Latham Scores Major Orphan Drug Exclusivity Win for Catalyst Pharmaceuticals

On September 30, 2021, Latham & Watkins secured a major victory for client Catalyst Pharmaceuticals (Catalyst) in a dispute concerning the exclusivity of its drug Firdapse, which treats the rare disorder Lambert-Eaton myasthenic syndrome. The Eleventh Circuit overturned a lower court ruling and confirmed the broad scope of Firdapse’s orphan drug exclusivity. 

Orphan drugs treat “rare diseases or conditions” and Congress created a seven-year statutory period of market exclusivity for approved orphan drugs, to incentivize drug companies to develop and seek Food & Drug Administration (FDA) approval of such drugs. Once a drug is designated by FDA as an orphan drug and approved, the statutory exclusivity provision bars FDA from approving the “same drug for the same disease or condition” for seven years from the date of the orphan drug’s approval. FDA tends to construe orphan drug and other similar statutory exclusivity provisions very narrowly. 

In this case, FDA regulations purported to authorize what Latham argued was an illegal exception to Catalyst’s exclusivity. That exception purported to allow a competitor to avoid Catalyst’s orphan drug exclusivity, even though the competitor sought to market the “same drug for the same disease,” by using a slightly different “indication” (a regulatory concept that may include the specific patient population for which the drug is approved). Because physicians can prescribe an FDA approved drug “off label,” FDA’s approval of the competitor’s drug would have allowed the competitor to sell its drug to Catalyst patients, even though Catalyst was meant to be the exclusive supplier. 

The Eleventh Circuit ruling adopts the statutory arguments that Latham put forward and concludes that the statute means what it says: FDA cannot approve the same drug for the same disease for the duration of Firdapse’s exclusivity, even for a different patient population. 

This is the latest in a string of wins by Latham in matters challenging FDA regulatory actions, including those related to electronic cigarettes, advertising, and bulk drug compounding, among others; and the second major win on orphan drug exclusivity, following a victory for Eagle Pharmaceuticals concerning its novel chemotherapy drug, BENDEKA. 

The Latham & Watkins team comprised a cross-disciplinary group of lawyers with extensive experience in both FDA regulatory and administrative law, with a particular focus on the power of regulatory agencies. Washington, D.C. partner Phil Perry argued the case before the Eleventh Circuit. The Latham team was led by Perry with Washington, D.C. partners Andrew Prins and John Manthei, as well as Washington, D.C. associates Ryan Baasch, Cherish Drain, Brent Murphy, and Monica Groat.