USPTO to study independent second opinion genetic diagnostic testing

The USPTO has issued a Federal Register notice announcing public hearings and seeking public comments for a study required by the Leahy-Smith America Invents Act.  All dates are coming up soon.  Please respond to this notice, and distribute this call widely to all who may be interested.


Jan 25: Federal Register notice published

Feb 8:  Deadline for oral testimony at public hearing

Feb 16:  Public hearing at USPTO

Mar 9:  Public hearing at Univ. San Diego Law

Mar 26:  Deadline for written comments

Genetic Diagnostic Testing

The USPTO is studying independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests.

Written comments should be submitted to  More information is available from Saurabh Vishnubhakat (

Congress has mandated that the study shall include an examination of at least the following:

(1) 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;

(2) The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;

(3) The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, including but not limited to: the interpretation of testing results and performance of testing procedures; and

(4) The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

The FRN is available here:

General information about the AIA studies and reports is available here: