pills-istock-525984851
sprng23 / iStockphoto.com
5 June 2017Americas

Direct purchasers fight to keep Takeda competition case alive

Direct purchasers including American Sales Company have fought to keep a competition suit against Takeda alive.

The parties filed an opposition to a dismissal that had been requested by Takeda, in a case centring on its diabetic drug Actos (pioglitazone). The opposition was filed on Friday, June 2 at the US District Court for the Southern District of New York.

In September 2015, the court dismissed the competition allegations brought by the direct purchasers, which claimed that Takeda was involved in an anti-competitive scheme to unlawfully delay generic competition and extend its “$3 billion-a-year monopolies” in relation to Actos.

The direct purchasers then filed an amended complaint. This was followed by Takeda requesting dismissal of the case.

In May 2016, the court stayed the case pending appellate review, and in February this year, the US Court of Appeals for the Second Circuit partly  revivedthe competition case, saying some of the allegations should be reassessed.

The direct purchasers then amended their complaint.

In response, Takeda pressed for dismissal and filed two supplemental briefs.

The direct purchasers fought to keep their claim alive in a supplemental response, alleging that Takeda had been involved in anti-competitive deals with generic companies.

The generic companies that allegedly conspired with Takeda are Mylan, Ranbaxy, Watson and Teva.

According to the direct purchasers’ supplemental response, Takeda unlawfully stalled generic competition of Actos.

The direct purchasers alleged that Takeda had given false information to the Food and Drug Administration, which resulted in Takeda’s patents being treated as if they covered the Actos product when in fact they included method of use claims.

“As a result, three generic companies (Mylan, Ranbaxy, and Watson) gained a false, shared 180-day exclusivity to generic Actos entry,” said the response.

In March 2010, Takeda and the three companies allegedly struck a pact in which the generic defendants agreed to stay completely off the market for Actos for 18 months after February 2011.

The direct purchasers added: “In exchange, they agreed to arrangements to protect their undeserved 180-day exclusivity from another generic (Teva) and prolong by about one year the bottleneck to entry by other would-be generic Actos makers.”

Teva was accused of joining the anti-competitive actions in December 2010, allegedly agreeing to gain a share of the profits from the generics.

Today’s stories:

Advocacy groups file brief to support Boehringer

Court grants order to resolve Amgen v FDA dispute

Allergan sues Taro Pharmaceutical

UroPep seeks attorneys’ fees from Eli Lilly

Mallinckrodt sues generic company

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.