Protection of intellectual property rights key to good clinical trials

Australian Life Scientist has recently published a feature article on the “Top 10 clinical trial mistakes”.  The article, which addresses some of the common mistakes made when drafting clinical trial agreements, is a reminder of the need for such agreements not only to deal with the existing intellectual property rights of all participants but also with the generation of intellectual property by participants during the trial.

It is usual for clinical trial agreements to identify the existing background IP of each participant and to include the appropriate licence(s).  However, agreements should also address the creation of intellectual property rights that may arise from the trial and specifically, who will own such rights.

As seen recently in the Full Court of the Federal Court’s decision in University of Western Australia v Gray [2009] FCAFC 116, our alert on which can be found here, failure to properly deal with intellectual property rights in the early stages of commercialisation may have serious consequences further down the track – consequences that can be easily avoided with a properly drafted agreement.

For further information on the top 10 mistakes, click here.

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About the Author

James EllsmoreJames is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.View all posts by James Ellsmore

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