Genetic Systems Corporation v United Biomedical Inc

[1991] APO 37

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent application No. 597884 by GENETIC SYSTEMS CORPORATION and an opposition by UNITED BIOMEDICAL INC under section 59 of the Patents Act 1952.- objection to application for an extension of time to lodge evidence under regulation 55.

Background

The Office advertised acceptance of application number 597884 on 14 June 1986.  United Biomedical Inc (United Biomedical) lodged a notice of opposition to the grant of the patent on 12 September 1990.

The Notice of Opposition lists the following grounds of opposition:

1. That the invention, so far as claimed in any claim, was obvious and did not involve an inventive step having regard to what was known or used in Australia on or before the priority date of that claim;

1. That the invention, so far as claimed in any claim, was, before the priority date of that claim, otherwise not novel in Australia;

1. That the complete specification does not comply with the requirements of Section 40;

1. That the invention, so far as claimed in any claim, was published in Australia before the priority date of that claim; and

1. That the invention, so far as claimed in any claim, is the subject of a claim of the complete specification of another application for a standard patent lodged in Australia or the claim of a petty patent specification of an application for a Petty Patent lodged in Australia, being a claim the priority date of which is earlier than the priority date of the first mentioned claim.

United Biomedical applied for and received three unopposed extensions of time as follows:

.one month to 12 January 1991 on the basis that they were "in the process of obtaining further evidence from Melbourne";

.three months to 12 April 1991 on the basis that "As we are still in the process of obtaining further evidence from Melbourne";

.two months to 12 June 1991 on the basis that "Our attempts to obtain evidence from Melbourne have been unsuccessful and we are accordingly attempting to obtain expert evidence in Sydney";

On 9 May 1991 United Biomedical lodged a further application for an extension of time to lodge evidence-in-support, but did not provide reasons.  On this occasion Genetic Systems chose to oppose the application and a hearing was set down for 17 July 1991.

Genetic Systems was represented by Mr M Royal of Phillips, Ormonde & Fitzpatrick, patent attorneys of Melbourne.  United Biomedical, represented by Ms C Champion and Mr A White, solicitors, of Corrs Chambers Westgarth Sydney, chose to present written submissions.

Specification

Accepted application 597884 relates to peptide sequences, capable of immunologically mimicking proteins encoded in the gag and/or env regions of the LAV/HTLV-III retrovirus, provided as reagents for use in the screening of blood and blood products for prior exposure to the retrovirus.  The peptides are of at least 5 amino acids and can be used in various specific binding assays for the detection of antibodies to LAV/HTLV-III virus, for the detection of LAV/HTLV-III antigens, or as immunogens.  There are claims to a number of peptide sequences per se and to their use as described above.

Submissions by United Biomedical

United Biomedical presented two written submissions.

The first, dated 15 July 1991, submitted the following:

"2.(a)  On 12 September 1990, the Opponent's Notice of Opposition was filed.

(b)On 14 November 1990, solicitors for the Opponent requested Dr R R Doherty to provide evidence in support of the Opponent's Notice of Opposition.

(c)On 27 November 1990, application for extension of time in which to serve evidence in support to 12 January 1991 was lodged.

(d)On 11 January 1991, application for extension of time in which to serve evidence in support to 12 April 1991 was lodged.

(e)On 6 March 1991, application for extension of time in which to serve evidence in support to 12 June 1991 was lodged.

(f)On 19 April, Dr Doherty advised he would be unwilling to devote sufficient concentrated effort to prepare a declaration in support of the Opponent's Notice of Opposition.

(g)On 30 April 1991, solicitors for the Opponent requested Professor D Cooper to provide evidence in support of the Opponent's Notice of Opposition.

(h)On 9 May 1991, application for extension of time in which to serve evidence in support to 12 August 1991 was lodged.

(i)On 31 May 1991, Professor Cooper advised he was unable to provide us with any assistance due to pressures of work.

