LABORATORIES (AUSTRALIA) PTY LTD and Objection to Extension of Time to Serve Evidence-in-Support

Background

Allergan Pharmaceuticals Inc (Allergan) lodged application 588049 on 20 August 1986 for an invention relating to cleaning contact lenses.  The Office advertised acceptance of the application on 7 September 1989.  Notices of opposition were lodged by Pilkington Visioncare Inc and by Alcon Laboratories (Australia) Pty Ltd (Alcon).  This decision relates to the latter opposition.
          The initial date for serving evidence-in-support was 6 March 1990 but Alcon was allowed three extensions of time to 6 December 1990, each extension being for three months.  Alcon served three lots of evidence on Allergan during that time.
          Alcon then lodged on 6 December 1990 an application for extension of time to 6 February 1991, and served a fourth lot of evidence on 10 December 1990.  Allergan objected to this extension and the matter was heard in Canberra on 29 January 1991.  The hearing officer allowed the extension in his decision dated 5 April 1991.
          On 6 February 1991 Alcon lodged another application for extension of time to 6 May 1991 which was accompanied by a fifth lot of evidence.  Allergan did not object to this extension, but warned that any extensions sought beyond 6 May would be "vigorously contested".

On 6 May 1991 Alcon lodged a further appliction for extension of time to 6 July 1991 which was accompanied by part of a sixth lot of evidence.  The remainder of this evidence was served on 15, 17 and 29 May, 24 June and 1 July 1991.  Allergan objected to this most recent application for extension and the matter was heard in Canberra on 3 July 1991.  Allergan was represented by Dr Peter Stearne, patent attorney with Davies & Collison, Melbourne and Alcon was represented by Mr Michael Houlihan, patent attorney with Callinan Lawrie, Melbourne.
Application for Extension
          The grounds upon which Alcon made its present application for extension of time are set out in some detail in its application lodged on 6 May 1991.  These grounds are summarised as follows:

"Our attorneys, Callinan Lawrie, have just received on 6 May 1991, a facsimile-transmitted copy of a Statutory Declaration by one of our Australian experts, Mr John P.F. Strachan.  The Strachan Declaration was facsimile-transmitted to Callinan Lawrie from Legian, Bali, where Mr Strachan is currently holidaying.  Mr Strachan, acting on a spur of the moment decision, left Australia for the Bali holiday on Sunday 28 April 1991 without advising Callinan Lawrie that he would be unavailable to finalise and subsequently complete his Statutory Declaration.  Consequently, upon completion of the final draft of the Strachan Declaration by Callinan Lawrie on 1 May 1991 (following considerable discussion and revision), Callinan Lawrie then contacted Mr Strachan's Melbourne Office only to be then advised that Mr Strachan was not in Australia and was on holiday in Bali.  Consequently, Callinan Lawrie then made substantial efforts to trace the whereabouts of Mr Strachan.  Having made contact with him on 2 May 1991, they subsequently forwarded the final draft of the Statutory Declaration for his execution.  It was pointed out to Mr Strachan that the Declaration, because it was to be signed outside Australia, needed to be executed before a Notary Public or an Australian Consular Officer as defined under Regulation 75(5).  Mr Strachan experienced difficulty in having the Declaration executed before a relevant Officer at the Australian Legation in Denpasar, Bali.  Mr Strachan was unable to obtain an appropriate witness, since by the time that he was able to present
himself at the Legation, it was outside their business hours.  Consequently, Mr Strachan made investigations to locate an appropriate person before whom he could sign the Declaration.  Mr Strachan was able to contact Mr H.D. Edwards, CD of Western Australia, who assured Mr Strachan that he was a person suitably qualified to witness documents.  As a result the Strachan Statutory Declaration was witnessed before Edwards CD.  After execution of the Statutory Declaration, a copy of it was then subsequently forwarded to Callinan Lawrie on 4 May 1991 via facsimile transmission and that copy has now been lodged as an Exhibit to a Statutory Declaration dated 6 May 1991 by Michael James Houlihan of Callinan Lawrie.

We are concerned that Edwards CD may not be a suitable qualified person for witnessing documents, where those documents are signed outside Australia.  Consequently, further time is required so that not only the original of the Strachan Declaration as dated 3 May 1991 and signed in Bali, can be lodged at the Australian Patent Office and a copy served upon the Applicant, but so as to remove any doubt as to whether the Strachan Statutory Declaration satisfies the regulations, we propose to have a fresh Statutory Declaration re-executed.  The substance of that fresh Statutory Declaration will not change from that which has already been signed by Mr Strachan.  Regretably, Mr Strachan does not return to Australia until after 6 May 1991 and the further time is thus therefore required to complete these matters.

The further time is also required so that we can place on file a Statutory Declaration and Exhibits by Dr Noel Anthony Brennan, Optometrist, who is a further Australian witness in these proceedings.  A final draft Statutory Declaration has been prepared by Callinan Lawrie and is currently awaiting formal consideration and execution by Dr Brennan.  Unfortunately, Dr Brennan has been overseas attending a conference and he will only be returning to Australia today 6 May 1991 but is not available to sign the Declaration until 9 May 1991 at the earliest.  Thus, the Brennan Declaration is all but formalised but due to circumstances wherein the witness has been overseas we are not therefore in a position to have the Declaration signed and lodged at the Patent Office and a copy served on the Applicant by 6 May 1991.

