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9 May 2017Americas

Generic companies ask district court to dismiss Takeda competition claims

Four generic companies have pushed a district court to dismiss competition allegations against them, stating that the latest amendments made by American Sales Company in a class action complaint are “purely cosmetic” and add no new factual allegations.

The generic companies are Teva, Sun Pharmaceutical, Actavis and Mylan.

The most recent amendments deal with Takeda’s listing of US patent numbers 5,965,584 and 6,329,404, which cover pharmaceutical compositions related to insulin, in the Orange Book.

Takeda had allegedly claimed with the Food and Drug Administration that these patents cover its drug Actos (pioglitazone)—an oral diabetes medicine that helps control blood sugar levels—while knowing that they did not.

According to the generic companies’ supplemental brief, filed on Friday, May 5 at the US District Court for the Southern District of New York, the changes made “do not support the joint conduct claims alleged against the defendants for entering into the settlement agreements, but instead address unilateral conduct that did not involve the generic defendants at all”.

The dispute began after Takeda allegedly operated an anticompetitive scheme with some of its generic competitors to delay competition in the market for pioglitazone hydrochloride tablets.

According to the supplemental brief by the generic companies, the consolidated complaint still does not address the fundamental defects which caused the district court to dismiss reverse payment accusations.

The original complaint alleged that settlement agreements between the generics and Takeda contained a reverse payment and led to overcharging.

But the generic companies claimed that these two allegations are no longer at issue, as the court rejected them.

The amendments in the class action complaint also stated that the settlement agreements between the generic companies and Takeda were unlawful, based on the theory that each generic company knew of Takeda’s allegedly improper patent descriptions at the time they entered into the agreements.

The generic companies said in response: “Plaintiffs’ latest amendments relate only to their third and fourth theories, and their contention that the defendants are somehow liable outside of Actavis’s reverse-payment framework for entering the settlement agreements because of the generic defendants’ supposed knowledge of Takeda’s allegedly false patent descriptions.”

In the supplemental brief, the generic companies asked the court to dismiss the class action claims against them with prejudice.

The initial complaint was filed at the same district court in April 2015.

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