(j)On 31 may 1991 solicitors for the Opponent requested Dr J V Wells to provide evidence in support of the Opponents Notice of Opposition.

(k)During June 1991, Dr Wells was unable to prepare the declaration in support of the Opponent's Notice of Opposition as he was attending an AIDS Conference in Florence, Italy.

(l)All other persons suitable to provide evidence in support of the Opponent's Notice of Opposition, recommended by Dr Doherty and Professor Cooper, were similarly attending the AIDS Conference in Florence.

1. (a)  The extension of time to 12 August 1991 is justified having regard to all the circumstances as, due to the delays caused by Dr Doherty and Professor Cooper, the Opponent was unable to locate a person suitable to provide a declaration in support of its Notice of Opposition until 31 May 1991.

(b)No suitable person, to the knowledge of the Opponent, was available in Australia to provide evidence in support of the Opponent's Notice of Opposition during June 1991.

(c)Dr Wells intends to provide his declaration in support of the Opponent's Notice of Opposition as soon as is reasonable following his return to Australia.

1. The subject matter of the Application is of significant commercial importance to the development of the technology in relation to AIDS research and diagnosis.  Therefore, it is in the public interest that the rights to exploit this subject matter are settled clearly before any grant of patent and any possible subsequent infringement proceedings."

On 16 July 1991 the Patent Office sent a facsimile to United Biomedical's representatives as follows:

".... I note that you do not intend to be heard, in person, and will rely on your written submissions.

I further note your comments in para 2 of your letter.  Where a party chooses to rely on written submissions rather than to appear at the hearing, it is Office practice to require such written submissions to be lodged prior to the hearing.

When considering an application for an extension of time, the Commissioner has regard to various matters in order to determine whether the extension is justified.  The Office practice in this regard is well established, as reference to decided cases shows.  For example, see the following selection of reported cases:

British-American Tobacco v Philip Morris 18 IPR 655

CSIRO v Western Mining 16 IPR 538

Baxter Travenol v Cutter Laboratories 9 IPR 36

(IPR - Butterworth's "Intellectual Property Reports")

You may wish to add to your previous submissions after considering matters referred to in the previous paragraph."

In response, United Biomedical presented the following further submissions, dated 17 July 1991:

"1.(a)  The Opponent has been granted Australian Patent No. 579467 which:

(i)has priority dates, in accordance with section 58 B(2) of the Patents Act, 1952, of 11 September 1985, 4 March 1986 and 2 April 1986; and

(ii)relates to a synthetic peptide process of using synthetic peptides for detection of antibodies to HTLV-III, diagnosis of AIDS and pre-AIDS conditions, and as a vaccine.

(b)The Applicant's Patent Application:

(i)claims priority dates of 29 April 1985, 19 August 1985 and 26 March 1986; and

(ii)relates to synthetic antigens for the detection of AIDS-related disease.

(c)The Opponent's Notice of Opposition, based on section 59(1)(d) of the Patents Act 1952 states as its fifth ground:

'That the invention, so far as claimed in any claim, is the subject of a claim of the complete specification of another application for a standard patent lodged in Australia .... being a claim the priority date of which is earlier than the priority date of the first mentioned claim.'

(d)The Opponent's Patent and the Applicant's Patent Application have overlapping priority dates and relate to essentially the same subject matter.  Therefore, there is currently, on record with the commissioner, evidence of a serious opposition which can be mounted by the Opponent to the Applicant's Patent Application.

(e)Further evidence in support of the grounds contained in the Opponent's Notice of Opposition will be provided by Dr Wells in his declaration in support of that Notice of Opposition.

1. (a)  The decision of J I Welsh, a delegate of the Commissioner of Patents, in British-American Tobacco Co Ltd v Philip Morris Ltd 18 IPR 655 sets out following the (sic) grounds for granting to the Opponents an extension of time in which to lodge evidence in support of it's Notice of Opposition:

(i)the Opponent must show there is a good reason why the evidence has not been served within the time allowed; and

(ii)the Opponent must establish it is mounting a serious opposition.

