AIA Blog
AIA Blog
Wednesday Jan 25, 2012

USPTO Issues Proposed Rules for Supplemental Examination and Announces Hearings and Written Comment Collection for Genetic Testing Study

From: Director David Kappos

I have two new items of information to share regarding our implementation of the America Invents Act.  The first concerns a new set of proposed rules and the second relates to one of the Congressionally-mandated studies.

Today, the agency published in the Federal Register proposed rules for supplemental examination and for revisions to reexamination fees.  This publication begins a sixty-day public comment period for these rules.  The agency will explain the scope of our supplemental examination and reexamination fee revision proposed rules at the upcoming AIA roadshows.  Likewise, I encourage you to provide feedback to the agency about our proposals during the public comment period and at the roadshows:

Supplemental Examination Proposed Rule (77 Fed. Reg. 3666, January 25, 2012)

Also today, the USPTO published in the Federal Register a request for comments and notice of public hearings for the Genetic Testing Study.  Congress has required the agency to study and report on 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.  I encourage the public to participate in the hearings by giving testimony and/or submitting written comments.  The deadline for receipt of written comments is March 26, 2012.  Here is more information about the Genetic Testing Study and how to participate in the hearings:

Request for Comments and Notice of Public Hearings on Genetic Diagnostic Testing (77 Fed. Reg. 3748, January 25, 2012)

Finally, the agency is expecting to issue several additional sets of proposed rules for the contested case provisions of the AIA in the next few days.  Stay tuned for those Federal Register publications.

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