Re Applications by CSIRO and Gilbert

[1995] APO 16

official notice

decision of a deputy commissioner of patents

Applications       :    PL2985 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION; Harry John GILBERT; and Geoffrey Peter HAZLEWOOD;

PL3238 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION;

PL8100 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION;

42983/93 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION;

43479/93 in the name of Geoffrey Peter HAZLEWOOD; Harry John GILBERT; The AGRICULTURAL and FOOD RESEARCH COUNCIL; and UNIVERSITY OF NEWCASTLE-UPON-TYNE;

Titles:    Recombinant Xylanase;

Recombinant Xylanase;

Recombinant Xylanase;

Recombinant Xylanase; and

Recombinant Xylanases - respectively

Action:    Requests under s.32 and 36 as between the various applicants.

Decision:    Issued            .

Abstract:    Parties were involved in a collaboration. Entitlement to inventions associated with the collaboration lies jointly with the parties.

In respect of one invention, there was no significant (if any) inventive contribution in its derivation over and above an invention of the collaboration - indeed it seems most probable that it was a mere "colourful variation", created with the benefit of knowledge derived from the collaboration.    /...

Matters brought into the collaboration at its commencement as part of its basis were subject to joint entitlement, together with the results of the collaboration.

Publication of one aspect of the invention, although relevant to the question of novelty, had no bearing on the question of entitlement.

patents act 1990

decision of a deputy commissioner of patents

Re:Patent Application No. PL2985 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION; Harry John GILBERT; and Geoffrey Peter HAZLEWOOD, and a request under s.32 by Harry John GILBERT and Geoffrey Peter HAZLEWOOD;

Patent Application No. PL3238 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION, and a request under s.36 by Harry John GILBERT and Geoffrey Peter HAZLEWOOD;

Patent Application No. PL8100 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION, and a request under s.36 by Harry John GILBERT and Geoffrey Peter HAZLEWOOD;

Patent Application No. 42983/93 in the name of COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION, requests under s.32 and s.36 by COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION, and a request under s.36 by Harry John GILBERT and Geoffrey Peter HAZLEWOOD; and

Patent Application No. 43479/93 in the name of Geoffrey Peter HAZLEWOOD; Harry John GILBERT; The AGRICULTURAL and FOOD RESEARCH COUNCIL; and UNIVERSITY OF NEWCASTLE-UPON-TYNE, and a request under s.36 by COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION.

background

Patent Application PL2985 was filed on 17 June 1992, in the name of Commonwealth Scientific And Industrial Research Organisation (hereafter referred to as CSIRO); Harry John Gilbert; and Geoffrey Peter Hazlewood. Later, CSIRO filed two other applications - PL3238 (on 29 June 1992), and PL8100 (on 1 April 1993).

On 17 June 1993 CSIRO filed an international application under the PCT - PCT/AU93/00294 - which inter alia designated Australia. The Australian application is 42983/93. This application claims priority from PL2985, PL3238, and PL8100.

Also on 17 June 1993, Harry John GILBERT and Geoffrey Peter HAZLEWOOD filed an international application under the PCT - PCT/GB93/01283 - which inter alia designated Australia. The Australian application is 43479/93. This application claims priority from PL2985. During the International phase of this application, The Agricultural And Food Research Council (hereafter referred to as AFRC) and University Of Newcastle-Upon-Tyne were added as applicants by way of Rule 92bis of the PCT.

As a result of a dispute between the parties, the following requests were filed:

24 May 1993s.32 request on PL2985 by Gilbert and Hazlewood, requesting a direction that PL2985 should stand in the names of Gilbert and Hazlewood alone.

17 Dec 1993s.32 request on 42983/93 by CSIRO

6 Apr 1994s.36 request on 42983/94 by CSIRO, requesting a declaration that it is the only eligible person in respect of this application.

26 Apr 1994s.36 request on 43479/93 by CSIRO, requesting a declaration that it is the only eligible person in respect of this application.

