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Who owns what employees invent? UWA v Gray v Sirtex [2008] FCA ...

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<strong>Who</strong> Owns an Academic’s<br />

Invention?<br />

Implications on IP Ownership and Commercialisation<br />

<strong>UWA</strong> v <strong>Gray</strong> & <strong>Sirtex</strong> Medical Limited<br />

(<strong>2008</strong>) 246 ALR 603 76 IPR 222<br />

Justice French, Federal Court, 17 April <strong>2008</strong><br />

Special CRC for Polymers Seminar<br />

10 July 2009<br />

Ed Heerey<br />

Victorian Bar<br />

Junior Counsel for <strong>Sirtex</strong> Medical Limited


<strong>UWA</strong> v <strong>Gray</strong> & <strong>Sirtex</strong>: the parties<br />

� Applicant: University of Western Australia<br />

� Incorporated under University of Western<br />

Australia Act 1911 (WA)<br />

� 1 st Respondent: Dr Bruce <strong>Gray</strong><br />

� 2 nd Respondent: <strong>Sirtex</strong> Medical Limited<br />

� Public company, incorp 1997, listed 2000<br />

� 3 rd Respondent: Cancer Research Institute<br />

� Charitable association


<strong>Gray</strong>’s employment by <strong>UWA</strong><br />

� January 1985 to March 1997<br />

� Full time Professor of Surgery<br />

� Based at Royal Perth Hospital (RPH)<br />

� Required to teach and to conduct and stimulate<br />

research<br />

� March 1997 to November 1999<br />

� Fractional 30% appointment focussing on clinical<br />

work at RPH


Contracts and <strong>UWA</strong> regulations<br />

� 26 October 1984 written contract<br />

� 1971 <strong>UWA</strong> Patents Regulations<br />

� employee must:<br />

� inform VC of patentable <strong>invent</strong>ion made wholly or<br />

partly during the course of that person’s duty or<br />

whilst using <strong>UWA</strong>’s research facilities<br />

� If required by <strong>UWA</strong>, assign rights to <strong>UWA</strong>


Contracts and <strong>UWA</strong> regulations<br />

� 1996 <strong>UWA</strong> IP Regulations<br />

� employee must:<br />

� promptly report the creation of any IP likely to be<br />

commercially significant<br />

� not apply for any form of protection or exploit or<br />

deal with any IP inconsistently with <strong>UWA</strong>’s rights<br />

� not apply for registration except in <strong>UWA</strong>’s name<br />

� if required, execute documents to prove <strong>UWA</strong>’s<br />

title or assist <strong>UWA</strong>’s commercialisation


<strong>UWA</strong>’s pleaded fiduciary obligations<br />

� On <strong>Gray</strong> during and after employment:<br />

� a duty to deal with the property rights and interests of<br />

<strong>UWA</strong> so as to protect and preserve that property and<br />

those rights and interests for <strong>UWA</strong><br />

� a duty not to make any secret profit or receive any secret<br />

payment or obtain any secret benefit from any third party<br />

with whom he was dealing<br />

� a duty to account for any such secret profit or secret<br />

payment or benefit<br />

� the duties of a trustee of such of <strong>UWA</strong>’s assets and<br />

property as were in his possession or control and/or under<br />

his direction from time to time


<strong>Gray</strong> and <strong>Sirtex</strong><br />

� 1997: <strong>Sirtex</strong> incorporated<br />

� 1997: <strong>Gray</strong> assigned <strong>invent</strong>ions to <strong>Sirtex</strong><br />

� 2000: Prospectus and listing on ASX<br />

� <strong>Gray</strong> a director of <strong>Sirtex</strong> from 1997 to 2007<br />

� Also Chairman, CEO and Medical Director<br />

� Since litigation started in 2004, disputes between<br />

<strong>Gray</strong> and other <strong>Sirtex</strong> directors<br />

� <strong>Sirtex</strong> cross-claim against <strong>Gray</strong> for non-disclosure<br />

