FTC Reveals Agenda for Follow-On Biologics Roundtable

By William T. Koustas & Kurt R. Karst –

We previously reported that the Federal Trade Commission (“FTC”) is planning a Roundtable on Follow-on Biologics (“FOBs”) to be held on November 21, 2008 in Room 432 at FTC Headquarters in Washington, D.C.  The Roundtable was first announced earlier this year in the Federal Register.  In that notice, the FTC requested comment on two sets of questions concerning regulatory exclusivities and FOB competition, and patent dispute resolution issues.  Comments responding to the FTC’s notice are available here.  Discussion at the Roundtable will likely aid the FTC as it drafts a report analyzing the potential impacts on the marketplace of FOBs, which the FTC reportedly plans to issue in spring 2009.

On November 18, 2008, the FTC issued a press release detailing the scope and providing an agenda for the November 21, 2008 Roundtable.  The Roundtable is scheduled to begin with remarks from FTC Commissioner Pamela Jones Harbour, who recently gave a speech on the FTC’s perspectives on FOBs, followed by a presentation on FOBs by FDA’s Rachel Behrman.  The FTC’s press release notes that the session will the be broken out into panel discussions on the following five issues: “the price and market share effect of entry of both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process.”

The panel session regarding the effects of entry by biosimilar and biogeneric products will specifically address how the competition between FOBs and innovator products will affect reimbursement by private and public payers.  The second panel, related to competitive effects of reference products and regulatory exclusivity, will focus on the benefits and drawbacks of FOB non-patent market exclusivity for innovator companies and follow-on applicants.  The third panel on biotechnology patent issues will discuss the differences between patents on biologics and small molecule drugs with specific emphasis on claim drafting, Patent and Trademark Office approval, judicial review, and how patent and non-patent market exclusivity affect business planning.  The fourth panel on the competitive effects of FOBs and regulatory incentives is scheduled to center on whether Hatch-Waxman-like statutory exclusivity incentives are needed to promote the growth of FOBs.  Finally, the patent dispute resolution panel will consider the different ways to structure a system to resolve patent disputes between innovator companies and follow-on competitors using case study. 

The Roundtable is free and open to the public without the need for pre-registration.  Only a photo ID is necessary to enter the FTC Headquarters.  A live webcast will be available on the day of the Roundtable. 

The issue of non-patent FOB market exclusivity has been hotly debated in Congress and by scholars.  Recent papers by the American Enterprise Institute’s Alex Brill and Duke University Fuqua School of Business Professor Henry Grabowski (both of whom are scheduled to present at the Roundtable) have taken different views about the appropriate period of such exclusivity, assuming FOBs can overcome the scientific, statutory, and regulatory hurdles currently in place.