Vanda loses Hetlioz patent court decision, vows to appeal and ask for stay on Teva, Apotex competitors
A federal judge invalidated four of Vanda Pharmaceuticals’ patents for sleep med Hetlioz on Tuesday, effectively opening the door to generic tasimelteon competition from Teva, Apotex and others. Vanda plans to appeal and is asking for a stay against the competition in the meantime.
“Vanda intends to appeal the decision to the United States Court of Appeals for the Federal Circuit and to request a stay of market entry by Teva and Apotex while the appeal is pending,” the company said in a statement.
Meanwhile, a Teva spokesperson said in an email to Endpoints News that it is “pleased by the decision,” but declined further comment as Vanda’s new appeal is pending.
US district court judge Colm Connolly’s straightforward decision found that the defendants Teva and Apotex’s proposed products do not infringe on Vanda’s RE604 patent, and additionally found Vanda’s four asserted patents “invalid for obviousness.”
Vanda had already settled with a third possible generic tasimelteon from MSN Labs and Impax almost a year ago, inking a non-exclusive licensing agreement that would go into effect in 2035. However, the terms of the deal stipulate that MSN and Impax would be able to enter the market earlier if related to the patent litigation there would be subsequent market entry “of certain other third-party generic versions.”
The ruling caused Vanda stock $VNDA to tumble by about 30%, from $11 before the ruling on Tuesday morning to around $7.50 in Wednesday midday trading.
The loss comes as Vanda is embroiled in a separate Hetlioz issue with the FDA. In November, Vanda wrote a letter to the FDA demanding a hearing for its sNDA on Hetlioz for the treatment of jet lag. Vanda attorney Paul Hughes gave the FDA a Christmas Eve deadline to set it up.
The latest Vanda letter followed a letter in October from CDER director Patrizia Cavazzoni to Vanda noting the sNDA would not be approved because of a lack of substantial evidence as had been laid out in a CRL in 2019. Cavazzoni said in the October letter that Vanda could file for a hearing if it can show “genuine and substantial issue of fact that requires a hearing to resolve.”