Teva faces fish oil patent complaint

Irish biopharmaceutical company Amarin has continued a patent battle over its fish oil product Vascepa (icosapent ethyl), with a lawsuit targeting Teva in Nevada.

In a complaint filed on October 11 at the US District Court for the District of Nevada, Amarin accused the Israel-based drug maker of infringing 12 of its patents.

Teva is seeking approval from the US Food and Drug Administration to market a generic version of Amarin’s pill, which is taken by people on diets to help reduce fats.

Teva submitted an Abbreviated New Drug Application (ANDA) in October last year, seeking to market a generic version of 1g icosapent ethyl capsules.

In August this year, it submitted an amendment to also cover 500mg capsules. Attached to the amendment was a paragraph IV certification highlighting the 12 patents and seeking approval to market the product before their expiry dates.

According to the complaint, if approved, the generic Vascepa will be administered to human patients as an “adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia”.

“This administration by, for example, physicians would constitute direct infringement, either literally or under the doctrine of equivalents, of one or more claims of the patents,” the complaint said.

It added: “Defendants’ manufacture, use, or sale in the US would actively induce and contribute to infringement of the patents. Plaintiffs will be irreparably harmed if defendants are not enjoined from infringing or actively inducing or contributing to infringement of the patents.”

On choosing Nevada as a venue, Amarin said Teva plans to sell the generic in the state and has a “continuous business presence” there, either directly or through subsidiaries and agents.

Amarin is seeking an order that no ANDA be approved until after its 12 patents have expired, as well as attorneys’ fees.

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