FDA Appeals Depomed Orphan Drug Case

By Michelle L. Butler & Kurt R. Karst –

On November 3, 2014, just short of the 60-day deadline, FDA filed a notice appealing to the U.S. Court of Appeals for the District of Columbia Circuit the Final Judgment and Order entered on September 5, 2014 by the U.S. District Court for the District of Columbia in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592.  As we previously reported, the District Court granted Depomed’s Motion for Summary Judgment and ordered FDA to recognize orphan drug exclusivity for Gralise (gabapentin) Tablets “without requiring any proof of clinical superiority or imposing any additional conditions on Depomed.” 

While the filing of the Notice of Appeal answers one of questions arising from the Court’s decision – namely, will FDA accede to the decision – many questions remain.  For example, we know that FDA is still granting orphan drug designations.  (Indeed, according to FDA’s Orphan Drug Designations and Approvals database, the Agency has granted 50 orphan drug designations since September 6, 2014 – the day after the District Court’s decision.)  However, we don’t know if FDA has changed its view on the necessity of articulating a plausible hypothesis of clinical superiority in order to obtain designation of a second drug containing the same active moiety as an approved drug for the same orphan indication. 

We also don’t know for sure what FDA’s views are on the scope of orphan drug exclusivity post-Depomed.  Post-Depomed, one issue is whether or not orphan drug exclusivity applies broadly, such that FDA is prohibited from approving any marketing application for a drug containing the same active moiety for the same indication, including an ANDA for a generic version of a brand-name drug that does not itself have a period of orphan drug exclusivity remaining.  For example, it could be argued that orphan drug exclusivity applicable to Gralise for postherpetic neuralgia prevents FDA from approving ANDAs for generic Neurontin for postherpetic neuralgia. 

We will continue to monitor the case and FDA’s activities and will post further information as it becomes available.