(b)As set out in paragraph 3(a) of the Opponent's submission dated 15 July 1991, the delays have been caused by Dr Doherty and Professor Cooper not being able to provide sufficient time to prepare a declaration in support of the Opponent's Notice of Opposition.  These delays were not caused by the Opponent.

(c)As set out in paragraph 1 of this further submission, there is currently before the Commissioner sufficient evidence to indicate that a serious opposition may be mounted by the Opponent."

Submissions by Genetic Systems

In summary, Mr Royal's major submissions are as follows:

1. Genetic Systems had been disadvantaged in that they had only been advised on 27 May 1991 of United Biomedical's request for an extension of time lodged on 6 March 1991. 

Had proper process been followed and Genetic Systems been advised about this application as soon as possible after the 6 March 1991 and not 3 months later as had been the case, then Genetic Systems would have been in the position of raising an objection and having the matter resolved before the time for lodgement of evidence expired.  Mr Royal argued that because the matter has been heard after the expiry of the time for lodgement of evidence-in-support, there is pressure on both the parties and the hearing officer to grant the request so that the opposition could proceed. 

As a result, he said, Genetic Systems has been denied the opportunity of giving due warning of its intention of opposing any further extensions of time at this stage.

1. The reasons given previously for extensions of time and the length of time requested bear investigation. 

The reasons for the first request are misleading.  This request indicates that the opponent was in the process of obtaining further evidence from Melbourne and implies that evidence has been obtained and that further evidence is required.  As the request is for one month it would appear that one month is all that is necessary to obtain the further evidence required.  This is relevant because no evidence of any sort has as yet been provided and because a further request for more than one month was made.  If one month was satisfactory during the 1990 Christmas holidays why is one month not satisfactory now.  Whether the reason for this has been deliberately misleading is open to question.  This matter is relevant to considerations of cost, he said.

The further requests suggest that the opponents are "some way down the track" in obtaining evidence and it is at the stage of the last request that objection is raised to further extensions of time for presenting this evidence.

1. There has been no hint or suggestion during this process as to what the opposition is about and nothing to suggest whether it is a serious opposition or not.  It was only on the morning of the day of the hearing that Genetic Systems received a copy of submissions, from the opponent, containing details of the basis for the opposition, that is the patent number of the alleged prior claim.  Mr Royal said that in his opinion the submissions has not included anything which could be taken as facts.  The opponents submissions should have been accompanied by a declaration to set out relevant facts.  It should have identified the people mentioned in United Biomedical's submissions, by name and address, place of employment (if relevant), and qualifications.

It was not until United Biomedical had provided the number of the patent alleged to be a prior claim that any information is provided to indicate whether or not there is a serious opposition.

Mr Royal conceded that there might be a serious opposition if the priority details and subject matter of patent are relevant.  The relevance of the alleged prior claim could not be determined at this hearing.  This is normally done, he said, through the eyes of a technical expert who can say that there seems to be some basis for the prior claim.  The submission being made in this regard is therefore open to some question.

1. Mr Royal also said that the hearing officer has no evidence before him to conclude whether this is a serious opposition or not.  The hearing officer should not be expected to make personal investigations and draw conclusions about the alleged prior claim.  The law is such that the opponent should put the facts before the hearing officer so that he/she can make an appropriate decision.  The opponent needs to support his application by evidence and not by the mere suggestion that there might be evidence which, if the hearing officer fully investigated, took advice and heard submissions about, might put him/her in a position to say yes the extension should be granted.  Genetic Systems has also been denied the opportunity of making submissions on this point.

