Inventing a new diagnostic test

BMJ 1994; 309 doi: https://doi.org/10.1136/bmj.309.6953.540b (Published 20 August 1994) Cite this as: BMJ 1994;309:540
  1. P Sonksen
  1. Division of Medicine, St Thomas's Hospital, London SE1 7EG
  2. Trinity College, Dublin 2, Republic of Ireland University of Wales College of Cardiff, Cardiff CF1 3KA.

    EDITOR, - I was most interested in the article by Tom O'Dowd and Nick Bourne about their experience in technology transfer from university to industry.1 They failed to mention how they handle the problems of indemnity against product liability and proof of intellectual property rights and how they and their industrial partners share this. It would be most helpful if they could give us the benefit of their experience on these issues.


    1. 1.

    Authors' reply

    1. T O'Dowd,
    2. N Bourne
    1. Division of Medicine, St Thomas's Hospital, London SE1 7EG
    2. Trinity College, Dublin 2, Republic of Ireland University of Wales College of Cardiff, Cardiff CF1 3KA.

      EDITOR, - We agree with Peter Sonksen that universities need to make sure that they have their act together in the complex world of exploiting medical research. He asks two important questions, on product liability and on proof of intellectual rights.

      Under the terms of our arrangement, our licensee was required to indemnify us against product liability claims against third parties. It is advisable actually to see a copy of the licensee's insurance cover to assess its extent. Such indemnities can prove extremely expensive in litigious territories like North America.

      We were licensing an idea, which was worked up to the stage of prototype kit. We did not actually license a product, but an idea on which the company itself would base a future product. It is important that the company makes its own assessment of the technology to ensure its “fitness for purpose.” As a further precaution the licensee should make a “no warranty” statement in the licence agreement. Our experience indicates that commercial partners see such precautions as good business and indeed sound investment.

      As to proof of intellectual rights, a licenser of a technology may be required by the licensee to confirm that he or she is the first and true owner of the intellectual property rights being licensed and that to the best of his or her knowledge no other agreement exists that might prejudice the licence agreement. In our case each of the four inventors was required to sign a declaration that we were the first and true inventors of the technology. This is done routinely as part of the inventor's standard agreement with the universities patent holding company. The patent examination procedures will throw up additional information, patents, and publications which go some way towards verifying the accuracy of the inventors' claims.

      For American patents the inventors must bring to the patent examiner's attention any information of which they are aware that might be relevant to the patent application. In our case ownership of intellectual property had to be confronted early on because the project involved two academic institutions. There is no ideal way of doing this, but obtaining the appropriate declarations early on and going through the patenting systems helped to clarify ownership for the licensee and indeed for those managing the project on behalf of the university.

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