Federal Circuit confirms validity of patent for UCB’s Vimpat®


On May 23, 2018, the Federal Circuit issued a decision in UCB, Inc. v. Accord Healthcare, Inc. (Before Prost, C.J., Bryson, and Stoll, J.)(Opinion for the court, Stoll, J.), a case arising under the Hatch-Waxman Act. The Appellees UCB, Inc. et al own and/or license U.S. Patent No. RE38,551., titled Anticonvulsant enantiomeric amino acid derivatives. The ‘551 patent covers lacosamide, an anti-epileptic drug for the treatment of epilepsy and other central nervous system disorders. UCB holds New Drug Applications (“NDAs”) that cover its lacosamide anti-epileptic drug approved by the Food and Drug Administration (“FDA”) and marketed under the tradename Vimpat®. The ‘551 patent is listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”) as covering Vimpat®.

Appellants were generic drug manufacturers who filed Abbreviated New Drug Applications (“ANDAs”), seeking approval for generic versions of Vimpat®. Pursuant to applicable Hatch-Waxman provisions, Appellants certified in their ANDAs that the ‘551 patent was invalid, unenforceable, or that their proposed generic lacosamide products would not infringe the ‘551 patent.

Consequently, as is their right under Hatch-Waxman, UCB sued Appellants for patent infringement in the United States District Court for the District of Delaware. Appellants stipulated to infringement of claims 9, 10, and 13 of the ‘551 patent but maintained that these claims are invalid for obviousness-type double patenting, obviousness, and anticipation.

Following a bench trial, the district court made exhaustive fact findings based on the trial evidence and concluded that the asserted claims of the ‘551 patent were not invalid. Appellants appealled that decision, arguing that the district court misapplied the legal standards for obviousness-type double patenting, obviousness, and anticipation, and that the prior art anticipates and/or renders the ‘551 patent obvious.

The Federal Circuit held that the district court applied the correct legal standards in its obviousness-type double patenting, obviousness, and anticipation analyses, and found no clear error in its underlying factual findings. As a result, the Federal Circuit affirmed the district court’s ultimate conclusion that the asserted claims were not invalid.

“We are pleased with the CAFC decision,” said Anna Richo, UCB’s Executive Vice President and General Counsel. “This confirms the strength of our intellectual property for Vimpat® and maintains UCB’s exclusivity position until March 2022.”


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