Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case
By Ali Sullivan · Listen to article
Law360 (May 10, 2024, 9:26 PM EDT) -- Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.
U.S. District Judge Amit P. Mehta did not rule from the bench following the two-and-a-half hour summary judgment hearing in Washington, D.C., but his questioning signaled that his decision could hinge on the meaning of the term "same drug" in the Orphan Drug Act.
Jazz Pharmaceuticals Inc., which sued the FDA in June 2023, is seeking summary judgment on claims that the FDA unlawfully approved a rival narcolepsy treatment in violation of Jazz's exclusivity rights under the ODA. The exclusivity rights, Jazz says, bar the FDA from approving a new drug application "for the same drug for the same disease or condition" until its seven-year period of orphan-drug exclusivity expires.
Jazz argues that two drugs are the same when they are marketed for the same condition and have the same "active moiety" — that is, "the portion of the drug substance responsible for pharmacological activity." And because rival drug Lumryz has the same active moiety as Jazz's Xywav treatment, the FDA acted unlawfully when it approved Lumryz in 2023, Jazz contends.
But Lumryz developer Avadel CNS Pharmaceuticals LLC, which intervened in the case and has filed its own bid for summary judgment, argues that the drugs aren't the same at all. Although they are both oxybate drugs aimed at helping patients get a better sleep, patients taking Lumryz only need one dose at bedtime, while patients taking Xywav must take a second dose midway through the night, according to Avadel.
The once-nightly dosing means Lumryz is clinically superior, making it a different drug, Avedal has argued.
"If you apply the clinical superiority test, you find we are clinically superior," Avedal's attorney Philip Perry of Latham & Watkins LLP told the judge on Friday.
During the hearing, Judge Mehta pressed attorneys for the three parties on Congress' 2017 changes to the Orphan Drug Act.
The change came after then-U.S. District Judge Ketanji Brown Jackson's 2014 ruling in Depomed Inc. v. U.S. Department of Health and Human Services. The judge ruled that drugmaker Depomed Inc. didn't have to prove that its drug Gralise was clinically superior to a similar medicine manufactured by Pfizer Inc. called Neurontin in order to obtain seven years of orphan-drug marketing exclusivity.
However, Congress in 2017 passed legislation that said drugmakers must show their orphan drug has clinical superiority to get the sought-after exclusivity period. And, among other things, lawmakers edited the law to block approval of the "same drug," rather than "such drug," during the exclusivity period.
While Judge Mehta remarked that there's "not a lick of legislative history" on the record indicating Congress' motives for changes, U.S. Department of Justice attorney Noah T. Katzen said it would be quite the coincidence for lawmakers to pass legislation authorizing exactly what the D.C. federal court said the FDA could not do.
The FDA has asserted in court filings that its regulations have long defined "same drug" to exclude clinically superior drugs. Congress using the same language creates an "irresistible assumption" that lawmakers intended for the term to align with the existing FDA definition, Katzen argued.
Counsel for Jazz declined to comment following the hearing, and counsel for Avedal did not immediately return a request for comment.
Jazz is represented by Kwaku A. Akowuah, Sean C. Griffin, Tobias S. Loss-Eaton and Peter A. Bruland of Sidley Austin LLP.
The FDA is represented by Noah T. Katzen and Isaac C. Belfer of the U.S. Department of Justice's Civil Division's Consumer Protection Branch.
Avedal is represented by Philip J. Perry, Andrew D. Prins, John R. Manthei and Nicholas L. Schlossman of Latham & Watkins LLP.
The case is Jazz Pharmaceuticals Inc. v. Xavier Becerra et al., case number 1:23-cv-01819, in the U.S. District Court for the District of Columbia.
--Additional reporting by Adam Lidgett and Hailey Konnath. Editing by Dave Trumbore.
