Takeda Chemical Industries Ltd v F. Hoffmann-La Roche & Co Aktiengesellschaft

[1991] APO 38

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No 592527 by TAKEDA CHEMICAL INDUSTRIES, LTD, Opposition by F. HOFFMANN-LA ROCHE & CO AKTIENGESELLSCHAFT and Objection to Extension of Time to Lodge Evidence-in-Support

Background

Patent application no 592527 for an invention entitled "Non-glycosylated human interleukin-2 recombinant production" was advertised as accepted on 18 January 1990.  On 18 April 1990
F Hoffmann-La Roche & Co Aktiengesellschaft (Hoffmann-La Roche) lodged notice of opposition under section 59 of the Patents Act 1952 to the grant of a patent on the application and has been granted three unopposed extensions of time in which to serve its evidence-in-support. However the applicant advised, following receipt of the third application for extension of time, that it would object vigorously to any further extensions of time.
          On 18 April 1991 a fourth application for extension of time was lodged seeking to extend the period for lodging evidence for a further 3 months until 18 July 1991.  Takeda Chemical Industries, Ltd (Takeda) through its patent attorneys gave notice of its objection to the application for extension being granted.  Both parties indicated that they would not be represented at a hearing and would rely on written submissions.
The Application for Extension
          The circumstances and grounds given in the present application for extension of time are as follows:

"Our Australian patent attorneys and expert witness are at an advanced stage in drafting evidence in support of this opposition.  Since our last application for an extension of time in which to serve our evidence we have forwarded

to them additional material and expect to forward further additional material in the near future based on prosecution of the corresponding European application.  Thus, further time is required to examine the latest material and the material yet to be sent.

It is emphasised that complex issues are under consideration in this opposition and this aspect together with the progression of the equivalent European application provides a basis for our request for extension of time."

The application is supported by two statutory declarations.  One is by John David O'Connor, a registered patent attorney and member of the firm of Spruson & Ferguson who declares:

1. I am responsible for the carriage of the above opposition.

1. Attached hereto and marked Annexure "A" is a list of the documentation which we have received from the opponent or gathered ourselves and which Dr Bernard and we are in the process of examining.

1. It is clear from that attached list that there is a substantial amount of material to be considered.

1. I have also been informed by the opponent that since the prosecution of the equivalent European application is proceeding, they intend to repeat the file inspection of that application at the European Patent Office in the near future to apprise themselves of the status of that application.

1. I therefore have yet to receive further material relating to the equivalent European application."

The other declaration is by Ora Bernard, a senior research scientist in the Walter & Eliza Hall Institute of Medical Research, who is assisting Spruson & Ferguson in preparation of evidence in support of the opposition.  Dr. Bernard describes how she was at an advanced stage in another opposition (concerning an application by Biogen N.V.) when her involvement with the present opposition began, and declares:

1. I was not able to devote any time to either of these oppositions on returning to Melbourne from the November conference with Spruson & Ferguson due to work commitments.

12.Further, I was absent from Australia for the period 18 December 1990 to 6 February 1991 and again was not able to devote any time to either of those oppositions.

13.It transpires that Biogen decided to withdraw their Australian application and consequently I was informed by Spruson & Ferguson on 14 February 1991 that the first opposition had reached a successful conclusion.

14.Further material was sent to me by Spruson & Ferguson on 13 and 15 March 1991.  I have also been supplied with documents relating to the European prosecution of the application equivalent to the opposed specification.  I am also informed by Spruson & Ferguson that the prosecution is not yet complete in Europe and therefore expect further material.

15.My understanding and appraisal of this second opposition is that it is a substantial matter requiring a considerable examination on my part.

16.I have progressed substantially in my examination of the material supplied to date.  However, I believe that in view of the complexity of this case further time is warranted for me to reach a considered and detailed opinion.

17.In any event, since the prosecution of the corresponding European application is in progress, I believe that I need to be informed of arguments and counter arguments being proposed there."

Submissions
          In support of its opposition to the application for extension of time Takeda, in written submissions from its patent attorney Mr J. Terry of Griffith Hack & Co, advanced the following arguments:

.The documents on file and the application for extension do not establish a proper basis for the 3 month extension requested.  The notice of opposition gives the statutory grounds only and the opponent is now seeking a serious basis for the opposition.  The statutory declaration by John O'Connor adds nothing to support an extension.

.There is strong onus on the opponent to justify an extension of time beyond the initial three months allowed, and this onus has not been discharged.  The reasons for the extension in Form 11 vaguely refer to drafting of evidence being at "an advanced stage" but no particulars are given.

.The opponent has had more than ample time to adduce its case.  The application was published more than 5 years ago.  It was advertised accepted in January 1990 and so the opponents have had in excess of 15 months to assess their position.

.To deny an extension of time does not deny the opponent the right ultimately to challenge the validity of the patent.

.In relation to the declaration by Dr Bernard:

-The other opposition referred to is totally irrelevant.

-Documents alleged to be pertinent to the present opposition were sent to Dr Bernard approximately 5 months after the notice of opposition was filed and no justification for this delay has been given.  There has been a further 8 months since then and no evidence has been served.

-The issues concerning the corresponding European application are totally irrelevant to the present considerations of an extension of time.

