Sang Lee v Commissioner of Patents
[2011] AATA 818
•18 November 2011
[2011] AATA 818
Division GENERAL ADMINISTRATIVE DIVISION File Number
2010/3924
Re
Sang Lee
APPLICANT
And
Commissioner of Patents
RESPONDENT
And
Komipharm International Co., Ltd
JOINED PARTY
DECISION
Tribunal Justice Downes, President
Dr Teresa Schafer, MemberDate 18 November 2011 Place Sydney Decision affirmed.
.............................[sgd]...........................................
Justice Downes, President
CATCHWORDS
PATENTS – patent application – inventive concept – who is an inventor – assignment of rights to invention – jurisdiction of the Administrative Appeals Tribunal under the Patents Act 1990 (Cth)
LEGISLATION
Administrative Appeals Tribunal Act 1975 (Cth) s 25
Patents Act 1990 (Cth) ss 15, 32, 36, 79B, 104, 224(1)(a), sch 1
CASES
JMVB Enterprises Pty Ltd v Camoflag Pty Ltd [2006] FCAFC 141; (2006) 154 FCR 348;
Polwood Pty Ltd v Foxworth Pty [2008] FCAFC 9; (2008) 165 FCR 527
Sang Bong Lee v Komipharm International Co., Ltd [2010] APO 14
University of Western Australia v Gray [2009] FCAFC 116; (2009) 179 FCR 346
University of Western Australia v Gray (No. 20) [2008] FCA 498; (2008) 246 ALR 603
Upham and Commissioner of Patents [1998] AATA 852; (1998) 28 AAR 276Wake v Cavitus Pty Ltd [2010] APO 11; (2010) 88 IPR 169
REASONS FOR DECISION
Tribunal Justice Downes, President
Dr Teresa Schafer, MemberDate 18 November 2011 SUMMARY
Sodium meta-arsenite may be a useful therapeutic agent in the treatment of some solid tumours. Two patent applications have been filed claiming this use. At least one of them is ready for sealing. Issues have arisen as to whether the applicant in these proceedings, Dr Sang Bong Lee, is an inventor who is entitled to recognition as an applicant for the patents and who would, on grant, become a patentee. The delegate of the Commissioner of Patents (Dr S.D. Barker) decided that Dr Lee’s claims failed. Dr Lee has applied to the Tribunal for review. We agree with the delegate’s decision. Dr Lee was not sufficiently associated with the inventive concept lying behind the patent applications to be an inventor and he has not shown a sufficient contractual basis to be recorded as an applicant by derivation from the rights of the inventor.
INTRODUCTION
Dr Lee seeks review of a decision of the delegate of the Commissioner of Patents under s 32 of the Patents Act 1990 (Cth) that Dr Lee was not an inventor of the invention disclosed in Australian Patent Applications 2002253713 and 2008255139 and was therefore not entitled to be recorded as an applicant who was an inventor. He also seeks review of the delegate’s further decision that Dr Lee was not entitled to be recorded as an applicant by derivation of that right from the inventor.
PA 253713 was originally filed in the Republic of Korea under the provisions of the Patent Cooperation Treaty by Korea Microbiological Laboratories Ltd. The inventors were listed as Dr Lee and Mr Yong Jin Yang. Mr Yang was the founder and chief executive officer of Korea Microbiological. Pursuant to the Patent Cooperation Treaty Dr Lee and Mr Yang were later added as applicants. Komipharm International Co., Ltd., to which Korea Microbiological changed its name, was substituted as an applicant. On 23 July 2008 a request was made with respect to the Australian application to record Dr Bernardus Rademaker as the sole inventor and on 12 August 2008 a request was made to change the applicant to Komipharm alone. These requests, however, must have been made under s 104 of the Patents Act, which permits an applicant to request changes, but were made by Komipharm alone. Since not all the existing applicants joined in the requests, the amendments were probably irregular. An appeal lies from decisions under s 104 to the Federal Court. PA 255139 was filed as a divisional application (s 79B) to PA 253713 on 4 December 2008. The applicant was Komipharm.
Dr Lee filed applications under s 32 that he be identified as an inventor and applicant with respect to both patent applications. The delegate determined that Komipharm should be recorded as the sole applicant for the patent applications and, rejecting Dr Lee’s claim to be an inventor, determined that Dr Bernardus Rademaker is the sole inventor of the invention disclosed and claimed in the applications.
LEGISLATION
Section 32 of the Patents Act provides:
If a dispute arises between any 2 or more interested parties in relation to a patent application whether, or in what manner, the application should proceed, the Commissioner may, on a request made in accordance with the regulations by any of those parties, make any determinations the Commissioner thinks fit for enabling the application to proceed in the name of one or more of the parties alone, or for regulating the manner in which it is to proceed, or both, as the case requires.
Schedule 1 to the Patents Act provides that an:
interested party, in relation to a patent application, means the applicant or a joint applicant, or a person who claims to be entitled to the grant of a patent on the application, either alone or jointly with another person.
Dr Lee is an “interested party” because he claims to be entitled to the grant of a patent in respect of the patent applications. Komipharm, the joined party, is also an interested party because it is the applicant in respect of the patent applications.
The Tribunal’s jurisdiction to review the decision arises from s 224(1)(a) of the Patents Act and s 25 of the Administrative Appeals Tribunal Act 1975 (Cth).
JURISDICTION
This case raises issues as to whether Dr Lee is an inventor for the patent applications and whether he is entitled to seek, partly in his name, any grant of patents made pursuant to the patent applications. The latter claim involves dealings between Dr Rademaker and Komipharm and between Komipharm and Dr Lee. The relevant dealings are private contractual dealings.
Issues as to title to an invention, particularly where they involve questions of contract law, are generally dealt with in civil litigation in courts of law. The same is generally true of disputes as to inventorship. A significant example is the protracted and complex litigation in University of Western Australia v Gray [2009] FCAFC 116; (2009) 179 FCR 346 and at first instance [2008] FCA 498; (2008) 246 ALR 603. Another recent example is Polwood Pty Ltd v Foxworth Pty Ltd [2008] FCAFC 9; (2008) 165 FCR 527.
Section 15 of the Patents Act identifies who may be granted a patent:
15 Who may be granted a patent?
(1)Subject to this Act, a patent for an invention 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).
Two sections of the Patents Act potentially deal with resolving disputes relating to entitlement. Section 36 confers power on the Commissioner to “declare in writing that the persons who… are eligible persons in relation to the invention…” “Eligible persons” is defined in Schedule 1 to mean “a person to whom a patent for the invention may be granted under section 15”. An appeal lies to the Federal Court from such a decision (s 36(5)).
