Genentech v Wellcome Foundation Ltd

[1988] APO 15

In the Matter of the Patents Act 1952 and - In the Matter of Patent Application No. 563031 in the Name of GENENTECH INC. - and - In the Matter of Opposition under Section 59 by THE WELLCOME FOUNDATION LIMITED.

DECISION OF A SUPERVISING EXAMINER OF PATENTS:

Application 563031 was advertised accepted in the Official Journal of Patents of 25 June, 1987. On 25 September, Wellcome lodged and served notice of opposition, but failed to serve evidence-in-support within the time provided by regulation 55, which would normally have expired on 25 December; however, pursuant to the provisions of the Acts Interpretation Act 1901, that time actually expired on the next working day which was the 28 December.

On 15 February, 1988 Wellcome lodged an application for extension of time under regulation 55 to 25 March, 1988, invoking the provisions of sub-regulation 82(b). Genentech sought to prevent the allowance of that application. Accordingly the matter was set down for hearing in Canberra at the earliest possible date which was convenient for the parties, viz. 22 April. This represents an extraordinarily long delay in the circumstances, as it extends beyond the period of the extension sought : suffice it to say that pursuant to submissions made on behalf of Wellcome and Genentech, the delegate of the Commissioner agreed to the postponement.

At the hearing Genentech was represented by Mr. B. Caine of Counsel advised by Dr. Peter Stearne of Davies & Collison and Wellcome was represented by Dr. M.G. Horner of Griffith, Hassel & Frazer.

The Application for Extension

The regulations governing this application are regulations 55 and 82. Regulation 55 provides, inter alia, that an opponent:

"may serve on the applicant, within 3 months after the notice of opposition has been lodged at the Patent Office or within such further time as the Commissioner ..... allows, a copy of each of the declarations on which he relies in support of his opposition; ...... "

Regulation 82 provides:

"An application for an extension of time under these Regulations shall be lodged at the Patent Office -

(a) before the expiration of the time sought to be extended; or

(b) if the Commissioner is satisfied that special circumstances existed which prevented the application being made before that time, within such time as the Commissioner allows."

In this case the time sought to be extended expired on 28 December, 1987 nominally, 25 December), and the application was lodged on 15 February, 1988. Therefore the conditions of paragraph (b) of regulation 82 became applicable. Unless the Commissioner is satisfied as stated in that paragraph, it would seem that the application is to be deemed not lodged, in the sense that though received by the Office and incorporated into the Genentech case file, it would not receive further consideration. Consequently, I will deal with the regulation 82 matter first.

Regulation 82

The application for extension by Wellcome was accompanied by a statutory declaration by Dr. Horner. Paragraphs 3 and 4 thereof, set out immediately below, relate to the provisions of sub- regulation 82(b):

"3. On 15 October 1987 we received an official letter dated 13 October 1987 confirming receipt of the Notice of Opposition. It is the normal practice of this firm that such an official letter should have been diaried by our Records Department for the lodgement of Evidence-in- Support on 25 December 1987. I have checked the diary of our Records Department and find that no such entry was made.

4. It is also my practice to enter in my personal diary .the dates on which evidence in oppositions is due. I have checked my personal diary and find that the date for lodgement of our Evidence-in-Support was not diaried for 25 December 1987, presumably because this was Christmas Day. However, there is in my diary an entry on 21 December 1987 in relation to this case to the effect that we are to renew the Special Retainer paid to Counsel in this matter. A copy of the relevant page of my diary is attached hereto as Exhibit MGH-1. In fact, we sent down a further Special Retainer for another three month period to Counsel on 24 December 1987 (copy enclosed as Exhibit MGH-2), but due to an oversight on my part did not at the same time apply for a further three months extension of time for lodgement of our Evidence-in-Support."

At the hearing I pointed out to Dr. Horner that in my view it would be necessary to exhibit copies of the relevant portions of his personal diary and that of the Records Department of his Firm to establish the facts set out in these paragraphs. Mr. Caine concurred, and I directed Dr. Horner to lodge this material (in declaratory form) as soon as possible. He did so on 27 April. Having considered this new evidence, I am satisfied that the statements in paragraphs 3 and 4 of the first declaration about the absence of relevant diary entries are correct.

In support of Wellcome's application Dr. Horner stated that the failure of the persons concerned to make appropriate entries in the Firm's official diarying system and in his own personal diary amounted to special circumstances in terms of regulation 82, as a result of which the applicant was prevented from making application within the prescribed time.

