Inventorship in the Spotlight Yet Again

Sang Bong Lee v Komipharm International Co., Ltd [2010] APO 14 (17 August 2010)

Inventorship – request under section 32 of the Patents Act 1990 and opposition to grant of patent – whether requestor/opponent is an inventor – Entitlement – whether requestor/opponent is entitled to be joint applicant under contract

ABSTRACT

This is a Patent Office decision of a Delegate of the Commissioner, Dr Steven Barker, relating to yet another dispute over inventorship and ownership of patents.

This decision comes hot on the heels of the Wake v Cavitus and Wake v Soniclean disputes, on which we recently reported.  Inventorship and ownership disputes seem very much the flavour of the month!

We can only assume that this is another situation in which business relationships have soured, leading to the removal of originally-named inventors and applicants from an application.  Although the Patent Office has resolved the dispute for the present (subject to any appeal), the decision raises questions that could arise again if the patent is ever challenged or litigated.  In particular, on the basis of the Delegate's findings, the PCT application was initially filed naming two individuals as inventors who were not inventors, and failing to name another person who was in fact the sole inventor.  Furthermore, the PCT application was amended to name two individuals as co-applicants, when they were not so entitled.

We emphasise that business relationships and politics should never be allowed to override legal requirements in relation to intellectual property matters.  Patent rights originate in inventorship, and the (legally) correct inventors must therefore be identified, as the source of any such rights.  Subsequent ownership of the invention derives only from legal transfer of title traceable back to the inventor(s), preferably in writing.

BACKGROUND

This decision relates to two Australian patent applications.  Application no. 2002253713 is the national phase of an international application filed under the Patent Cooperation Treaty (PCT), while application no. 2008255139 is a divisional of this first application.  Both relate to a pharmaceutical composition suitable for treating solid tumours. The active ingredient is the known compound sodium meta-arsenite.

In this case, there were two "inventors" originally identified in the PCT application, Dr Sang Bong Lee and Mr Yong Jin Yang.  These individuals were also named as co-applicants, along with Korea Microbiological Laboratories Ltd (KML), which subsequently changed name to Komipharm International Co., Ltd (Komipharm).

During the international phase of the PCT application, the applicant details were amended to add Dr Lee and Mr Yang as co-applicants.  However, after entry into the national phase in Australia, requests were filed to remove both originally-named inventors, instead naming Dr Bernardus Rademaker as sole inventor, and to change the applicant to be Komipharm only.

The amendment requests were made by Komipharm alone, and it is therefore reasonable to conclude that Dr Lee and Mr Yang may have been unaware of these actions.  (As a procedural aside, the amendment request should have been refused, on the basis that it was required to be made by the applicant of record, ie Komipharm jointly with Dr Lee and Mr Yang.  However, the Delegate's decision in this case supersedes any prior errors in relation to the applicant and inventor.)

Application no. 2002253713 was accepted, and subsequently opposed by Dr Lee on the ground that Komipharm was not entitled to sole ownership.  Dr Lee also filed requests under section 32 of the Patents Act 1990 seeking a determination that he was an inventor and applicant of both applications.

All of the related matters were heard together.  Dr Lee represented himself at the hearing.

THE EVIDENCE

As is typical with disputes over inventorship and ownership, the evidence in this case is incomplete and inconsistent.

It is clear that Dr Lee met with Dr Rademaker at the Novotel Hotel in Amsterdam in December 1998.  In April 1999, Dr Rademaker sent samples of three compounds (one of which was sodium meta-arsenite) to a Dr Fiebig, for testing. Dr Fiebig reported in November 1999 that sodium meta-arsenite was the most potent of the three compounds tested.

Dr Rademaker entered into a written agreement with KML on 25 February 2001, under which patentable inventions arising from the project (except methodological innovation) would be the property of KML.  A contract between Dr Lee, Mr Yang and Komipharm, dated 16 May 2005, states that the international application would continue to be jointly owned by the three parties.