Pursuant to s 32, referred to above, where “a dispute arises between… interested parties… whether, or in what manner, the application should proceed” the Commissioner is empowered to “make any determination the Commissioner thinks fit for enabling the application to proceed in the name of one or more of the parties alone, or for regulating the manner in which it is to proceed, or both, as the case requires”. An appeal lies to the Administrative Appeals Tribunal from such a decision (s 224(1)).
Although s 36 appears to address issues associated with entitlement to a patent more directly than s 32, which primarily depends on a dispute as to how an application should proceed, s 32 does give jurisdiction to determine whether the application should proceed “… in the name of one or more of the parties alone…”.
It is not entirely clear to us how ss 32 and 36 interact when a question concerning entitlement to be granted a patent arises as part of an issue concerning the parties to a patent application. In Upham and Commissioner of Patents [1998] AATA 852; (1998) 28 AAR 276 (3 November 1998) Deputy President McMahon determined, under s 32, to add a person he decided was a co-inventor as an applicant for a patent. We are not aware of any appeals to the Federal Court under s 36. In Wake v Cavitus Pty Ltd [2010] APO 11; (2010) 88 IPR 169 the delegate of the Commissioner (O L Haggar) rejected, under s 36, a claim by Mr Wake that he was the inventor of a cleaning method and apparatus and determined that Cavitus was “the sole eligible person”. The delegate then determined, under s 32, “that the patent application is to continue to proceed in the name of Cavitus.”
Section 36 seems to be concerned with identifying persons to whom a patent for an invention may be granted. Section 32 seems primarily concerned with matters of procedure. This appears to be the way that Delegate Haggar approached the question in Wake v Cavitus. All of the parties in the present matter, including the Commissioner, asserted, however, that the Tribunal had jurisdiction to hear this matter. In the circumstances, we are prepared to accept that we have jurisdiction by reason of the conferral of jurisdiction under s 32 to make determinations “enabling the application to proceed in the name of one or more of the parties alone, or for regulating the manner in which it is to proceed, or both, as the case requires”. In this respect it is relevant to note the irregularity in the amendment of the application to delete Dr Lee as an inventor and applicant. If he remains recognised as applicant and inventor the power to delete parties will be attracted.
THE ISSUES
Section 15(1) of the Patents Act provides that a patent for an invention may only be granted to a person who, for the relevant purposes of this application, is the inventor (s 15(1)(a)) or derives title from the inventor (s 15(1)(c)). Dr Lee claims in both categories.
In determining whether Dr Lee is an “inventor” for the purposes of section 15(1)(a), the Tribunal must:
(a)identify what the inventive concept is which supports the patent applications; and
(b)in doing so, determine whether Dr Lee made a material contribution to the inventive concept.
In the alternative, Dr Lee claims to derive title, in part, based on a “three party agreement” executed by Dr Lee, Komipharm and Mr Yang. In determining whether Dr Lee “derives title to the invention” for the purposes of section 15(1)(c), the Tribunal must determine the status of the three party agreement.
THE INVENTIVE CONCEPT
In relation to an invention, the inventor is “the person who makes or devises the invention” (JMVB Enterprises Pty Ltd v Camoflag Pty Ltd [2006] FCAFC 141 at [72]; (2006) 154 FCR 348 at 361). To identify the inventor, it is necessary to determine the “inventive concept” described in the relevant patent application, and then determine who conceived or devised that “inventive concept” (University of Western Australia v Gray (No. 20) [2008] FCA 498 at [1418], [1442]-[1443]; (2008) 246 ALR 603 at 940, 948; University of Western Australia v Gray [2009] FCAFC 116 at [221], [253], [258]; (2009) 179 FCR 346 at 395, 400, 402; Polwood Pty Ltd v Foxworth Pty [2008] FCAFC 9; (2008) 165 FCR 527). This involves examining the patent application to determine the invention disclosed.
In the present case, the Delegate held that the inventive concept is the idea that sodium meta-arsenite could be active against specific solid tumours.[1] This is consistent with the inventive concept disclosed in PA 253713:
The use of pharmaceutical composition… comprising sodium meta-arsenite (NaAsO2) and any acceptable auxiliary for the treatment of solid tumours, more particularly “a solid malignancy chosen from the group consisting of colon tumour, gastric tumour, mammary tumour, ovarian tumour, prostate tumour and renal tumour”.
[1] Sang Bong Lee v Komipharm International Co., Ltd [2010] APO 14 at [13]-[14].
The same inventive concept was disclosed in PA 255139.
BACKGROUND FACTS
In 1998, Dr Lee was an executive employed by Ilsung Pharmaceutical Company. Dr Rademaker was the Chief Operating Officer of International Life Sciences Associates B.V. (ILSA), which was engaged by Ilsung in a project (the dimer project) to study the anti-cancer activity of the compound arsenic hexoxide, which has the chemical formula As4O6 (the dimer). The dimer is essentially two monomers of arsenic trioxide (As2O3) joined together.
On 21 October 1998, ILSA issued a final report in relation to the dimer project, which identified solubility issues relating to the dimer, and recommended that further studies be conducted. Around the time the final report was issued, arsenic trioxide was also being studied in clinical trials to determine whether it had anti-cancer activity.
One of the issues of concern which Ilsung expressed in relation to the dimer project was whether, in vivo, the dimer would behave in the same way as arsenic trioxide. Dr Lee claimed that his view from about late November 1998 was that the dimer and arsenic trioxide were essentially the same because, he thought, the dimer would metabolise in the body to form two monomers of arsenic trioxide, and then arsenic trioxide would be further metabolised into its known metabolites. If this was the case, it followed that there would be no difference in the anti-cancer activity of the dimer as compared with arsenic trioxide. Ilsung management considered that if the dimer and arsenic trioxide behaved in the same way in vivo, then the dimer project would no longer be viable because it would not lead to a patentable invention.
From October 1998, Dr Lee, Dr Rademaker and a Mr Genghis Kang (an agent who ILSA worked with on a commission basis to assist in identifying Korean companies as potential clients, and making introductions to those companies) explored ways in which Ilsung could be convinced to continue the dimer project.
In a facsimile dated 26 November 1998, Mr Kang asked Dr Rademaker whether he considered that, in vivo, the dimer is metabolised to form two monomers of arsenic trioxide, such that the dimer and arsenic trioxide are the same.[2] Mr Kang stated that, if that was the case, “there will be no value in conducting the continuous study [of the dimer] for the further development.” On the same day, Dr Rademaker responded to Mr Kang and stated that it would not be known whether arsenic trioxide was the active substance derived from the dimer until a bioavailability study was conducted.[3] He also noted that there was no information available from the literature about the metabolites of the dimer.
[2] Section 37 Documents, T 7, p 142.
[3] Section 37 Documents, T 7, p 144-145.