26 Dec 1994s.36 request on 42983/93, PL3238 and PL8100, by Gilbert and Hazlewood, requesting a declaration that they are the only eligible persons in respect of these applications.

By agreement of the parties, all requests were heard together. The hearing was conducted in Canberra on Feb 16 and 17, 1995. CSIRO was represented by Ms A Hall-Brown of counsel instructed by Mr R Kelly (patent attorney of Fisher & Kelly, Brisbane); Dr Gilbert and Prof Hazlewood were represented by Dr J Emmerson of counsel, instructed by Dr V Santer (patent attorney of Griffith Hack & Co, Melbourne).

At the outset I raised the issue of the extent of the decision to be made as a result of the present hearing; I noted that the terms of any declaration under s.36 will critically depend upon the findings of fact, and to explore the detail of such declarations before determining the questions of fact would seem inappropriate. Consequently I suggested that the approach to be followed should be similar to that in Harris v CSIRO 26 IPR 469 - viz an initial decision setting out a finding of facts relating to entitlement, with the terms of any declarations or determinations being dealt with at a subsequent hearing (if required). The parties agreed.

History of the dispute

The present actions involve the disclosures in 5 patent specifications, and a series of cross-claims for declarations under s.36, and determinations under s.32. Viewed from this perspective the matter is somewhat complex. On the other hand, the facts as reflected in the actions of the parties are reasonably straight forward.

By way of initial background, the inventions in dispute relate to recombinant xylanases derived from anaerobic fungi. These enzymes have a high activity and are xylan specific (that is, they do not degrade cellulose.) This is particularly important in the pulp and paper industry, where xylan needs to be removed and lignin dissociated from plant fibre, without cellulose fibre being damaged.

The development of the invention involved 4 individuals:

Dr. Orpin, at relevant times employed by CSIRO, but formerly employed by the AFRC.

Dr. Xue, employed by CSIRO

Dr. Gilbert, employed by AFRC; and

Professor Hazlewood, employed by University of Newcastle-upon-Tyne

In the 1980's, Orpin isolated an anaerobic fungus Neocallimastix Patriciarum whilst working for the AFRC. When Orpin changed employment to CSIRO, he took with him a number of cultures including N. Patriciarum. (There is no suggestion that this sample was in any way improperly taken.)

In the late 1980's, Gilbert and Hazlewood were funded to conduct research on plant cell wall hydrolases, including xylanases. Later Gilbert found that many of their fungi cultures held in storage had perished, and on 16 April 1991 wrote to Orpin asking for replacement stock.

On 18 April 1991, Orpin responded advising that he would bring some culture samples when he next visits. He also advised that 'we now have a good cDNA library' from N. Patriciarum, and that Xue has a number of xylanase clones from that library. In offering the clones, he goes on to state "Needless to say we shall be happy to collaborate with you."

On 18 June 1991, Hazlewood wrote to Xue acknowledging receipt of lysates containing 17 putative xylanase sequences from N. Patriciarum, and outlines the investigations planned. He concludes with:

"We had planned to make our own cDNA library (probably from Orpinomyces) but that may not be for some time as we will be giving highest priority to our collaboration with you and Colin and the xylanases. It would be nice to get a sequence published quickly as I am sure that the anaerobic fungi will become more popular in the future."

On 24 June 1991, Xue replied with some details about how they isolated the clones. He concludes with:

"I greatly appreciate your strong interest in our collaborative work. I am always keen to read your publications and would be grateful if you could send me your recent papers or Pre-prints."

On 25 July 1991, Hazlewood wrote to Orpin outlining their progress, and concluded with:

"Will keep you informed of progress; tell Gangping [Xue] that up to now, the xylanase stuff is looking good."

