REMS Archives -

Federal Circuit Upholds Decision to Delist System Patent from the Orange Book

Posted at 21:09h March 9, 2023 in ANDA Litigation, Orange book, Paragraph IV, REMS by Seung Sub Kim

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS […]

A Duty to Deal? District of New Jersey Says, Yes.

Posted at 19:00h January 12, 2015 in Antitrust, REMS by Carlson Caspers

In the antitrust case of Mylan v. Celgene, pending in the District of New Jersey (Civil Action No. 14-2094), Judge Esther Salas issued an oral order, finding that Mylan had stated a claim under the Sherman Antitrust Act based on Celgene’s refusal to sell samples of certain pharmaceutical products to Mylan. In particular, Judge Salas […]