AstraZeneca owns a patent for Faslodex, with U.S. Patent Nos. 6,774,1227,456,1608,329,680, and 8,466,139.Which has the chemical name fulvestrant, used in the treatment of breast cancer for post-menopausal women who have not responded to any other hormonal therapies.

AstraZeneca alleges the complaint against Mylan for filing the abbreviated new drug application recently with U.S. Food and Drug Administration for a generic version of Faslodex which would be an infringement of four of its patents on the Faslodex formula that belong to AstraZeneca.

Mylan on making, using, offering to sell, selling and/or importing the drug in U.S. will infringe the patents of Astra Zeneca if U.S. FDA approves. Since the patent expires in 2021 and the application for generic approval comes before protection of formula ends, says AstraZeneca. And Mylan did not acknowledge their Filing with FDA though they know it before.
Hence AstraZeneca filed a patent infringement suit on Mylan at New Jersey federal court with the aim to halt production of a generic version of the breast cancer drug Faslodex.

Pharmaceutical giant AstraZeneca wants generic-drug maker Mylan Inc. to enjoin the court to avoid irreparable harm to its business since the AstraZeneca’s patents expire on Jan. 9, 2021, for adult use and July 9 of that year for pediatric use.

Mylan, the top generic drug makers in U.S. submission for approval of application was an act of infringement. AstraZeneca demands the court to declare its patents are valid and enforceable and in addition expects legal fees for injunction and declaratory judgement.

AstraZeneca already have sued the case for the same drug Faslodex generic and its approval against Glenmark Pharmaceuticals Ltd., Sagent pharmaceuticals Inc and Sandoz Inc.

According to the patent act and rules Mylan have to wait until 2021 for AstraZeneca’s patent to expire, then can seek for its approval with FDA.

AstraZeneca hit the Case against Mylan for Faslodex-The Brest Cancer Drug.

Keywords: AstraZeneca, Mylan, Faslodex, Brest Cancer Drug, Patent infringement.