[Ip-health] USPTO to offer new incentives to license patents for humanitarian uses, based upon FDA priority review voucher

James Love james.love at keionline.org
Thu Sep 23 04:25:34 PDT 2010


USPTO to offer new incentives to license patents for humanitarian uses,
based upon FDA priority review voucher

The USPTO has a new federal register notice out, asking for public
comment on a welcome new initiative, modeled after the FDA priority
review voucher, to create new incentives to license patents for
humanitarian uses. The initative is set out here:

Public comments are due by November 19, 2010. Unfortunately, no public
hearings will be held. This is an initative Arti Rai worked on before
she left the USPTO. It is hard to say who its champion will be now that
Arti has returned to Duke.

Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 /
Notices 57261

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 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

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.

In the public comments, KEI was address the types of humanitarian uses
to the covered, and propose deep discounts or waivers of patent filing
fees, for such licenses.

The USPTO is discussing this initiative at a press conference in Geneva
today. Below is the USPTO press release.

http://www.uspto.gov/news/pr/2010/10_41.jsp [2]

USPTO Launches Effort to Incentivize Humanitarian Technologies
CONTACT: Peter Pappas or Jennifer Rankin Byrne

September 20, 2010

+1 (571) 272-8400 or peter.pappas1 at uspto.gov;

jennifer.rankin_byrne at uspto.gov;

New initiative encourages businesses to develop and disseminate
technologies that address humanitarian needs

Washington – Under Secretary of Commerce and Director of the United
States Patent and Trademark Office (USPTO) David Kappos announced today
that the USPTO is seeking public comments on proposals to incentivize
the creation and wider distribution of technologies that address
humanitarian needs. Under a proposed pilot program, patent holders who
make their technology available for humanitarian purposes would be
eligible for a voucher entitling them to an accelerated re-examination
of a patent.

Among the technologies which address humanitarian needs that would be
eligible for the program are treatments for tropical diseases,
diagnostic medical tools, crops with higher yields or better nutritional
value, and treatments for sanitation or clean water. Participants could
qualify for the proposed pilot in two ways: by making their patented
technologies available to impoverished populations for humanitarian use,
or by making their patented technologies available to researchers who
are developing technologies that address humanitarian needs.

Under the proposed pilot program, patent holders who disseminate their
patented technologies for humanitarian purposes would qualify for a
fast-track ex parte re-examination voucher. Because patents under
re-examination are often among the most commercially valuable patents,
fast-track re-examination of a patent allows a patent owner to affirm
the validity of his or her patent more quickly and less expensively.
This voucher could then be used on any patent owned by the patent holder
or transferred on the open market.

“A voucher for fast-track re-examination of a patent is a valuable
incentive for entities to distribute humanitarian technologies through
licensing or other means,” Kappos said. “Our hope is that this new
program will incentivize innovators to develop technologies that will
benefit those in need.”

The program seeks to increase the diffusion of technologies that address
humanitarian needs through market forces. Existing technologies often do
not reach impoverished populations. The humanitarian fast-track voucher
provides patent holders with a significant incentive to distribute their
technology more widely to such groups. It also creates an incentive to
provide patented technologies for humanitarian research, which in turn
may spur the development of new technologies to address humanitarian

The USPTO seeks cooperation with industry, government, the humanitarian
aid community, academic researchers, and the public to create a
successful program. This is the first step in a broader effort to
develop business-friendly strategies that encourage inventions to
address humanitarian needs.

Further information about the proposed fast-track ex parte
re-examination voucher pilot program can be found in the Federal
Register notice at:

James Love, Director, Knowledge Ecology International
http://www.keionline.org | http://www.twitter.com/jamie_love
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.6584

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