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15 August 2016Americas

Dexcel seeks non-infringement ruling against Takeda’s patents

Dexcel Pharma, an Israel-based company, has sought a declaration of non-infringement against four Takeda patents.

The patents involved in the case are US numbers 6,328,994; 7,431,942; 7,875,292; and 7,399,485, and the case was filed at the US District Court for the District of New Jersey on Friday, August 12.

The case arose after Dexcel received a letter from the Food and Drug Administration (FDA) granting approval of a New Drug Application (NDA) on June 7.

Dexcel’s NDA covered lansoprazole delayed-release orally disintegrating tablets. The drug is due to launch at the beginning of 2017. Takeda’s patents are directed to lansoprazole.

Shortly after the FDA’s approval, Takeda requested information concerning the FDA approval for the Dexcel NDA.

Takeda also sought information about the formulation of Dexcel’s NDA product and an explanation of why Dexcel believes that its product does not infringe Takeda’s patents.

After Dexcel had corresponded with Takeda regarding the patents and its NDA drug, Takeda disagreed with its non-infringement claims, but was willing to negotiate “in the hope of avoiding patent litigation, if possible”.

This was followed by further correspondence, which resulted with Takeda allegedly not responding to Dexcel, hence the filing of the declaration of non-infringement against the Takeda patents.

According to the court document, there is a strong likelihood that Takeda will seek to disrupt Dexcel’s planned launch through a preliminary injunction.

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