UCB, Inc. v. Accord Healthcare, Inc.

by
The 551 patent discloses and claims lacosamide, the active ingredient in Vimpat®, a drug that treats epilepsy and other central nervous system disorders. UCB holds New Drug Applications that cover the FDA approval of Vimpat®. The 551 patent is listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). Generic drug manufacturers filed Abbreviated New Drug Applications (ANDAs), seeking approval for generic versions of Vimpat®. Pursuant to the governing Hatch-Waxman Act provisions, they certified in their ANDAs that the 551 patent is invalid, unenforceable, or that their proposed generic lacosamide products will not infringe the patent. UCB sued and the generic manufacturers stipulated to infringement of claims 9, 10, and 13 but maintained that these claims are invalid for obviousness-type double patenting, 35 U.S.C. 101, obviousness, and anticipation. The district court concluded that the asserted claims are not invalid. The Federal Circuit affirmed, holding that the district court applied the correct legal standards and that there was no clear error in its underlying fact findings. The district court did not err by focusing its double patenting analysis on the claims’ differences, as well as the claims as a whole. View "UCB, Inc. v. Accord Healthcare, Inc." on Justia Law