Regarding the meeting in December 1998, Dr Lee's and Dr Rademaker's accounts differ.  Dr Lee asserts that he suggested testing metabolites of arsenic trioxide for anti-cancer activity, while Dr Rademaker disagrees with this assertion.  In any event, sodium meta-arsenite is a metabolite of arsenic trioxide that was chosen by Dr Rademaker for testing because it was commercially available.

INVENTORSHIP

As in the Cavitus and Soniclean cases, the starting point for assessing the inventive concept was critical in this case.

As the Delegate stated (at [13]):

...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.

He went on to conclude that:

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.

In reaching this conclusion, it appears that he was influenced by the fact that selection of sodium meta-arsenite for testing was somewhat arbitrary (ie due to its commercial availability, rather than any pre-existing expectation of efficacy), and thus Dr Lee could not have had this compound specifically in mind in December 1998 (at [15]).

Having thus defined the inventive concept, it was not necessary to decide between Dr Lee's and Dr Rademaker's accounts of the Novotel meeting, because Dr Lee was no longer involved at the time when the inventive concept became clearly defined in the inventor's – ie Dr Rademaker's – mind.

OWNERSHIP

The Delegate found that the contract between Dr Lee, Mr Yang and Komipharm confirmed an existing understanding regarding ownership of the international application.  However, the contract did not purport to effect any transfer of rights (at [20]).

As a consequence, neither Dr Lee nor Mr Yang could be entitled to a share in any patent(s) granted on the application.  They were not inventors, nor had they derived any rights (directly or indirectly) from the inventor.  The contract was Komipharm was based on a "mistaken understanding of the ownership of the patent application" (at [21]).

Komipharm is therefore the sole applicant of the Australian patent applications.

COMMENTARY

Importance of correctly identifying inventors and applicants

There were a number of clear failures on the part of the various parties to this dispute.

They failed to correctly identify the inventor in the first instance (or, it seems, even to attempt to do so).

They also failed to distinguish between merely being named as an applicant on a patent application, and actually being entitled to ownership of the associated rights.  It cannot be emphasised enough (because it is a common misconception) that the naming of inventors and applicants amounts to a statement to the relevant authorities of a pre-existing factual situation.  It does not actually result in any transfer of ownership, or acquisition of rights.

In some instances (depending on the circumstances and the relevant national laws) erroneous identification of inventors or applicants may be considered fraudulent, and render the resulting patent invalid and/or unenforceable.

The law and practice in Australia is relatively forgiving of these these kinds of lapses, at least prior to the grant of a patent.  However, there is at least one example of a case in which doubt has been cast over the possibility of correcting certain types of errors in ownership after a patent has been granted (see Conor Medsystems, Inc. v The University of British Columbia (No 2) [2006] FCA 32).

The evolving law of inventorship?

This decision arguably continues an ongoing "Americanisation" of the law of inventorship in Australia.  Certainly, the US law in this area is more highly developed, and for this reason the Federal Court of Australia has referred to US cases on a number of recent occasions.

However, part of the reason for the more-developed approach in the US is the "first to invent" system, which requires not only identification of the inventor, but also may require the establishment of a (more or less) specific date of invention.  The division between "conception" and "reduction to practice" assists this identification.  Under the US law, the conception is complete once the invention is fully-formed in the inventor's mind.  Reduction to practice, by definition, is a non-inventive process.

This is not necessarily so in Australia.  There is no need, in most cases, to ascribe a date to invention, and thus no need to draw a bright line between inventive and "routine" activity.  As the Full Federal Court has stated, "the reduction to practice of an inventive concept may or may not require an invention or inventive step" (University of Western Australia v Gray [2009] FCAFC 116).  Thus, care should be in affording too much weight to US authorities.

We also wonder about the apparently diminishing role of the "but for" test of inventorship (see Harris v CSIRO [1993] APO 43).  While the Delegate may well have been correct in this case that Dr Lee was not an inventor, it may not always be the case that a suggestion of a productive research direction is insufficient to establish inventorship.

In any event, it is apparent that determining inventorship is a heavily fact-based enquiry, and that each case needs to be considered on its particular merits.

Tags: Australia, Inventorship, Ownership