THE NOVOTEL MEETING
On 2 December 1998, Dr Lee and Dr Rademaker met at the Novotel Hotel in Amsterdam. Dr Rademaker claims that the purpose of the meeting was specifically to discuss the dimer project and to explore ways of trying to salvage it.[4] Dr Lee claims that at the Novotel meeting, he introduced the idea that the metabolites of arsenic trioxide may be more successful in treating cancer than arsenic trioxide itself.[5]
[4] Statutory Declaration of Dr Bernardus Rademaker dated 19 February 2009, at paragraph 7.
[5] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 14.
Dr Lee contends that in introducing the idea that Dr Rademaker should test the metabolites of arsenic trioxide, he intended to refer to the testing of a group of compounds which included sodium meta-arsenite. He stated that he had obtained information on the metabolites of arsenic trioxide from a Japanese chemistry text book, which referred to “arsenite, arsenate, mono-methyl arsenic acid (MMA), dimethyl arsenic acid (DMA) (also known as cacodylic acid) and trimethyl arsine oxide (TMA)” as the metabolites. Dr Lee claims that he understood the reference to arsenite to be a reference to meta-arsenite.[6]
[6] Statutory Declaration of Dr Sang Bong Lee dated 26 May 2009, at paragraph 13.
However, evidence before us indicates that:
(a)the arsenite which is a metabolite of arsenic trioxide is not sodium meta-arsenite; and
(b)sodium meta-arsenite is not a possible metabolite of arsenic trioxide.
Professor Philip Hogg is the Director of the Lowy Cancer Research Centre and a Senior Principal Research Fellow and Conjoint Professor at the National Health and Medical Research Council. Professor Hogg gave evidence that in the case of arsenite, the ion that is formed following metabolism of arsenic trioxide has the chemical formula AsO33- (which is not the same as meta-arsenite, which has the chemical formula AsO2-).[7] He also stated that strongly alkaline conditions (of pH greater than 10) would be required in order for sodium meta-arsenite to be formed from arsenic trioxide,[8] but conditions throughout the gastrointestinal system would not exceed a pH of 8.0-8.5.[9] We accept this evidence. We find that sodium meta-arsenite is not a metabolite of arsenic trioxide.
[7] Second Report from Prof Philip Hogg re Declaration by Dr Sang Bong Lee – March 23, 2011, at p 3.
[8] Ibid; Transcript, p 1154, 34.
[9] Transcript p 1148, 32-45.
Nevertheless, Dr Lee says that in a telephone conversation in December 1998 he informed Dr Rademaker that “in vitro tests should be performed on three arsenic compounds: arsenic sodium salt, sodium meta-arsenite and cacodylic acid”.[10] The issue that remains to be resolved in this application is whether or not Dr Lee made a significant contribution to the invention as disclosed in the patent applications, which claims the use of sodium meta-arsenite in the treatment of solid tumours.
[10] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 19.
Dr Lee contends that the notion of sodium meta-arsenite as a potential candidate for anti-cancer activity was conceived at the Novotel meeting, when the idea of testing the metabolites of arsenic trioxide was introduced,[11] and was developed further during subsequent communications between Dr Lee and Dr Rademaker which took place after the meeting.[12] Thus, from the evidence of Dr Lee, the discussion at the Novotel meeting is central to his case that he is an inventor of the inventions disclosed in the patent applications.
[11] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 14 - 15.
[12] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 17 and 19.
The relevant issues for the Tribunal to determine are whether, during the discussion at the Novotel meeting and in the communications between Dr Lee and Dr Rademaker which occurred after the Novotel meeting:
(a)Dr Lee told Dr Rademaker that he should test the metabolites of arsenic trioxide for anti-cancer activity;
(b)there was any agreement that Dr Rademaker would conduct some initial experiments into the efficacy of the metabolites of arsenic trioxide; and
(c)Dr Lee told Dr Rademaker that three specific compounds should be tested, which included sodium meta-arsenite, notwithstanding the fact that sodium meta-arsenite is not a metabolite of arsenic trioxide.
Dr Rademaker claimed that the purpose of the Novotel meeting was to discuss the dimer project, and specifically to try to salvage it.[13] He denied that there was any discussion at the meeting about tests involving the metabolites of arsenic trioxide.[14] Dr Rademaker’s evidence was that he suggested to Dr Lee that the metabolites of the dimer, which were unknown, be compared with the known metabolites of arsenic trioxide, and if the metabolites of the dimer were different to those of arsenic trioxide, then they could be tested to determine whether they had any anti-cancer activity.[15]
[13] Statutory Declaration of Dr Bernardus Rademaker dated 22 June 2009, at paragraph 20.
[14] Statutory Declaration of Dr Bernardus Rademaker dated 22 June 2009, at paragraph 23.
[15] Statutory Declaration of Dr Bernardus Rademaker dated 22 June 2009, at paragraph 22.
In cross-examination, Dr Lee admitted that at the Novotel meeting, he and Dr Rademaker discussed the dimer project, but contended that Dr Rademaker was more concerned with experiments involving the dimer, whereas he was more concerned with experiments involving arsenic trioxide.[16]
[16] Transcript, p 104, 39-46 and p 105, 1-44.
The evidence of Dr Lee and Dr Rademaker needs to be tested against the following correspondence sent after the Novotel meeting, which suggests that the communications at, and subsequent to, the Novotel meeting concerned the dimer project:
(a)On 9 December 1998, Mr Kang sent a facsimile to Dr Rademaker. Dr Rademaker was introduced to Dr Lee through Mr Kang in about the middle of 1998. In his facsimile, Mr Kang referred to questions raised by Dr Lee, and requested evidence as to whether or not the metabolites of the dimer and arsenic trioxide were different. His facsimile also stated that if the metabolites between the dimer and arsenic trioxide were the same, then Ilsung’s management would not pursue the dimer project.[17]
(b)On the same day, Dr Rademaker replied to Mr Kang (copied to Dr Lee) and stated that ILSA expected major differences in both the bioavailability of arsenic trioxide and the dimer, and the occurrence of metabolites and the yield of each metabolite, after oral gavage.[18]
(c)On 17 December 1998, an agreement was drafted between Ilsung and ILSA relating to a study of the bioavailability of HD-2 (the dimer), which would assess the efficacy of the dimer against 3 tumour types in mice.[19] The study was identified with the label “ISK-02”.
