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OCA Limitations Imposed by ANDA Filer Provided a Basis for Filing Suit

On March 12, 2010, In re: Cyclobenzaprine Hydrochloride Extended Release Capsule Patent Litigation, the District of Delaware found that it was permissible for a patent holder to file suit under 35 U.S.C. § 271(e)(2)(A) where an ANDA filer had placed unreasonable conditions on the Offer of Confidential Access for pre-suit receipt of information about the ANDA. No. 09-2118, 2010 WL 902552 (D. Del. March 12, 2010).

This case could be useful for innovator patentees faced with OCA restrictions by ANDA filers. The courts opinion does not describe the details of the restrictions. We therefore describe below certain facts we obtained from the available files.


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