By Donald Zuhn --
On Monday, the U.S. Patent and Trademark Office announced via a press release and a notice in the Federal Register (75 Fed. Reg. 57261) that it is seeking comments regarding a proposal for incentivizing the creation and wider distribution of humanitarian technologies. In the notice, the Office states that it has begun to consider "pro-business strategies for incentivizing the development and widespread distribution of technologies that address humanitarian needs," including a proposed fast-track ex parte reexamination voucher pilot program in which a fast-track ex parte reexamination voucher will be offered to patent holders "demonstrating humanitarian uses of patented technologies." The Office notes that fast-track vouchers secured under the pilot program could be used on any patent owned by the patent holder or could even be transferred on the open market.
According to the notice, 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," and would be given accelerated treatment at the Board level. The notice suggests that during fast-track proceedings, the Office would only take a cumulative period of six months to issue actions whereas the Office currently takes between 19-20 months (according to a review of 100 reexamination certificates issued between June 15, 2010, and July 31, 2010).
With respect to what patent holders would have to do to secure fast-track reexamination vouchers, the notice states that "organizations may be eligible for the program if they engage in intellectual property practices that qualify as either humanitarian use or humanitarian research." The notice defines "humanitarian use" as comprising four principles: subject matter, effectiveness, availability, and access, wherein:
[S]ubject 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 notice also defines "humanitarian research" as comprising two principles: significance and access, wherein:
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 Office notes that it is seeking to "develop a workable test to apply these principles that is clear, concise, administratively efficient, and resistant to abuse."
According to the notice, the pilot program would be similar to a program being offered by the FDA, which grants priority review vouchers to entities that develop drugs to treat neglected tropical diseases. In the Office's press release, the Office indicates that technologies that address humanitarian needs would include treatments for tropical diseases, diagnostic medical tools, crops with higher yields or better nutritional value, and treatments for sanitation or clean water. The release notes that the fast-track voucher program is a "first step in a broader effort to develop business-friendly strategies that encourage inventions to address humanitarian needs."
The notice concludes by posing a dozen questions for which it seeks comments (the questions can be found on page 57261 of the Federal Register notice). Comments regarding the fast-track ex parte reexamination voucher proposal must be submitted by November 19, 2010, and can be sent by e-mail to [email protected] or by regular mail to Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Joni Y. Chang.
Comments