Gilbert and Hazlewood characterised the clones; identified one of them as a full-length gene for a xylanase; identified several catalytic domains in that full-length sequence; and showed that the full length gene had a high activity and was xylan specific. Additionally, Gilbert and Hazlewood produced a number of fragments of that gene which expressed a xylanase at much higher levels than the full-length gene. They called the full length gene pNX1, and identified 9 fragments which they labelled pNX2 through to pNX10, with the most significant fragment being pNX5.

On 21 November, Orpin wrote to Gilbert acknowledging receipt of "the m/s for the xylanase sequencing", and congratulates him "on getting it written so quickly". On 13 December 1991, Hazlewood wrote to Orpin, noting that the paper has been sent off. The letter states, inter alia:

"We also had a good chance to compare the outcome of our collaborative efforts with results from other groups interested in fungal xylanases..";

"We are obviously keen to continue working with you and Gangping [Xue] ..."

"Don't think that we are reluctant to complete a partial clone or do anything that proves a bit more difficult; that certainly isn't the case, but if our joint objective is to get a couple of decent papers out as soon as possible, it would be nice to minimise complications. Do you agree or have you other opinions on the subject?"

"We are particularly interested in some of the accessory enzymes involved in xylan degradation, so feel that we should have our own cDNA library to screen (I presume that you would not be keen for us to screen your library, although you have our assurance that anything isolated would only be studies as part of our existing collaboration)."

"If you have an alternative strain to N. Patriciarum which you are keen to look at, we would be amenable to making a cDNA library which we could all look into or exchange clones from."

On 23 December 1991, Orpin responded stating:

"Of course we shall be pleased to continue our collaboration."

and offered to send some 200 more xylanase +'ve plaques.

On 28 May 1992, Orpin wrote to Hazlewood advising:

"Mark Carver [of ICI] sent a fax to me overnight - quick working! - expressing their interest in xylanase. Everyone here is quite happy to have you and Harry as co-inventors - which is as it should be. "

That same day Hazlewood responded, stating inter alia:

"We shall need to move fairly quickly with the patent as it is important to get the paper published & we have only asked for a delay of two months.

"Please let me have copies of any relevant documents.  Let me know if you need further information. Obviously, we must not let anyone have the clone!"

On 10 June, Nuventures (the technology development and transfer company of the University of Newcastle-upon-Tyne) wrote to Orpin with regard to the patent application. The letter says, inter alia:

"I do not have anything on file which relates to the ownership of the IPR. I am assuming that there is already verbal agreement that ownership is split equally between the three academic parties and that therefore any upside is split in the same proportion. Is this your understanding?"

In response, CSIRO responded on 15 June stating:

-the application has already been lodged

(in fact the application was not filed until June 17)

-that the application recognises four inventors and that it was proposed that ownership be distributed equally between them.

On 22 June CSIRO wrote to Hazlewood and Gilbert. That letter stated that they wished to continue with the collaborative effort between the institutions. It also includes a copy of a letter to ICI in which CSIRO state that they have entered into a licence agreement with a Brisbane based company, and that it was not appropriate for CSIRO to deal with ICI through Nuventures. Subsequently CSIRO advised Nuventures that the agreement with the Brisbane company was confidential; that CSIRO had exclusive rights to pNX1, and that Nuventures could not discuss pNX2-pNX10 with ICI without the consent of the Brisbane company unless they could produce them from a source other than pNX1.

After some further correspondence, in which commercial arrangements were discussed, CSIRO wrote to Nuventures asserting their rights, noting their previous offer of royalties, and advised that "if this is not satisfactory then I regret we cannot be of any further assistance to you in this matter."

Subsequent to these events CSIRO filed PL3238; it omits some material present in PL2985, apparently to restrict it to subject matter they considered was properly theirs; apparently PL3238 has no disclosure over and above PL2985 other than a reference to a deposit of pNX1 at an International Depository Authority under the Budapest Treaty. Much later CSIRO filed PL8100, in which they identified a number of clones of higher activity than the full-length pNX1 gene. In particular, they identified a fragment they call pNX-Tac (which, apparently, has the same catalytic region of pNX1 as that present in pNX5).