of <strong>UWA</strong>’s patent claims prior to ASX listing<br />

� <strong>Gray</strong> still <strong>Sirtex</strong>’s largest shareholder


Field of technology<br />

� Treatment of liver cancer<br />

� Use of microspheres injected into hepatic<br />

artery to attack tumors in liver by:<br />

� radiation by yttrium<br />

� cytotoxic drugs (doxorubicin)<br />

� hyperthermia (heating) by magnetic hysteresis<br />

� General concepts not novel<br />

� Patents focus on specific developments


Field of technology<br />

� Key problem – radioactive microspheres<br />

� Targetting radiation to tumors, limiting radiation<br />

to other parts of the body<br />

� Radioactive yttria leaching off microspheres,<br />

travelling in blood out of liver into lungs etc<br />

� Key problem – doxorubicin microspheres<br />

� Need controlled release of drug, not burst<br />

� Key problem – hyperthermia microspheres<br />

� High magnetic fields affect nervous system


<strong>Gray</strong>’s <strong>invent</strong>ions – SIRT 1<br />

� “Selective Internal Radiation Therapy”<br />

� Method for making resin-based microspheres<br />

containing radioactive yttrium<br />

� Key <strong>invent</strong>ive concept:<br />

� use of phosphate precipitation to bind yttrium into<br />

the microspheres<br />

� addressed problem of yttrium leaching off the<br />

microspheres to other parts of body


<strong>Gray</strong>’s <strong>invent</strong>ions – SIRT 1<br />

� Idea conceived by <strong>Gray</strong> prior to 1985<br />

� ie, before employment with <strong>UWA</strong><br />

� Early 1990s, <strong>Gray</strong> supervised clinical trials<br />

at <strong>UWA</strong> (RPH)<br />

� Commercialised by <strong>Sirtex</strong><br />

� Substantial sales worldwide<br />

� <strong>Sirtex</strong> has not yet sold any other product


<strong>Gray</strong>’s <strong>invent</strong>ions – SIRT 2<br />

� Hollow or cup-shaped ceramic<br />

microspheres of pure yttrium<br />

� Addressed problem of heavy microspheres<br />

not travelling in the blood to the tumours<br />

� Idea conceived by <strong>Gray</strong> before 1985<br />

� ie before employment with <strong>UWA</strong><br />

� Early 1990s - further research with Monash<br />

� Never clinically trialled or commercialised


<strong>Gray</strong>’s <strong>invent</strong>ions – Dox Spheres<br />

� Named co-<strong>invent</strong>or on patent:<br />

� Dr Yan Chen, <strong>UWA</strong> employee<br />

� <strong>Gray</strong> claimed there were other <strong>invent</strong>ors<br />

outside <strong>UWA</strong><br />

� Key <strong>invent</strong>ive concept:<br />

� use of metal ions to suppress burst release of<br />

doxorubicin from microsphere<br />

� Never clinically trialled or commercialised


<strong>Gray</strong>’s <strong>invent</strong>ions: Thermo Spheres 1,<br />

2 and 3<br />

� Co-<strong>invent</strong>or named on patents: Steve Jones<br />

� Employed by <strong>UWA</strong> 1990 – 1997, <strong>Sirtex</strong> 1997 to present<br />

� Prior art: use of magnetic fields to cause metal<br />

microspheres to heat and kill tumors<br />

� Thermo 1: specific magnetic heating efficiency of metallic<br />

material<br />

� Thermo 2: use of certain rotational magnetic fields<br />

� Thermo 3: further developments<br />

� Tested on animals only – serious problems<br />

� Never clinically trialled or commercialised


Assignments and patent filings<br />

� 1993 – Dox Spheres patent application<br />

� 1994 – SIRT 2 patent application<br />

� 1997 – assignment by <strong>Gray</strong> to <strong>Sirtex</strong><br />

� 1997 – Thermo 1 & 2 patent application<br />

� 1999 – Thermo 3 patent application<br />

� 1999 – end of <strong>Gray</strong>’s <strong>UWA</strong> employment<br />

� 2000 – SIRT 1 patent application


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� <strong>UWA</strong>’s case against Dr <strong>Gray</strong> and <strong>Sirtex</strong><br />

was critically dependent upon the<br />

proposition that it was an implied term of Dr<br />

<strong>Gray</strong>’s contract of employment that<br />

intellectual property developed in the<br />

course of his employment belonged to<br />

<strong>UWA</strong>.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Although there seems to have been an<br />

assumption among some at <strong>UWA</strong> that such<br />

an implied term operates generally in the<br />

case of academic staff who research and<br />

use university facilities, I have concluded<br />

that the assumption is not well founded.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Absent express agreement to the contrary,<br />

rights in relation to <strong>invent</strong>ions made by<br />

academic staff in the course of research<br />

and whether or not they are using<br />

university resources, will ordinarily belong<br />

to the academic staff as the <strong>invent</strong>ors<br />

under the 1990 [Patents] Act.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� The position is different if staff have a<br />

contractual duty to try to produce<br />

<strong>invent</strong>ions.<br />

� But a duty to research does not carry with it<br />

a duty to <strong>invent</strong>.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Citing Monotti and Ricketson in Universities<br />

and Intellectual Property who expressed:<br />

� "lingering discomfort with equating an<br />

academic’s general duty to research with a duty<br />

to <strong>invent</strong>, even though the research is that from<br />

which an <strong>invent</strong>ion might reasonably be expected<br />

to result".


