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(258)                       DEPARTMENT OF COMMERCE
                   United States Patent and Trademark Office
                         [Docket No. PTO-P-2010-0066]

                    Request for Comments on Incentivizing
                   Humanitarian Technologies and Licensing
                   Through the Intellectual Property System

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Request for comments.

SUMMARY: The United States Patent and Trademark Office (USPTO) is
considering pro-business strategies for incentivizing the development
and widespread distribution of technologies that address humanitarian
needs. One proposal being considered is a fast-track ex parte
reexamination voucher pilot program to create incentives for
technologies and licensing behavior that address humanitarian needs.
Because patents under reexamination are often the most commercially
significant patents, a fast-track reexamination proceeding would allow
patent owners to more readily and less expensively affirm the validity
of their patents. Therefore, the opportunity to utilize a voucher for a
fast-track reexamination proceeding could provide a valuable incentive
for entities to pursue humanitarian technologies or licensing. The
USPTO is requesting comments from the public regarding this proposal as
well as other incentive proposals set forth in this notice.

DATES: Comment Deadline Date: To be ensured of consideration, written
comments must be received on or before November 19, 2010. No public hearing
will be held.

ADDRESSES: Written comments should be sent by electronic mail message over
the Internet addressed to Comments may also
be submitted by mail addressed to: Mail Stop Comments - Patents, Commissioner
for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the
attention of Joni Y. Chang. Although comments may be submitted by mail, the
USPTO prefers to receive comments via the Internet.

   The written comments will be available for public inspection at the
Office of the Commissioner for Patents, located in Madison East, Tenth
Floor, 600 Dulany Street, Alexandria, Virginia, and will be available
via the USPTO's Internet Web site (address:
Because comments will be made available for public inspection, information
that is not desired to be made public, such as an address or phone number,
should not be included in the comments.

FOR FURTHER INFORMATION CONTACT: Robert A. Clarke (at 571-272-7735) or
Joni Y. Chang (at 571-272-7720), Office of Patent Legal Administration,
Office of the Associate Commissioner for Patent Examination Policy.
Inquiries regarding the current reexamination practice may be directed
to the Office of Patent Legal Administration, by telephone at
(571) 272-7703, or by electronic mail at

   Inquiries regarding electronic filings should be directed to the Patents
Electronic Business Center (EBC) at 866-217-9197.

SUPPLEMENTARY INFORMATION: The USPTO is considering a fast-track ex parte
reexamination voucher pilot program as an incentive to stimulate technology
creation or licensing that addresses humanitarian needs. Under the proposed
pilot program, a fast-track ex parte reexamination voucher would be offered
to patent holders demonstrating humanitarian uses of patented technologies.
This voucher could then be used on any patent owned by the patent holder or
transferred on the open market. The U.S. Food and Drug Administration (FDA)
currently has a similar voucher program for fast-track review in place. Under
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this program, the FDA awards priority review vouchers to entities that
develop drugs to treat neglected tropical diseases. Recent legislative
proposals such as the Creating Hope Act, S. 3697 (2010), on rare childhood
diseases shows a desire on the part of Congress to expand such efforts. The
USPTO is also exploring ideas for other strategies that would use the patent
system to incentivize activity addressing humanitarian needs.

   Fast-track ex parte reexamination proceedings would be given the highest
priority, such that an examiner would take any necessary action in a
reexamination proceeding as if the proceeding were the next item in the
examiner's queue. In addition, the USPTO would accelerate the time for
which fast-track ex parte reexamination proceedings are handled by the USPTO
(i.e., examiner and the Board of Patent Appeals and Interferences (BPAI)).
The USPTO's goal for this time would be six months. The patent owner would
not be required to waive any current statutory and procedural rights, and
would have the same time periods for filing responses and other communications
as those under the existing procedure. The six-month goal would only measure
the time periods that the USPTO takes for actions (e.g., from the date of
filing of a response to the date of mailing of the action), excluding the
time that the patent owner takes for responding to an action. This goal
compares to the current 19 to 20-month period that the USPTO takes for action in
ex parte reexamination based on a review of 100 certificates issued between
June 15, 2010, and July 31, 2010.

