decade3d /
6 August 2014Americas

US District Court judge throws out Takeda’s case against Mylan

US District Court for the Northern District of California judge Lucy Koh has dismissed Japanese pharmaceutical company Takeda’s patent infringement case against generic maker Mylan concerning acid reflux drug Dexilant (dexlansoprazole).

Takeda filed the case after Mylan sent an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to make and sell a generic version of Dexilant. It pleaded two counts: the first for infringement under the Hatch-Waxman Act, and the second for a declaratory judgment of infringement.

It asserted its US patent 7,339,064, which covers Dexilant’s active ingredient in crystalline forms.

Mylan moved to dismiss the second count for lack of subject matter jurisdiction, or to terminate the 30 month stay against FDA approval of the ANDA that would be triggered by Takeda’s assertion of the patent.

It argued that there can be no immediate controversy, as the FDA’s stay would last until January 2016, a trial would take place in November 2015, the FDA has not approved its ANDA, and it has not declared its intent to launch a Dexilant generic.

It added that Takeda’s second count contains “few facts”, reciting only the “bare allegation” that Mylan is preparing to make and sell its generic product before the ‘064 patent expires.

In the August 1 judgment, Judge Koh said that exercising jurisdiction over the second count “serves no useful purpose and will not resolve any issues that adjudication of Count I will not also resolve”.

She added: “Permitting Takeda to proceed on Count II appears unnecessary in light of (if not contrary to) the Hatch-Waxman Act.”

Koh granted Mylan’s motion to dismiss the case, and the second count of Takeda’s complaint without prejudice.

In the 12 months up to March 31, 2014, Dexilant generated sales of 50.3 billion yen ($490 million) outside Japan.

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