FEDERAL COURT OF AUSTRALIA

F.Hoffman-La Roche AG v Commissioner of Patents [2000] FCA 1845

PATENTS – patent application – claims in relation to a purified thermostable DNA polymerase – appeal from decision of a delegate of the Commissioner of Patents – application pursuant to Patent Regulations 1991 (Cth), reg 6.2(1)(b) for orders postponing grant of patent until application to Commissioner for leave to amend patent application determined – whether in public interest for any amendment that may affect the validity of a patent to be made prior to grant

Patents Act 1990 (Cth) ss 60, 61, 104, 105 & 138

Patent Regulations 1991 (Cth) regs 5.3 & 6.2

F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 cited

Genetics Institute Inc v Kirin-Amgen Inc (1996) 67 FCR 527 referred to

ON APPEAL FROM THE COMMISSIONER OF PATENTS

F. HOFFMAN-LA ROCHE AG v COMMISSIONER OF PATENTS & ANOR

NG 947 OF 1997

EMMETT J

15 NOVEMBER 2000

SYDNEY

ON APPEAL FROM THE COMMISSIONER OF PATENTS

THE COURT ORDERS THAT:

1.         The proceeding be stood over for directions Friday 9 March 2001 at 9.30 am.

2.         The notice of motion filed 30 October 2000 be stood over for directions on Friday, 9 March 2001 at 9.30 am.

2.         Costs of the motion to date be reserved.

Note:    Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

ON APPEAL FROM THE COMMISSIONER OF PATENTS

REASONS FOR JUDGMENT

1                     This proceeding arises out of patent application 632857 filed by Cetus Corporation on 8 October 1990.  Cetus Corporation subsequently assigned the rights in respect of the application to F.Hoffman-La Roche AG (“the Applicant”).   The application was accepted on 14 January 1993 and a notice of opposition was filed by New England Biolabs Inc (“New England Biolabs”) on 14 April 1993.  A hearing of that opposition took place in Canberra on 27 to 30 May 1997 and on 12 November 1997 the Commissioner's delegate published a decision and reasons for that decision.

2                     I raised a question as to whether there has in fact been a decision of the case as contemplated by s 60 of the Patents Act 1990 (Cth) (“the Patents Act”).  However, I am satisfied from what has been said by the solicitor for the Commissioner and counsel for the parties that, so far as the practice within the Office of the Commissioner is concerned, it is clear that the document published as a decision must be taken to be the decision of the case.

3                     The delegate in her conclusions summarised five major findings.  Two of them might be characterised as being against the Applicant, three of them against New England Biolabs.  The Applicant appealed from the decision insofar as it was contrary to its interest.  New England Biolabs also appealed from the decision insofar as it was contrary to its interest.   Both appeals were brought pursuant to s 60 of the Patents Act.

4                     Section 59 of the Patents Act provides that any person may oppose the grant of a standard patent.  Section 60(1) then provides:

“Where the grant of a standard patent is opposed the Commissioner must decide the case in accordance with the regulations.”

Section 60(4) provides further as follows:

“The applicant, and any opponent, may appeal to the Federal Court against a decision of the Commissioner under this section.”

5                     Both appeals came before me and I embarked on a hearing of them in April this year. On 28 April 2000, in giving a ruling on the admissibility of evidence in the course of the hearing, I expressed my views as to the nature of a proceeding by way of appeal under s 60 – see F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283.  As a consequence of the views that I expressed, New England Biolabs withdrew its appeal and indicated that it no longer wished to be heard on the appeal by the Applicant.  The Applicant, however, indicated that it wished to pursue its appeal.  I was subsequently informed on behalf of the Commissioner that, having been furnished with the additional information contained in the evidence that was intended to be relied upon in the proceedings before me, the Commissioner had formed the view that the Commissioner did not wish to be heard in opposition to the Applicant’s appeal.  However, the Commissioner was prepared to give such assistance as the Court required in relation to that appeal.

