On September 20, 2010, the USPTO issued a “Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System.” The proposal under consideration would offer a “fast-track ex parte reexamination voucher” designed to incentivize technologies “that address humanitarian needs.” At times like these I wish I had more “inside” information so I could understand the forces behind this proposal, but perhaps some of my readers can enlighten me.
Following in the FDA’s Footsteps
The USPTO notes that the FDA has a voucher program for fast-track review of drugs that target certain tropical diseases, which is codified at 21 USC § 360n. Under the FDA program, the “sponsor of a tropical disease product application” can obtain a “priority review voucher” that entitles the holder to priority review of a new human drug application. As explained in the FDA’s guidance document, the voucher need not be used to obtain expedited review of the tropical disease product, but can be sold on the open market to any party for use with regard to any drug.
(The Creating Hope Act of 2010 would expand the FDA program to include rare pediatric disease products.)
The USPTO proposes to open its program to organizations that “engage in intellectual property practices that qualify as either humanitarian use or humanitarian research.”
Humanitarian use would be assessed with reference to four principles:
- Subject matter: Does the patented technology address a recognized humanitarian problem?
- Effectiveness: Can the technology be used (or is it being used) to address that issue?
- Availability: Is the technology available to an affected impoverished population?
- Access: Has the applicant made significant efforts to increase access to the technology among such populations?
Humanitarian research would be assess with reference to two principles:
- Significance: Will the technology make a significant contribution to research on a problem that predominantly affects an impoverished population?
- Access: Has the patented technology been made available to researchers on generous terms?
The USPTO will strive to develop “workable” tests to apply these principles in a manner “which is clear, concise, administratively efficient, and resistant to abuse.”
Why Expedite Reexamination?
While it is easy to understand how the FDA’s priority review voucher program would promote the development of drugs that target tropical diseases—either by expediting FDA approval to market such drugs or providing a source of funding through sale of the voucher—it is more difficult to understand how the USPTO’s program would work.
According to the USPTO’s announcement, the USPTO believes that “patents under reexamination are often the most commercially significant patents,” and “a fast-track reexamination proceeding would allow patent owners to more readily and less expensively affirm the validity of their patents.” Apparently, that extra “seal of approval” would facilitate development and/or licensing of the subject technology.
Putting aside the implications this has for non-reexamined patents (why should you need to “affirm the validity of a patent” via reexam when the presumption of validity pertains to all granted patents? does the USPTO believe that only reexamined patents are worth investing in?), it is not clear that the availability of expedited reexamination would encourage development. For example, this proposal presumes that the biggest threat to the validity of a patent in these fields is published prior art (the only issue that can be raised in reexamination), where enablement and written description issues could loom equally large.
Of course, if the USPTO permits the proposed “fast-track ex parte reexamination vouchers” to be sold on the open market, revenue from the sale of a voucher could be used to invest in the targeted “humanitarian technologies.” I will defer to reexamination experts on this issue, but I think that the USPTO should tread very carefully here, particularly in view of the interplay between reexamination proceedings and patent infringement litigation. Permitting high-stakes litigants to buy fast-track ex parte reexamination vouchers from “humanitarian” patent owners could create perverse incentives to game the system or commit outright fraud.
The Expedited Process
Under the proposed program, fast-tracked ex parte reexamination proceedings would be given the “highest priority,” with the examiner expected to “take any necessary action . . . as if the proceeding were the next item in the examiner’s queue.” Proceedings at the Board of Patent Appeals and Interferences (BPAI)) also would be expedited.
The USPTO sets a six month goal for its time to reexamine an application, “not counting the time that the patent owner takes for responding to an action.” (According to the announcement, the USPTO typically takes 19-20 months in ex parte reexamination, although this is based on a review of 100 certificates issued between June 15 and July 31, 2010 only.)
The USPTO believes that “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.”
Request for Comments
The USPTO requests written comments (by November 19, 2010) on a number of specific topics including “big picture” questions such as:
- Should fast-track ex parte reexamination vouchers be transferable on the open market?
- What humanitarian issues should qualify for the program?
- How can a patent owner demonstrate that it qualifies for the program?
- Should the USPTO consult or rely on 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?
- Should the USPTO instead offer vouchers to accelerate initial examination?
- 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?
- Would non-monetary prizes sponsored by the USPTO encourage greater investment in the field?
While I am by no means a USPTO “insider,” I am surprised that I have not heard anything about this proposal, or about the “problem” that it aims to solve. If there is a large number of humanitarian technologies that would be reaching impoverished populations (presumably in other countries) if only the underlying U.S. patents could be promptly reexamined, this is the first I’ve learned of it. I would be more convinced of my own ignorance if the USPTO’s questions did not suggest that the proposal itself is under-developed and lacking clear direction and purpose.
While the goal of incentivizing technologies that address humanitarian needs is a laudable one, it is not clear that this proposal outlines a realistic program for doing so. Instead, it seems to fall under the unfortunate category of recently proposed programs that single out narrow technical fields or narrow categories of applications for expedited examination (or reexamination), while the USPTO is unable to address the backlog that has over 728,000 applications awaiting examination, and is taking 30 months to complete ex parte reexamination proceedings.