(d)On 25 December 1998, Mr Kang sent a facsimile to Dr Rademaker and stated that Dr Lee requested a letter confirming that “the project (ISK-02)” included isolation of metabolites, purified metabolites and testing of the metabolites in vivo for their anti-tumour activity.[20]
(e)On 28 December 1998, Dr Rademaker sent a facsimile to Mr Kang which confirmed that study ISK-02 would investigate the possible metabolites of the dimer, would either isolate and purify the metabolites or synthesize them in a sufficient amount, and would investigate the anti-tumour activity of the major metabolites.[21]
(f)On 30 December 1998, Mr Kang raised concerns as to whether study ISK-02 would lead to a patent which Ilsung could claim in respect of the dimer.[22]
(g)Dr Rademaker responded on 31 December 1998 and stated that the dimer was not a chemical which could be patented because it was known prior to his research but that ILSA was confident that a better patent could be prepared on the use of the dimer.[23]
(h)However, on 18 January 1999, Dr Lee advised Dr Rademaker that the chairman of Ilsung had decided that Ilsung would give up the dimer project because of a lack of funding. Dr Lee requested that Dr Rademaker return any remaining samples of the dimer to him. In the same facsimile, Dr Lee included a “TOP SECRET” letter which stated that Dr Lee was personally and secretly looking for a financial supporter and wished for the project to continue.[24]
[17] Section 37 Documents, T 12, p 980-981.
[18] Section 37 Documents, T 12, p 976-978.
[19] Section 37 Documents, T 10, p 587-593.
[20] Section 37 Documents, T 10, p 580.
[21] Section 37 Documents, T 10, p 574.
[22] Section 37 Documents, T 12, p 971.
[23] Section 37 Documents, T 12, p 973-4.
[24] Section 37 Documents, T 10, p 582-585.
Dr Lee also stated during cross-examination that his view at the time the Novotel meeting was held was that there was no difference between the metabolites of the dimer and those of arsenic trioxide.[25] However, this view that Dr Lee allegedly held is inconsistent with evidence provided in Dr Lee’s first statutory declaration dated 18 March 2009. In that document, Dr Lee stated that he told Dr Rademaker that he preferred to focus on metabolites of arsenic trioxide, but Dr Rademaker wanted to focus on metabolites of the dimer. Dr Lee stated “When I pointed out to Dr Rademaker that metabolites of As2O3 were commercially available, which was not the case for the metabolites of As4O6, it became clear that the As2O3 metabolites were far preferable candidates for ongoing testing.”[26]
[25] Transcript, 107, 43-46.
[26] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 14.
This evidence suggests that Dr Lee did not, in fact, consider that the metabolites of the dimer and arsenic trioxide were the same. He differentiated the two by stating that the metabolites of arsenic trioxide were commercially available, whereas the metabolites of the dimer were not.[27]
[27] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 14.
The P43 Report
Following the facsimile of 18 January 1999, Dr Lee did not contact Dr Rademaker for almost two years.
However, in April 1999, Dr Rademaker arranged to test sodium arsenate, sodium meta-arsenite and cacodylic acid (the test compounds) for anti-cancer activity. Dr Rademaker stated that he had selected the test compounds on the basis of their commercial availability in at least 98% pure form. He also stated that he was unaware of any previous cytotoxicity tests involving the test compounds. [28]
[28] Statutory Declaration of Dr Bernardus Rademaker dated 19 February 2009, at paragraph 13.
On 20 April 1999, Dr Rademaker wrote to Professor H H Fiebig, the chief executive officer of Oncotest GmbH, requesting an in vitro cytotoxicity study of the test compounds. Dr Rademaker’s company, Rephartox BV, was wholly responsible for the funding of the study.[29]
[29] Statutory Declaration of Dr Bernardus Rademaker dated 19 February 2009, at paragraph 14.
On 26 November 1999, Oncotest produced a final report which described the results of the in vitro cytotoxicity study. This report is called “the P43 report”.[30] The P43 report describes the results of cytotoxicity testing on the test compounds. It shows that sodium meta-arsenite was the most cytotoxic compound in the nine tumour cell lines tested, followed by sodium arsenate and then cacodylic acid, which was considered inactive.
[30] Section 37 Documents, T 7, p 159-171.
The P43 Report was subsequently used as the basis of an agreement which Rephartox entered into with Korea Microbiological (now Komipharm).
Dr Lee claims that he met for the first time with Mr Yang of Korea Microbiological on 21 November 2000.[31] Mr Yang, however, disputes this evidence.[32] At the time the meeting was held, Dr Lee was working for Kwang Dong Pharmaceutical Co., Ltd. Dr Lee says he told Mr Yang that he was working on an anti-cancer drug development program based on arsenic as the active ingredient. He also mentioned his frustration at Kwang Dong’s lack of enthusiasm to progress development of the drug.[33]
[31] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 28.
[32] Statutory Declaration of Mr Yong-Jin Yang dated 23 June 2009, at paragraph 4.
[33] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 29.
On 6 December 2000, Dr Lee sent a facsimile to Dr Rademaker requesting that they discuss the “metabolite study” which they had previously discussed at the Novotel meeting.[34] The facsimile was sent on the letterhead of Kwang Dong. Dr Lee stated that he had commenced working with Kwang Dong on 7 September 1999 as a research director.[35]
[34] Section 37 Documents, T 10, p 578.
[35] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 22.
Dr Lee claims that in December 2000, he telephoned Dr Rademaker to advise him that he believed he had found a new sponsor for the metabolite study. Dr Lee stated that Dr Rademaker advised that he had conducted his own experiments through Rephartox and that the results of the experiments were much more encouraging than the dimer experiments had been.[36] These December 2000 contacts direct between Dr Lee and Dr Rademaker were the first since January 1999.
[36] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 25.
On 4 January 2001, an agreement (KD001) was drafted between Kwang Dong and Rephartox to develop an arsenic compound as an anti-tumour agent.[37] The agreement referred to Rephartox studies which were undertaken to investigate whether other arsenic compounds “which could be metabolites of” arsenic trioxide had potential as anti-cancer compounds. The proposed study which was the basis of the agreement included testing of some metabolites of arsenic trioxide as anti-cancer drugs in cell lines to confirm the earlier results obtained by Rephartox.
[37] Section 37 Documents, T 10, p 699-707.
On 19 January 2001, Dr Rademaker met with Dr Lee and an executive director of Kwang Dong in Seoul, during which it seems that Kwang Dong advised that they were not willing to fund the metabolite study.[38] However, in correspondence dated 9 February 2001, Dr Lee confirmed that the Chairman of Kwang Dong had decided to proceed with the study. At this time Dr Lee asked Dr Rademaker to provide the name of the arsenic compound he was testing.[39] This contradicts the notion that it was Dr Lee who first identified the compound or compounds which Dr Rademaker subsequently tested, and which led to the patented invention. When challenged in relation to this evidence in cross examination, Dr Lee stated that he “talked about the material…but not the research”,[40] that is, Dr Lee claimed that he knew about the materials to be tested, but not about the research which was to be conducted. However, if we accept the truth of this evidence, it would then have been unnecessary for Dr Lee to ask Dr Rademaker for the name of the compound.
