31 May 2013Americas

Takeda sues generics over heartburn drug

Japanese pharma company Takeda has sued generic drug-makers Impax and Sandoz for allegedly infringing a patent directed to its anti-heartburn drug Dexilant.

The separate lawsuits, filed in the US District Court for the Northern District of California, come after the companies filed Abbreviated New Drug Applications (ANDA) to market generic versions of Dexilant.

Dexilant, which was approved by the US Food and Drug Administration (FDA) in 2009, is sold in 30mg and 60mg dosages. It treats gastroesophageal reflux disease, a major symptom of which is heartburn, releasing medicine in two different stages.

Takeda’s cited patent protects “methods of treating gastrointestinal disorders independent of the intake of food”, and expires in 2028.

The Japanese company, one of the world’s leading pharma companies, hasn’t requested a jury, which is available in ANDA litigation. This may show that it feels a court can deal with the case more efficiently on its own, said Kevin Noonan, partner at McDonnell, Boehnen, Hulbert & Berghoff LLP.

Noonan said the FDA will have to delay the generic companies’ ANDA requests for at least 30 months – known as the 30-month stay – while the litigation continues.

He noted that Impax and Sandoz are trying to invalidate Takeda’s patent, and will probably use prior art arguments.

“Generics have to show clear and convincing evidence that the patent is invalid, which is a higher burden than proving non-infringement,” Noonan said.

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