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For those in the pharmaceuticals industry, this decision raises the interesting question of whether an innovator pharmaceutical company like Vanda can properly assert that parameters proposed by the FDA during the approval process for the innovator's New Drug Application (NDA) constitute the company's trade secrets. In confidential exchanges between the FDA and Vanda during the approval process for Vanda's NDAs for two drugs, Fanapt® and Hetlioz®, the FDA proposed that the drugs meet specific dissolution requirements and, in the case of Hetlioz®, impurity profiles and particle size requirements. To gain FDA approval for these drugs, Vanda adopted
The COFC denied the government's motion to dismiss Vanda's claim that the government committed an unconstitutional taking by disclosing Vanda's trade secrets but also shared doubts about its merits. The COFC found that Vanda's claim satisfied the minimal threshold requirement that a takings claim must involve an action falling within the
The COFC did dismiss Vanda's breach of contract claim, holding that any disclosure of Vanda's alleged trade secrets or confidential commercial information could not be a breach of an implied-in-fact contract because it was at best an alleged failure to abide by legal confidentiality requirements imposed by statute and regulation—an implied-in-law contract claim outside the COFC's jurisdiction.
The COFC also dismissed all of Vanda's claims related to one of the generic drug manufacturers, finding that the claims were time-barred under the Tucker Act's requirement that all claims must be brought within six years after the claim first accrues. The COFC was not persuaded by Vanda's invocation of the accrual suspension rule (triggered when a plaintiff can demonstrate that the government concealed its acts and plaintiff was unaware of its claim, or the injury was "inherently unknowable" at the time the cause of action accrued) and dismissed these claims for lack of jurisdiction.
Key Takeaways:
Although Vanda's takings claim survived the government's initial motion to dismiss, the COFC expressed skepticism that information a company gleans during government interactions (like the
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