[38] Statutory Declaration of Dr Sang Bong Lee dated 18 March 2009, at paragraph 27.
[39] Section 37 Documents, T 10, p 613.
[40] Transcript, p 192, 26.
Dr Rademaker’s response to Dr Lee dated 9 February 2001 stated “Currently our research is focussing on the following arsenic compounds: cacodylic acid, arsenic acid sodium salt and sodium meta-arsenite”.[41] It appears from the evidence, therefore, that this is the first time that Dr Lee became aware that the compounds that Dr Rademaker was proposing to test included sodium meta-arsenite. Again, this correspondence is inconsistent with the notion that it was Dr Lee who had introduced the idea to Dr Rademaker as to the compounds which ought to be tested, and particularly that he introduced the idea to Dr Rademaker that sodium meta-arsenite was a candidate for testing. Indeed, Dr Rademaker says in his statutory declaration dated 19 February 2009 that the email he sent to Dr Lee on 9 February 2001 was the first time he disclosed the test compounds and cell lines that he had been studying to Dr Lee.[42]
[41] Section 37 Documents, T 7, p 191.
[42] Statutory Declaration of Dr Rademaker dated 19 February 2009, at paragraph 22.
Following Dr Rademaker’s fax of 9 February 2001, Dr Lee advised in an email to Dr Rademaker dated 16 February 2001 that if Kwang Dong decided not to pursue the metabolite study, then Korea Microbiological was interested in the project.[43]
[43] Section 37 Documents, T 7, p 193.
On 24 February 2001, Dr Lee advised Dr Rademaker that Kwang Dong had decided not to pursue the metabolite study, but requested that Dr Rademaker prepare another proposal which listed Korea Microbiological as the project sponsor.[44]
[44] Section 37 Documents, T 7, p 195.
On 25 February 2001, Korea Microbiological entered into a contract with Rephartox to develop an arsenic compound as an anti-tumour agent.[45] Relevantly, this agreement provides, at clause 9:
All discoveries and patentable inventions, excepting methodological innovation arising during the project, shall be the property of the Sponsor.
[45] Section 37 Documents, T 7, p 198-206.
The parties accept that this clause effectively assigned the rights to the patented invention to Komipharm, which was the sponsor of the project.[46]
[46] Statutory Declaration of Mr Yong-Jin Yang dated 19 February 2009, at paragraphs 5 and 11; Transcript pp 44, 4-9 and 232, 6-7.
Dr Rademaker alleges that following execution of the agreement for this new arsenic project, he provided a copy of the P43 report to Dr Lee for the first time. However, the copy he claims to have provided Dr Lee is a version of the P43 report dated 26 March 2001. Dr Rademaker claims that the re-dated report had a new title page and signature page, and some updated charts.[47]
[47] Statutory Declaration of Dr Bernardus Rademaker dated 19 February 2009, at paragraph 26.
THE KOREAN PATENT APPLICATION
Mr Yang claims that in early April 2001, Dr Lee advised him that he believed there were active studies (apart from the arsenic project) being conducted on arsenic compounds, and that he was concerned that Dr Rademaker might file a patent application based on the arsenic project or some other researcher would file a patent application before Korea Microbiological (by now Komipharm) and thereby gain priority over any later application by Komipharm. Mr Yang alleges that Dr Lee also told him that he had conducted some initial secret studies that would provide a sufficient basis for a patent application in Korea which, once filed, would block any later-filed patent application by Dr Rademaker or anyone else from issuing.[48]
[48] Statutory Declaration of Mr Yong-Jin Yang dated 23 June 2009, at paragraph 20.
Mr Yang claims that based on Dr Lee’s concerns and the results of Dr Lee’s alleged earlier secret studies, Mr Yang agreed that Komipharm should file a Korean patent application. Dr Lee subsequently arranged for a Korean patent application to be prepared and filed.[49]
[49] Statutory Declaration of Mr Yong-Jin Yang dated 23 June 2009, at paragraph 21.
Mr Yang claims in his evidence that he was unaware that the data from the alleged earlier secret studies that Dr Lee had used as the basis for the Korean patent application were, in fact, taken directly from the P43 report dated 26 March 2001.[50] Mr Yang further claims that he was unaware of the existence of the P43 report until some time after August 2005, when Komipharm began an investigation into the arsenic project due to serious questions which were raised regarding inventorship.[51]
[50] Ibid.
[51] Statutory Declaration of Mr Yong-Jin Yang dated 23 June 2009, at paragraph 26.
In August 2001, Dr Rademaker arranged for further testing of sodium meta-arsenite and sodium arsenate by Oncotest to confirm the results disclosed in the P43 report and to test additional cell lines. This time, twelve human tumour cell lines and five different concentrations were selected for the test compounds.[52]
[52] Statutory Declaration of Dr Bernardus Rademaker dated 19 February 2009, at paragraph 29.
The results of the further testing conducted by Oncotest were described in a final report entitled “In Vitro Evaluation of Arsenic Compounds in a Panel of Human Tumour Cell Lines”.[53] This report is called the “P43E report”. The results in the P43E report show that sodium meta-arsenite has anti-cancer activity against a number of specific human tumours, including prostate, mammary, gastric and ovarian tumours.
[53] Section 37 Documents, T 8, p 378-443.
According to Mr Yang, the results in the P43E report were provided to Dr Lee on or about 4 March 2002, and Dr Lee used these to supplement the specification of the pending Korean patent application. Again, Mr Yang claims that he was not aware of the existence of the P43E report until after August 2005, when Komipharm began its investigation into the arsenic project.[54]
[54] Statutory Declaration of Mr Yong-Jin Yang dated 23 June 2009, at paragraph 22.
Mr Yang claims that based on his understanding of inventorship and the information made available to him in the P43 and P43E reports, neither he nor Dr Lee are inventors in the patent applications. He stated that Dr Lee misrepresented his role in the development of the invention disclosed and claimed in the patent applications, and that Dr Rademaker should be listed as the sole inventor.[55]
[55] Statutory Declaration of Mr Yong-Jin Yang dated 23 June 2009, at paragraphs 28 and 29.
THE MEMORANDUM
At paragraph 32 of his statutory declaration dated 18 March 2009, Dr Lee referred to a memorandum that he claimed Dr Rademaker had sent him on 21 February 2001. Dr Lee stated: “[i]n point 5 of this memorandum, Dr Rademaker confirms that the suggestion to do the initial experiments with several potential metabolites was made by me at our meeting in December 1998 at the Novotel Hotel in Amsterdam.”
