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:
  • 5-Aminosalicylate Induced Nephrotoxicity:
    • Provisional patent application (December 2014, link to pdf)
    • Non-provisional patent application (December 2015, link to pdf)
  • Acute Hypersensitivity Syndrome:
  • DILI (GWAS biomarkers):
  • DILI (exome sequencing biomarkers):
    • Provisional patent application (October 2013, link to pdf).
    • Non-provisional patent application (October 2014, link to pdf).
    • Letter of Restriction Requirement (February 2017, link to pdf).
  • Elongated QT Interval and Torsades de Pointes (GWAS biomarkers):
    • Provisional patent application (September 2011, link to pdf).
  • Elongated QT Interval and Torsades de Pointes (exome sequencing biomarkers):
    • Provisional patent application, (October 2013, link to pdf).
    • Non-provisional patent application (October 2014, link to pdf).
    • Letter of Restriction Requirement (January 2017, link to pdf).
  • Osteonecrosis of the jaw:
    • Provisional patent application (October 2013, link to pdf).
    • Non-provisional patent application (October 2014, link to pdf).
    • Letter of Restriction Requirement (February 2017, link to pdf).
  • Serious Skin Rash:
    • Provisional patent application (May 2010, link to pdf).
  • Thiopurine-Induced Pancreatitis:
    • Provisional patent application (December 2014, link to pdf).
    • Non-provisional patent application (December 2015, 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).
  • Serious Skin Rash Provisional Patent Applications – Letter of Abandonment, March 17, 2011 (link to pdf).
  • Elongated QT Interval and Torsades de Pointes – September 29, 2011 (link to pdf).
  • Elongated QT Interval and Torsades de Pointes Notice of Extension -- September 18, 2012 (link to pdf).
  • Elongated QT Interval and Torsades de Pointes Notice of Abandonment -- March 28, 2013 (link to pdf).
  • Accute Hypersensitivity Syndrome – April 16, 2015 (link to pdf).
  • Drug Induced Liver Injury (exome sequencing biomarkers) – April 16, 2015 (link to pdf).
  • Elongated QT Interval and Torsades de Pointes (exome sequencing biomarkers) – April 16, 2015 (link to pdf).
  • Osteonecrosis of the jaw – April 16, 2015 (link to pdf).
  • Drug-Induced 5-Aminosalicylate Nephrotoxicity – June 2, 2016 (link to pdf).
  • Thiopurine-lnduced Pancreatitis – June 2, 2016 (link to pdf).
  • Accute Hypersensitivity Syndrome Notice of Abandonment – August 24, 2017 (link to pdf).
  • Drug Induced Liver Injury (exome sequencing biomarkers) Notice of Abandonment – September 07, 2017 (link to pdf).
  • Osteonecrosis of the jaw Notice of Abandonment – September 18, 2017 (link to pdf).
  • Thiopurine-lnduced Pancreatitis – January 19, 2018 (link to pdf).
  • 5-Aminosalicylate Induced Nephrotoxicity - January 19, 2018 (link to pdf)