Innovator Forest Labs and H. Lundbeck have settled pending litigation with generic player Sun pharma and its subsidiary Caraco on Orange Book listed patents USRE34712, US6916,941, and US7420,069 (As per Forest’s press release Here and Sun Pharma's press release Here) on Escitalopram Oxalate (Lexapro) 5, 10, and 20 mg tablets .
Before settlement, the companies were litigating on USRE34712 (innovator sued Caraco on patent covering substantially pure Escitalopram in July, 2006), US6916941 (Caraco filed Declaratory Judgment action of patent non-infringement against patent covering particle size of Escitalopram in Feb, 2007), and US7420069 (Caraco filed Declaratory Judgment action of patent non-infringement against patent covering median particle size of 40-200 micrometer size of Escitalopram in Jan, 2009)
As per Caraco's press release Here, Forest has agreed to provide licenses to Caraco for any patents related to Escitalopram Oxalate (Lexapro) 5, 10, and 20 mg tablets with respect to the marketing of Caraco's generic version of the product as of the date that any third party generic enters the market with final approval from the USFDA other than an authorized generic or the first filer with Hatch-Waxman related exclusivity. Also, Forest will reimburse Caraco for a portion of its attorney's fees related to this litigation. Additionally, Sun Pharma will license some patents to innovator pertaining to Escitalopram.
Background
In May 2006, generic player Caraco filed ANDA with para IV certification against ‘712 and ‘941 patent listed for Escitalopram Oxalate (Lexapro) 5, 10, and 20mg tablets. Subsequently, innovator sued Caraco for the infringement of ‘712 patent in Eastern district of Michigan, however, innovator did not sue Caraco on ’941 patents. Importantly, a court decision on ‘941 patent was essential for Caraco to trigger first generic player Ivax’s (Teva) 180 days exclusivity.
Caraco then filed a complaint seeking a declaratory judgment that its generic version of Lexapro does not infringe the '941 patent. Forest granted Caraco a ‘covenant not to sue’ for infringement of the '941 patent. Due to the ‘covenant not to sue’, the district court dismissed Caraco's complaint for lack of jurisdiction.
Later on, Caraco appealed against District court’s decision in the US Court of appeal for Federal Circuit (CAFC), which opined that an ANDA applicant's declaratory judgment action for non-infringement meets Article III's "case or controversy" requirement. The Federal Circuit further determined that the issues are relevant and the case is not moot. Further, the court held that Caraco's action presents an ongoing Article III case and controversy, reversed the district court's decision dismissing the case, and remanded the case for a decision on the merits.
The patent litigation of Caraco on this product paved the way for other generic players on declaratory Judgment provisions, wherein, subsequent generic players could establish the certainty in generic launch by initiating the first generic filer's 180 days exclusivity through DJ action.
Background
In May 2006, generic player Caraco filed ANDA with para IV certification against ‘712 and ‘941 patent listed for Escitalopram Oxalate (Lexapro) 5, 10, and 20mg tablets. Subsequently, innovator sued Caraco for the infringement of ‘712 patent in Eastern district of Michigan, however, innovator did not sue Caraco on ’941 patents. Importantly, a court decision on ‘941 patent was essential for Caraco to trigger first generic player Ivax’s (Teva) 180 days exclusivity.
Caraco then filed a complaint seeking a declaratory judgment that its generic version of Lexapro does not infringe the '941 patent. Forest granted Caraco a ‘covenant not to sue’ for infringement of the '941 patent. Due to the ‘covenant not to sue’, the district court dismissed Caraco's complaint for lack of jurisdiction.
Later on, Caraco appealed against District court’s decision in the US Court of appeal for Federal Circuit (CAFC), which opined that an ANDA applicant's declaratory judgment action for non-infringement meets Article III's "case or controversy" requirement. The Federal Circuit further determined that the issues are relevant and the case is not moot. Further, the court held that Caraco's action presents an ongoing Article III case and controversy, reversed the district court's decision dismissing the case, and remanded the case for a decision on the merits.
The patent litigation of Caraco on this product paved the way for other generic players on declaratory Judgment provisions, wherein, subsequent generic players could establish the certainty in generic launch by initiating the first generic filer's 180 days exclusivity through DJ action.
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