July 23, 2012 at 1:31 PM by cdisc
Last week CDISC sent a letter to many of our members alerting them to a potentially damaging and costly patent application which is currently under review by the United States Patent Office. The text of the letter is below and was prompted in part by a thread on Linkedin which can be found here.
The jist of the patent is this: a company, DataSci, filed a patent application in 2009 that effectively patents the use of metadata in clinical research. If this patent is granted there is a real possibility that a fee will be due to the patent holder for any use of metadata over the internet for every study done by any BioPharmaceutical company, academic research institution, government agency – basically ANY clinical research. See the original email below for more details and links that provide additional information.
Almost immediately after the email went out CDISC was contacted by Pharmaceutical, Biotech, Government, CRO and Technology company representatives company representatives asking how they could help prevent this patent from being approved. Most have forwarded the original email to their legal counsel and are looking into the process to protest this patent. Several of the large Pharma companies are also discussing how to combine efforts to fight this patent application.
CDISC appreciates all this effort and the support shown by our members. We will periodically update this blog with the status of these efforts.
Original email follows:
It has come CDISC’s attention that a company, DataSci, filed a patent application in 2009 that effectively patents the use of metadata in clinical research. If this patent is granted there is a real possibility that a fee will be due to the patent holder for any use of metadata over the internet for EVERY study done by ANY BioPharmaceutical company, academic research institution, government agency – basically ANY clinical research. This same company, DataSci, was granted a patent for the use of the internet to check data at entry several years ago. To date, DataSci has collected several million dollars in patent fees from some of the largest data management/EDC software vendors:
See some information from 2006 here on the earlier patent. Here’s another reference on the earlier patent.
CDISC standards are open and freely available and consist of standardized metadata which may fall under this patent and, if approved may force anyone using CDISC standards as well as any metadata over the internet to pay a substantial fee to DataSci. We would encourage you to forward this information to you internal legal counsel since there is a specific procedure to protest a pending patent application details of which can be found here.
To see the patent application follow the link below and instructions:
click here, enter captcha code(s), select Publication Number then enter this number in the box - 2010-0268544. This will take you to the Patent application information. Click on the Image file wrapper tab for all the docs related to this patent app. You can click on the other tabs to see additional information.
DataSci, the applicant, has asked for a 3 month extension from 1-Jun-2012 and as recently as 27-Jun-2012 has filed additional information in the effort to have this patent granted so the clock is ticking. This is a very serious matter which needs the attention of legal experts familiar with the patent application process, the patent protest process and patent law. We ask for your expeditious help to invalidate this patent application.