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14 August 2017Americas

Pfizer’s patents for overactive bladder drug not obvious, rules US judge

A US judge has ruled that five patents owned by Pfizer are not invalid as obvious, in a dispute over a generic produced by Mylan.

Pfizer sued Mylan back in January 2015 at the US District Court for the District of Delaware, alleging infringement of five patents in the filing of an Abbreviated New Drug Application (ANDA) by Mylan.

Mylan had filed the ANDA to market a generic version of Pfizer’s Toviaz (fesoterodine fumarate), used to treat symptoms of overactive bladder.

Toviaz was approved by the US Food and Drug Administration in October 2008.

Mylan informed Pfizer of the ANDA in December 2014.

The five patents alleged to be infringed are US numbers 6,858,650; 7,384,980; 7,855,230; 7,985,772; and 8,338,478.

Numbers ‘980, ‘230, ‘772 and ‘478 are the “compound patents”, while the ‘650 patent is called “Stable salts of novel derivatives of 3,3-diphenylpropylamines”.

In January, the court held a three-day bench trial where Mylan argued that the asserted claims are invalid as obvious under 35 USC section 103.

Under section 103, a patent may not be obtained “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious to a person having ordinary skill in the art”.

District Judge Gregory Sleet, in a memorandum opinion published on Wednesday, August 9, held that the patents were not invalid.

“The court concludes that the defendant has failed to establish by clear and convincing evidence that the asserted claims of the asserted patents would have been obvious to a person of ordinary skill in the art,” said Sleet.

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