Zydus, Sandoz generic of Amgen's psoriasis drug Otezla blocked until 2028
New Delhi: Amgen has won a ruling in New Jersey federal court that blocks Sandoz Inc and Zydus Pharmaceuticals' proposed generics of its blockbuster psoriasis drug Otezla until 2028, the company said.
U.S. District Judge Michael Shipp in Trenton, N.J. said in a Monday order that the companies' proposed generics each infringe three Amgen patents.
Amgen said in a statement the decision blocks Sandoz and Zydus from making generic versions of the drug -- which earned Amgen nearly $2.2 billion in worldwide sales last year -- until the patent covering Otezla's composition expires.
Shipp's full opinion is sealed.
According to Amgen's post-trial brief, Sandoz and Zydus had admitted before a June bench trial that their drugs would infringe most of the patents but argued that the relevant parts of them were invalid. Amgen said in the statement that the court affirmed the validity of four of the patents, but invalidated parts of one.
A Sandoz spokesperson said in a Tuesday email that the company was pleased with the decision because it invalidated parts of an Amgen patent that would expire in 2034, freeing the company to launch its generic in 2028 instead.
Shipp's Monday order also said that Sandoz didn't infringe one of the five patents at issue and Zydus didn't infringe two of them.
Amgen said in the statement that it "will continue to vigorously defend its intellectual property rights." Its attorneys Philip May of Covington & Burling and Charles Chevalier of Gibbons PC didn't immediately respond to a request for comment.
Zydus and its attorneys Lauren Cooper and Theodora McCormick of Epstein Becker & Green didn't immediately respond to a request for comment; neither did Sandoz's attorneys Eric Abraham of Hill Wallack and Lisa Rodriguez of Schnader Harrison Segal & Lewis.
Amgen bought Otezla from Celgene Corp in 2019 for $13.4 billion, which had sued Novartis subsidiary Sandoz and Indian generic drugmaker Zydus Cadila's U.S. subsidiary Zydus Pharmaceuticals for infringement. Related cases involving 17 other makers of proposed Otezla generics have already settled.
The case is Amgen Inc v. Sandoz Inc, U.S. District Court for the District of New Jersey, No. 3:18-cv-11026.
