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|Title:||ECVAM's Approach to Intellectual Property Rights in the Validation of Alternative Methods|
|Authors:||LINGE JENS; HARTUNG THOMAS|
|Citation:||ATLA-ALTERNATIVES TO LABORATORY ANIMALS vol. 35 p. 441-446|
|Type:||Articles in periodicals and books|
|Abstract:||Intellectual Property Rights (IPRs) such as patents, designs, trademarks and copyright play an important role in all industries investing in research and development. Protection for products and production processes is routinely sought. Also, IPRs often cover methods and materials used in research and development, e.g. patents for toxicity testing methods have been issued. The European Centre for the Validation of Alternative Methods (ECVAM) receives submissions of alternative methods which are often, at least partially, protected by IPRs. As participant in projects under the sixth framework programme, ECVAM is also obliged to provide for the adequate and effective protection of results in these projects. Many of ECVAM’s stakeholders thus ask how IPRs affect the development, validation, and regulatory acceptance of alternative methods. ECVAM has already been confronted several times with patented methods. During the EC/HO study on non-animal tests for eye irritation, the question arose as to how EYETEX, a patented method, should be handled. At that time, no action was taken, since EYETEX did not meet the performance standards for the study. During the ECVAM study on skin corrosivity, two of the methods involved in the study, EpiSkin and Skin2, were not only patented, but were not freely available. Meanwhile, another method, EPIDERM, had come on the market, but too late for inclusion in the study. Therefore, Michael Balls, then head of unit of ECVAM, wrote a paper about structural and performance criteria  suggesting that precisely defining the nature of a test and specifying the level of performance required for it to be acceptable, would both deal with the problem of patented methods and with speeding up the progress of a new method very similar to one which had already been validated. Furthermore, ECVAM funded a catch-up study , which established that EPIDERM met the structural and performance criteria of EpiSkin, the method successfully validated in the ECVAM study. When the EU and OECD test guidelines for in vitro skin corrosivity tests were drawn up, patented methods were not mentioned, but the structural and performance characteristics for the tests were defined. In this article, we give an overview of IPR issues concerning the validation of alternative methods at ECVAM and discuss recently published OECD documents. We provide guidelines for dealing with IPRs during the validation of alternative methods. These guidelines will be further developed in close collaboration with ECVAM's scientific advisory committee (ESAC).|
|JRC Institute:||Institute for Health and Consumer Protection|
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