IPO and BIO Submit Comments on USPTO Reexamination Voucher Proposal

By Donald Zuhn --

Earlier this fall, the U.S. Patent and Trademark Office announced that it was seeking comments regarding a proposal to incentivize the creation and distribution of humanitarian technologies by offering fast-track ex parte reexamination vouchers to patent holders "demonstrating humanitarian uses of patented technologies" (see "USPTO Looking for Ways to Incentivize Humanitarian Technologies").  The Office noted that the proposed voucher pilot program would be similar to a program being offered by the Food and Drug Administration, which grants priority review vouchers to entities that develop drugs to treat neglected tropical diseases.  On Friday, both the Intellectual Property Owners Association (IPO) and Biotechnology Industry Organization (BIO) submitted comments to the Office regarding the proposed voucher pilot program.

In the IPO letter, IPO President Douglas Norman stated that:

[T]he proposed program raises significant concerns regarding access to and availability of reexaminations for all patent applicants and risks unintended consequences.  For example, the Notice envisions that a patent owner could use its voucher for a different patent in its portfolio or to transfer it "on the open market" to another party.  As a result, ex parte reexaminations of patents wholly unrelated to humanitarian uses might be accelerated.  Also, the Notice could adversely impact small businesses that are not in the position to get such vouchers because of their limited resources and may find reexaminations they filed for the purpose of having validity determined delayed unfairly in the face of larger entities that have the potential and resources to take advantage of these rules.

The IPO also believed the proposed voucher system might conflict with both U.S. Patent Law and TRIPS, pointing out that "[t]he program might be understood to conflict with the statutory mandate to conduct all reexamination proceedings with 'special dispatch,' to the detriment of patent owners who do not demonstrate 'humanitarian uses' of their patented technology and may not be able to obtain the necessary vouchers on the open market," and further noting that the proposal "may violate treaty obligations under TRIPS, providing that 'patent rights [shall be] enjoyable without discrimination as to . . . the field of technology,'" citing TRIPS Art. 27(1).  Finally, the IPO suggested that the task of defining "humanitarian technologies" posed its own set of problems, stating that "[d]etermining whether a use of a patented technology is 'humanitarian' may simply be too subjective to serve as the basis for a fair, predictable program."

In the BIO letter, BIO President and CEO James Greenwood "commend[ed] the USPTO for . . . exploring creative and market-oriented ways to incentivize the development and distribution of humanitarian technologies, a goal that BIO and its members have long shared and are working hard to achieve."  The organization, however, noted that it was "reluctant to endorse an approach that leverages the patent system to parse such technologies into those deemed 'essential' and those that are not, some worthy of a special examination privilege but not others" (emphasis in original).

If the Office were to move forward with the proposal, BIO outlined a number of concerns that should first be addressed.  For example, the group argued that "[m]aintaining the strict technology-neutrality of the patent system is critically important to BIO's member companies from an international comparative, trade, and treaty obligation perspective."  In addition, BIO warned that "the proposed program could create a resource-intensive bureaucracy for the review of voucher requests, under which the adjudication of requests, and appeals or petitions from their denial, would consume resources that would better be deployed on the USPTO’s core missions."  BIO also suggested that the commercial value of the vouchers was likely to be "very small when measured against the operating budgets of even small biotech companies," and that "the voucher's value could be further increased within existing statutory authority if it could additionally be used to accelerate, at the patentee/applicant's option, the examination of original patent applications and reissue applications as well as any appeals to the Board of Patent Appeals and Interferences in ex parte proceedings."  Finally, BIO asked the PTO to clarify how the vouchers could be used in order to prevent "use[] by third party requesters, or even unrelated third parties, to accelerate the ex parte reexamination of other party's patents without the patentee’s consent."

Comments

[patent litigation]

The question as to exactly what qualifies as a "humanitarian" technology would seem to be ripe for legal challenge. While it's a laudable proposal, and David Kappos once again deserves credit for his ethics and flexible approach, this latest idea may need a little more development.
http://www.aminn.org/webcast-aipr-patent-reform-presentation-us-patent-and-trademark-office