11th circ ‘eviscerated’ orphan drug rights, says petition
New Jersey pharma company Jacobus Pharmaceutical has asked the US Supreme Court to review an 11th Circuit verdict that it claims “eviscerated” decades of precedent regarding Orphan Drug Act (ODA) exclusivity.
The US Food and Drug Administration (FDA) has the ability to grant orphan drug designation to drugs in order to incentivise the development of rare treatments for rare diseases.
The incentives offered by orphan drug designation include tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval.
According to the New Jersey pharma company, the US Court of Appeals for the Eleventh Circuit’s decision to overturn the FDA’s approval of its pediatric Lambert-Eaton myasthenic syndrome (LEMS) treatment “created a split” from prior interpretations of incentives provided by the ODA.
In a petition submitted to the court on April 7, Jacobus asks the Supreme Court to consider whether the ODA “unambiguously forecloses the FDA’s decades-long, consistent interpretation that the scope of orphan drug exclusivity is tied to a drug’s approved use?”
Jacobus said: “The Eleventh Circuit eviscerated FDA’s longstanding practice and created a circuit split. It held that the ODA’s plain language unambiguously forbade FDA from approving a drug designated for the same rare disease or condition as a previously approved orphan drug—even though FDA limited its approval of the second drug to uses for which the first drug was not FDA-approved.
“In doing so, the Eleventh Circuit created a split with the Fourth and DC Circuits over whether the ODA unambiguously forecloses FDA’s use-based approach.”
Exclusivity debate
Catalyst Pharmaceuticals had developed the original treatment for LEMS, which it branded as Firdapse (amifampridine), and was awarded orphan drug exclusivity.
It sued Jabcobus, claiming that the FDA’s approval of its amifampridine 10mg tablets violated Catalyst’s rights awarded by the orphan drug exclusivity. The district court decided to uphold the FDA’s approval.
On appeal, the Eleventh Circuit ruling found that the FDA unlawfully infringed on the orphan exclusivity period when it awarded approved Jacobus’ amifampridine treatment.
Jacobus’petition states: “[The] FDA has always construed the ODA to tie the scope of exclusivity to the uses for which the orphan-designated drug is approved, not to the scope of the orphan drug designation itself.
“For three decades, FDA has continuously applied that interpretation—through a codified regulation enacted through notice and comment rulemaking—to approve subsequent orphan-designated drugs to treat a population or other use that the first orphan designated drug is not approved to treat.”
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