Orion sues Sun Pharmaceuticals over Stalevo patent

Orion has filed a patent infringement lawsuit in the US to enforce its formulation patent against Sun Pharmaceuticals.

The Orion Corporation has enforced US patent number 6,500,867 following the announcement by Sun Pharmaceuticals that it was to market generic versions of Stalevo tablets in the US.

Stalevo is an enhanced levodopa treatment developed by Orion and marketed by Novartis for the treatment of Parkinson’s disease in the US.

Both Orion and Novartis have declared that they will vigorously defend the intellectual property rights covering Stalevo.

Sun Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the US Food Drug Administration (FDA) in October.

The ANDA contained a Paragraph IV certification which challenged Orion’s formulation patents protecting Stalevo.

Orion, as a result of suing to enforce its patent within the 45 days period after receipt of the Paragraph IV certification, is now entitled to an automatic stay prohibiting the FDA from approving Sun Pharmaceutical’s ANDA for 30 months provided there is no adverse court decision.

Last month, Orion announced the retirement of its president and chief executive officer Jukka Viinanen, with his replacement Timo Lappalainen, expected to take up the new role at the start of 2008.