1. Mr Royal referred to the following decisions:

1. Vangedal Nielson v Commissioner of Patents and Gelphen Nominees 1981 AOJP 298 where Bowen C.J. said, on page 300, "... the Commissioner will have to consider the interests of the prospective opponent who, for some good reason, has not been able to mount his opposition within the initial period of three months.  The Commissioner will further have to have in mind, where a serious opposition is foreshadowed, the public interest which has been mentioned, but he will have to require to be satisfied by an Application for an extension that a proper case has been made out justifying the extension.  It would be wrong if he granted an extension simply because no-one had raised rather exceptional circumstances why it should not be granted.  Reasons why this is so include the desirably of operating the system efficiently and without unreasonable delays and also the interests of Genetic Systems for a patent which are also clearly involved."

Mr Royal submitted that a proper case had not been made out to justify the extension.

(II).Baxter Travenol v Cutter Laboratories 9 IPR 36 where the hearing officer said on page 38 that "It is apparent therefore in deciding whether an extension of time should be allowed the Commissioner:

1. must be satisfied that an Applicant who seeks such an extension has made out a proper case justifying the extension; and

1. must consider not only the respective interests of the Applicants and opponents, but also those of the public by ensuring that worthless patents are not granted and that there are no unreasonable delays in the proceedings."

Again Mr Royal argued that a proper case had not been made out justifying the extension.

(III).The Dupps Company v Stord Bartz 17 IPR 397 where the hearing officer said on page 399, in relation to extensions of time under Regulation 55 that "The opponent carries the burden of establishing a case to justify the extension, there should be a good reason why the evidence has not been served within the time allowed under the regulation, there should be some indication that there is a serious opposition and there should be no unreasonable delays" and on page 403 "I am bound to determine whether there is, in fact, a serious opposition which is not the same thing as a serious desire to oppose. In this case I have no serious evidence before me of a serious opposition. The opponent has not been able to obtain evidence from any expert resident in Australia ....".

Mr Royal argued that the opponent had not shown that there was a serious opposition and not met this requirement.

(IV).Mr Royal also referred to in relation to Viscount Plastics v Deta Nominees 1980 AOJP 2073, in relation to his submissions that the opponent had not met the criteria to be applied when considering applications for extensions of time.

1. In relation to public interest Mr Royal argued that a distinction should be drawn between various grounds of opposition.  The public interest is not served, he said with "some squabble", over issues of entitlement to the patent such as issues of obtaining. In those circumstances, he said, public interest is removed because that is a battle over which of the parties will get the patent and the public are not involved.  This is relevant here because the only objection which has a semblance of support is one of prior claim and this is simply a battle over who gets the patent for the subject matter which is within the scope of the claim.  Mr Royal referred to Genetics International v Serano Diagnostics 13 IPR 31 which deals with the issue of "obtaining" in relation to the public interest. Drawing on this decision Mr Royal argued that the result of the opposition in respect to prior claiming is not relevant to the public interest in the same way as the obtaining argument is not relevant. That is, it is an argument about who gets a patent rather than about whether a patent will be granted.

(VI).Mr Royal argued that costs should be awarded to Genetic Systems even if the extension were granted on the basis that the hearing officer had to rely on evidence produced at the hearing to make a decision.  This was because the evidence was not available beforehand to enable the other party to make submissions on the matter.  He referred to CSIRO v Western Mining 13 IPR 424, Nautical Services v Hitech Distillation 7 IPR 567, Gerber Scientific Products v North Broken Hill 18 IPR 78, Conry v Atlas Air 18 IPR 285 in relation to this matter.

After considering Mr Royal's submission that Genetic Systems had not been able to consider and make submissions on the alleged prior claim, I wrote to him on 19 July 1991 offering seven days within which to make written submissions on the matter.

Mr Royal submitted the following:

"1.We have not been served with a copy of the patent specification 579467.  Is it expected of us to obtain ourselves copies of the evidence to be relied on by the other party?