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Citing Monotti and Ricketson’s Universities<br />

and Intellectual Property:<br />

� A general obligation of secrecy may be imposed<br />

on the employee who has a duty to <strong>invent</strong>, with<br />

safeguards on the duration of secrecy.<br />

� However, an automatic implied obligation sits<br />

uncomfortably with the notion of "academic<br />

freedom", shared ownership and free exchange<br />

of research results.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Citing Monotti and Ricketson in Universities<br />

and Intellectual Property:<br />

� “... in the absence of an express or implied duty<br />

to <strong>invent</strong> and to hold any information secret, the<br />

principles that operate in industrial settings seem<br />

to have no application to the creation of<br />

<strong>invent</strong>ions in the performance of normal<br />

academic duties of teaching, research and<br />

administration.”


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Citing Monotti and Ricketson’s Universities<br />

and Intellectual Property:<br />

� “... it will be unwise for a university to rely upon<br />

general principles if its intention is to claim title to<br />

<strong>invent</strong>ions that are made by its academic<br />

<strong>employees</strong> during their working hours and using<br />

university facilities and funding.”


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� A person engaged to carry out research only is in<br />

a different category even when the possibility or<br />

probability exists that the research will lead to the<br />

development of an <strong>invent</strong>ion.<br />

� Such a person has a duty to research, but no duty<br />

to <strong>invent</strong>.<br />

� Where, as is often the case, the pathways that<br />

may be taken in research are a matter of choice,<br />

the question whether or not to <strong>invent</strong> will be a<br />

matter of choice.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Given the nature of universities and the public<br />

purposes served by such as <strong>UWA</strong>:<br />

� no basis to imply a contractual duty for academic<br />

staff not to disclose the results of research<br />

� even if such disclosure could destroy the patentability<br />

of an <strong>invent</strong>ion.<br />

� Absent such a duty and given a choice to<br />

<strong>invent</strong> or not <strong>invent</strong>:<br />

� difficult to see basis for a term to be implied as a<br />

matter of law that the university has entitlement to the<br />

<strong>invent</strong>or’s property rights in the <strong>invent</strong>ion.


French J: implied term <strong>UWA</strong> <strong>owns</strong> IP?<br />

� Implied term even more problematical where<br />

researcher expected to secure funding from<br />

sources external to <strong>UWA</strong>.<br />

� This was even though <strong>UWA</strong> administered funding<br />

received from sources such as NH&MRC and<br />

CSIRO.<br />

� A striking feature of this case was the significant<br />

amount of time and effort devoted by Dr <strong>Gray</strong> and<br />

those researching with him in applying for<br />

research grant grants to a myriad of funding and<br />

grant bodies and agencies.


French J: <strong>Gray</strong> a “member” of <strong>UWA</strong><br />

� <strong>Gray</strong> employed by <strong>UWA</strong>, a statutory body<br />

established for public purposes.<br />

� Not merely employee, but a “member” of <strong>UWA</strong>.<br />

� Linked historically by definition of "university" in<br />

<strong>UWA</strong> Act to the idea of a university as a<br />

community of teachers and scholars.<br />

� Statutory definition traces back to the 16th<br />

century statute for Oxford University.


French J: Commercial activities of<br />

<strong>UWA</strong>?<br />

� Contemporary reality: universities, including <strong>UWA</strong>,<br />

engage in commercial activities.<br />

� Eg Quickenden v O’Connor (2001) 109 FCR 243:<br />

<strong>UWA</strong> a trading corporation for the purposes of the<br />

Workplace Relations Act 1996 (Cth).<br />

� But Quickenden considered trading activities<br />

unconnected to teaching and research.<br />

� <strong>Gray</strong> was not required to advance a <strong>UWA</strong><br />

commercial purpose when selecting the research<br />

work he would undertake.


French J: fiduciary breach?<br />

� <strong>UWA</strong>’s case for breach of fiduciary<br />

obligations rested on premise that <strong>Gray</strong><br />

was dealing with rights owned by <strong>UWA</strong>.<br />

� That premise was misconceived.<br />

� <strong>UWA</strong> failed to establish it had any rights in<br />

any of the <strong>invent</strong>ions even if made by <strong>Gray</strong><br />

in the course of employment with <strong>UWA</strong>.


