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Mundipharma Defeats Australia Early Generic OxyContin Bid

Mundipharma Pty defeated a bid for the early introduction of a generic version of the pain medication OxyContin in Australia, where it has the rights to sell the drug.

Australia Federal Court Justice Steven Rares upheld the Commissioner of Patent’s decision in 2000 to extend Mundipharma’s OxyContin patent to July 23, 2014. He rejected a claim by Spirit Pharmaceuticals Pty, a maker of generic drugs, that the extension was invalid.

Spirit had argued that OxyContin isn’t a “pharmaceutical substance per se,” with the patent only referring to the drug’s active ingredient, oxycodone, making the extension invalid, according to the July 5 ruling. Spirit also argued that the application for the extension was invalid because Euro-Celtique SA, a company related to Mundipharma, was granted the extension in 2000 even though it had assigned the patent to Mundipharma Medical GmbH a year earlier.

Rares dismissed both challenges, ruling OxyContin is a pharmaceutical substance which relies on a mixture of dosages of oxycodone. The judge also said that while Mundipharma Medical had been assigned the patent, Euro-Celtique remained registered as the patentee for the drug until 2005, with the companies apparently having forgotten about the 1999 assignment.

Purdue Pharma LP, the Stamford, Connecticut-based drugmaker which granted the OxyContin rights to Mundipharma, in April agreed to allow Actavis Inc. to sell a generic of the drug in the U.S. as early as the start of next year.

The case is Spirit Pharmaceuticals Pty v Mundipharma Pty. NSD721/2010 and NSD1054/2010. Federal Court of Australia (Sydney).

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