An act of infringement, Pfizer sued a case on Lupin, Zydus, Impax, Amneal, Amerigen and Accord over Toviaz.

According to patent laws of United States Title 35 of the United States Code, Lupin seeks approval to market a generic version of Toviaz ® by filing an Abbreviated New Drug Application “ANDA” with the United States Food and Drug Administration which is a Pfizer Inc.’s pharmaceutical product.

Lupin’s ANDA No. 204983 is a search for the approval for the extended release of fesoterodine fumarate tablet inn 4 and 8 mg doses.

Already Pfizer holds five patents for Toviaz, interalia and which is chemically fesoterodine fumarate and the patent numbers are 6,858,650, 7,384,980, 7,855,230, 7,985,772,  8,338,478. And Lupin has filed an ANDA before the expiration of the Pfizer patent and hence Pfizer claims that it is an act of infringement.

Toviaz (fesoterodine) reduces spasms of the bladder muscles.

Toviaz is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence.

Pfizer not only on Lupin but also sued a case on Zydus for the same issue of filing ANDA on the same drug Toviaz carrying the ANDA number 204946 and seeking approval from FDA to market extended release tablets of fesoterodine fumarate in 4 and 8 mg doses

The sue not only stopped with Lupin and Zydus but also extended for other companies like Impax, Amneal, Amerigen.

Pfizer demands the court for a valid reason and seeks the infringing pharmaceutical companies to enjoin the case at the court and the company expects the court to issue an order to stop their manufacturing and using of the chemical compound. The defendants failed to allege the invalidity or unenforceability of the companies patents in their ANDA.

The pharmaceutical companies often deal with the same type of cases fighting for the generics in order to improve the company’s margin, but before doing so they fail to check the patent owning companies periods of expiration which leads to unwanted quarrelling and loss of penny.

Key words: Pfizer, Zydus, Tovianz, fesoterodine fumarate, Patent infringement.