French J: validity of <strong>UWA</strong> IP Regs?<br />

� <strong>UWA</strong>’s IP Regulations assert ownership by<br />

<strong>UWA</strong> of all intellectual property developed<br />

by its staff (apart from most copyright).<br />

� <strong>UWA</strong>’s Regulations which purport to vest<br />

intellectual property rights in <strong>UWA</strong> or<br />

interfere with the intellectual property<br />

generated by its academic staff, are not<br />

valid.


French J: validity of <strong>UWA</strong> Regs?<br />

� <strong>UWA</strong> was authorised, by the <strong>UWA</strong> Act, to<br />

make regulations relating to the control and<br />

management of its own property.<br />

� <strong>UWA</strong> was not authorised by the Act to<br />

make regulations acquiring property from<br />

others or interfering with their rights.


French J: how could <strong>UWA</strong> acquire IP?<br />

� The only secure way for <strong>UWA</strong> to acquire<br />

property rights from its academic staff in<br />

respect of intellectual property developed<br />

by them in the course of research at <strong>UWA</strong><br />

is by express provision in their contracts of<br />

employment.


French J: how could <strong>UWA</strong> acquire IP?<br />

� Even then, as this case demonstrates, the<br />

transaction costs of administering and<br />

enforcing such provisions and the<br />

uncertainty surrounding their scope and<br />

application, raises a real question as to<br />

their utility.


French J: how could <strong>UWA</strong> acquire IP?<br />

� The length [50 days] and complexity of this<br />

litigation has been exceptional.<br />

� However any claim by a university to<br />

intellectual property rights whose creation<br />

has involved a team of research workers,<br />

external funding, collaborative<br />

arrangements and extended periods of<br />

conceptual and practical development is<br />

likely to pose similar difficulties.


French J: how could <strong>UWA</strong> acquire IP?<br />

� <strong>UWA</strong> and other universities might well consider<br />

the alternative of deriving benefits from <strong>invent</strong>ions<br />

produced by their staff by offering highly<br />

competent and experienced commercialisation<br />

services in exchange for a negotiated interest in<br />

the relevant intellectual property.<br />

� That alternative offers many benefits in terms of<br />

incentives, harmony and certainty that are not<br />

available through the enforcement of legal rights<br />

unlikely to be capable of precise definition.


Inventions during employment?<br />

� French J accepted <strong>Sirtex</strong>’s defence that:<br />

� Only conception, not reduction to practice, gives<br />

rise to patent entitlement<br />

� The <strong>invent</strong>ive concepts for SIRT 1 & 2 were<br />

conceived before <strong>Gray</strong>’s employment at <strong>UWA</strong><br />

� All research and trials at <strong>UWA</strong> on SIRT 1 & 2 were<br />

merely reduction to practice, not conception<br />

� Thermo Spheres 1, 2 & 3 were conceived after<br />

<strong>Gray</strong>’s employment at <strong>UWA</strong>


Timing of <strong>invent</strong>ion – narrowest<br />

claim?<br />

� French J rejected <strong>UWA</strong>’s contention:<br />

� that timing of <strong>invent</strong>ion could be established by<br />

reference to the narrowest claim in patent as<br />

specifying the most specific elaboration of the<br />

<strong>invent</strong>ion [usually later in time]<br />

� French J accepted <strong>Sirtex</strong>’s submission:<br />

� analysis of entitlement should focuss on the<br />

broad “<strong>invent</strong>ive concept” [usually earlier in time]


Timing of <strong>invent</strong>ion –<br />

conception v reduction to practice<br />

� French J: “The <strong>invent</strong>ive concept marks a<br />

boundary between <strong>invent</strong>ion and<br />

verification.”<br />

� Cited US and Canadian authorities:<br />

� Wellcome discovered that AZT might work<br />

against HIV/AIDS<br />

� Idea tested and proved by US NIH scientists<br />

� NIH only reduced idea to practice<br />

� NIH not involved in conception, no entitlement


Timing of <strong>invent</strong>ion –<br />

conception v reduction to practice<br />

� French J rejected <strong>UWA</strong>’s claim by claim<br />

analysis.<br />

� cited several English decisions and Polwood v<br />

Foxworth (<strong>2008</strong>) IPR 1 on the relevance of the<br />

“<strong>invent</strong>ive concept” or “heart” of the <strong>invent</strong>ion.


Timing of <strong>invent</strong>ion –<br />

conception v reduction to practice<br />

� French J:<br />

� The “<strong>invent</strong>ion” is generally as described in the<br />

specification.<br />

� Time of <strong>invent</strong>ion and identity of <strong>invent</strong>or are<br />

ascertained by reference to that <strong>invent</strong>ive<br />

concept so described.<br />

� Time of <strong>invent</strong>ion and identity of <strong>invent</strong>or are not<br />

affected by subsequent process of reduction to<br />

practice, some elements of which may have<br />

found their way into the claims in the application.


