clu
clu / iStockphoto.com
24 May 2018Americas

Fed Circuit sides with district court in UCB win against generics

Pharmaceutical company UCB has emerged victorious in a case against major generic drug companies after its patent win was affirmed on appeal.

Yesterday, May 23, the US Court of Appeals for the Federal Circuit said in a 2–1 decision that a UCB patent covering anti-epileptic drug Vimpat (lacosamide) was not invalid.

UCB, UCB BioPharma, Research Corp Technologies and Harris FRC Corp—referred to as UCB in the decision—own and/or license US patent number RE38,551. The patent covers lacosamide, which treats epilepsy and other central nervous system disorders.

According to the court, lacosamide belongs to a class of compounds known as functionalised amino acids (FAAs). “The R, R1, and R3 positions are variables, representing the many different chemical groups that can be placed at each position [in the structure] resulting in a vast number of possible FAA compounds,” the court said.

Several drug manufacturers, including Mylan, Amneal and Apotex, sought to sell generic versions of Vimpat, before UCB sued the companies for patent infringement in the US District Court for the District of Delaware.

According to the appeals court, the appellant companies agreed that they had infringed claims 9, 10 and 13 of the ‘551 patent but “maintained that these claims are invalid for obviousness-type double patenting, obviousness and anticipation”.

The Delaware court said the asserted claims are not invalid, with Circuit Judges Bryson and Stoll affirming the findings. However, Chief Judge Prost issued a dissenting opinion.

Prost, who said the district court had “clearly erred”, disagreed with the other judges that the asserted claims are “patentably distinct” from claims in another patent that had been referenced.

The court’s main ruling had explained that, “for its R, R1, and R3 positions, lacosamide has an un- substituted benzyl at R, an unsubstituted methyl at R1, and a nonaromatic methoxymethyl at R3”.

In his dissenting opinion, Prost said the evidence before the district court strongly contributed to a person of ordinary skill in the art’s “having a reasonable expectation of success in creating an FAA with anticonvulsant activity by selecting an unsubstituted benzyl for R and an unsubstituted methyl for R1”.

Prost concluded by saying that, “taking the district court’s clear error together with the remainder of its fact findings”, he would reverse the district court’s conclusion and hold that the asserted claims are invalid for obviousness-type double patenting.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.


More on this story

Americas
3 July 2013   Belgian pharmaceutical company UCB SA has sued drug-maker Teva Pharmaceutical Industries to stop it manufacturing a generic version of epilepsy drug Vimpat.
Americas
15 December 2016   Biopharmaceutical company UCB Biopharma has filed a complaint against biotech developer MedImmune for alleged patent infringement.
Americas
14 January 2019   US-based Amerigen Pharmaceuticals has lost in its bid to prove that claims in a patent owned by biopharmaceutical company UCB were covered by a prior invention.

More on this story

Americas
3 July 2013   Belgian pharmaceutical company UCB SA has sued drug-maker Teva Pharmaceutical Industries to stop it manufacturing a generic version of epilepsy drug Vimpat.
Americas
15 December 2016   Biopharmaceutical company UCB Biopharma has filed a complaint against biotech developer MedImmune for alleged patent infringement.
Americas
14 January 2019   US-based Amerigen Pharmaceuticals has lost in its bid to prove that claims in a patent owned by biopharmaceutical company UCB were covered by a prior invention.