Finally, CSIRO filed PCT/AU93/00294 with CSIRO as sole applicant and naming Orpin and Xue (only) as inventors, claiming priority from the above 3 provisional specifications; on the same day Gilbert and Hazlewood filed PCT/GB93/01283 in their names alone, again claiming priority from the first of the above provisional applications.

In summary, there had apparently been a highly successful and cooperative scientific collaboration. However it would seem that the initial steps taken to commercialise the results of that collaboration rapidly developed into a breakdown of the relationship between the parties.

Decision

Inventiveness

At the hearing a range of issues were canvassed. One noteworthy aspect is that the respective sides asserted that the contribution of the other side to the 'invention' was the performance of routine steps which was not inventive - that their contribution was the inventive part, and that as a result they were the only persons entitled to the invention. Whilst it is tempting to accept each side's argument that the contribution of the other was non-inventive - and come to a conclusion that there is no invention at all - I do not think that is appropriate. In particular it is well established that inventiveness is assessed by reference to whether an invention was obvious to the hypothetical non-inventive skilled addressee; the ease or difficulty to the inventor of making the invention is irrelevant. It follows, in my view, that rights in an invention do not flow from an assessment of the inventiveness of respective contributions, but rather from an objective assessment of the contribution simpliciter to the invention. See, for example, the judgement of the US District Court in Meuller Brass Co v Reading Industries 176 USPQ 361 @372:

"The exact parameters of what constitutes joint inventorship are quite difficult to define. It is one of the muddiest concepts in the muddy metaphysics of the patent law. On the one hand, it is reasonably clear that a person who has merely followed instructions of another in performing experiments is not a co-inventor of the object to which those experiments are directed. To claim inventorship is to claim at least some role in the final conception of that which is sought to be patented. Perhaps one need not be able to point to a specific component as one's sole idea, but one must be able to say that without his contribution to the final conception, it would have been less - less efficient, less simple, less economical, less something of benefit. This Court has found no case in which co-inventorship status was recognised where the alleged co-inventor was not deemed in some way, at least presumptively, to have beneficially affected the final concept of the claimed invention, and if such a case exists, it would be so anomalous as to warrant little attention."

Another related matter is that there has not been any investigation of the inventiveness of the subject matter disclosed in the present applications - none have even reached the stage of being examined. It seems to me that in these circumstances I should only make findings of lack of inventiveness where it clearly is necessary to do so - and then only where I am in no doubt. Otherwise, I think that when I refer to inventions, I should do so in the context of the definition in the Patents Act 1990 that an invention includes an alleged invention.

Entitlement

Much of the submissions put before me related to arguments of who invented what, with reference to Harris v CSIRO (Supra). However the key issue in the present case is not one of inventiveness, but entitlement. S.15 of the Act provides that a patent may only be granted to a person who:

(a)  is the inventor; or

(b) would, on the grant of a patent for the invention, be entitled to have the patent assigned to the person; or

(c)derives title to the invention from the inventor or a person mentioned in paragraph (b); or

(d)is the legal representative of a deceased person mentioned in paragraph (a), (b) or (c);

and the status of inventor is only one basis for entitlement.

In the present case, it is clear that Orpin and Xue were responsible for creating a cDNA library and identifying a set of clones having Xylanase activity. Gilbert and Hazlewood were responsible for investigating those clones, sequencing pNX1, and identifying fragments of pNX1 having greater activity. However, when looking at entitlement to an invention, one must have regard to the 'invention' as a whole as well as the component parts, and the relationhip between the participants. And in the present case the fact that the parties were in a collaboration is a major consideration - more important than the issue of who invented what in the component parts of the invention.

