Sang Bong Lee v Komipharm International Co., Ltd
[2010] APO 14
•17 August 2010
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Sang Bong Lee v Komipharm International Co., Ltd [2010] APO 14
Patent Applications: 2002253713 and 2008255139
Titles:Pharmaceutical composition comprising arsenite for the treatment of malignancy (in both instances)
Patent Applicant: Komipharm International Co., Ltd
Opponent/Requestor: Sang Bong Lee
Delegate: Dr S.D. Barker
Decision Date: 17 August 2010
Hearing Date: 1 June 2010, in Canberra
Catchwords: PATENTS - opposition to grant – requests under section 32 – inventive concept – whether person who provides input is an inventor – whether invention subsequently transferred by contract
Representation: Patent applicant: Mr Wiseman of Allens Arthur Robinson, assisted by Ms Govenlock, patent attorney of Allens Arthur Robinson.
Opponent/requestor: Dr Lee represented himself, assisted by Miss Lee.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Applications: 2002253713 and 2008255139
Titles:Pharmaceutical composition comprising arsenite for the treatment of malignancy (in both instances)
Patent Applicant: Komipharm International Co., Ltd
Date of Decision: 17 August 2010
DECISION
Bernardus Rademaker is the inventor for patent applications 2002253713 and 2008255139.
Komipharm International Co., Ltd is the applicant for patent applications 2002253713 and 2008255139.
I direct that the applications are to proceed in the name of Komipharm International Co., Ltd. I further direct that the inventor is to be recorded as Bernardus Rademaker.
The opposition by Dr Lee fails. I direct that application 2002253713 proceed to sealing (subject to appeal).
Costs according to Schedule 8 are awarded against Dr Lee.
REASONS FOR DECISION
Patent application 2002253713 was filed under the provisions of the Patent Cooperation Treaty (PCT) by Korea Microbiological Laboratories Ltd (KML). The inventors were listed as Sang Bong Lee and Yong Yin Yang . Pursuant to Rule 92bis of the PCT, the applicant was amended to also include Sang Bong Lee and Yong Jin Yang. After the application had entered the national phase, the applicant was changed to Komipharm International Co., Ltd (Komipharm), Sang Bong Lee and Yong Jin Yang (as a consequence of a change of name of the company).
On 23 July 2008, a request was filed to amend the inventor details, to record Bernardus Rademaker as the sole inventor. On 12 August 2008 a request was filed to amend the applicant to Komipharm. Both of these requests were allowed. However, it is apparent that both requests were made under section 104, and were requested by Komipharm only. An amendment under section 104 can only be made by the applicant, and at the relevant dates the applicant was Komipharm, Dr Lee and Mr Yang. However, nothing turns on these errors as my determination under section 32 will rectify any errors in relation to the applicant and inventor.
The application was advertised accepted on 18 September 2008. On 28 November 2008, Dr Lee filed a request under section 32, alleging that he is the inventor and an applicant of the application. A notice of opposition to the grant of a patent was filed by Dr Lee on 17 December 2008. The sole ground of opposition is section 59(a)(ii), i.e. that the nominated person is entitled to a grant of a patent but only in conjunction with some other person.
Patent application 2008255139 was filed as a divisional application (pursuant to section 79B) to application 2002253713 on 4 December 2008. The applicant is Komipharm. Dr Lee filed a request under section 32 in relation to the application on 9 January 2009. Dr Lee again alleged that he is the inventor and an applicant.
The actions were heard together, and the evidence taken as a whole. The matters were heard in Canberra on 1 June 2010. Dr Lee represented himself, assisted by Miss Lee. Komipharm was represented by Mr Wiseman of Allens Arthur Robinson, assisted by Ms Govenlock, patent attorney of Allens Arthur Robinson.
For all practical purposes, the specifications of the two applications are identical, and the parties dealt with them as such. The applications relate to a pharmaceutical composition suitable for treating solid tumours. The active ingredient is the known compound sodium meta-arsenite.
The relevant history of the invention is straight forward. In the late 1990s Dr Lee and Dr Rademaker were involved in a project investigating whether the dimer of arsenic trioxide (As4O6) had anti-cancer activity. The dimer project was funded by the Korean company Ilsung Pharmaceutical Company (Ilsung). In December 1998 Dr Lee met with Dr Rademaker at the Novotel Hotel in Amsterdam to discuss the project. There are differing accounts of what was discussed at this meeting. Dr Lee asserts that he suggested testing metabolites of arsenic trioxide for anti-cancer activity. Dr Rademaker disagrees with this assertion.
