The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself.
The U.S. Court of Federal Claims on Wednesday sided with the FDA in its legal tussle with Vanda Pharmaceuticals, which alleged that the regulator leaked trade secrets related to two of its assets to companies developing generic versions of the drugs.
In its original complaint, filed in May 2023, Vanda claimed that the FDA “has breached its confidentiality obligation” to the company and “blatantly and forthrightly relied on data in one of Vanda’s drug applications and then disclosed that information to Vanda’s competitors.” The biotech pointed to protected information about the manufacturing process for its schizophrenia treatment Fanapt and Hetlioz, indicated for non-24-hour sleep-wake disorder.
Vanda at the time alleged that this disclosure of trade secrets to potential competitors “constitutes a taking under the Fifth Amendment for which Vanda has never received compensation.” Additionally, the company argued that the FDA breached an implied-in-fact contract, leading to “substantial monetary damages” for the company.
In January 2024, the U.S. Court of Federal Claims delivered a mixed verdict for the parties. The ruling rejected Vanda’s claim that the FDA breached a contract, while also denying the FDA’s attempt to have the biotech’s constitutional claim thrown out.
The 22-page court opinion on Wednesday, however, leaned strongly in the government’s favor, pointing out that the disclosed information under contention wasn’t developed by Vanda in the first place.
“Vanda did not develop or propose the approved rates to the FDA,” the opinion read, noting that the regulator had initially rejected Vanda’s proposed dissolution rates for Fanapt and Hetlioz, and then suggested alternatives that ultimately became the final approved rates.
“While Vanda developed the brand-name drugs, the trade secret and confidential and proprietary information claimed to have been taken by the government was, in fact, proposed and recommended to Vanda by the FDA,” the opinion continued.
In a statement to Endpoints News, Vanda counsel Paul W. Hughes, a partner at McDermott Will & Emery LLP, said that the company is planning to appeal the verdict.
Aside from the confidentiality suit, Vanda also has a running row with the FDA over the rejection of its gastroparesis drug tradipitant. In September 2024, right after the rejection, Vanda blasted the FDA’s decision, saying that it “generally disregarded the evidence provided” and that it came past the mandated deadline of 180 days.
Earlier this month, Vanda wrote to former FDA Commissioner Robert Califf, escalating the matter and criticizing what it said was a “culture of obfuscation and closemindedness” at the agency.
Last week, the regulator finally issued an explanation for the rejection, citing a data package that “did not demonstrate a statistically significant” effect versus placebo.
