3 October 2014Americas

Supernus hits Actavis with patent infringement claim

US-based specialty drugs company Supernus Pharmaceuticals has sued generics maker Actavis, accusing it of infringing three patents related to an antiepileptic drug.

The complaint, filed at the US District Court for the District of New Jersey, centres on Supernus’s Trokendi  XR (extended-release topiramate) drug.

Supernus said the lawsuit was sparked by Actavis’s submission to the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of the drug.

The application, Supernus claimed, would infringe three of its patents: US numbers 8,298,576, 8,298,580, and 8,663,683.

Dublin-based Actavis filed a paragraph IV certification at the FDA claiming that its generic product would not infringe the patents.

When a generic company files an ANDA with a paragraph IV certification, the branded company is notified and has 45 days in which to file a patent infringement action.

Once a lawsuit has been filed, the FDA cannot approve the application until the generic company has successfully defended the suit or until 30 months, whichever comes first.

In a statement, Jack Khattar, president of Supernus, said it intends to “vigorously enforce its patent rights."

Supernus, based in Maryland, focuses on developing and commercialising products for the treatment of the central nervous system. It has two marketed products for epilepsy: Oxtellar XR (extended-release oxcarbazepine) and Trokendi XR.

It has asked the court to issue a permanent injunction against Actavis and its subsidiaries, preventing them from marketing a generic until after the three patents have expired in 2029.

It is also seeking damages and attorneys’ fees.

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