Jazz Pharmaceuticals lost its recent appeal to the Circuit Court of Appeals for the Federal Circuit related to its narcolepsy drug Xyrem, which had several of its "subsets" of Xyrem patents invalidated by PTAB.
The drug, which utilizes an illicit drug more commonly known as GHB, or the date rape drug, is, under the Controlled Substances Act, a Schedule III drug. The drug was only approved by the FDA under "restricted distribution regulations." Interestingly, along with patents for the drug, Jazz also sought patent protection for their method of monitoring and controlling the distribution of sensitive drugs, like Xyrem. Unfortunately, both the patent board and federal appellate court found the patents a little too obvious.
Distributing Restricted Generics
As reported by Reuters, the patent board ruled in favor of the challenge brought by Amneal Pharmaceuticals in 2016, which has been trying to put out a generic version of Xyrem.
After losing at the appellate court, Jazz Pharma may not have many options left to stop it from happening when their patent lapses, but it was happening in a few years anyway. Despite Amneal winning these matters, Jazz claims that it still has robust patent protection for its sensitive drug. However, that could change as Amneal has other challenges pending.
Now, Amneal can work on getting their generic through the approval process to try to get a piece of the $1 billion plus annual sales.