BIO’s Comments on proposed PTO Humanitarian Technologies and Licensing Through the Intellectual Property System

Here are the highlights from BIO’s recent submission on the proposed PTO “Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System.”  

Background:

1.  “BIO’s members also understand that problems with access to medicines and other biotechnology products in the developing world have very little to do with the patent system, and are generally caused by other factors outside the control of individual stakeholders, such as lack of adequate local manufacturing, delivery, public health and sanitation infrastructure, trade and tariff barriers, regulatory obstacles, lack of market incentives, inequitable local distribution and corruption, diversion of products to more lucrative markets, and a chronic underinvestment in public health, education and environmental conservation. In fact, access issues persist even in countries where there are no patents covering humanitarian products and technologies.”

 2.  “While the patent system cannot be a primary policy lever to address these complex questions above, BIO nonetheless believes that innovative businesses from all sectors of the U.S. economy, including the biotechnology industry, can help improve the lives of underprivileged populations in the developing world. Indeed, BIO member companies have long participated in specific access and licensing initiatives that have informed the policy choices of members of the industry.”  (See http://www.globalhealthprogress.org/, http://www.ifpma.org/healthpartnerships, http://www.bvgh.org/LinkClick.aspx?fileticket=867bPGw-kYo%3d&tabid=105, http://www.aatf-africa.org/, and http://www.cimmyt.org/.)

 “Most recently, in May of this year, BIO announced a policy statement containing its Options for Increasing Access to Medicines in the Developing World that it believes should be considered during the development and commercialization of biotechnology products.  Accordingly, BIO commends the USPTO for likewise 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. In addition, BIO would support efforts to bring together all potential stakeholders to explore various approaches and initiatives.”

Key Points:

1.  Any program should be technology-neutral – “In BIO’s view, such a program should be applicable to innovators from all sectors who engage in the creation and dissemination of technology that has the potential to address the needs of impoverished populations in the developing world.”

 2.  Any proposal should ensure USPTO’s core mission is maintained and adequately resourced.

 3.  Value of any proposed vouchers should be maximized, but will remain limited – “BIO believes that the commercial value of the proposed voucher could be substantial under some situations, but difficult to express in monetary terms at this time.” 

4.  Clarity of standing for voucher use needed – “BIO members are seriously concerned that vouchers could potentially be used 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.”

5.  Policy options for voucher award process require further discussion – “BIO members also raised the question whether the proposed vouchers should be awarded as an entitlement for meeting certain objective criteria, or as a more subjective prize for extraordinary humanitarian licensing efforts.”

Conclusion:

“BIO understands this Federal Register notice to be a first conceptual step in what will be a deliberative process with additional opportunities for public review and comment as more specific details and approaches are proposed. With this understanding, we look forward to engaging further on this effort in partnership with the USPTO and other industries and stakeholders.”

BIO’s Full Comment

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USPTO Requesting Comments on Humanitarian Technologies

In case you missed it, on September 20 the United States Patent Office issued a request for comments on incentivizing humanitarian technologies and licensing through the intellectual property system.

 The USPTO is trying to incentivize humanitarian technologies by creating a “fast-track ex parte reexamination voucher pilot program.”  The program will give priority to humanitarian technology patents shortening the review process to six months.  The USPTO also hopes the program will reduce costs for humanitarian technology patents.

 The proposed legal standard the PTO will use to define “humanitarian use” and “humanitarian research” are as follows;

 “‘‘Humanitarian use’’ would comprise four principles: subject matter, effectiveness, availability, and access. In general terms, subject 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.”

 “‘‘Humanitarian research’’ would comprise two principles: significance and access. 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 PTO asks comments to focus on the twelve questions found in the Request for Comment.    

 To make a comment to the USPTO on this issue send an email to HumanitarianProgram@uspto.gov