6                     The two matters in respect of which conclusions adverse to the interests of the Applicant were reached are as follows.  First, the Commissioner’s delegate concluded that claims 1 to 7 and omnibus claim 86 in the Complete Specification are not novel, in the light of the prior publication of the Kaledin Paper (as I defined that term in my reasons of 28 April 2000).  Secondly, the Commissioner’s delegate concluded that there are two s 40 problems with the Specification as it presently stands.  The delegate also observed that there were typographical errors in certain claims.  The delegate allowed the Applicant 60 days to propose amendments to overcome “the problems I have identified above”.  That phrase appears to refer to the s 40 problems although it may possibly be construed as relating to the finding concerning claims 1 to 7 and claim 86.

7                     In its original notice of appeal, the Applicant included an order that its application to amend be granted.  In the course of the hearing, senior counsel for the Applicant foreshadowed an application to the Court for orders directing amendment of the Specification.  However, in the course of directions hearings following the withdrawal of New England Biolabs, I tentatively expressed the view that I did not have power on the hearing of the appeal to direct amendments.  I expressed that view tentatively, in the light of a contrary view expressed by Heerey J in Genetics Institute Inc v Kirin-Amgen Inc (1996) 67 FCR 527.

8                     The tentative view that I had formed was that the only source of power for the Court to direct amendment is s 105.  Section 105, however, is limited to relevant proceedings in relation to a patent.  A “patent” is defined in Schedule 1 as “a standard patent or a petty patent”.  I considered that a proceeding by way of appeal under s 60 is not a proceeding in relation to a patent since, by definition, no patent has yet been granted.  While the Patent Regulations 1991 (Cth) (“the Regulations”), in relation to an amendment application under s 104, prescribe a lengthy notification period, no such notification is required in relation to amendments sought under s 105.  That distinction indicates that s 105 must be restricted to amendments made after grant, and therefore, by necessity, after the lengthy notification period that precedes sealing.  It would be a departure from the scheme of the Act to say that the Court may direct amendment prior to grant, without the advertisement that would be required by the Regulations if an application to amend had been made to the Commissioner pursuant to s 104. 

9                     In any event whether or not I was right in the view that I had formed, the question does not fall for decision since, apparently as a result of my having expressed that view, the Applicant abandoned any further application to the Court for the making of orders directing amendment.  Rather, application has been made by the Applicant to the Commissioner pursuant to s 104 of the Patents Act. 

10                  Under s 104(1) an applicant for a patent may, in accordance with the Regulations, ask the Commissioner for leave to amend the relevant patent request or complete specification for any purpose.  The Commissioner must then consider and deal with the request in accordance with the Regulations.  Under s 104(4), any person may oppose allowing an amendment.  Under reg 5.3(4):

“A person must not oppose the allowance of a proposed amendment of a complete specification, except on the grounds that the amendment is not allowable under section 102 of the Act.”

The Regulations provide a process for advertising proposed amendments after the Commissioner is satisfied that they are otherwise allowable.  The Commissioner has concluded that the amendments presently proposed by the Applicant are allowable and has, accordingly, advertised the amendments.  Under the Regulations, three months must elapse to enable any person to indicate intention to oppose the amendments.

11                  In connection with the disposition of the Applicant’s appeal, the Applicant has applied, by motion on notice, for orders under reg 6.2(1)(b) that any grant of a patent pursuant to application number 632857 be postponed until the Applicant’s request to amend the Complete Specification, which was filed on 19 June, 2000, and any opposition, has been finally determined. 

12                  I have granted New England Biolabs leave to be rejoined to the Applicant’s appeal for the purposes of opposing the orders sought in the notice of motion.  I have heard argument on that question for the last two days and this morning.  In the course of the hearing of the appeals, New England Biolabs foreshadowed that, if a patent is granted pursuant to the application under consideration, it intends to commence proceedings for revocation on a number of grounds.  The grounds intended to be relied on include the ground referred to in s 138(3)(d) of the Patents Act, namely:

“…that the patent was obtained by fraud, false suggestion or misrepresentation.”

Of necessity, of course, such a ground would not be available in the hearing of any opposition since it is dependent upon the obtaining of the patent which is, as I have said, by definition, has not yet been granted.