In the previous application for extension of time dated 6 February 1991, we advised that Statutory Declarations/

Affidavits were being arranged through our affiliated US Company Alcon Laboratories Inc (hereinafter the US Company).  Two of the Affidavits which have been organised by the US Company are originating from experts who reside in the United States, whereas the other Affidavits are from experts who are either from the United States or Europe.  Three of the four Affidavits from overseas are from persons who are independent of both Alcon Laboratories (Australia) Pty Ltd or our affiliated US
Company.  One of the overseas Affidavits is to be in the name of Ruth Ann Rosenthal.  A draft of that Affidavit has been prepared and is currently under revision by Mrs Rosenthal and we expect to be able to present the Rosenthal Affidavit in the immediate future.  Unfortunately, due to the requirement for Mrs Rosenthal to generate further data in relation to the question of synergism between enzyme and peroxides, Mrs Rosenthal had been unable to complete the tests within the present time table.

A further overseas Affidavit will be forthcoming from Dr Daniel M. Ziegler.  Dr Ziegler has carried out tests in relation to the so-called synergistic affect between enzymes and peroxides which is claimed by Allergan Pharmaceuticals Inc to occur and which is the substance of their invention.  The US Company is currently preparing an appropriate Affidavit that will be lodged on behalf of Dr Ziegler.  However, the US Company has been experiencing difficulties in communicating with Dr Ziegler and working within his available time table.  It is however expected that the Ziegler Affidavit will be completed prior to the end of May 1991.

The US Company has also arranged for Affidavits to be provided by independent scientists from Bausch & Lomb which will also comment on the synergism aspect.  The US Company has been experiencing difficulties in communicating with the Bausch & Lomb personnel and in organising the finalisation of Affidavits by those scientists that will be used in this Australian opposition, but has now been able to arrange a meeting with Bausch & Lomb's US patent counsel for the week of 13 May 1991 to work on the forthcoming Affidavits.

The Rosenthal, Ziegler and Affidavits that will be forthcoming from the Bausch & Lomb scientists, have to be considered, and will be commented on, by our third Australian witness, namely Professor Anthony Linnane.  Consequently, due to the unavailability of the final Rosenthal, Ziegler and Bausch & Lomb Affidavits, our Australian attorneys Callinan Lawrie have not been able to finalise the Linnane Statutory Declaration.  Thus further time is also required so that we can not only lodge the Rosenthal, Ziegler and Bausch & Lomb Affidavits, but to also permit Professor Linnane time to give due consideration thereon, subsequently comment on that information and data and for that comment to therefore appear in suitable evidentiary form."

Submissions
          Mr Houlihan advanced the following arguments as justification for the extension of time being allowed:

(a)In his decision following the previous hearing the hearing officer found that a serious opposition was already in train.

(b)Alcon's efforts to finalise its supporting evidence within the immediately preceding extension period had been frustrated by unforeseen difficulties in locating two of its Australian witnesses, and difficulties beyond its control in gathering evidence from overseas experts for comments by its third Australian witness.  Alcon had nevertheless ensured the service of all of its supporting evidence within the extension period sought and, consequently, no further extensions are required.

(c)The reasons given to justify the extension are in accordance with the principles set out in Vangedal-Nielsen v Smith (Commissioner of Patents) (1980) 33 ALR 144 (see also Kaiser Aluminium & Chemical Corp v Reynolds Metal Co (1969) 120 CLR 136).

(d)The circumstances of the present application for extension of time strongly shadow those in the case of Underwood v Toby Construction Products Pty Ltd 13 IPR 139 and, consequently, it is in the best public interest to allow the extension.

(e)The extension sought should be allowed for the reasons given in British-American Tobacco Co Ltd v Philip Morris Ltd (1991) AIPC 90-738 in view of the progress made by Alcon in the preparation of its case.

(f)Even if the extension sought is not allowed, the Commissioner would still have to consider the evidence served after 6 May 1991 as a matter of public interest.

In answer, Dr Stearne made the following points:

(a)The hearing officer from the previous hearing stated that he would be in some doubt as to the seriousness of the opposition but for evidence lodged at the time of the hearing.

(b)Alcon was put on notice that Allergan would object to any extensions beyond 6 May 1991.

(c)This is the seventh occasion on which Alcon has applied for extension of time in which to serve evidence.  Allergan considers this to be an excessive number of extension applications.

(d)Alcon seems to have left its efforts in these proceedings to the very last to finalise its supporting evidence -

-the notice of opposition was lodged on 6 December 1989 but Alcon had done little during the initial twelve months from that time,

-effectively no evidence of any substance was lodged by Alcon until some eighteen months after lodgement of the notice of opposition,

-the bulk of Alcon's evidence was lodged out of time.

