Otsuka says Teva’s REXULTI generic infringes patents
Otsuka Pharmaceutical has sued Teva Pharmaceuticals, alleging that the company’s planned generic of Otsuka’s REXULTI antipsychotic (brexpiprazole) tablets infringe five of its patents.
The Japanese pharma firm filed a complaint with the US District Court for the District of Delaware on Tuesday, claiming that Teva Pharmaceuticals was looking to manufacture generic brexpiprazole prior to the expiration of Otsuka’s key patents.
The patents-in-suit are US Patent 7,888,362 (reissued as RE48,059), 8,349,840, 8,618,109, 9,839,637, and 10,307,419, the last of which is set to expire in October 2032.
The patents are broadly directed to “piperazine-substituted benzothiophenes for treatment of mental disorders.”
Otsuka currently licenses all five of the patents to Denmark drugmaker Lundbeck exclusively. Through the partnership, the two companies are conducting clinical trials to evaluate the drugs treatment for dementia.
Teva sought approval from the US Food and Drug Administration to manufacture and develop the generic and notified Otsuka that it had filed an Abbreviated New Drug Application (ANDA) seeking approval to manufacture the generic around September 2019.
Within 45 days of receiving the letter, Otsuka filed an infringement case in the Delaware court. Parts of the complaint were later consolidated into its lawsuit against Zenara Pharma, which it had also targetted over a planned generic brexpiprazole, in October 2020.
However, Otsuka reserved the right to challenge the sufficiency of Teva’s notice letters and ANDAs separately.
Otsuka requests that the court find at least one claim in each of the patents to have been infringed by Teva’s ANDA and seeks a preliminary or permanent injunction enjoining Teva from manufacturing or selling its planned generic.
Otsuka also sued GW pharma in October last year over royalties related to a “milestone” epilepsy drug candidate derived from cannabis in the England and Wales High Court.