   In the pilot program, a fast-track ex parte reexamination voucher would be
offered to patent holders demonstrating humanitarian practices with patented
technologies as described below. Specifically, organizations may be eligible
for the program if they engage in intellectual property practices that qualify
as either humanitarian use or humanitarian research.

   ``Humanitarian use'' would comprise four principles: subject matter,
effectiveness, availability, and access. In general terms, subject matter
evaluates whether the patented technology addresses a recognized
humanitarian problem. Effectiveness judges whether the technology can be used
or is being used to address that issue. Availability determines whether the
technology is available to an affected impoverished population. Access
evaluates whether the applicant has made significant efforts to increase
access to the technology among such populations. The USPTO seeks to develop a
workable test to apply these principles that is clear, concise,
administratively efficient, and resistant to abuse.

   "Humanitarian research" would comprise two principles: significance and
access. Significance requires that the patented technology make a significant
contribution to research on a problem that predominantly affects an
impoverished population, such as the tropical diseases identified by the FDA
in its priority review voucher scheme. Access determines that the patented
technology was made available to researchers on generous terms. The USPTO
seeks to develop a workable test to apply these principles which is clear,
concise, administratively efficient, and resistant to abuse.

   Comments on one or more of the following questions would be helpful
to the USPTO:

   1. The FDA awards priority review vouchers to entities that develop
drugs which treat a tropical disease under 21 U.S.C. 360n. Should
recipients of this FDA voucher automatically receive a humanitarian
fast-track ex parte reexamination voucher from the USPTO?

   2. FDA priority review vouchers are transferable on the open market.
Should USPTO fast-track ex parte reexamination vouchers similarly be
transferable on the open market?

   3. What humanitarian issues should qualify for the voucher program?
Neglected diseases, debilitating health conditions in developing countries,
chronic hunger, widespread public health problems such as lack of
sanitation or potable water, and/or other issues predominantly affecting
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impoverished populations? Can these be defined with reference to existing
humanitarian aid organizations?

   4. Other than actual use, how can a patent owner demonstrate that a
patented technology would be effective at addressing a particular
humanitarian issue? What kinds of expertise would be required to make
those judgments?

   5. Should the USPTO consider statements from independent third parties
(particularly humanitarian organizations or researchers) on the
effectiveness or actual use of an invention to address humanitarian needs?
Should such submissions be required to qualify for a voucher?

   6. Should certain elements (e.g., neglected diseases, tropical crops,
developing countries) of qualifying humanitarian criteria be defined with
reference to lists or criteria provided by external organizations experienced
in such matters, such as the World Health Organization, National Institutes
of Health, Food and Drug Administration, United Nations, or U.S. Agency for
International Development? If so, which criteria of other public or private
organizations should be followed?

   7. What actions should be considered to determine whether a patent holder
has made significant efforts to increase access to a patented technology?
What types of evidence of such actions can be submitted to minimize the
burden on both patent owners and the USPTO?

   8. How should a patented technology's significance to a humanitarian
research project be determined? Should significance mean that the research
could or would not have occurred without the use of the patented technology?
Would considering economic or logistical factors suffice? Should qualifying
research efforts meet certain minimum thresholds (resources, number of
researchers involved, involvement from recognized humanitarian groups, etc.)
to prevent abuse?

   9. For the humanitarian research qualification, what factors should
determine whether terms of use are generous? Should it only focus on the cost of
the patented technology or consider other factors? What if the granting
entity retains any rights over the results of the humanitarian research?

   10. How can the program encompass humanitarian issues affecting
impoverished populations in more developed countries in a way that is
efficient to administer and deters abuse? In particular, how should an
applicant demonstrate the existence of an impoverished group and that
the product or treatment primarily targets that group?

   11. Should vouchers to accelerate initial examination rather than
reexamination be offered for technologies addressing humanitarian needs? Are
there other pro-business strategies that the Department of Commerce or the
USPTO should pursue in future programs to incentivize humanitarian research
and development and/or best practices for intellectual property with
humanitarian uses?

   12. Would non-monetary prizes or awards sponsored by the USPTO recognizing
humanitarian efforts encourage greater investment in the field? What criteria
should be used for selecting recipients?

September 13, 2010                                          DAVID J. KAPPOS
                                            Under Secretary of Commerce for
                                  Intellectual Property and Director of the
                                  United States Patent and Trademark Office

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