Mr. Caine submitted that the situation here was not representative of special circumstances; he referred me to a number of early British cases in support of this submission and to a decision of the Registrar of Trade Marks relating to regulation 69 of the Trade Marks Act which is similar to regulation 82 at issue here.

The decision of the Registrar appears at (1986) AIPC 90-280 at 36,582 (R.E. Jamieson & Anor. v. American Dairy Queen Corporation). That action concerned a belated application under regulation 43 of the Trade Marks Act for an extension of time in which to lodge evidence-in-support of an opposition, whereby the provisions of regulation 69 became operative. There had been a hearing on an earlier application under regulation 43, the decision for which was issued after some delay. The hearing officer held that the issuing of the Registrar's decision on the earlier application not only constituted a sufficient reason why it was inappropriate before then to make requests for further extensions of time but also constituted a "special circumstance" for the purposes of regulation 69 which prevented the applications being made before the due date. Accordingly, the opponent's current requests for extension of time fell within the provisions of sub-regulation 69(b) and were thus properly made and receivable under that regulation.

Representative of the early British cases is Re Coles and Ravenshear (1907) 1 KB 1 (C. of A.). This matter concerned an application for special leave to appeal, made out of time. The applicable rule of Court gave the Court power "under special circumstances" to extend the time for appealing. The main fact of the case was that a mistake had been made by the clerk of the appellants' solicitors. Collins M.R. in refusing leave to appeal commented that:

"I cannot see that a mistake made by the solicitor of the party who is applying for extension of the time is a sufficient ground for extending it."

Mr. Caine suggested that the decision of the Registrar illustrated a good example of "special circumstances" in that the failure by the Attorneys concerned to make application on time was due to circumstances arising pursuant to the delay in issuing that decision and was not solely due to error in their own records system. As to the British cases, these, he said, make it clear that simple error or omission do not constitute "special circumstances".

Having heard Mr. Caine on this matter, I am not convinced that the law has remained static since the times of the British judgements cited by him. It seems to me that the situations arising out of regulation 55 and regulation 82 of the Patents Act are analogous to situations which one might expect would arise in relation to appeals to Australian Courts. Thus Order 52 rule 15 of the Federal Court reads, in part, as follows:

"15.(1) The notice of appeal shall be filed and served -

(a) within 21 days after -

(i) the date when the judgment appealed from was pronounced;

(ii) the date when leave to appeal was granted; or

(iii) any later date fixed for that purpose by the court appealed from; or

(b) within such further time as is allowed by the Court or a Judge upon application made by motion upon notice filed within the period of 21 days referred to in the last preceding paragraph.

[Sub-r (1) amended SR No. 217 of 1982, r 23 and Sch; SR No. 258 of 1984, r 12 and Sch]

(2) Notwithstanding anything in the preceding sub- rule, the Court or a Judge for special reasons may at any time give leave to file and serve a notice of appeal."

I draw particular attention to the judgement of Lockhart, Sheppard and Burchett J.J. of the Federal Court in Jess v. Scott and Others 70 ALR 185. This judgement deals extensively with situations such as existed in the British cases cited by Mr Caine, and such as are apposite to the circumstances in the present action. In this case, the original proceedings brought by the applicant were dismissed by Wilcox J. The applicant's solicitor received instructions to file and serve a notice of appeal to a Full Court. The notice of appeal filed one day after the period allowed in Order52, rule15(1). The applicant applied for leave to file the notice of appeal under rule 15(2). The respondents argued that the simple error of the applicant's solicitor did not amount to a sufficiently special ground to constitute "special reasons" under rule 15(2). The Court, while making reference to Re Coles and Ravenshear (supra), chose not to follow that case, commenting that:

"the modern view is that :a failure of a solicitor to take the proper steps could itself be regarded as establishing sufficient cause for an extension of time": Martin v. Nominal Defendant (1954) 74 WN (NSW) 121 at 125 per Walsh J."

Inter alia, the Court referred also to a judgement of the Court of Appeal:

"In R v. Secretary of State for the Home Department: Ex parte Mehta [1975] 1 WLR 1087 the Court of Appeal (Lord Denning Mr. Browne and Geoffrey Lane LJJ) considered the effect of r 11(4) of the Immigration Appeals (Procedure) Rules 1972 which made provision for an appeal out of time in the following terms: " the appellate authority shall not be required to dismiss the appeal but may allow it to proceed if the authority is of the opinion that, by reason of special circumstances, it is just and right so to do".