The dimer project was discontinued in January 1999. Dr Lee did not have contact with Dr Rademaker for about two years.
In April 1999 Dr Rademaker sent samples of three compounds to Dr Fiebig for testing of their anti-tumour activity. The compounds were all metabolites of arsenic trioxide, and included sodium meta-arsenite. Dr Fiebig reported in November 1999 that sodium meta-arsenite was the most potent compound, and could be of interest in in vivo testing. Dr Fiebig’s report is known as the P43 report.
The law governing disputes over entitlement was recently considered by the Full Court of the Federal Court of Australia in University of Western Australia v Gray [2009] FCAFC 116. The Court accepted that entitlement is assessed by considering three matters:
(i)identify the “inventive concept” of the invention as defined by the claims
(ii)determine inventorship including the person responsible for the inventive concept and the time of conception as distinct from its verification and reduction into practice;
(iii)determine how many contractual or fiduciary relationships give rise to proprietary rights in the invention
The inventive concept
The present invention started with an idea that metabolites of arsenic trioxide could be useful as therapeutic agents, and a research project was commenced. Preliminary results in the P43 report showed that sodium meta-arsenite had more promising activity than other metabolites. Further experiments confirmed the usefulness of sodium meta-arsenite. The key questions in this case are what the inventive concept is, and when is the inventive concept complete?
The Full Court in Gray accepted that there is a line “between a complete invention on the one hand and its verification or reduction to practice on the other” (paragraph [254]), albeit that it is not a bright line. Some insight into the dividing line between invention and verification is found in the decision of French J at first instance in University of Western Australia v Gray (No 20) [2008] FCA 498, (2008) 246 ALR 603. His Honour considered the approach to entitlement in the United States of America, and particularly the decision of the US Court of Appeals in Burroughs Wellcome Co v Barr Laboratories Inc, 40 F 3d 1223 (Fed Cir, 1994). At [1426] French J listed the following principles derived from that case:
i)Conception is the touchstone of inventorship, the completion of the mental part of inventions.
ii) Conception is the “formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is hereafter to be applied in practice”. It is complete only when the idea is so clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice without extensive research or experimentation.
iii) An inventor need not know that the invention will work for conception to be complete. The inventor need only show that he or she had the idea. The discovery that an invention actually works is part of its reduction to practice.
iv) It is not the law that the inventor’s definite and permanent idea must include a reasonable expectation that the invention will work for its intended purpose even when it deals with uncertain or experimental disciplines where the inventor cannot reasonably believe that an idea will be operable until some result supports that conclusion.
In the present case the inventive concept could be viewed as the idea that sodium meta-arsenite could be active against specific solid tumours, or alternatively it might be viewed as the broader idea that metabolites of arsenic trioxide might be active against tumours. In the Burroughs case the court said that “[a]n idea is definite and permanent when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan he hopes to pursue.” The broader formulation of the inventive concept is an idea for an area of research, and is not sufficiently developed to be regarded as the inventive concept. I am satisfied that the inventive concept is the use of sodium meta-arsenite.
Who was responsible for the inventive concept
The inventive concept is the idea that sodium meta-arsenite could be active against specific solid tumours. An important question is what degree of knowledge was necessary for the inventive concept to be complete. It is clear that an inventor need not know for certain that an invention will work for the conception of the inventive concept to be complete. However, as the Burroughs case noted, the conception is complete only when the idea is so clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice without extensive research or experimentation.
Although Dr Lee did not articulate it this way, I believe that his view was that the inventive concept was complete at the time that it was postulated that metabolites of arsenic trioxide (including specifically sodium meta-arsenite) could be worth investigation. However, the evidence shows that prior to the P43 report, sodium meta-arsenite was known to be a metabolite of arsenic trioxide, but was only chosen for testing because it was commercially available. The idea of using sodium meta-arsenite was not clearly defined until there was an indication that sodium meta-arsenite possessed useful activity. This knowledge only existed once the P43 report was available.
