Teva has “earned nothing, let alone entitlement to 180-day exclusivity,” the US Food and Drug Administration (FDA) said in a court filing this week after Teva filed suit last month over its first filer status regarding generic versions of Restasis (cyclosporine).
Calling Teva’s demands “baseless and premature,” the agency noted that although Teva submitted its abbreviated new drug application (ANDA) for a cyclosporine generic in January 2012, Teva has yet to win FDA approval or even a tentative approval, which FDA makes clear “is a necessary predicate for Teva’s proposed product to meet the statutory criteria to be eligible for a 180-day exclusivity period.
“When (and whether) Teva will do so is inherently uncertain, and by the time Teva obtains approval or tentative approval (if it does), any exclusivity to which Teva currently thinks it is entitled may have been forfeited under the myriad statutory provisions for forfeiture,” FDA said.
The response from FDA follows Teva’s seeking declaratory and injunctive relief, claiming it’s entitled to 180 days of exclusivity as first filer and that the court enjoin FDA from approving any ANDA for other generic versions of Restasis. FDA approved Allergan’s new drug application (NDA) for name-brand Restasis in 2002.
Teva alleges that it is a first applicant for generic cyclosporine because it filed a substantially complete ANDA and a paragraph IV certification for one of the patents, and timely notified the NDA holder and patent holder of the paragraph IV certification.
Teva fears, however, that based on a decision FDA made regarding
the “first applicant” for Suboxone generics, FDA will determine that another cyclosporine applicant that submitted a paragraph IV certification for another patent was a “first applicant” and the 180-day generic drug exclusivity for cyclosporine was forfeited when that patent expired such that no applicant, including Teva, is eligible for 180-day exclusivity.
But according to FDA, Teva “comes nowhere close to meeting the requirements for the extraordinary remedy of a preliminary injunction,” as the company “may believe it will ultimately garner FDA approval for its cyclosporine product, and it may fear that FDA will wrongly approve a competitor’s application before its own, but its entire case is built atop a tottering tower of conjecture, dependent upon events that may or may not come to pass in the manner Teva envisions.”
The agency further notes that each exclusivity and forfeiture decision is fact-specific, and the facts continue to evolve until FDA approves or tentatively approves an application and/or until commercial marketing of the product begins, meaning Teva’s claims “are manifestly unripe as no cyclosporine application has been approved or tentatively approved. For these reasons alone, the Court should deny Teva’s motion for preliminary injunction and, instead, dismiss Teva’s complaint.”
The agency further notes that even if Teva were determined to be the first applicant, “the agency may decide exclusivity was forfeited for any reason specified in the statute, including failure to obtain approval in 30 months or subsequent developments in Teva’s ongoing patent litigation.”
FDA further said that its policy is to make complex decisions on 180-day exclusivity and forfeiture at the time it must decide whether to approve ANDAs.
“Given the possibilities of forfeiture, patent expiration, application withdrawal, and the myriad other events that could potentially influence the exclusivity outcome under the statute, it simply serves no purpose for FDA to decide complex exclusivity issues in the abstract before any applicant’s ANDA is ready for approval,” FDA wrote.