In the memorandum itself, at paragraph 5, Dr Lee relies on the words “as you suggested this study of metabolites at Novotel hotel in Amsterdam in 1998” to support his contention that the idea for testing of the arsenic compounds originated from him.
Dr Rademaker denied in his statutory declaration dated 22 June 2009 that the memorandum that Dr Lee had referred to in his statutory declaration was sent on 21 February 2001. He stated that it was not created until 29 October 2004 and also referred to a number of versions of the memorandum and their dates of creation.[56]
[56] Statutory Declaration of Dr Bernardus Rademaker dated 22 June 2009 at paragraph 54.
In a subsequent statutory declaration dated 24 September 2009,[57] Dr Lee stated that the “memorandum dated 21 February 2001 is the same as the original even though [Dr Rademaker] has edited it by my request on 29 October 2004”. Dr Lee denied that the reference to the Novotel meeting was inserted at his request and, in another statutory declaration dated 8 July 2011,[58] stated that “[t]he reference to the Novotel Hotel and metabolites of arsenic trioxide were included in the Memorandum since 20 January 2001.”
[57] Statutory Declaration of Dr Sang Bong Lee dated 24 September 2009 at paragraph 12.
[58] Statutory Declaration of Dr Sang Bong Lee dated 8 July 2011 at paragraph 4.
THE VERSIONS OF THE MEMORANDUM
The following five versions of the memorandum were submitted to the Tribunal:
(a)Version 1, created on 20 January 2001
(b)Version 2, created on 22 January 2001
(c)Version 3, created on 5 April 2001
(d)Version 4, created on 28 October 2004
(e)Version 5, created on 29 October 2004.
Version 1 of the Memorandum was created on 20 January 2001 by Dr Rademaker at the request of Dr Lee, following a meeting in Seoul on 19 January 2001 between Dr Rademaker, Dr Lee and Mr Choi of Kwang Dong. The reference to the Novotel meeting did not appear in Version 1. In cross examination, Dr Lee accepted that he received Version 1 on about 20 January 2001.
On 22 January 2001, Dr Lee sent an email to Dr Rademaker and raised issue with Dr Rademaker’s reference to sharing the patent rights (in paragraph 1 of the Memorandum). Dr Lee also stated that he had not received information in relation to four more questions that were in his email.
Version 2 of the Memorandum was created on 22 January 2001. It referred to Dr Lee’s email and telephone call of the same day and deleted the reference in paragraph 1 which Dr Lee had raised issue with. It also addressed the issues identified in the email. The reference to the Novotel meeting did not appear in Version 2.
Version 3 of the Memorandum was created on 5 April 2001, but is dated 22 January 2001. It is identical to Version 2 apart from replacement of “Kwang Dong” with “Korean Bicrobiol. Lab Ltd”, which should have read “Korea Microbiol. Lab Ltd” (now Komipharm). The reference to the Novotel meeting does not appear in Version 3.
On 28 October 2004, Dr Lee sent an email to Dr Rademaker and stated:
I would like to receive one document. Do you remember your suggestion document for this project in 2001….In this document I would like you to write “Dr. LEE suggested the study of metabolite at NOVOTEL hotel in Amsterdam in 1998.” in addition…First of all I want to receive one copy by e-mail.
This email was recovered by a computer expert from a DVD attached to a statement of Dr Lee dated 8 July 2011. The email was in evidence although it was not referred to by the parties.
Later that day, Dr Lee sent another email to Dr Rademaker. Dr Lee stated “I found old version in memorandum.” The email then set out a modified text of version 1, which substituted Komipharm for Kwang Dong and also included the reference to the Novotel meeting. Dr Lee then went on to say: “As you remember that situation, I sent a fax for changing another company to you on February 21 (not Kwangdong on January). So date will be changed on February 21, 2001.”
Dr Lee denied that he asked for the reference to the Novotel meeting to be included in the Memorandum, but it is clear from the first email on 28 October 2004 that he did. Nevertheless, we note, because no party relied upon this email, that our decision would be the same even without it.
After Dr Lee’s second email on 28 October 2004, Dr Rademaker emailed Dr Lee another version of the Memorandum (Version 4). Version 4 was created on 28 October 2004 but is dated 21 February 2001, which is the date quoted in Dr Lee’s second email. Relevantly, the modifications to Version 4 as compared with Version 3 were identical to those requested in Dr Lee’s emails of 28 October 2004.
Subsequent to the creation of Version 4 of the Memorandum, it appears that Dr Lee and Dr Rademaker discovered that Version 4 was based on Version 1 and not Version 2, which amended paragraph 1 and added the further information requested in Dr Lee’s email of 22 January 2001. Accordingly, on 29 October 2004, Version 5 of the Memorandum was prepared and sent to Dr Lee by email. The email stated “This is the version you were looking for. And adapted.” Version 5 of the Memorandum was created on 29 October 2004, but was also dated 21 February 2001 and included the reference to the Novotel meeting.
THE THREE PARTY AGREEMENT
The three party agreement was made on 16 May 2005. The parties are Komipharm, Mr Yang and Dr Lee. The agreement is governed by Korean law. Section 12 of the agreement is as follows:
This Agreement shall be governed by the laws of the Republic of Korea and Seoul Central District Court shall be the court of jurisdiction for all disputes arising out of this Agreement.
In the agreement sodium meta-arsenite as an anti-cancer agent is called “Kominox”.
The thrust of the three party agreement was to delineate the rights and obligations of Komipharm, Dr Lee and Mr Yang in relation to Kominox and its development and exploitation. Most importantly for present purposes, it provided that the rights to Kominox products, including patent rights, should be co-owned by the three parties.
Proceedings relating to the three party agreement were commenced in the Seoul Central District Court by Komipharm against Dr Lee. We have been provided with a translation of one decision of that court from which it appears that, apparently on 14 December 2007, the court, comprised of three judges, reversed a contrary “provisional disposition” of the court, pronounced by the court on 4 July 2007, and rejected Komipharm’s claim that Dr Lee “… is not an inventor of subject patent and has no contribution on subject patent…”. The decision does not appear to address the validity of the three party agreement.
We have also been furnished with a decision of the Seoul High Court, comprised of three judges, given on 30 June 2011 in proceedings between Komipharm as plaintiff/appellee and Dr Lee and Mr Yang as defendants/appellants. The decision appealed from was apparently given by the Seoul Central District Court on 20 May 2010. It is not clear whether this proceeding was an appeal from the decision in the Seoul Central District Court referred to above or even an appeal in the same matter. What is clear, however, is that the decision of the Seoul High Court was given in an appeal from the Seoul Central District Court in which each of Komipharm, Dr Lee and Mr Yang, the parties to the three party agreement, were parties.
