Vanda Pharmaceuticals Inc., et al. v. Roxane Laboratories, Inc., C.A. Nos. 13-1973 – GMS; 14-757-GMS, August 26, 2016.

Sleet, J. Post-trial rulings issue after a five-day bench trial from February 29, 2016 to March 4, 2016. 

In this ANDA trial, the disputed technology relates to the treating a patient suffering from schizophrenia with iloperidone.  The court finds that all asserted claims in the patents-in-suit are valid. The ‘610 patent is not invalid for lack of patentable subject matter because the court is not persuaded it will preempt biological sampling or genotyping.  Defendant’s proposed products induce infringement of the asserted claims of one patent because the product labels instruct users to perform each element of the claimed patented method. They do not contributorily infringe the asserted claims of that patent because a physician could prescribe iloperidone without practicing the claims of the patent by not using a genotyping test.  Defendant is enjoined from commercial manufacture, use, offer to sell, or sale within the US prior to the expiration of the patent-in-suit issued prior to the defendant’s ANDA submission, and also the November 2, 2027 expiration date of the later-issued patent.