Par Pharmaceutical in pre-emptive strike to protect Latuda generic

Par Pharmaceutical has sought a declaratory judgment that it did not infringe patents belonging to Sumitomo and its subsidiary Sunovion that protect bipolar disorder drug Latuda (lurasidone hydrochloride).

Filed at the US District Court for the District of Massachusetts yesterday, January 4, Par alleged that it had not infringed US patent numbers 8,729,085; 8,883,794; and RE45,573.

Sunovion is the holder of new drug application number 200603 for lurasidone hydrochloride oral tablets, in 20, 40, 60, 80 and 120mg, marketed under the brand name Latuda.

Latuda is an atypical antipsychotic for the treatment of schizophrenia and depressive episodes associated with bipolar I disorder (bipolar depression).

Par submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration requesting regulatory approval to sell lurasidone hydrochloride oral tablets before the Sunovion-owned patents expired.

In December 2014, Par provided the companies with notice of the ANDA, including a statement of the “factual and legal basis why the ‘085 and ‘794 patents are invalid, unenforceable, and/or will not be infringed”.

This triggered a 45-day statutory period during which the defendants had an opportunity to initiate patent infringement litigation, but the companies did not initiate any litigation.

Then, in September 2016, Par provided an amended notice, triggering a second statutory period and providing the defendants with an opportunity to commence litigation.

Under 21 USC, section 355(j)(5)(C)(i)(II), and 35 USC, section 271(e)(5), the court can allow ANDA filers to obtain a declaratory judgment of non-infringement and/or invalidity with respect to Orange Book-listed patents.

Par is seeking a declaration of non-infringement of the three patents, costs and reasonable attorneys’ fees, and other relief the court deems just and proper.