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

The USPTO has a federal register notice out asking for public comment on a welcome new initiative, modeled after the FDA priority review voucher, to create incentives to license patents for humanitarian uses. The initiative is set out here: http://edocket.access.gpo.gov/2010/pdf/2010-23395.pdf.

Public comments are due by November 19, 2010. Unfortunately, no public hearings will be held. This is an initiative 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 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.

In the public comments, KEI will address the types of humanitarian uses to the covered, and propose deep discounts or waivers of patent filing and maintenance 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

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

September 20, 2010

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

jennifer.rankin_byrne@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 needs.

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: http://edocket.access.gpo.gov/2010/pdf/2010-23395.pdf