1. The question of prior claim depends on the relative priority dates.  Application 597884 is based on three United States patent applications dated

29 April 1985

19 August 1985

26 March 1986

We understand that the alleged prior claim specification 579467 is based on three United States documents dated

11 September 1985

4 March 1986

2 April 1986

Thus, it is only where the opposed application 597884 is disentitled to a priority date based on the first two of its priority dates and where the citation 579467 is entitled to its earliest priority date that a prior claim could exist.  The determination of this depends upon an inspection and consideration of the various priority documents.  Copies of these have not been served on us.  Again, is it expected that we ourselves obtain copies of the evidence which is to be relied upon by the opponent?

1. There is no evidence before you relevant to the prior claim question.  You have simply been given reference to a document with a suggestion that it is a prior claim.  In our submission it is necessary for the applicant for extension to put before you evidence to show that there is a serious opposition contemplated.  This has not been done.  There is no evidence before you and there is no evidence before us to which we can respond.

1. It is inappropriate to expect the Hearing Officer to obtain for himself copies of relevant documents and to read them to decide whether there is a serious opposition?  Evidence should be put before you that would entitle you to draw that conclusion or to dismiss the seriousness of the opposition.

1. The number of the alleged prior claim was first given to us during the hearing. Hence, when the matter was to be decided there was no evidence before us nor before you that would indicate there was a serious opposition.

1. Is it appropriate that the matter be allowed to be drawn on for as long as the applicant for the extension wishes?  Surely relevant material must be provided in time to allow an appropriate hearing to take place.

1. As its stands we have not been put in possession of the information prior to the hearing.  We have not been heard in relation to the material now relied on.  To invite us to provide written submissions is an insufficient remedy.  It denies us the opportunity to be heard on the very issue of the objection.

10.It may be that there is a serious question of prior claim to be determined: you and we are not in a position to tell.  Failure of the opponent to put you and us in that position at the time the request for extension was lodged and at least at a sufficient time before the hearing to allow consideration clearly disentitles the applicant to an exercise of discretion in its favour.  It has had its opportunity to be heard and has not taken it up.

Decision

It is clear from the decided cases, for example, Vangedal Nielson v Commissioner of Patents and Gelphen Nominees 1981 AOJP 298, British-American Tobacco v Philip Morris 18 IPR 655, CSIRO v Western Mining 16 IPR 538 and Baxter Travenol v Cutter Laboratories 9 IPR 36 that my decision in this matter must be based on the following basic considerations:

1. the applicant for an extension must justify the extension;

2. whether there is a serious opposition in train;

(iii)the private interests of the parties to the action and the public interest.

I will now explain the reasons for my conclusions against each of these considerations.

(i)  the applicant for an extension must justify the extension.

There have already been three extensions of time granted to lodge evidence-in-support.  It is ten months since the Notice of Opposition was lodged on 12 September 1990. 

I have before me written submissions, from the solicitors representing United Biomedical, providing reasons why the evidence-in-support has not as yet been obtained.  The first submission presents a chain of events as an explanation of why evidence has not as yet been served.  In the second submission I have been given an indication of the basis of the opposition, that is an alleged prior claim by Australian Patent No. 579467. 

Mr Royal argued that I do not have any facts before me to support the claims made by United Biomedical.  However, in the absence of any evidence to the contrary from Mr Royal, I must accept United Biomedical's explanation of the circumstances under which evidence-in-support has not as yet been served. 

Therefore, on the basis of what I have before me, I am prepared to accept that United Biomedical has made a serious attempt to obtain evidence-in-support and that the application for an extension of time has been justified.

(ii) whether there is a serious opposition in train.

The only indication I have that a serious opposition is train is in statements made in paragraphs 1(a) to (d) of United Biomedical's submission of 17 July 1991, referred to previously in this decision, which suggest that Genetic System's Australian application No. 597884 is prior claimed by United Biomedical's patent No. 579467.

Mr Royal argued there is no evidence before me relevant to the prior claim question.  It is inappropriate, he said, "to expect the Hearing Officer to obtain for himself copies of relevant documents and to read them to decide whether there is a serious opposition.  Evidence should be put before me that would entitle me to draw that conclusion or to dismiss the seriousness of the opposition."

