Expert Group Report Management of Intellectual Property in ... - KoWi

Respect for Third Party IPR
It is essential that, having become aware of its own IPR, the PRO ensures that wherever possible it
accords respect for the IPR of other parties. In general, because PROs are not-for-profit organisations,
it is rare for patent infringement or other problematic events to affect them. But as PROs become more
involved in licensing and engaging in collaborations with industry, there may be an increase in the
situations where a PRO is seen to be a threat to the IPR of a third party.
Research Exemption
While carrying out due diligence into research in a PRO, it is important that TOs are aware of the
relationship between certain IPRs and research practice. A political storm has been brewing for several
years around the impact of certain biotechnology patents and freedom to carry out research. Examples
can be seen when we look at the PCR and Cre-lox technologies where licences for their use in research
environments is required.
In most countries of the world, patent statutes exempt certain acts from being seen as infringement of
valid patents. To what extent are PROs protected from infringement proceedings in the course of
conducting research?
In the USA the research exemption persists but in very narrow form. The Court of Appeals for the
Federal Circuit has held that is limited to acts done “ for amusement, to satisfy idle curiosity or for
strict philosophical enquiry” and that it does not apply if the act has the slightest commercial
implication. Therefore the research exemption may not extend to research with no commercial
application but which may be seen to further a university’s legitimate business objectives, for example
by increasing the status of the university and thereby luring research grants, students and faculty to it.
The Supreme Court refused to interfere with this judgement.
In the UK the research exemption applies to acts “ done for experimental purposes relating to the
subject matter of the invention, it being irrelevant whether the act is done for commercial purposes or
not. One view therefore is that in the UK the use of the patented research tools will require a licence
while research into the tools themselves will fall under the exemption. A similar interpretation of UK
legislation applies. However there is a European school of thought that clearly supports the notion that
if the use of the tools is for non-profit-making purposes, then the exemption should apply.
The pragmatic position for PROs to take is to be aware of the existence of third party patents and find
out what approach the owner is taking. In certain circumstances research sponsor may wield some
authority to persuade patent owners not to render the cost of undertaking research too high by insisting
upon licences.
Material Transfer Agreements
As well as information as described above, it may be that there are quantities of tangible research
materials that a PRO has developed and currently holds. Although all the methodology for replication
and production may be published, it may be that third parties wish to access the particular supply held
by the PRO. Industry also makes such materials available for research purposes, usually under
material transfer terms. Although there may no formal IPR position in terms of any of the rights
described here, there are frequently licence type arrangements entered into governing the supply of
this type of material. In such agreements, care needs to be taken to address the situation where future
IPR may arise as a result of use of the materials and parties should be pragmatic about what terms
ought to be reasonable. There has been much debate about material transfer agreements and for an
example; reference is made to the Uniform Biological Material Transfer Agreement, which is the
result of many years negotiation in the USA between the National Institutes of Health and industry.
(See AUTM manual)
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