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5 December 2019Big PharmaSaman Javed

Takeda sues Mylan over gout generic

Takeda has sued Mylan for patent infringement and breach of a licencing agreement over Takeda’s Colcrys (colchicine) drug.

The complaint, filed December 2 at the US District for the District of Delaware, comes two years after Takeda previously sued Mylan for seeking approval from the Food and Drug Administration ( FDA) to market a colchicine generic.

The parties later entered into a licencing agreement, which Takeda claims Mylan has breached. The latest complaint is sealed to protect the terms of the confidential licencing agreement.

In October 2016, Takeda filed a patent infringement suit against Mylan. It argued that Mylan was seeking FDA approval for its generic prior to the expiration of 17 of Takeda's patents, which cover a method of using colchicine for treating and preventing both gout flares and Familial Mediterranean Fever (FMF).

FMF is a rare disease characterised by chronic inflammation.

In its complaint, Takeda said Mylan was seeking FDA approval for its generic solely for the treatment of FMF, and not for gout.

It said the National Institute of Health Office of Rare Diseases classifies FMF as a “rare disease” with fewer than 200,000 affected individuals in the US, and that Mylan intends to manufacture its generic version of Colcrys in quantities that “far exceed the available market for FMF treatment”.

Takeda said it believes that Mylan intends to market its version to healthcare practitioners for the treatment of gout.

“By the time a generic version of a branded drug becomes available, physicians typically have had years of experience prescribing the brand drug, and will follow the same prescribing practices for the generic version.

“Thus, physicians generally prescribe a generic drug for all of the approved indications associated with the branded drug whether or not that indication appears on the generic label,” the complaint said.

It said that even if Mylan’s generic label indicates that the drug is only approved for FMF, doctors will also prescribe it for gout.

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