The Seoul High Court decision did not finally determine what role Dr Lee played in the invention on which the Korean patent was based. It dismissed Komipharm’s claim that Dr Lee was not an inventor. It did this because the claim was “illegitimate”. The Court appears, however, to have recognised that although Dr Lee made at least some contribution to the inventive process, he “either transferred to defendant Komipharm or gave up his right as the inventor to obtain patent even if he was the inventor…”. The court also said “even if it is acknowledged that the plaintiff made certain contribution to the invention, there is still room for seeing the invention as an employee invention.”
The decision of the Seoul High Court as to the validity of the three party agreement is, however, clear. The court made the following order:
It is affirmed that the agreement dated May 16, 2005 between the Defendant (Counter Plaintiff) Komipharm International, Co., Ltd. and the Plaintiff (Counter Defendant) in respect of Kominox and all the results produced through the research and development process is null and void.
The essential reasoning of the Court was as follows:
Since all the results of the research by Rephartox (Ben Rademaker) are attributed to the properties of Defendant Komipharm under the Development Agreement in this case executed between Defendant Komipharm and Rephartox, all the Achievements in this case are the properties of Defendant Komipharm. The Joint Ownership Agreement in this case transfers parts of rights to the Achievements in this case, which are the properties of Defendant Komipharm, to the Plaintiff and Defendant Yong-Jin Yang, who were directors of Defendant Komipharm at the time of the agreement, and therefore constitutes a self-dealing by directors. There is no dispute between the parties regarding the fact that the executive of the Joint Ownership Agreement was not approved by the board of directors. The Joint Ownership Agreement in this case is, therefore, null and void.
…
As to this, the Plaintiff argues that the Joint Ownership Agreement in this case was ratified post factum…
… [I]t is acknowledged that Defendant Komipharm entered into an agreement with Kominox Inc. on December 15, 2005 regarding Defendant Komipharm’s transfer of all the rights to the Achievements in this case and Kominox Inc.’s conduct of clinical tests and research for improvement of the invention and payment of loyalties. It is also acknowledged that Defendant Komipharm’s board of directors approved the agreement on the same day.
However, a director’s self dealing is deemed to have been ratified post factum by the company only when it can be acknowledged that the board of directors, which has the proper authority to approve such a dealing, ratified such dealing conceding that losses could be incurred by the company because a transaction that is originally null and void will become valid and that there is a possibility that the directors will be held jointly liable, with the full understanding of effects of such dealing on the interests of the directors and other material facts related to such dealing…
There is no sufficient evidence that it was reported to the directors when the board of directors ratified the agreement between Defendant Komipharm and Kominox Inc. that parts of the rights attributed to Defendant Komipharm had been transferred to the Plaintiff and Defendant Yong-Jin Yang through the Joint Ownership Agreement and that the board of directors ratified the above mentioned agreement between Defendant Komipharm and Kominox after giving full consideration to the losses that the company and the directors could possibly incur.
On 16 September 2011 a statement of grounds of final appeal was lodged with the Supreme Court of Korea by Dr Lee. The only particulars we have of the appeal are “Confirmation of Co-ownership of Patent Rights and etc.” On the same day Dr Lee “and two other parties” also lodged notice of grounds of final appeal with the Supreme Court in a case described as “Transfer of Patent Registration Name”.
Given that the three party agreement contained both a choice of law clause which selected Korean law and provided that disputes should be resolved in the Korean court system there is no basis upon which the Tribunal should reconsider the result in the Seoul High Court. We add that as the parties are all Korean and the original patent application was a Korean application, even without the choice of law and courts provisions, there would have been no basis for us to consider separately the correctness of the Korean decisions.
There has been no suggestion made to us that the decision of the Seoul High Court has been stayed or that its operation is in any way affected by the pending Supreme Court appeal. Accordingly, we propose to accept, for the purposes of the matters we must decide, that the three party agreement is null and void and that Dr Lee cannot assert any rights under it in connection with the Australian patents.
Should the Supreme Court of Korea reverse the decision of the Seoul High Court, Dr Lee may then have rights to revisit his entitlement to be named as a patentee.
DR LEE WAS NOT AN INVENTOR
The inventive concept in the present case is the idea that sodium meta-arsenite might be active against solid tumours. One possible contribution to that inventive concept might be that metabolites of arsenic trioxide could be so active, provided that sodium meta-arsenite was such a metabolite. A question would remain, however, whether such a contribution was sufficiently material to the inventive concept to constitute the person with the idea a co-inventor.
There is no doubt in the present case that Dr Rademaker did or organised the research and testing which led to the making of the patent applications. Dr Lee says, however, that he was the inspiration for both the idea to test metabolites of arsenic trioxide and to test sodium meta-arsenite itself. Komipharm says, based on the evidence of Dr Rademaker, that the idea to test sodium meta-arsenite was solely Dr Rademaker’s and that it was not based on a suggestion by Dr Lee that metabolites of arsenic trioxide should be tested.
The issue comes down to what was said in the meeting and possible phone call between Dr Rademaker and Dr Lee in December 1998. They have both given evidence and been cross-examined about what took place. We must form a view as to where the truth lies. As is often the case in circumstances such as this it is ultimately not the evidence of the two witnesses which provides the most reliable guide to what was said, but surrounding circumstances and, particularly, what was written, or not written, contemporaneously and later, even much later.
What is surprising about the facsimiles which follow the Novotel meeting is that they do not include any facsimile between Dr Lee and Dr Rademaker, although Mr Kang appears to be writing, in part, at the behest of Dr Lee. The emails certainly refer to metabolites, but not to any particular proposal that the metabolites of arsenic trioxide should be tested. Nor is there any particular reference to arsenic trioxide. Mr Kang’s facsimile refers to what Dr Rademaker told Dr Lee about As4O6, which is the dimer, rather than anything Dr Lee told Dr Rademaker about metabolites of As2O3 or at all.
The only written communication by Dr Lee with Dr Rademaker is the puzzling facsimile of 18 January 1999 with its “top secret” addendum. The thrust of the facsimile is that Ilsung, Dr Lee’s employer, has determined to give up “this project”, an expression of regret at this decision because “this project must be succeeded” and a request to Dr Rademaker “to send HD-2 (the remainder) to my home as soon as possible”. HD-2 is the dimer. Notwithstanding Dr Lee’s denials in the witness box, there can be no doubt that “this project” refers to the dimer project. It is that project which Dr Lee thinks must succeed, not a project with sodium meta-arsenite or metabolites of arsenic trioxide, neither of which were referred to. Not only does Dr Lee not refer to such a strategy, or any idea of his, but, referring to Dr Rademaker, he says: “I think your idea is very good for patent strategy”.