The terms of the collaboration were never put in writing. But this is not a reason to deny its existence - the correspondence between the parties clearly recognises a real and ongoing collaboration. Dr Emmerson sought to distinguish a 'scientific' collaboration from a 'commercial' collaboration. I think that is an artificial distinction absent a clear indication that such a distinction was present in the minds of the collaborators. Indeed, it seems to me irreconcilable that a person could have a right to recognition as a joint author of collaborative research paper, yet have no entitlement to any proprietary rights to commercial matters that arise from the paper.

As to the scope of the collaboration, the Macquarie Dictionary defines collaborate as

1. to work, one with another; cooperate, as in litrary work. 2. to cooperate treacherously. (I ignore this second meaning here.)

and Roget's Thesaurus gives as synonyms:

alliance, colleagueship, joint-stock, co-partnership, coalition, syndicate.

These synonyms are, in my view, in complete accord with the relationship between the parties as evidenced in their correspondence.

In my view the collaboration between the present parties was based on a sharing of all 'advantages' arising from their collaboration. The respective contributions to the collaboration were the clones (including the method of their production, as is apparent from the section on experimental procedures in the joint paper) provided by Orpin and Xue, and the investigation of those clones by Gilbert and Hazlewood. All the correspondence up until the dispute evolved is consistent with this understanding as between the parties.

I conclude that a consequence of the collaboration is that entitlement to any inventions associated with the collaboration are shared between the parties of the collaboration; that is, if an individual is not considered to be an actual inventor, they derive title by way of the collaboration. Thus, the entitlement to any invention associated with the provision of the clones by Orpin and Xue is shared by reason of the collaboration; and the entitlement to any invention associated with the end results of the collaboration (esp. pNX1 to pNX10) are also shared by reason of the collaboration.

Publication in EMBL of the Sequence of pNX1

As a condition for publication of the joint paper, the authors were required to submit a machine readable form of the sequence of pNX1 to the EMBL sequence database. The sequence listing provided the full sequence of pNX1, and noted that it was a xylanase and was obtained from Neocallimastix Patriciarum. The listing was submitted by Gilbert on 10 April 1992. It is apparent that at that time the parties were not aware of when the sequence would be publicly available through EMBL; after the present dispute arose, they established that it was publicly available as of 5 May 1992 (before the filing date of any patent application).

The publication of the sequence of pNX1 in EMBL before the filing of PL2985 raises an interesting question. Dr Emmerson argued that the publication of this sequence would anticipate any claim to pNX1 (which, prima facie, I agree with). He then argued that the rights in an invention need to be determined by having regard to what was the invention; that invention was necessarily determined by reference to the prior art base; that in the present case pNX1 was part of the prior art base prior to the filing of any specification; that consequently any invention only resided in making fragments pNX2-pNX10; that these fragments were made by Gilbert and Hazlewood; and that consequently they were the only persons entitled to that subject matter. That is, any rights of Orpin and Xue in pNX2 to pNX10 were extinguished by the EMBL publication.

I do not agree with Dr Emmerson's argument. His analysis focuses entirely on the issue of inventiveness, and ignores entitlement that arises otherwise. The rights of the present parties are governed primarily by the existence of the collaboration, rather than an analysis of who invented what. Consequently, although the publication of the sequence of pNX1 may affect issues of novelty, it does not affect the issue of entitlement arising from the collaboration.

Even if the rights of the parties are not determined by the collaboration, I would reach the same conclusion following Viziball Ltd's Application [1988] RPC 213 where, under similar provisions in the UK Patents Act it was said:

"I regard the invention as that which was conceived by the applicant to be an invention at the time he filed his application whether that be a patentable invention or not i.e. the alleged invention."

following which no regard was had to a US Patent said to disclose certain features - the parties being unaware of its existence at the time. When PL2985 was filed, the parties were apparently unaware of the public availability of the pNX1 sequence through EMBL - or if they did, there is no evidence to suggest that the parties considered the publication to affect their rights in the invention at that time. Consequently I believe the publication by EMBL should be disregarded in determining entitlement to the invention.

pNX-Tac

Besides the matters relating to pNX1 to pNX10, PL8100 and 42983/93 disclose some other constructs. At the hearing CSIRO stated that the s.36 request in respect of their own application 42983/93 was to establish their rights in one of those constructs - pNX-Tac. Likewise, Gilbert and Hazelwood sought to have their rights in pNX-Tac determined, they in effect asserting that it was almost the same (if not the same) as pNX5. (Because the comparison was made with pNX5, I will likewise make comparisons with pNX5 although, as will become evident later, comparison with pNX9 or pNX10 may be more appropriate.)

