Lacosamide Patent Valid_District Court Decision

UCB has received a major boost after a Delaware district court confirmed the validity of the company’s patents on one of its major drugs, the anti-seizure drug Vimpat (lacosamide).

The case relates to ANDA litigation and involves patent number RE38551 (OB Listed).

The court agreed with plaintiffs general characterization of the record: Vimpat® is the result of Dr. Kohn’s decade long search for a safe, effective and well-tolerated AED using FAAs – a class of compounds that, when Dr. Kohn began his work, lacked any evidence of the anticonvulsant activity, low neurological toxicity, high margin of safety (PI), and minimal adverse effects, such as low toxicity, needed for an AED.

Defendants (various generic companies including Accord ANDA No. 205011; Alembic having ANDA No. 204974; Amneal ANDA Nos. 204857 and 204839; Aurobindo ANDA No. 204994; Breckenridge and Vennoot ANDA No. 204921; Sun ANDA No. 205031; Actavis ANDA No. 204855; Apotex ANDA Nos. 204986 and 206355; Mylan ANDA No. 205026; and Zydus ANDA No. 204947) have failed to prove by clear and convincing evidence that the asserted claims of the ‘551 patent are invalid for obviousness-type double patenting, obviousness, anticipation, indefiniteness, or improper reissue.

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