Takeda, along with four other generic drug producers, is looking to dismiss antitrust claims in federal court. This month, generic pharma attorneys for the generic drug manufacturers argued in New York federal court that the suit based on the diabetes drug Actos should be tossed. The direct purchasers, and plaintiffs in the case, allege that Takeda told the FDA that US patents 5,965,584 and 6,329,404 covered Actos ingredients instead of methods of using the drug. The plaintiffs allege that this misrepresentation began a six month period of exclusivity for the three companies who first sought FDA approval for generic verisons of the drug.
Originally, the direct purchasers had argued that Takeda had entered into an illegal reverse payment scheme with the generic pharma companies in order to keep copycat versions of Actos off of the market. But now the defendants claim that the pay-for-delay allegations are off the table and were rejected in the end payor case.
The recent amendments to the case focus entirely on Takeda’s listings of the 584 and 404 patents, which were due to expire in June of 2016. Takeda claims that all of its patent listings were correct and that all claims against the company should be dismissed. Takeda has maintained that the plaintiffs have not shown that the company acted in bad faith or used fraudulent methods. Takeda is asking the court not to allow direct buyers to amend their claims if they are dismissed.
Takeda released a statement on the case. “Plaintiffs filed this case more than two years ago, after having benefit of the three complaints, hundreds of pages of motion-to-dismiss briefing and oral argument in the end payor case,” the company said. “Before filing their current complaint, moreover, they had the benefit of this court’s and the Second Circuit’s decisions in the end payor case, as well as copies of the confidential settlement agreements. Enough is enough. Dismissal should be with prejudice.”
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