At the time of filing PL8100, the evidence strongly suggests that the collaboration had ceased. If the collaboration was continuing at that time, the entitlment to PL8100 would clearly be joint, as a result of that collaboration. However I need to determine entitlment to PL8100, and in particular pNX-Tac, on the basis that the collaboration had ceased before the time of filing.

By way of background, application PL2985 disclosed, beside the full length clone pNX1, truncated clones including pNX5 and pNX6. pNX5 was identified as having 15 times the expression level as pNX1, and each was identified with a respective one of two catalytic domains in pNX1. The specification explains the presence of the two catalytic domains as "clearly a result of tandem duplication of an ancestral gene". I also note that in 43479/93, pNX5 is said to have an activity some 100's of pNX1. Finally, on page 21 of PL2985, it is stated (after discussing the activity of pNX5):

Interestingly, a further increase in xylanase activity was achieved by deletion of a few amino residues from the C-terminus of the second catalytic domain to generate pNX9.

The sequences of pNX1 to pNX10 are given in the sequence listing in 43479/93. PL2985 suggests that pNX9 is slightly shorter than pNX5, and pNX10 is somewhat longer (as shown in fig 1). The sequence listing in 43479/93 has pNX9 somewhat longer than pNX5, and pNX10 slightly shorter; I conclude that the entity identified as pNX9 in PL2985 is the entity identified as pNX10 in 43479/93. Hereafter I shall refer to this entity as pNX10.

A comparison of the sequence of pNX-Tac with pNX5 and pNX10 shows:

-they both contain the same catalytic region;

-pNX-Tac has a START and STOP codon added;

-the 5' end of pNX-Tac preceding the catalytic region is of the same length as for pNX5. The only difference (apart from the START codon) is that the first two aminoacids coded for after the START codon are different - but I note that for both, the difference is apparently no more than the conservative substitution of one aminoacid for another (Alanine for Threonine, and Serine for Alanine); and

-the 3' end of pNX-Tac following the catalytic region is shorter than pNX5, but is the same as pNX10 (with the STOP codon added).

That is, pNX-Tac is the same as pNX10 apart from the addition of a START and STOP codon, and coding for the conservative substitution of the first two aminoacids.

With this background it is appropriate to consider the specifications by CSIRO to ascertain their asserted development of pNX-Tac.

In the specification of 42983/93, the first reference to pNX-Tac is on page 11, under the heading "10. Optimisation of growth conditions of pNX-Tac clone", where it states

E. Coli strain JM83 harboring pNX-Tac plasmid grew...

with no details of how pNX-Tac was identified.

A little later, the specification refers to the pNX1 to pNX7. It goes on to state:

"In an attempt to obtain more highly active xylanase clones, further screening of 4 x 106 clones from the library was conducted ... Ten highly active clones were isolated and purified. Two of these recombinant bacteriophages (lambdaNPX29 and lambdaNPX30) have much stronger xylanase activity than previously isolated clones."

The specification describes excising the cDNA inserts into plasmid form, referred to as pNPX29 and pNPX30, and proceeds to describe three genetically modified constructs. Under the heading pNX-Tac it states:

"pNPX30 plasmid (pNPX21 or other xylanase cDNAs listed in Fig. 2 can be used) was digested with ... The 709 fragment was ligated ... This construct is designated pNXP2... Two oligonucleotide primers ... were then designed for PCR amplification ... The amplified fragment was digested with ...and ligated to EcoR1 and Hind111 digested pBTac2 to produce pNX-Tac."

The description proceeds to describe the properties of pNX-Tac, and then the optimisation of growth conditions with reference to E. Coli strain JM83. The activity is suggested to be about 90 times that of pNX1.

There are two matters I would observe with this description. Firstly, the derivation of pNX-Tac is associated with pNPX30. Although the description suggests that pNX-Tac could be derived from other plasmids (and refers to pNPX21, which is earlier stated to be the same as pNX1) a fair reading of the description suggests that pNX-Tac was derived from revisiting the library of clones, identifying pNPX30, and deriving pNX-Tac therefrom.

Secondly, the sequence of the primers used in that process is not given.

CSIRO's application PL8100 was filed some 2½ months previous. Its disclosure is somewhat different. Starting at page 29 of the specification:

".. it will also be apparent that the invention may also include within its scope truncated forms of pNX1 which may enhance the expressed level of the xylanase clone in a suitable host cell...  In order therefore to maximise the potential use of the recombinant xylanase in industrial application, the xylanase has now been genetically modified."

"The original clone pNX1 was truncated in any suitable manner such as by use of a restriction enzyme. The truncated form may be obtained by any suitable fractionation technique... An appropriate fragment of the original clone may then be ligated ..."

"The resulting construct may then be amplified by PCR techniques using suitable primers ... which may then ligate to another plasmid such as pBTac2 vector to produce pNX-Tac as described hereinafter."

"The truncated form of pNX1 should include a START signal which is required to initiate the synthesis of xylanase, a STOP signal located at a terminal end of the truncated XynA cDNA to terminate translation and a promoter designed to provide strong expression ..."

The specification then proceeds to detail the construction of pNX-Tac in more detail. It states (on page 32):

"Two oligonucleotide primers were designed for PCR amplification of pNXP2 [derived from pNX1] XynA insert. The sequences of these primers are as follows: ..."

"The PCR amplified fragment ... was digested ... and ligated to EcoR1 and Hind111 digested pBTac2 vector. The resulting construct is designated pNX-Tac ... with modification at the N-terminal sequence of the truncated XynA and introduction of translational stop codon (TAA) into the end of coding region of pNXP2."

On comparing the sequence of pNX-Tac, pNX1, pNX5, pNX10, and the primers used, it is apparent that the different sequence in the 5' end preceding the catalytic domain arises from the primer - the altered sequence matches that of the first primer given in PL8100. That is, the primer designed to include a START codon also provides coding for the conservative substitution of two amino acids in a region outside the catalytic domain.

Finally, the specification asserts that the xylanase activity was 60 times that of pNX1.

In summary:

-PL8100 includes a detailed description of the derivation of pNX-Tac from pNX1;

-the derivation set out in PL8100 makes explicit use of the knowledge of pNX1, and of the catalytic regions of pNX1, to create a fragment containing the catalytic region;

-in PL8100 it is said that some changes were made to the sequence in the terminal regions, to add a START signal, and a STOP signal; and the sequences of primers to achieve that are given;

-apart from the addition of a START and STOP codon (which prima facie a person skilled in the art would insert, having regard to their common general knowledge), the changes from pNX5 are no more than:

-coding for two conservative substitutions at the 5' end outside the catalytic region (introduced by the design of the primer); and

-truncation at the 3' end, matching the truncation present in pNX10;

-42983/93 suggests that pNX-Tac was not derived from pNX1, but from revisiting the cDNA library;

-much of the detailed information on how pNX-Tac was derived in PL8100 is not provided in 42983/93; in particular, the sequences of the primers are not indicated.

-although 42983/93 states that the constructs are modified at the 5' end sequence, the body of the specification does not indicate what modifications are made - the changes can only be gleaned from a comparison of the actual sequences given; and

-there is no actual comparison of the properties of pNX5 and pNX-Tac.