Lord Denning, stating the reasons of the court, said (at p 1091):

"One of the special circumstances here was the fact that the omission was the mistake of Miss Mehta's solicitors.  It was said that the mistake of her solicitors could not amount to 'special circumstances' within r 11.  I do not agree.  In applying r 11, I should have thought that the appellate authority might well adopt the practice which we adopt in this Court of Appeal here.  We are often asked to extend the time of giving notice of appeal.  We never let a party suffer because his solicitors make a mistake and are a day or two late in giving notice of appeal.  We always treat it as a ground for extending the time:  "

In relation to Ex parte Mehta the Court drew a comparison between the wording of the Immigration Appeals (Procedure) Rules and order 52 rule 15(2) of the Federal Court rules in these terms:

"Ex parte Mehta is of particular interest for present purposes because of the presence in the rule there considered of the words "by reason of special circumstances" which correspond to the words in r 15(2) "for special reasons" and indeed might be thought, if anything, to pose a somewhat more stringent requirement."

The point is that both Courts appeared to take the view that the particular expression with which we are here concerned - even though, apparently, a somewhat more stringent requirement than that of the Court rule - ought to be liberally interpreted by the Tribunal so as not to let an appellant suffer unfairly. Ultimately, the Federal Court allowed the extension applying Martin v. The Nominal Defendant (supra).

Consequently, it seems to me that the errors made by Dr. Horner's Firm in failing to make appropriate diary entries do qualify as special circumstances.

As to the use of the word "prevented" in paragraph (b) of the regulation, both parties submitted that it would be a harsh interpretation to consider that the intention was that there had to be some positive hindrance: e.g. in the nature of "force majeure", before the Commissioner would be satisfied. I agree. In my view the word "prevented" ought be given a broad meaning so as to give effect to the regulation in situations where the person concerned has failed to apply on time owing to some circumstance which has prevented the knowledge of the need to apply coming to that person's attention. If this were not so, firstly, there would be little point in the law including agents' errors or omissions within the expression "special circumstances"; secondly there would exist a situation where an extension which could not be granted on the basis of satisfying sub-regulation 82(b) could well be granted under the provisions of the Act proper, viz. section 160.

In addition, I note that there has been no undue delay overall in Wellcome's actions in this matter and certainly its agent, Dr. Horner, acted with despatch as soon as he became aware of the problem.

Thus I am satisfied in accordance with the conditions set out in paragraph (b) of regulation 82.

Regulation 55

It remains to be decided whether Wellcome has made out grounds justifying an extension. Wellcome is seeking a first extension from 25 December, 1987 (nominally) to 25 March, 1988, on the basis that:

"Further time is required for our attorneys, Griffith Hassel & Frazer to consider voluminous documents provided by us, the opponents from corresponding proceedings in the British Patents Court, to prepare expert evidence, and to present it in the prescribed format."

The statutory declaration by Dr. Horner which accompanied the application elaborates the above reasons in the following terms, in paragraph 5 thereof:

"Our client, The Wellcome Foundation Limited, is vitally interested in the prosecution of this opposition and has already provided us with a great number of documents from the corresponding proceedings in the British High Court of Justice (Patents Court). The thickness of these documents is approximately eight inches. Attached hereto as Exhibit MGH-3 is a copy of the frontsheet of the judgment of the U.K. Patents Court in which The Wellcome Foundation Limited were partially successful in revoking the corresponding U.K. Letters Patent 2119804 granted to Genentech Inc. Thus, the opponent's (sic) have a serious interest in this opposition."

At the hearing Dr. Horner lodged a copy of the full judgement of the High Court of Justice referred to in his declaration. This judgement amounts to 87 pages. He sought to use this judgement as further evidence of Wellcome's seriousness in this opposition, and, if my decision should prove favourable to Wellcome, and should a further extension be granted (i.e. beyond 25 March, 1988), it was to form part of the evidence in support. Dr. Horner went on to explain that there was a mass of material comprising a pile of documents approximately 8 inches thick, given to his Firm by Wellcome, and this represented the bulk of the material used in the action before the British High Court; presently he said, he is having discussions with experts in the field of the invention to arrange for appropriate witnesses to draw up declarations in support of the opposition.

