USPTO to Study Genetic Testing

The U.S. Patent and Trademark Office is seeking comments on how to address the issue of independent second opinion genetic diagnostic testing and its relationship to medical care and medical practice, the rights of innovators, and considerations relevant to medical costs and insurance coverage. The feedback will be incorporated into a report on genetic diagnostic testing that is required by the America Invents Act

Congress has tasked the USPTO with examining several topics related to genetic testing, including:

  • 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;
  • The effect that providing independent second opinion genetic diagnostic testing would have on the existing patent and license holders of an exclusive genetic test;
  • 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
  • The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

To collect information on these topics, the USPTO will hold two hearings on:  (i) Thursday, February 16, 2012 at 9 AM, Eastern Standard Time, in Alexandria, Virginia, and (ii) Friday, March 9, 2012 at 9 AM, Pacific Standard Time, in San Diego, California.

The deadline for receipt of written comments is March 26, 2012.

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