In support of its application for extension of time Hoffmann-La Roche, in written submissions from Mr John O'Connor of Spruson & Ferguson, advanced the following arguments:

.3 Statutory declarations served on the applicant and lodged in the Patent Office on 6 June 1991 are evidence of the opponent's diligence in preparing the evidence and the opponent's serious attempt at mounting an opposition.

.The opponent has been unable to serve all its evidence in support due to, inter alia: "the complexity of the issues; the extensive prior art located; the recent uncovering of further documentation which is now being analysed by the opponent's expert witness; and the continuing prosecution of the corresponding European patent application."

.Locating an expert witness in the area of DNA technology in Australia is difficult, and reference is made to a statutory declaration by Paul Anthony Power in this regard.

Mr O'Connor's written submissions then address the arguments put forward by Takeda.  The main points may be summarised as follows:

.The notice of opposition was based on preliminary searches and examination of the application and the opponent was not, at the filing of the notice, in a position to provide more extensive objections.  Subsequent to filing the notice of opposition the opponent has conducted searches of the prior art, located an expert witness, conducted a conference with the expert witness, received on-going reports from the prosecution of the European application, and served most of the publications on which it intends to rely.  All this indicates the opponent is mounting a serious opposition.

.The material facts have been set out in the application for the extension of time, and this is all that is required.

.The opponent's knowledge of the application prior to its acceptance is an irrelevant consideration (see Re Application by John Gumley (1989) 17 IPR 107). Furthermore the time to serve evidence initiates from the date of the notice of opposition. Consequently the opponent has had 12 months to serve evidence and only 9 months of extensions.

.The opponent rejects the suggestion that its interest will not be unduly affected if the extension of time is not granted because revocation proceedings may be available.  Revocation proceedings cost more than opposition proceedings and the availability of revocation proceedings is not a relevant consideration in these matters (Kimberley-Clark Ltd v Commissioner of Patents (No 2) (1988) 13 IPR 551).

.Dr Bernard was chosen as the expert witness not merely because she was the opponent's personal choice but because she was qualified and willing.  It is therefore very relevant that she was not able to initially devote a substantial amount of her time to this opposition because of prior commitments.

.There was no undue delay in sending documents to Dr Bernard.  Prior art searches had to be conducted and a suitable independent expert witness had to be located before documents could be sent.

.Prosecution of the corresponding European application is very relevant to these opposition proceedings since the subject application and the European application are for the same invention.

Mr Terry lodged further submissions on behalf of Takeda, making the following points:

.The part of the evidence-in-support lodged on 6 June 1991 "merely amounts to several kilograms of paper with no indication of relevance of any particular portion and

allowance for an extension of time for this material would put an undue burden on not only the applicants but the Commissioner."

.The corresponding European case is not a matter to which much weight should be given at present: "the mere fact that relevant information might come out at a future date in another proceeding in another country is not ground for an extension of time for evidence in support."

Decision
          In consideration of the matter of extension of time I am required to have regard to the respective interests of the applicant, the opponent and the public.  The onus rests on the applicant for the extension of time to show good reason why the evidence has not been lodged within the time allowed.  Furthermore I must consider whether a serious opposition is foreshadowed and whether there have been any unreasonable delays.
          I consider Hoffmann-La Roche has demonstrated it is mounting a serious opposition in that it has located an expert witness to consider the prior art documentation.  The declaration of Mr Power testifies to the difficulties of locating an expert witness in the field of DNA technology.  I believe it would be unreasonable to expect an expert witness to immediately drop all prior commitments to attend to this opposition and I consider Dr Bernard's declaration exaplains sufficiently her actions in this matter.  While I would agree with Mr Terry that the term "at an advanced stage" in the application for extension of time is vague, I believe Dr. Bernard's accompanying declaration clarifies the matter to some extent.
          Concerning the question of delay, I agree with Mr Terry that little weight should be given to the corresponding European application.  However I do not agree with his contention that the opponent has been able to assess its position since publication of the application.  It is not uncommon for the scope of the claims of a specification to change considerably between publication and acceptance.  To require an opponent to prepare its opposition prior to publication of the accepted claims would be an unnecessary burden.
          I believe Dr Bernard's declaration accompanying the application for extension of time together with Mr O'Connor's submissions concerning her selection as expert witness are sufficient to show that, while there has been some delay in lodging the evidence-in-support, that delay has not been undue.
          In determining whether the extension of time ought to be allowed I must also consider the interests of the respective parties and the public interest in having the application proceed to grant in a reasonable time frame.  However I am inclined to think that in the present case where, as I have indicated previously, I believe there is a serious opposition, the applicant's interest is outweighed by the public interest in having all relevant matters put before the Commissioner before the opposition is determined.  I would also agree with Mr O'Connor's submissions that the availability of revocation proceedings is not a relevant consideration.
          In view of all the above considerations I believe Hoffmann-La Roche has discharged the onus of establishing a case to justify the extension of time.
Conclusion
          I am satisfied the extension of time sought is justified.  Accordingly I allow the extension of time to 18 July 1991 to serve evidence-in-support.  I note that Hoffmann-La Roche lodged a statutory declaration from Dr Bernard on 17 July 1991 accompanied by a letter indicating this completed the opponent's evidence-in-support.  As this falls within the current extension period Takeda is due to serve its evidence-in-answer within three months from the date of this decision.

(JANET WERNER)
  Delegate of The Commissioner of Patents

Patent attorneys for the applicant: Griffith Hack & Company, Sydney
Patent attorneys for the opponent : Spruson & Ferguson, Sydney