Partnering for Global Health

David J. Kappos

Partnering for Global Health (BIO and BIO Ventures for Global Health Joint Meeting)

McCormick Place, Lakeside Center, Chicago

May 3, 2010

I'd like to thank Biotechnology Industry Organization and Bio Ventures for Global Health for inviting me to speak at this important event.

I'd also like to take this opportunity to applaud the important step BIO has taken today, and the important step BIO Ventures for Global Health has taken today in recognizing the significant unmet health needs of the developing world, and committing themselves to a policy that will help to address those needs.

As BIO and BIO Ventures for Global Health recognized, the public health issue has two components. One component involves the need to develop products to cure or treat diseases in those areas of the world where the market is generally unable to bear the market cost of treatments. Much has been done in these neglected disease areas. But much more remains to be done.

The other component involves situations where products have been developed for affluent markets. In these cases, tiered pricing or other mechanisms are generally necessary for the applicable products to be accessible to impoverished populations.

Many biopharmaceutical companies have taken groundbreaking steps in this arena. But again, more remains to be done.

The principles being adopted here today take important steps to address both of these problems, and we applaud the BIO and Bio Ventures for Global Health commitments.

At the USPTO, and in the Obama administration more generally, we are committed to these same principles. And we believe government can, and should, play a role in providing incentives to encourage humanitarian commitments to treating disease in impoverished parts of the world.

As some of you may know, several years ago the Food and Drug Administration launched a program known as the Priority Review Voucher, or PRV. The PRV is a transferable voucher awarded to a company that secures approval for a product that treats or prevents a neglected disease. The voucher, which is fully transferable, entitles the bearer to priority review for a future new drug application. Such priority review can take as many as 12 months off of the standard time for FDA review.

Similarly, we at the USPTO are actively looking to you to provide us with ideas regarding the types of incentives we might be able to provide, either for research on neglected diseases or for exemplary humanitarian licensing practices.

One mechanism we are currently discussing with various other government health agencies is the possibility of an annual award to companies that have done breakthrough R&D in a neglected disease area. We at the USPTO are already very much involved in the innovation awards space, through our work with the National Inventors Hall of Fame. So a neglected disease award would be a natural extension of our work.

Thank you again for inviting me here today and for your attention and commitment to the critically important issue of developing world health needs.

And, once again, we actively invite your thoughts as to what the USTPO can do to further encourage neglected disease research as well as creative licensing strategies.