By Donald Zuhn —

In a notice published last week
in the Federal Register (77 Fed. Reg. 71170), the U.S.
Patent and Trademark Office announced that it was interested in gathering
"additional information" on independent second opinion genetic
diagnostic testing for purposes of preparing a report on the subject as
required by the Leahy-Smith America Invents Act, and as a result would be holding
a public roundtable on genetic diagnostic testing from 1:00 to 4:00 pm (EST) on
January 10, 2013 at the USPTO's Madison Auditorium in Alexandria, Virginia.  The Office is collecting additional
information in order to complete a report to the Committee of the Judiciary for
both the Senate and House pursuant to § 27 of the AIA.

AIA § 27(d) specifies that
"[n]ot later than 9 months after the date of enactment of this Act, the
Director shall report to the Committee on the Judiciary of the Senate and the Committee
on the Judiciary of the House of Representatives on the findings of the study
and provide recommendations for establishing the availability of such
independent confirming genetic diagnostic test activity."  The notice acknowledges that AIA § 27 "charges
the Director of the USPTO with delivering to Congress a study and
recommendations no later than nine months after the enactment of the Act (i.e.,
by June 15, 2012)."  The notice
states, however, that "[i]n the final days before the deadline for receipt
of written comments [to the Office's January 2012 request for comments], the
Supreme Court of the United States issued two rulings with potential
ramifications for the present study." 
Those two rulings were the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and GVR
order in Association for Molecular
Pathology v. Myriad Genetics, granting a petition for writ of certiorari,
vacating the Federal Circuit's decision, and remanding the case for
reconsideration in light of Mayo.  The notice also indicates that a letter was
sent by the Department of Commerce to the House and Senate Judiciary Committee leadership
on August 28, 2012, updating them on the status of the genetic testing report,
and stating that "[g]iven the complexity and diversity of the opinions, comments,
and suggestions provided by interested parties, and the important policy
considerations involved, we believe that further review, discussion, and
analysis are required before a final report can be submitted to Congress."

The notice on the
roundtable indicates that those wishing to share commentary at the roundtable
must request an opportunity to do so in writing no later than December 20,
2012, and that such requests must include the requester's name and contact
information (telephone number and e-mail address), organizations the requester
represents (if any), and the amount of time the requester needs to present such
commentary.  Requests must be submitted by
e-mail to Saurabh Vishnubhakat at saurabh.vishnubhakat@uspto.gov.  Requesters selected to provide commentary
will be expected to submit a document explaining their position for inclusion
in the record of the proceedings no later than thirty days after the
roundtable.

The Office is seeking
commentary "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."  In
addition AIA § 27 requires that the Office's report include an examination of
the following topics.

(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 notice indicates that
the roundtable will be webcast, with information regarding the webcast to be
posted on the USPTO's website.

Readers
may recall that the Office published a notice in the Federal Register in
January seeking written comments and announcing that two hearings would be held
on February
16, 2012 at the USPTO's Madison Auditorium, and on March 9, 2012 at the Joan B.
Kroc Institute for Peace & Justice at the University of San Diego (see
"USPTO News Briefs").  Patent
Docs author Dr. Kevin Noonan provided testimony at the first hearing (see "Patent Docs Author Testifies
at Genetic Diagnostic Testing Hearing").  In May, the Office published the comments it
received in response to its request on a webpage
on genetic diagnostic testing that was established as part of the Office's
AIA implementation site (see "USPTO
Posts Comments on Genetic Diagnostic Testing").  However, the June deadline passed without the
completion of the report.

For
additional information regarding this subject, please see:

•
"USPTO News Briefs," January 26, 2012
•
"USPTO to Hold Hearing on Genetic Diagnostic Testing," February 15,
2012
•
"USPTO Holds First Hearing on 'Second Opinion' Genetic Testing,"
February 16, 2012
•
"Patent Docs Author Testifies at
Genetic Diagnostic Testing Hearing," February 16, 2012
•
"USPTO Posts Comments on Genetic Diagnostic Testing," May 22, 2012
•
"USPTO Report on Genetic Testing Delayed," June 18, 2012