Mr. Caine countered Dr. Horner's submissions by pointing out that those submissions revealed a number of matters for the first time at the hearing, which matters he felt could have been brought to attention as part of the application for extension. He said that while he agreed I was entitled to take account of these new matters I should consider that Genentech ought receive a favourable award of costs. Further, said Mr. Caine, as Wellcome was obviously aware of the Court action in the U.K. since it was involved in it, why could not all the relevant documentation have been sent to Wellcome's agents in Australia much earlier? He concluded that I should refuse the application for extension.

The law regarding this class of extension has been comprehensively reviewed by the Federal Court in Vangedal-Nielsen v. Smith and Gelphen Nominees (1980) 33 ALR 144 and in Lyons v. Registrar of Trade Marks 1 IPR 416; in addition there are many Office decisions dealing with such extensions, quite a few of which are published in the Butterworth Industrial Property Reports (IPR) and in the CCH publication Australian Industrial & Intellectual Property (AIPC). This law can be stated simply as follows:

(i) The Commissioner, before allowing the extension, must be satisfied that the person seeking the extension, has made out a proper case justifying the extension;

(ii) The Commissioner must consider not only 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.

There are three important matters in the present case to be considered within the framework of the above law:

• the technology of the Genentech application;

• whether Wellcome is mounting a serious opposition; and

• whether granting the extension sought will lead to undue delay prejudicial to Genentech or the public.

The technology of the Genentech application is new and complex - it relates to human plasminogen activator corresponding to that found in human tissues and serum, and to means and methods for its production in therapeutically significant quantities. In the public interest, it is important that new technology such as this should be carefully and fully considered before the grant (or refusal) of a patent thereon - this is not disputed by the parties. To do this in the present instance obviously requires a great deal of time and documentation; again this is not disputed : what is disputed by Mr. Caine is the date by which action could have been taken, once the judgement of Whitford J. had issued. I do not agree with this viewpoint; in mounting opposition in Australia using obviousness as a ground it is essential to have evidence available from experts in the field of the invention in this country (see Minnesota Mining v. Beiersdorf (Aust.) Ltd. 144 CLR 253). It may also be necessary to utilise the evidence of such experts in interpreting the meaning of various cited documents as at their respective dates of availability to the public. According to Dr. Horner, he or his staff are having discussions with some experts and actively seeking others to assist in the opposition action. Consequently, it seems to me that because of the technology involved, not only is it in the public interest that the opposition be allowed to proceed, but that by its very nature, it will require considerable time for its proper execution.

There does not appear to be any real dispute by Genentech as to whether Wellcome is attempting to mount a serious opposition. I think on the basis of events in the U.K., and having regard to Dr. Horner's submissions and that portion of the evidence which he has already filed to support Wellcome's contention in this matter, there can be no doubt here.

As to the question of undue delay, the extension being sought would take the total time for lodging evidence-in-support to six months. It is true that, as submitted by Mr. Caine, Parliament provided for an initial period for lodging evidence-in-support of 3 months. However, regulation 55 which makes that provision, also provides for further time, as may be allowed by the Commissioner. It is not unusual for time taken to lodge evidence in the various stages of an opposition to be substantially greater than 3 months. In fact, this has become the norm, due, no doubt, largely to some of the factors I have referred to above in relation to the technology. Thus the perception of the public is that the various evidence stages are normally much longer than the minimum 3 months provided by the regulations. In any event, because of the nature of the invention in this case, it is my view that the public interest would be far better served if the opposition were allowed to proceed so that the subject invention could be carefully and fully considered before possible grant, rather than that it were to be stopped.

Consequently, I extend the time for lodging evidence-in- support to 25 March, 1988. I note that there is an application for a further extension of time to 25 June next on file. At the hearing I drew this application to Mr. Caine's attention and through him invited Genentech to lodge objection to that application if it so wished within 14 days.

Costs

Obviously, Genentech would have been aware of most of the matters I have referred to above in relation to regulation 55, consequently I can see no basis for an award of costs in their favour on that aspect of this action.

Regarding the regulation 82 aspect of the action, I have pointed out earlier in this decision that the evidence submitted by Wellcome was insufficient; therefore Genentech had every right to object as it did. Hopefully, the objection could have foreshortened the section 59 action. Consequently, I award the costs of this action in favour of Genentech.

(J L Roveta)
Supervising Examiner of Patents
16 MAY 1988