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Intellectual Property Program

iSAEC’s Public Genetic Marker Intellectual Property Program

In order to promote the public welfare and to enable the broadest beneficial use of the results of the Consortium’s Research Programs, research data will be made available by the iSAEC to qualified biomedical researchers, at no charge, in a uniform manner. To limit the risks to privacy of the data subjects and to comply with any other limitations on the use of such data (e.g., limitations contained in consents obtained from data subjects), only those research data which are made anonymous and approved by the Scientific Management Committee of the iSAEC shall be released to qualified researchers (click link to the iSAEC data access portal).

It is also the goal of the Consortium to maximize the public benefit of research supported by the Consortium and, accordingly, to make freely available DNA markers for susceptibility to drug-induced severe adverse events and related data and analyses. Accordingly, the Consortium has adopted a policy of limiting the intellectual policy constraints on genetic markers discovered by or arising from the research program activities conducted or funded by the Consortium.

The Consortium undertakes to proactively make intellectual property filings to reduce the likelihood that use of it’s public data will be encumbered by “follow-on patents” filed by other parties (commercial or otherwise). The Consortium has determined the most effective way to ensure that its public data is securely placed in the public domain (with the earliest available priority date) is to file provisional patent applications covering all novel discoveries made prior to the filing, and to include claims directed toward these data (including genetic markers and genotype/haplotype-phenotype associations).  Subsequent to the initial provisional application, the Consortium files additional utility applications to further validate or expand on its initial utility claims.  At the end of a given research program sponsored by the iSAEC, a final utility application is filed, with the intention that such application will either be abandoned following publication or converted to a statutory invention registration.

To date, the iSAEC has filed the following patent applications:

  • DILI Biomarkers Non-provisional Patent Application (link to pdf)
  • Serious Skin Rash Patent Application (link to pdf)
  • Elongated QT Interval and Torsades de Pointes Provisional Patent Application (link to pdf)

To date, the iSAEC has received the following patent applications publication notices:

  • Biomarkers for Drug Induced Liver Injury – February 11, 2010 (link to pdf)