I note that all the specifications are inconsistent with respect to the level of activity of both pNX5, and pNX-Tac. That is, absent a proper comparison of the properties of pNX5 (or pNX10) and pNX-Tac, there is no basis to conclude that one is 'better' than the other on the basis of the activity figures provided in the various specifications.

Further, the absence of any details about the primers, and of the modification required at the 5' end of the sequence of pNX-Tac, suggests to me that the conservative changes made to the 5' end of the sequence are of no particular importance to the functioning of the invention.

Finally, the truncation at the 3' end is no more than the truncation that existed in pNX10 as compared to pNX5.

I am therefore led to believe that there has been no significant (if, indeed, any) inventive contribution in the derivation of pNX-Tac - indeed it seems most probable that pNX-Tac is a mere "colourful variation" of pNX5 or pNX10, created with the benefit of the knowledge of pNX5 and pNX10 derived from the collaboration.

Consequently, I am of the view that pNX-Tac is properly the invention of the parties to the collaboration, and not CSIRO alone.

Effect of s.16

At the hearing, reference was made to s.16 of the Act, which sets out the mutual entitlements of the patentees (subject to any agreement to the contrary), and precludes licencing or assignment without the consent of the joint patentees. It was asserted that the licence that CSIRO negotiated with a Brisbane company was contrary to s.16, as it was negotiated without approval from Gilbert and Hazlewood.

At the hearing, I observed that s.16 related only to patents; the present applications were not yet patents; and there is no equivalent provision in respect of applications. It is not clear to me what effect (if any) this provision has vis-a-vis licences and assignments entered into during the application stages.

If s.16 has some effect on licences and assignments entered into during the period before the patent is granted, the question arises as to the status of the AFRC and University of Newcastle-upon-Tyne as applicants/entitled persons. In my view the collaboration entailed Orpin and Xue as employees of CSIRO, Gilbert as an employee of the AFRC, and Hazlewood as an employee of University of Newcastle-upon-Tyne; none of the four individuals were involved in the collaboration personally, as distinct from representing their employer. Consequently, whilst PL2985 named Gilbert and Hazlewood as coapplicants, and Gilbert and Hazlewood are the persons involved in the present actions, I would not view a substitution of their employer's name as requiring the approval of the other applicants, nor otherwise contrary to s.16 (if it applies).

Conclusion

My findings of fact in the present disputes are:

1. The entitlement to pNX-Tac lies jointly with the three parties to this dispute; there was no significant inventive contribution in the derivation of pNX-Tac over and above pNX5 - indeed it seems most probable that pNX-Tac is a mere "colourful variation" of pNX5, created with the benefit of the knowledge of pNX5 which was derived from the collaboration.

1. Otherwise (and subject to my comments with regard to s.16 above), the entitlement to the inventions disclosed in all applications the subject of this hearing lies jointly with the three parties to this dispute, by way of the collaboration.

As a result of these findings, there are a number of possible courses of action open to the parties, including inter alia amendment of the respective applications to reflect the joint entitlement, or my making declarations and/or determinations under ss 36 and 32. I also understand that there have been some discussions between the parties as regards settlement of the disputes.

Accordingly, I allow the parties 3 months to either:

-settle the dispute on the basis of my findings of fact; or

-provide me with proposed declarations and/or determinations (with copies to the other parties) to form the basis of a further decision on the terms of any such declarations and/or determinations.

Finally, I advise that I will be prepared to give the parties further time to settle the dispute upon the request of all parties, supported by appropriate justification.

Costs

In actions before the Commissioner, an award of costs usually follows the event. In the present case both parties were claiming the invention to be theirs alone; my finding is that entitlement to the inventions is joint. However the parties did not address me on the matter of costs, and it is therefore inappropriate that I give any further consideration to an award of costs at this time.

D. Herald
Deputy Commissioner of Patents

Patent attorneys for the CSIRO:  Fisher & Kelly, Brisbane

Patent attorneys for Gilbert & Hazlewood:  Griffith Hack & Co, Melbourne