[Federal Register Volume 75, Number 181 (Monday, September 20, 2010)]
[Pages 57261-57262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23395]



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 [email protected]. 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 
    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: http://www.uspto.gov). 
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 [email protected].
    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 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

[[Page 57262]]

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 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 
    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?

    Dated: September 13, 2010.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2010-23395 Filed 9-17-10; 8:45 am]