AstraZeneca Wins Ruling on Extended-Release Seroquel Patent

von freakoutcrazy

by Bloomberg

AstraZeneca Plc (AZN) won a U.S. court ruling that will help ward off some generic competition to the extended-release version of its Seroquel antipsychotic drug until a patent expires in 2017.


U.S. District Judge Joel Pisano in Trenton, New Jersey, ruled today that four generic-drug makers, including Mylan Inc. (MYL), were infringing a patent on the recipe for making the extended- released version of the drug. The judge rejected their arguments that the patent was invalid.


AstraZeneca, based in London, is relying on sales of Seroquel XR after low-cost versions of the immediate-release version of the medicine entered the market this week. Seroquel generated $5.83 billion in global sales last year, with $1.4 billion from Seroquel XR, the company said in a statement Feb. 2.


The other generic-drug makers are Par Pharmaceutical Cos.’s Anchen Pharmaceuticals Inc., Osmotica Pharmaceutical Corp. and Torrent Pharmaceuticals Ltd. (TRP)


A spokesman for Canonsburg, Pennsylvania-based Mylan, Nina Devlin, declined to comment on the ruling. A spokesman for Wilmington, North Carolina-based Osmotica, Tim Albury, didn’t immediately return a call seeking comment. A spokeswoman for Woodcliff, New Jersey-based Par, Allison Wey, didn’t immediately return a call seeking comment.


Pisano conducted a trial in October that focused mostly on the validity of the patent, which covers a sustained-release formula for quetiapine, the active ingredient in Seroquel.


Gelling Agent


The generic-drug makers had argued it was common to use a gelling agent so drugs are released over the course of a day and patients take fewer doses.


In his 100-page ruling, Pisano sided with AstraZeneca’s argument that doctors originally thought a sustained-release version of Seroquel wouldn’t provide enough medicine to be effective. He also said it wouldn’t have been obvious to use a gelling agent because of the unique properties of quetiapine.


The XR version had an unexpected result of being effective in treating bipolar disorder, which causes massive mood swings, in people who need to have a consistent ability to function, for instance, during a work day, the judge said.


On Sept. 29, AstraZeneca settled its patent infringement case against Handa Pharmaceuticals LLC. Handa, which won’t dispute that two AstraZeneca patents are valid and enforceable, will get a license to launch a generic version in the U.S. on Nov. 1, 2016, or earlier if certain conditions are met, according to a company statement at the time.


On Oct. 5, AstraZeneca settled its patent infringement case against Intas Pharmaceuticals Ltd. Under the settlement, AstraZeneca gave Intas’s Accord Healthcare Inc. unit a license to sell generic Seroquel starting Nov. 1, 2016.