What was Dr Lee’s contribution to the process leading to the P43 report? There is disagreement over Dr Lee’s contribution, but for the purposes of this decision I have not had to decide whether Dr Lee’s evidence should be preferred over that of Dr Rademaker, because Dr Lee’s evidence, taken at its highest, does not support a conclusion that he is an inventor. Dr Lee’s assertion is that he provided an idea that eventually led to the inventive concept. However, Dr Lee had no part in the project after that. US cases indicate that such a person is not an inventor. This is because an inventor may “consider and adopt ideas and materials derived from many sources … [such as] a suggestion by an employee, or hired consultant … or adopt a material suggested by a friend … as long as he maintains intellectual domination of the work of making the invention down to the successful testing, selecting or rejecting as he goes … and he does not lose his quality as inventor by reason of having received a suggestion or material from another even if such suggestion proves to be the key that unlocks his problem” (Morse v Porter, 155 USPQ 280 (Bd Pat Inter, 1965). This seems consistent with the approach in Gray, and I can see no reason to come to a different view.
The evidence of Dr Lee is that he provided input to the development of the inventive concept, but after that he maintained no involvement with the project. This is not sufficient to make him an inventor. It seems clear that as Dr Lee is not the inventor, then Dr Rademaker should be recorded as the inventor.
Subsequent transfer of rights
Ownership originates with the inventor, and remains with the inventor unless it is transferred to another person. Has Dr Rademaker transferred his rights to another person? Dr Rademaker entered into an agreement with KML dated 25 February 2001. The agreement appears as Exhibit BR-43. There is a provision related to patents that states “All discoveries and patentable inventions, excepting methodological innovation arising during the project, shall be the property of the Sponsor”. The sponsor is KML. Although the P43 report predates this agreement, I am satisfied that the parties intended to transfer the present invention. Dr Rademaker’s rights were transferred to KML, which subsequently changed its name to Komipharm.
Dr Lee relied upon a contract between himself, Mr Yang and Komipharm dated 16 May 2005 (referred to as the Three Party Agreement) as the basis for asserting that the applications should be owned by him, Mr Yang and Komipharm jointly. This contract clearly states that the international application from which the present applications derive will continue to be owned by Dr Lee, Mr Yang and Komipharm. There is disagreement over the effect of this agreement.
I have had considerable difficulty deciding how to interpret the Three Party Agreement. The Agreement does not indicate whether it was based on a belief that Komipharm owned the rights to the patent, or a belief that Komipharm, Dr Lee and Mr Yang owned the rights to the patent. The translation of the contract provided to me as Exhibit SBL 51 does not include an assertion that Dr Lee (or any other person) invented the subject matter. Rather, it is stated that Dr Lee and Mr Yang “agreed to co-research and co-develop an anti-cancer agent using the meta-arsenite which is metabolite of arsenic trioxide”. Mr Yang indicates at paragraph 25 of his second declaration that he entered into the Three Party Agreement in the belief that Dr Lee and he were inventors, and I infer that he believed that the patent rights were owned by Komipharm, Dr Lee and Mr Yang. It follows that the Three Party Agreement was not intended to transfer the ownership of the patent applications, but rather to confirm the ownership and agree on the further development of the technology. Dr Lee appears to agree at paragraph 6 of his fourth declaration:
“I am the inventor and as for the right of being an inventor, 3 party agreement, a mutual agreement, which deals about sharing of profit, future process of patent, and ownership was made between me and KML.”
It is clear that the Three Party Agreement was based on a mistaken understanding of the ownership of the patent application, and was not intended to transfer the interests of Komipharm to Mr Yang and Dr Lee. It follows that it was probably non est factum, and cannot provide a basis for transferring the interest of Komipharm.
Conclusion
The central issue in this dispute is who the inventor is. Dr Lee has failed to establish that he is an inventor. He has also failed to establish that he is an applicant.
Bernardus Rademaker is the inventor of patent applications 2002253713 and 2008255139. Komipharm International Co., Ltd is the applicant for patent applications 2002253713 and 2008255139. I will give directions under section 32 to give effect to this finding.
The opposition by Dr Lee fails.
Costs
It is normal in actions before the Commissioner for costs to follow the event. In the present case Dr Lee has failed to establish that he is the inventor or an applicant. I can see no reason to depart from the normal award of costs. Costs according to Schedule 8 are awarded against Dr Lee.
Dr S.D.Barker
Delegate of the Commissioner of Patents
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