(e)Alcon has not made out a proper case justifying the extension -

-these proceedings have undoubtably been protracted as a result of Alcon's reliance on evidence from independent experts in the United States, however, there is nothing on file to establish that the expertise in question was not available in Australia,

-Alcon has not established why there was such a significant delay in finalising the Strachan and Brennan declarations,

-the Rosenthal affidavit is based on material filed with the US courts well before these proceedings,

-Alcon's decision to seek independent US experts and the associated delays is not a proper basis for the extension application; it was Alcon's duty to ensure that the evidence was prepared and executed within a reasonable time frame,

-the evidence gathered from overseas is immaterial to the opposition grounds of novelty and obviousness under the 1952 Act since these are "local" considerations,

-it is questionable whether the Commissioner would have to consider the evidence anyway.

(f)The public interest would not be served by allowing the extension since Alcon has not fully justified its case.

Decision
          The law regarding this type of extension has been comprehensively reviewed by the Federal Court, and there are also quite a few published Office decisions dealing with such extensions.
          Stated simply, before allowing an extension the Commissioner:

(a)has to be satisfied that there is a serious opposition in train,

(b)has to be satisfied that the party seeking the extension has made out a proper case, and

(c)must not only consider the private interests of applicants for patents, and opponents, but also the public interest, by ensuring that invalid patents are not granted and that proceedings are not unreasonably protracted.

I think that Alcon is mounting a serious opposition in view of the substantial volume of material it has served on Allergan.  I am somewhat symnpathetic to Dr Stearne's concern that approximately eighteen months elapsed before the bulk of this material was lodged, and that such lodgement occurred outside the immediately preceding extension period.  However Alcon has now completed the service of all its supporting evidence and, from the evidence before me, appears to have made a conscious effort to ensure that the balance of this evidence was served within the extension period sought.
          I do not agree with Dr Stearne's argument that Alcon has under the circumstances sought an "excessive" number of extensions of time.  In considering this matter, I am mindful of the fact that the previous six extensions allowed have amounted to a total of sixteen months.  However I am guided by precedent in which relatively long total amounts of extension of time have not been considered as unreasonable where a substantial amount of evidence had already been served.  See for example Roussel-Uclaf v Shell International and Ciba-Geigy (1987) IPR 475. As stated above, Alcon has in fact completed the service of its evidence.
          I think that the grounds set out in the present application for extension are satisfactory.  In his submission Dr Stearne stated that although considerable delays had undoubtedly
occurred through Alcon's pursuit of evidence from overseas experts, no explanation was forthcoming as to why this approach had been taken given that the expertise in question should have been readily available in Australia.  Mr Houlihan replied that Alcon was indeed using the services of Australian experts (three in all).  While I agree to some extent with Dr Stearne's submission, I note from the extension application dated 6 February 1991 that the need for overseas expert evidence was unanticipated and had only come to light "following the considerations and recommendations of one of our Australian expert witnesses".
          Dr Stearne also submitted that the material forming the basis of the Rosenthal affidavit was available to Alcon (or at least its affiliated US Company) prior to the commencement of these proceedings.  Mr Houlihan explained that the test data and composition upon which the affidavit in question is based had been files as exhibits in a US Court action.  Rather than reconduct the tests, Alcon's US affiliate felt it best to obtain additional test results from the original date and composition once the exhibits were released by the courts.  I agree with Dr Stearne's submission that Alcon has not established why it did not use the original test data and composition to prepare the Rosenthal affidavit.  On the other hand, the reasons given by Alcon in its applications for extension dated 29 August 1990 onwards are indicative of why extensions have been necessary to finalise the Strahan and Brennan declarations.  Overall then, I accept Mr Houlihan's submission that Alcon has been unable to complete its evidence in time primarily as a result of the unexpected problems it has encountered in gathering
evidence from independent experts, yet has gone to considerable lengths to ensure that any resultant delays are not unreasonable.  The present application for extension of time has, in my view, adequately detailed these circumstances.  I note here that where an opponent is relying on the evidence of a third party, it is "notoriously difficult" to expeditiously obtain such evidence (see Lyons v Registrar of Trade Marks 50 ALR 496). Furthermore, Dr Stearne's contention that the evidence gathered from overseas is not relevant to the question of alleged anticipation is not a matter for me to decide at these proceedings. This is a matter for determination of the opposition.
          Finally, I think that the public interest would be better served, at least now that service of the supporting evidence has been completed, if both parties were allowed to argue the merits of the patent application in the light of that evidence (see Underwood v Toby Constructions, cited above).  As Mr Houlihan rightly pointed out, the Commissioner would have to consider that evidence anyway (see Tate v Haskins (1935) 53 CLR 594), as a matter of public interest, and that interest would be better served if Alcon was to be present to argue accordingly.
          Taking account of all the above factors, the application for extension is in my view justified, and I allow the extension.
Costs
          I have decided that the extension sought is justified in all the circumstances and, consequently, I award costs against Allergan.

As Alcon has completed the service of all its supporting evidence, Allergan is due to serve its evidence-in-answer within three months from the date of this decision.

(O.L. HAGGAR)
  Delegate of the Commissioner of Patents

Patent Attorneys for the Applicant: Davies & Collison, Melbourne
Patent Attorneys for the Opponent : Callinan Lawrie, Melbourne