Vanda Pharmaceuticals Inc. (Vanda), a biopharmaceutical company, announced that a favourable Markman ruling has been issued by the United States District Court for the District of Delaware in the patent infringement lawsuit filed by the company against Roxane Laboratories Inc. (Roxane) regarding Roxane's submission of an Abbreviated New Drug Application to make and sell a generic version of Fanapt, schizophrenia drug.
A Markman ruling, also known as a Claim Construction Ruling, is a court ruling in which the judge determines the meaning of key terms from certain disputed patent claims. The Delaware court, which was asked to construe disputed patent claim terms in US patent number 8,586,610 ('610), rejected Roxane's proposed construction of all the disputed claim terms. The '610 patent is expected to expire in November 2027.
Fanapt is an atypical antipsychotic agent indicated for treatment of schizophrenia in adults. In choosing among treatments, prescribers should consider the ability of Fanapt to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.