One of the breakout sessions offered at the recent FDLI conference was titled, Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs and Biologics. The panel for this session included representatives from FDA, industry, and attorneys that specialize in this practice area. While the session covered both patent and exclusivity issues, I will be focusing strictly on exclusivity concerns in this blog.
FDA’s representative Nisha Shah presented updates to the Food, Drug, and Cosmetic Act (FD&C Act) over the past several years. One such change was from the “Ensuring Innovation Act” which altered the eligibility clause for products eligible for five (5) years of New Chemical Entity (NCE) exclusivity, where text in the statute was changed to now reference the “active moiety” of the drug rather than the “active ingredient” of the drug. FDA also covered some of the five-year NCE exclusivity provisions that are encountered much less frequently, including eligibility under 505(u) for single enantiomers of previously approved racemic mixtures and 505(v) for certain antibiotics submitted prior to November 21, 1997, the date that Section 507 of the FD&C Act was repealed as part of the Food and Drug Administration Modernization Act (FDAMA). Five (5) years of NCE exclusivity under section 505(u) and 505(v) occur with much less frequency than other grants of NCE but firms that are seeking approval of drugs that will qualify under either 505(u) or 505(v) need to be aware of the additional nuances and requirements that apply.
Perhaps the most important portion of FDA’s presentation wasn’t related to five-year exclusivity but rather to some of the issues that FDA has encountered over the past several years when administering three-year exclusivity. Ms. Shah mentioned both the Braeburn and Veloxis three-year exclusivity cases, both of which dealt with the scope of three-year exclusivity. Furthermore, she noted the amount of effort and resources the Agency puts into analyzing and documenting these decisions. One important note from this discussion that is worth pointing out is the fact that because submissions of 505(b)(2) applications have increased over the years, there are more instances of multiple sponsors developing similar products via the 505(b)(2) pathway which results in a greater possibility of subsequent 505(b)(2) to be unexpectedly denied approval by a blocking exclusivity. In some instances, FDA’s three-year exclusivity determinations can take a lengthy period to finalize. When this happens and nothing is published in the Orange Book, pending applicants may believe that FDA has decided not to grant exclusivity, but speaking from personal experience, having worked on these issues while at the Agency, I can assure you this isn’t always the case. A relatively simple solution would be for the Agency to publish a list of pending exclusivity determinations which would at minimum provide sponsors with awareness that they could potentially be blocked from approval.
Potential exclusivity changes to Orphan Exclusivity in Europe were also covered during this session. While the changes are not yet final, the proposal would alter the current 10 years of Orphan Drug exclusivity granted in Europe to nine (9) years of exclusivity for new active ingredients, with five (5) years of exclusivity available for well-established uses, and the potential for additional one-year extensions for certain changes. Since this is a little outside the scope of my day-to-day work, I’ll have to attend FDLI next year with the hopes that someone will provide an update on Orphan Drug exclusivity administration in Europe.