13                  The parties appear to be ad idem that one possible consequence, and I emphasise possible consequence, of some of the amendments proposed by the Applicant is that the ground contemplated by s 138(3)(d) may be affected.  By way of example, New England Biolabs has foreshadowed an argument that a false suggestion is contained in the Specification, and in particular in Example XIII, that the purification process there described had actually been carried out by the inventors.  New England Biolabs asserted that such an alleged false suggestion was designed to overcome the conclusion that the Commissioner’s delegate in fact reached that claims 1 to 7 had been anticipated by the Kaledin Paper. 

14                  As I understand the position, it is common ground that the purification process described was not carried out as a single process.  Whether or not that is a false suggestion is not a matter upon which it is appropriate for me to express any view at this stage.  However, one class of amendment that the Applicant seeks to make is designed to remove any suggestion that the process described in Example XIII had in fact been carried out as a single process prior to the application.  One object of the amendment is to make clear that the process was not carried out as a single process.

15                  The substantive issue on the hearing of the motion has been whether I should direct the deferral of the grant of a patent until after the amendments have been dealt with.  One of the bases upon which that course was opposed by New England Biolabs was that, if the amendment were made before grant, New England Biolabs would be deprived of a ground of revocation.  It would certainly be curious if an opponent opposed the making of an amendment in order to avoid false suggestion, simply because that would deprive the opponent of the right to move for revocation.  In one sense the opponent would be advocating the grant of the patent on the basis of false suggestion. 

16                  It seems to me that there may be a public interest in ensuring that any amendment that might affect the validity of a patent should be made prior to grant.  The solicitor for the Commissioner has indicated that the general practice in the Commissioner’s office, where an amendment is made after acceptance, is to process the amendment before proceeding to grant.  I did not understand counsel for either party to contest the proposition that that is the general practice. 

17                  Section 61 of the Patents Act provides that the Commissioner must grant a standard patent by sealing a standard patent in the approved form if, in spite of opposition, the Commissioner’s decision, or the decision on appeal, is that a standard patent should be granted.  Under section 61(2) a standard patent must be granted within the prescribed period.  Regulation 6.2 provides that for the purposes of that section:

“(1)…the prescribed period is from three 3 after publication under paragraph 49(5)(b) of the Act… of the notice of acceptance of the request and complete specification to:

(a)       6 months after that publication; or

(b)       such later date as:

(i)        in the case of proceedings before a court or the Tribunal - the court or Tribunal directs; or

(ii)       in any other case - the Commissioner reasonably directs;

            being satisfied that the grant of the patent should be postponed.”

Regulation 6.2(2) provides that a person may request the Commissioner to give a direction referred to in subparagraph (1)(b)(ii).  While it would have been open to the Applicant to make such a request to the Commissioner, the course that has been adopted, I understand with the concurrence of the Commissioner, is to request the Court to deal with the question, on the basis that the appeal before me attracts paragraph 6.2(1)(b)(i).  It is for the exercise of the discretion conferred by that provision that the notice of motion asks.

18                  The proposed amendments were advertised on Friday, 10 November 2000.  It will be three months from that date before it will be known whether, and to what extent, the amendments will be opposed.  I tentatively indicated that one possible course for disposing of the appeal would be to uphold the appeal and to direct the grant of the patent if, and only if, the proposed amendments are made after due process in accordance with the Act and the Regulations.  However, that would place the Applicant in a position where, if the amendments were granted then the patent would be granted but, if any of the amendments was refused, the patent would be refused. 

19                  In the circumstances it appears to me to be appropriate to defer making any orders on the Applicant’s appeal or on the notice of motion at this stage.  The parties consider that it would be appropriate to defer the making of any order until after the determination of the opposition to the amendment proceedings.  Such a suggestion initially came from me today, although it was one that was foreshadowed by junior counsel for the Applicant at an earlier stage in the proceedings.  The suggestion was not opposed by New England Biolabs when it was made today.  Accordingly, I propose to adjourn the hearing of the motion and appeal to a date convenient to the parties, being a date shortly after the expiration of the period in which opposition of the amendment is to be notified.  At that time, after considering the extent of opposition, I will be in a better position to determine whether any further adjournment of the hearing should be ordered, pending the final resolution of the question of amendment.  I will reserve the costs of the motion to date.

Associate:

Dated:              15 December 2000