19 November 2013Americas

Cadence wins Ofirmev patent infringement case

Cadence Pharmaceuticals announced on November 14 that the US District Court for the District of Delaware ruled in its favour in its patent infringement suit against Exela Pharma Sciences LLC.

Cadence is a biopharmaceutical company that acquires, licenses, develops and commercialises drugs for use in hospitals.

Its Ofirmev (acetaminophen) injection product is used to treat mild to moderate pain and to manage moderate to severe pain with adjunctive opioid analgesics, and to reduce fever. It was approved by the US Food and Drug Administration (FDA) in 2010.

In 2011 Cadence and SCR Pharmatop, from whom Cadence licenses patents covering Ofirmev, sued Exela for infringing two patents covering the product. They are US 6,028,222, which expires in August 2017, and US 6,992,218, which expires in June 2021.

Exela filed an Abbreviated New Drug Application (ANDA) with the FDA in July 2011 seeking approval to commercially manufacture and sell an acetaminophen injection before the two patents expired.

The district court has now rejected Exela’s claims that the patents are invalid, also finding that Exela’s ANDA for a generic version of Ofirmev infringes both of the patents.

Ted Schroeder, president and chief executive officer of Cadence, said: “We are very pleased with the court’s decision, as it confirms our belief in the strength and validity of the patents covering Ofirmev.”

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