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Friday Nov 25, 2011

Status Update on Prior User Rights and International Patent Protection Studies

From: Janet Gongola, Patent Reform Coordinator

The agency is in the process of preparing reports for Congress for the Prior User Rights and International Patent Protection Studies.  Thank you all for participating in these studies by attending and/or giving testimony at our respective public hearings as well as by submitting written comments to the agency.  Your input is invaluable to our ability to address the issues that Congress posed to us and prepare comprehensive reports.

For the Prior User Rights Study, we held our public hearing on October 25, 2011, at the USPTO, and six witnesses gave testimony.  Additionally, we have received 33 written comments during our comment period, which closed on November 8, 2011.  You can view a webcast of the hearing and read all of the written comments here on our micro-site on the Studies page.

For the International Patent Protection Study, we held two public hearings on October 27 and November 1, 2011, at the USPTO and the University of Southern California Gould School of Law, respectively.  A total of twelve witnesses gave testimony, six at each hearing.  We likewise have received 19 written comments during the comment period, which also closed on November 8, 2011.  Similar to the Prior User Study, a webcast of the hearing held at the USPTO along with all written comments are available for your viewing on the Studies page of our micro-site.

For both the Prior User Rights and the International Patent Protection Studies, we will issue our reports to Congress in mid-January 2012 and make them available for you on the Studies page as well.  At that point, we will turn to the Genetic Testing Study, which we must report to Congress at the end of June 2012.  Our plan is to follow the same protocol for the Genetic Testing Study as for the Prior User Rights and International Patent Protection Studies, specifically, we will issue a Federal Register Notice requesting written comments and announcing hearing dates. 

As a sneak preview of coming events for the Genetic Testing Study, Congress has required the agency to study the following:  (i) the impact that the current lack of independent second opinion testing has had on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing and on inhibiting innovation to existing testing and diagnoses; (ii) the effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test; (iii) the impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine; and (iv) the role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.  We are planning for hearings in mid-February and our written comment period to run from mid-January to mid-March 2012.  We understand that there is much interest in the Genetic Testing Study, and we look forward to the productive interaction with you on this study that we experienced for the Prior User Rights and International Patent Protection Studies.

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