Pfizer seeks Toviaz protection
Wilmington, Delaware | 02 July 2013

Pfizer has filed patent infringement complaints against a host of generic drug companies that are seeking approval for their own versions of the pharmaceutical company’s overactive bladder treatment Toviaz.

The complaints were filed between 21 and 28 June in Delaware and Illinois district courts, against generic drug companies Sandoz, Zydus Pharmaceuticals, Accord Healthcare and Alkem Laboratories.

Pfizer has also reportedly filed other complaints against Amneal Pharmaceuticals, Cadila Healthcare, Impax Laboratories, Lupin and Amerigan Pharmaceuticals over Toviaz.

None of the cases have reportedly been assigned judges, but Pfizer is claiming that the generic drug companies have infringed five US patents relating to Toviaz, after filing abbreviated new drug applications (ANDAs) with the Food and Drug Administration.

The ANDAs were for fesoterodine fumarate extended-release tablets in 4 and 8mg dosage strengths. Their applicants demonstrated that the generic versions and Pfizer’s Toviaz are bioequivalent, according to the complaints, which added that the patents have yet to expire.

Pfizer is seeking findings of infringement, injunctions banning the generic drug companies from launching their bioequivalent products, and damages.

It is yet to release a public statement on the complaints, but Pfizer launched a similar campaign in June 2012 in defence of its depression drug Pristiq.

It took approximately 10 generic drug companies to court, alleging that they infringed its patent for Succinate Salt of O-Desmethyl-Venlafaxine.

Last month, Pfizer agreed a $2.15 billion settlement with Teva Pharmaceuticals and Sun Pharmaceutical Industries for infringement damages resulting from the launch of their own versions of the patented acid reflux drug Protonix.

A New Jersey court found that Teva and Sun infringed Pfizer’s patent when they launched their generic drugs before it expired in January 2011.

Speaking early in June, Amy Schulman, executive vice president and general counsel at Pfizer, said: “We are pleased with [the] settlement, which recognises the validity and value of the innovation that led to Protonix. Protecting intellectual property is vital as we develop new medicines that save and enhance patients’ lives.”

The parties agreed on the $2.15 billion settlement ahead of the trial to determine damages in New Jersey.

“[The] settlement reflects our resolve to enforce our patents both in and out of the courtroom. We are proud of the work of the scientific colleagues who developed this medicine and the lawyers who defended it."

Author: Mark Dugdale



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