I can not accept this argument.  I have easy access to the Patent Office file for application No 597884.  Although I am not here to determine whether or not this application is prior claimed by patent no. 579467, I can determine whether or not there is a serious question of prior claim, that is whether, prima facie, the conditions exist for prior claim by the claims of patent no. 579467.

Patent No 579467 is for a method for the detection and diagnosis of AIDS, ARC (AIDS related complex) and pre-AIDS conditions in body fluids by the use of a chemically synthesized peptide, a vaccine for AIDS, ARC and pre-AIDS conditions and a method for stimulating the production of antibodies to HTLV-III to provide protection against infection by HTLV-III or LAV in healthy mammals, including humans.  There are claims to a peptide sequence per se and its use as described above.  I note also that the earliest priority claimed for patent no. 579467 is earlier than the filing date of application no. 597884 and that 579467 is currently in force.  I conclude from this that conditions exist for a prior claim by the claims of application no. 597884 and a serious opposition is therefore in train.

(iii)  the private interests of the parties to the action and the public interest.

I consider both parties have been treated fairly in this matter because they have been given adequate opportunities to present submissions.

It is clear the interests of the opponent would be best served if I allowed the application for extension of time.

I accept Mr Royal's submission that Genetic Systems may have been disadvantaged in that it was not notified of Biomedical's previous request for an extension of time until almost three months after the request had been made.  I will ensure that appropriate notice is taken of his concern about the procedure adopted by the Patent Office in this case, however I note that the actions relating to the previous application are not relevant to the current application.

Mr Royal argued that the grounds of opposition of prior claiming merit a similar consideration to those of obtaining, in relation to the public interest.  What is at issue, he said, is who gets the patent rather than whether a patent will or will not be granted.  He also argued that an analogy can be made between the issues of obtaining and prior claiming where the public interest is involved, that is, the public interest is not relevant where the issue is one of prior claiming.  In relation to this, he referred to the decision in Genetics International v Serano Diagnostics (supra).

I cannot accept this argument.  It is not in the public's interest for the Commissioner to grant an invalid patent and prior claiming is a ground of invalidity.

Under the current circumstances, the public interest would be best served by the allowance of the extension of time.

Conclusion

After carefully considering all the arguments presented to me I have, in the light of my findings in relation to considerations above, decided to allow the application for an extension of time  under regulation 55, to 12 August 1991.

I note that United Biomedical has in fact completed service of evidence-in-support within the period allowed.

United Biomedical also lodged further written submissions on this matter, dated 14 August 1991, after the hearing which I have not referred to in arriving at my decision.

My decision relies on United Biomedical's submissions lodged on 15 and 17 July 1991.

The period allowed under regulation 56 will commence from the date of this decision because Genetic Systems could not be expected to serve evidence-in-answer until I issued this decision.

Costs

In an action of this nature costs normally follow the event.

However, Mr Royal argued that costs should be awarded to Genetic Systems, even if the extension were granted, on the basis that the hearing officer had to rely on submissions made on the day of the hearing (17 July 1991) to make a decision.  Genetic Systems, he said, had not had the opportunity to consider and make submissions on these matters.

United Biomedical's  present application did not give any circumstances and grounds for the extension of time.  Therefore I consider Genetic Systems was justified in opposing the extension of time.

I consider that Genetic Systems did not have knowledge of these written submissions in adequate time prior to the hearing.  Had United Biomedical provided this information in adequate time, the reasons for the extension of time would have been clearer to Genetic Systems.  It is therefore likely that the hearing may not have taken place.

Consequently, I award costs of this action in favour of Genetic Systems.

Bob Sawyer
Supervising Examiner

Patent Attorneys for the applicant:    Phillips Ormonde & Fitzpatrick, Melbourne

Solicitors for the opponent :         Corrs Chambers Westgarth, Sydney