In addition to the main facsimile referring twice to “this project” in a context in which it must be referring to the dimer project, the top secret addendum refers to “this project” four times in the same way. Again there is no reference to Dr Lee’s ideas; only to raising funds for, and progressing, “this project”.
After that communication Dr Rademaker did not hear from Dr Lee for nearly two years. In the meantime, Dr Rademaker, on behalf of his company, Rephartox, procured a report from Oncotest on “the cytotoxicity of cacodylic acid, arsenic acid sodium salt and sodium meta-arsenite”. The report, which has been referred to extensively above, was designated “In Vitro Study No. P43” and was furnished on 26 November 1999. Its findings became the basis of the invention and certainly the commissioning of the report and the implementation of its findings do represent inventive steps. Dr Rademaker said that it was his idea to commission the report and to specify the three arsenic compounds to be tested.
When Dr Lee made contact again with Dr Rademaker in December 2000 he knew nothing about what Dr Rademaker had been doing. He sent a handwritten facsimile on the letterhead of his then employer, Kwang Dong. It refers to “that metabolite study is still possible in your new company” and adds:
In 1998, December, you and me already discussed about <which material (metabolite) acts on a antitumor agent in the body> in Novotel Hotel. Do you remember that situation? Let’s go that project.
It is to be noted that although Dr Lee’s facsimile refers to “metabolites” it does not indicate which metabolites he is referring to. Metabolites were plainly referred to in the Novotel meeting and in the following correspondence, but they were generally metabolites of the dimer and not specifically metabolites of arsenic trioxide. There was no proposal to target sodium meta-arsenite or, specifically, metabolites of arsenic trioxide.
We do not consider that the Memorandum assists Dr Lee and the circumstances in which its final form was adopted may tell against him. Again, the reference is to metabolites generally and not specifically to metabolites of arsenic trioxide. It was added as late as 2004 long after the relevant research was completed. The circumstances in which it was added suggest that it was part of an attempt by Dr Lee to generate evidence to support his claim. Of course such an attempt is not inconsistent with the claim being true, but if the claim is true it is surprising that there was no prior concrete evidence.
Dr Lee placed substantial reliance upon the fact that Dr Rademaker did recognise in the Memorandum that Dr Lee had made a substantial contribution, whatever were the circumstances in which the sentence was added. Other similar recognitions were also relied upon. One was Dr Rademaker’s execution of a proposed patent application on 10 April 2002 which showed Korea Microbiological as applicant and included Dr Lee and Mr Yang as inventors, along with himself. Dr Rademaker explained these apparent concessions on the basis that he had transferred the rights to the invention to Korea Microbiological and he was not concerned to continue to assert his inventorship if those associated with the purchaser wished to record something different. On this basis he was prepared to add the sentence to the Memorandum and sign the patent application. We accept this explanation. We also note that, in any event, Mr Yang was named in the patent application as an inventor although he had no association with conceiving the inventive idea behind the patent.
We do not doubt that metabolites were discussed at the Novotel meeting. They were discussed with respect to the dimer. They might have been discussed with respect to arsenic trioxide. However, we are satisfied that Dr Lee did not make any suggestion that a project of studying metabolites of arsenic trioxide should be undertaken. At most his contribution was passing comments not intended to introduce any aspect of an inventive step or concept and not taken as such. We are satisfied that Dr Lee did not refer to the study of metabolites of arsenic trioxide as a project in that meeting or in any subsequent telephone conversation. Such a suggestion is wholly inconsistent with the subsequent communications including the absence of any follow up directly between Dr Lee and Dr Rademaker.
We find that Dr Rademaker alone selected three arsenic compounds for testing, separately from and after his 1998 contacts with Dr Lee. The results of his testing were disclosed in the P43 and P43E reports, and were used as the basis of the patent applications. It follows that Dr Rademaker alone is responsible for the inventive concept behind the patent applications.
Even if Dr Lee did suggest to Dr Rademaker that metabolites of arsenic trioxide should be studied we do not think that, having regard to the context in which any such suggestion would have been made, this suggestion would have contributed sufficiently to the inventive concept.
Dr Rademaker was apparently the source of the idea which led to the dimer project and he was responsible for the developments which sprang from it. It was he that commissioned the studies described in the P43 report and the P43E report, which specifically identified sodium meta-arsenite and other arsenic compounds for inclusion in the studies and tested their anti-cancer activity. Dr Lee merely seems to have flitted in and out from time to time. Even giving full effect to Dr Lee’s claimed contribution in the present case we do not think that the contribution reached a level which qualified it as a sufficient contribution to the inventive concept behind the patent application to qualify Dr Lee as an inventor. There will, of course, be times when the utterance of a single sentence might carry such significance that it alone will amount to a sufficient inventive step to qualify the maker as an inventor. The sentence would normally, however, be more than a suggestion of something to try, particularly if what was to be tried was not even a particular compound but, a group of compounds (metabolites of something) or even three particular compounds.
Finally, we must note that our finding that sodium meta-arsenite is not a metabolite of arsenic trioxide means that Dr Lee must fail, for that reason alone, on his claim to be an inventor based on a suggestion that metabolites of arsenic trioxide should be tested. It was submitted that this finding is not ultimately significant because at the time the suggestion was made both Dr Rademaker and Dr Lee understood sodium meta-arsenite was such a metabolite and was accordingly in their contemplation. We do not accept this. It shows just how tangential rather than inventive any idea of Dr Lee’s was. For an idea of Dr Lee to be sufficiently inventive for Dr Lee to qualify as inventor it would certainly require more than a suggestion to try a class of compounds one of which, although not within the class, Dr Lee and Dr Rademaker are said to have thought was in the class. Dr Lee’s claim, then, must depend on having suggested the compound sodium meta-arsenite either alone or with two other compounds. For the reasons we have given, this claim fails on the facts.
DR LEE IS NOT ENTITLED TO BE RECOGNISED AS AN APPLICANT
Because Dr Lee is not entitled to be recognised as an inventor with respect to the two patent applications his only claim to recognition as an applicant is through the three party agreement. That agreement is, however, null and void. Dr Lee’s claim to be recognised as an applicant must, therefore, also fail.
CONCLUSION
The decisions under review will be affirmed.
I certify that the preceding one hundred and six (106) numbered paragraphs are a true copy of the reasons for decision herein of the Honourable Justice Downes, President and Dr Schafer, Member.
S. Robson, Associate:
Dated: 18 November 2011
Dates of hearing 19 - 23 September 2011 Date final submissions received 26 September 2011 Counsel for the Applicant Mr Christopher Wood Solicitors for the Applicant LSB Lawyers Pty Ltd Solicitors for the Respondent Australian Government Solicitor Counsel for the Joined Party Mr Garry Rich Solicitors for the Joined Party Allens Arthur Robinson
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