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24 July 2015Americas

Watson sued over proposed hypertension generic

Biotechnology company United Therapeutics has sued Watson Laboratories claiming it has infringed three of its patents covering one of its hypertension treatment drugs.

United Therapeutics asserted three of its patents: US numbers 6,521,212, 6,756,033 and 8,497,393.

All of the patents cover its drug Tyvaso (treprostinil), an inhalation solution used to treat pulmonary arterial hypertension, a type of high blood pressure affecting the pulmonary arteries.

According to the complaint, filed at the US District Court for the District of New Jersey on July 22, Wednesday, Watson Laboratories submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) to market a generic version of the drug.

Based in Maryland, United Therapeutics focuses on the “development and commercialisation of unique products to address the unmet medical needs of patients”, according to its website. It currently has four approved products including Tyvaso.

Watson Laboratories, a subsidiary of Actavis (now known as Allergan), develops, manufactures and distributes generic and biosimilar products.

According to the complaint, Watson Laboratories notified United Therapeutics in a letter last month that it had filed ANDA at the FDA seeking approval to commercially “manufacture, market, use, and sell” generic copies of Tyvaso before the three patents had expired.

The ‘212 and ‘033 patents are both due to expire in 2018, while the ‘393 patent is set to expire in 2028.

Watson Laboratories’s letter, according to the complaint, included a statement claiming that the patents are not valid or enforceable and would not be infringed by the proposed generic.

But United Therapeutics denied the claims.

“The statement ... did not include anything beyond conclusory statements regarding alleged non-infringement. Watson provided no explanation as to the alleged unenforceability,” the company said in the complaint.

United Therapeutics is seeking a judgment that any FDA approval of the generic is not given until after the three patents have expired and requested damages.

Actavis declined to comment.