Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International, Ltd., No. 16-2707 (Fed. Cir. 2018)Annotate this Case
Vanda had an exclusive license to the now-expired 198 patent and owns the 610 patent, relating to treatment of schizophrenia with iloperidone wherein the dosage range is based on the patient’s genotype. Vanda owns the New Drug Application for Fanapt® (iloperidone), an atypical antipsychotic approved by the FDA in 2009 under 21 U.S.C. 355(b) and based on the invention disclosed in the 610 patent, which reduces the side effects, enabling safer treatment of schizophrenia. The 198 and 610 patents are listed in connection with Fanapt® in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, (Orange Book). In 2013, West-Ward filed an Abbreviated New Drug Application (ANDA) seeking approval to commercially manufacture, use, offer to sell, and sell a generic version of Fanapt® for the treatment of schizophrenia (21 U.S.C. 355(j)). At that time, the 610 patent had not yet issued and only the 198 patent was listed in the Orange Book. The ANDA contained a Paragraph IV certification that the 198 patent was invalid and/or would not be infringed by West-Ward. The proposed ANDA label is substantially identical in all material respects to the Fanapt® label. The Federal Circuit affirmed a holding that the 610 patent is infringed and not invalid.