Dox Spheres – other <strong>invent</strong>ors?<br />

� French J found Dox-Spheres <strong>invent</strong>ed<br />

during time of <strong>Gray</strong>’s employment by <strong>UWA</strong><br />

� But French J accepted <strong>Gray</strong>’s defence that:<br />

� Dox-Spheres was not in fact <strong>invent</strong>ed by Chen<br />

� Dox-Spheres co-<strong>invent</strong>ed by other persons<br />

outside <strong>UWA</strong><br />

� Dox-Spheres probably not <strong>invent</strong>ed by <strong>Gray</strong> at all


Subsequent developments<br />

� French J appointed Chief Justice of High<br />

Court of Australia<br />

� Pending Full Federal Court decision on<br />

appeal by <strong>UWA</strong> against <strong>Gray</strong><br />

� No appeal against patent owner <strong>Sirtex</strong><br />

� Appeal heard November <strong>2008</strong><br />

� Outstanding costs disputes between all<br />

parties


Subsequent developments<br />

� Commonwealth v Charlesworth [<strong>2008</strong>] APO<br />

16 (3 June <strong>2008</strong>)<br />

� S 32 & 36 application to Commissioner.<br />

� Commonwealth successfully claimed<br />

entitlement to a patent lodged by a former<br />

employee.


Subsequent developments<br />

� Commonwealth v Charlesworth (<strong>2008</strong>) 77 IPR 170<br />

� Delegate applied <strong>UWA</strong> v <strong>Gray</strong> approach to entitlement:<br />

� Identify the "<strong>invent</strong>ive concept" of <strong>invent</strong>ion.<br />

� Determine <strong>invent</strong>orship including the person responsible<br />

for the <strong>invent</strong>ive concept and the time of conception as<br />

distinct from its verification and reduction into practice.<br />

� Determine how “many” [should be “any”] contractual or<br />

fiduciary relationships between employer and <strong>invent</strong>or at<br />

time of <strong>invent</strong>orship give rise to proprietary rights claimed<br />

by employer.<br />

� NB “many” is typo by French J, now repeated by APO!


Subsequent developments<br />

� Novogen Research Pty Ltd v G.J. Consultants Pty Ltd<br />

[<strong>2008</strong>] APO 24 - opposition to patent registration<br />

� Patent Office’s approach to entitlement summarised further:<br />

� Identify the "<strong>invent</strong>ive concept" of each relevant <strong>invent</strong>ion as<br />

defined by the claims.<br />

� Determine <strong>invent</strong>orship including the person responsible for the<br />

<strong>invent</strong>ive concept and the time of conception as distinct from its<br />

verification and reduction into practice.<br />

� Determine if contractual or fiduciary relationships between the<br />

parties at the time of the <strong>invent</strong>orship give rise to the proprietary<br />

rights claimed by the opponent.<br />

� Summary avoids typo: [m]any


Subsequent developments<br />

� Other applications of <strong>UWA</strong> v <strong>Gray</strong> & <strong>Sirtex</strong> by the Patent<br />

Office in disputes over patent entitlement:<br />

� Razmik Abnoos v CSR Building Products Limited<br />

[2009] APO 7<br />

� Craige Jonathan Henrick v Granite Works Pty Ltd<br />

[<strong>2008</strong>] APO 21


Advice for public sector employers?<br />

� Review incorporating legislation<br />

� statutory purposes include the creation and<br />

commercialisation of IP?<br />

� statutory power to take IP rights from <strong>employees</strong>?<br />

� Review own employment contracts<br />

� Review assignments and licences<br />

� to other parties – valid?<br />

� from other parties – infringement of true owner’s rights?


Advice for private sector employers?<br />

� Review your employment contracts<br />

� explicit duty to <strong>invent</strong>?<br />

� explicit term vesting IP in employer?<br />

� Review rights assigned or licensed from<br />

academics, universities or other public<br />

organisations<br />

� validly assigned or licensed?<br />

� infringing true owner’s rights?


Advice for <strong>employees</strong>?<br />

� Academics and other University staff<br />

� Universities exploiting <strong>employees</strong>’ <strong>invent</strong>ions<br />

without employee’s consent?<br />

� Right to demand royalties?<br />

� Employees of other public organisations<br />

� Review employer’s enabling legislation<br />

� Compare employee to academic - duty to <strong>invent</strong>?

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